>> GOOD MORNING, EVERYONE, I'M ALAN GUTTMACHER DIRECTOR EUNICE KENNEDY SHRIVER OF NATIONAL CHILD HEALTH AND HUMAN DEVELOPMENT WELCOME TO THIS CONFERENCE. GOOD TO SEE Y'ALL HERE AND ALSO THE FOLKS THAT ARE TUNED IN VIA THE WEBCAST. GLAD TO KNOW YOU'RE OUT THERE AS WELL. WHENEVER WE HAVE THESE KINDS OF CONSENSUS CONFERENCES, IT'S GREAT TO SEE EVERYONE HERE, PARTICULARLY GOOD TODAY, MANY OF YOU MAY NOT KNOW THIS, THERE WERE DISCUSSIONS WHETHER WE NEED TO CANCEL THIS CONFERENCE. WE AT THE NIH HAVE BEEN CANCELING MANY MARCH CONFERENCES BECAUSE OF SEQUESTER HAS OCCURRED. SO MANY MAYBE GETTING NOTICES ABOUT OTHER NIH CONFERENCES WE WILL NOT BE ABLE TO HAVE THIS MONTH BECAUSE OF THE SEQUESTER. FOR VARIOUS REASONS WE WERE ABLE TO HOLD THIS ONE AS SCHEDULED. I'M VERY GLAD YOU'RE HERE. OF COURSE THIS IS A VERY IMPORTANT TOP, GESTATIONAL DIABETES MELLITUS, I DON'T HAVE TO TELL THIS GROUP IS NOT ONLY ONE OF THE MOST COMMON DISORDERS AFFECTING 7% OF U.S. PREGNANCIES BUT HAS IMPORTANT IMPACT FOR PREGNANT WOMAN AND FETUS AND IMPACT NOT JUST DURING PREGNANCY BUT IN TERMS OF LIFE LONG HEALTH. ONE MEASURE OF THE IMPORTANCE OF THIS IS CURRENT ESTIMATES OF TREATMENT FOR GDM ARE GREATER THAN $600 ANNUALLY. 6 PUN FIELDS FALL -- $600 MILLION ANNUALLY. THAT WOULD BE GREAT TO GET THAT DOWN TO $600 IF YOU COULD, THAT WOULD HELP OUR BUDGET. THERE'S A NUMBER OF CONTROVERSIES ABOUT CLINICAL PRACTICE AND GDM. TODAY'S MEETING WILL FOCUS ON WHAT IS MANY WAYS KEY TO ALL OF THEM AND THAT IS QUESTION OF DIAGNOSIS. USING THE MOST CURRENT INFORMATION AND SCIENTIFIC EVIDENCE AVAILABLE THE PANEL WILL PROVIDE CONSENSUS, APPROPRIATE DIAGNOSTIC METHODS FOR GDM. WHAT'S THE OUTCOME WE'LL SEE FROM THIS, IT'S IMPORTANT ASSISTANCE FOR PRACTITIONERS, BUT ALSO FOR PATIENTS, RESEARCH COMMUNITY, THROW THAT BETTER HEALTH FOR WOMEN AND LATER MANY LIFE AND CHILDREN LATER IN LIFE. THERE ARE PEOPLE TO PATIENT FOR MAKING THIS CONFERENCE HAPPEN. FIRST FIRST TO THE PANEL WHO HAVE SPENT COUNTLESS HOURS OF TIME WORKING WITH KEY QUESTIONS, REVIEWING FINDINGS FROM THE AHRQ REVIEW. THE SPEAKER WHOSE ARE TRULY EXPERTS IN THIS AREA FOR THEIR PREPARATION SAYING FOR WHAT I'M SURE WILL BE A LIVELY THREE DAYS OF DISCUSSION. NIH OFFICE OF DISEASE PREVENTION WHICH PROVIDES CRITICAL LEADERSHIP FOR NIH CONSENSUS DEVELOPMENT CONFERENCES, SPECIFICALLY FOR THIS CONFERENCE, DR. SUSANNA OCALA AND HER TEAM WORK FOR MARVELOUS WORK PUTTING THIS TOGETHER. AND THERE'S COLLABORATORS ON THESE SERVICES, HRSA CDC, AHRQ, THE OFFICE OF WOMEN RESEARCH AND HEALTH, NATIONAL INSTITUTE OF DIABETES, DIGESTIVE KIDNEY DISEASES AN NATIONAL INSTITUTE OF NURSING RESEARCH. I ALSO LIKE TO THANK THE NICHD STAFF INVOLVED IN THIS, GILL MA'AM GRAVE, KATHERINE SPONG, WHO BROUGHT THIS FORWARD IN A COUPLE OF WAYS. THEY HAVE THEIR COME PATE TREE I DON'T THINKS ACROSS THE NIH THAT PROVIDE SO MUCH ACROSS RESEARCH TO PROVIDE EVIDENCE FOR WHICH THIS CONFERENCE RESTS. AND BY ALSO WORKING WITH OTHER NIH STAFF IN TERMS OF PLANNING AND LOGISTICS FOR THIS MEETING ITSELF. FINALLY, THANKS TO ALL OF YOU WHO ARE HERE FOR BRINGING OVER MANY, MANY YEARS CRITICAL INSIGHTS TO THIS TOPIC, TO THE ATTENTION YOU'RE PAYING AT THIS CONFERENCE TO THE HELP I KNOW YOU WILL BE IN TERMS OF IMPLEMENTING THE CONSENSUS, THAT COMES OUT OF THIS CONFERENCE AND MAKING IT MORE THAN SIMPLY A CONFERENCE STATEMENT BUT SOMETHING THAT DOES TO NIH CONSENSUS CONFERENCES HAVE A TRUE IMPACT ON THE WAY WE CONDUCT RESEARCH AND VERY IMPORTANTLY ON THE WAY WE PROVIDE HEALTHCARE AND THEREFORE PEOPLE'S HEALTH NOT JUST ACROSS THE U.S. BUT GLOBALLY. SO NOW I'M VERY HAPPY TO TURN THIS TO DAVID MURRAY, NIH ASSOCIATE DIRECTOR OF PREVENTION AND NIH OFFICE OF DISEASE PREVENTION TO ISSUE THE CHARGE. DAVID. [APPLAUSE] >> SO I WANTD THE TO START BY PUTTING THIS IN CONTEXT. THESE ARE DEFINITIONS OF DECISION MAKING FROM LEON GORDESS. WHO OFFEREDDED THIS HELP US THINK ABOUT CONSENSUS CONFERENCE AFTER ATTENDING ONE FEW YEARS AGO AND HE TALKS ABOUT THREE LEVELS OF DECISION MAKING. FIRST LEVEL IS WHICH YOU HAVE THIS DONE FOR YOURSELF OR SOMEONE ELSE IN YOUR FAMILY. THIS KIND OF DECISION MAKING DOESN'T AFFECT MANY PEOPLE, IT AFFECTS YOU OR YOUR IMMEDIATE FAMILY PERHAPS. SO A FAIRLY LOW LEVEL. INTERMEDIATE LEVEL WHAT WOULD I RECOMMEND FOR MY PATIENT OR MY CLIENT? THIS IS A HEALTH PROFESSIONAL, PERHAPS A PHYSICIAN, MAKING RECOMMENDATIONS FOR HIS OR HER PATIENTS AND CERTAINLY COULD AFFECT MANY MORE SCORES OF L. WE HAVE A -- PEOPLE. WE HAVE A THIRD LEVEL, WHAT DO I RECOMMEND TO THE NATION TO THE WORLD, THESE RECOMMENDATIONS AFFECT THE ENTIRE POPULATION, THEY AFFECT HUNDREDS OF THOUSANDS, EVEN MILLIONS OF PEOPLE, THIS IS THE LEVEL OF DECISION MAKING WE ARE ENGAGED IN TODAY. THE PANELS STATEMENT, WE WILL SEE IN A COUPLE OF DAYS ARE BASED ON THREE PRINCIPLE SOURCES. THERE'S PUBLIC INPUT FROM ADVOCATES, RESEARCHERS, HEALTH PROFESSIONALS, PATIENTS AND FAMILY MEMBERS, PROFESSIONAL SOCIETIES AND OTHERS. WE HAVE THE EVIDENCE REVIEW THEY HAVE HAD FOR SOME TIME NOW PREPARED BY THE UNIVERSITY OF ALBERTA EVIDENCE BASED PRACTICE CENTER. THESE EVIDENCE BASED REVIEWS ARE PREPARED BY THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY. OUR SISTER AGENCY AHRQ. FINALLY, THE PANEL WILL HEAR EXPERTS TODAY AND TOMORROW PRESENTING TESTIMONY AND THOSE WILL TAKE THE BETTER PART OF TWO DAYS. WHAT MAKES A CONSENSUS CONFERENCE HERE AT NIH DIFFERENT FROM CONFERENCES THAT WE SEE AT OTHER -- AT OTHER LOCATION, OFFERED BY OTHER GROUPS. WE HAVE CONTENT EXPERTS AS OTHER MEETINGS HAVE SPEAKERS PLANNERS THESE PRESENTERS MAY HAVE CONFLICTS OF INTEREST, THAT'S COMMONLY THE CASE PROFESSIONAL MEETINGS. THEY'RE SUPPOSED TO REGISTER THOSE IN THE HANDBOOK Y'ALL HAVE THE PURPLE BOOK THAT YOU HAVE A COPY OF. WHAT DISTINGUISHES THIS GROUP IS THE PANELISTS INCLUDING THE CHAIR, OF THE PANEL MEMBERS INDEPENDENT OF NIH, NOT ADVISORY TO NIH AND MAY NOT HAVE CONFLICTS OF INTEREST. THERE'S A CAREFUL VETTING PROCESS SUSANNA OCALA AND STAFF MEMBERS GO THROUGH TO MAKE SURE PANEL MEMBERS ARE FREE OF CONFLICT OF INTEREST. TO HIRE NOT ADVOCATES OF OOH PARTICULAR POSITION, NO FINANCIAL INTEREST IN ANY OUT I DON'T MEANS. -- OUTCOMES. WE HAVE 16 MEMBERS. THEY'RE MULTI-DISCIPLINARY FROM A VARIETY OF FIELDS. PETER VAN DORSEN IS PANEL CHAIR, MEMBER OF THE PLANNING COMMITTEE AND PARTICIPATED IN PART OF THE WORK OF THE EVIDENCE REVIEW PANEL. REMAINING PANEL MEMBERS WILL INTRODUCE THEMSELVES IN A FEW MINUTES. THE TIME LINE FOR THIS CONFERENCE. IT ALWAYS STARTS WITH ONE OF THE INSTITUTES OR CENTERS PROPOSING A CONFERENCE TOPIC. ONCE THE TOPIC IS SELECTED FOR CONSENSUS CONFERENCE WE HAVE AN ORGANIZATIONAL MEETING WITH PARTNERS AROUND THE FEDERAL GOVERNMENT INTERESTED IN TOPICS. A PLANNING COMMITTEE IS ORGANIZED MEETS WITH EXPERTS WITHIN AND WITHOUT NIH TO DEVELOP THE PLAN FOR THE MEETING. THEN THERE IS A PAUSE, THEY PREPARE THE EVIDENCE BASED REVIEW AND IN GENERAL MOVE STRAIGHT TO THE CONFERENCE. THIS ONE WAS A LITTLE BIT DIFFERENT. THOSE THAT PLANNED AS I HAD IN LATE OCTOBER TO ATTEND THE CONSENSUS CONFERENCE OF GUESS STATIONAL DIABETES, WE WERE INTERRUPTED BY HURRICANE SANDY ROLLING THROUGH THE EAST COAST BUT WE ADDED THAT TO THIS PARTICULAR SLIDE ON OUR TIME LINE. SO WE HAVE BEEN A LITTLE BIT DELAY. BUT WE'RE NOW READY TO ACTUALLY HOLD THE CONFERENCE THE CONFERENCE IS BEING WEBCAST LIVE. SO EVERYTHING THAT YOU SEE THAT IS SAID HERE IS AVAILABLE ONLINE. WE'LL HAVE A DAY AND A HALF OF PRESENTATIONS BY EXPERTS. THIS WILL BE QUITE A BIT OF DISCUSSION RELATIVE TO THE PRESENTATIONS AND DURING THE DISCUSSION THE PANEL GETS FIRST SHOT AT ASKING QUESTIONS. THEN ONCE THEY HAVE EXHAUSTED THEIR QUESTIONS THE MICROPHONES ARE OPEN TO THE PUBLIC, ANYONE IN THE AUDIENCE WHO WANTS TO ASK. THERE ARE COMPUTERS LOCATED OUTSIDE THE MAIN AUDITORIUM, IF YOU HAVE QUESTIONS APPROXIMATE WE DON'T HAVE TIME TO E GET TO THEM DURING THIS SESSION. WE HAVE AN AMBITIOUS AGENDA. ALL DAY TODAY THERE WILL BE SPEAKER PRESENTATIONS AND PUBLIC INPUT. THEN THE PANEL DISN'T GET TO TAKE IT EASY THIS EVENING, THEY'RE WORKING, SYNTHESIZING WHAT I HAVE THEY HAVE HEARD. WE'LL DO IT AGAIN TOMORROW WITH WITH PRESENTATIONS TOMORROW MORNING. THE PANEL WILL WORK TOMORROW AFTERNOON TO DRAFT A PRELIMINARY STATEMENT AND THEN PRESENT THAT STATEMENT HERE TO THE AUDIENCE ON WEDNESDAY MORNING. FOLLOWING THAT INITIAL PRESENTATION WE'LL HAVE MORE PUBLIC INPUT AND COMMENT. THEN THE PUBLIC COMMENT SESSION WILL CLOSE AND THE PANEL WILL CONSIDER THE ADDITIONAL COMMENTS THEY HAVE HEARD MAKING ANY REVISIONS TO THE STATEMENT THAT THEY THINK ARE APPROPRIATE. AND THEN WEDNESDAY AFTERNOON AT 2 O'CLOCK WE'LL READ THE FINAL STATEMENT AT A PRESS CONFERENCE AND THE STATEMENT WILL BE POSTED ON OUR WEBSITE WEDNESDAY EVENING. YOU HAVE INFORMATION ABOUT CONTINUING EDUCATION CREDITS IN YOUR PROGRAM SO I JUST REFER YOU TO THAT. THE SPEAKERS HAVE BEEN ASKED TO DISCLOSE ANY FINANCIAL CONFLICTS IN THE PROGRAM, THAT SHOULD BE THERE. PANELISTS SHOULD BE FREE FROM CONFLICTS AS NOTED BEFORE. WE HAVE A LOT OF PEOPLE TO THANK FOR ORGANIZING THIS MEETING.9SÖoœ KATHERINE SPONG FROM NICHD, J. PETER VAN DORSEN, PANEL CHAIR. MEMBERS OF THE NIH COMMUNITY AN FRIENDS FROM OTHER GROUPS AS WELL WHO HELPED ORGANIZE THIS MEETING. WE ALSO WANT TO THANK OUR COLLEAGUES, DR. GUTTMACHER AND DR. MADDOX AND DR. SPONG AT NICHD, SUSANNA OCLAF FROM MY STAFF. WE HAD A NUMBER OF PARTNER GROUPS CO-SPONSORING NATIONAL INSTITUTE ON NURSING RESEARCH OFFICE OF RESEARCH ON WOMEN'S HEALTH AND CENTERS FOR DISEASE PREVENTION, CONTROL AND PREVENTION AND HEALTH RESOURCES AND SERVICES ADMINISTRATION. DR. (INDISCERNIBLE) OF THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, THE CENTERS FOR DISEASE CONTROL PREVENTION HELPED WITH WITH CONTINUING EDUCATION PARTNERSHIP, IQ SOLUTIONS IS OUR CONTRACTOR THAT MAKES THE LOGISTICAL ARRANGEMENTS AND WE WANT TO THANK ALL THE SPEAKERS WHO TRAVELED HERE AND ESPECIALLY THE PANEL AND OUR PANEL CHAIR FOR THE HARD WORK THEY HAVE DONE. SO PLEASE WELCOME,LOOK FORWARD TO A PRODUCTIVE COUPLE OF DAYS AN VERY MUCH LOOK FORWARD TO SEEING THE CONFERENCE REPORT ON WEDNESDAY. THANK YOU. [APPLAUSE] >> THANK YOU DR.S GUTTMACHER AND MURRAY. THANK YOU FOR LETTING THE CONSENSUS CONFERENCE PROCEED. WE FIGURED THERE MIGHT BE SOME ISSUES AFTER THE SEQUESTER. WE GOT DERAILED BACK IN OCTOBER, THANKS, EVERYONE FOR MAKING THESE ALTERNATIVE PLANS. I'M DR. PETER VAN DORST,N. I WAS CHAIRMAN OF THE MEDICAL DEPARTMENT UNIVERSITY OF SOUTH CAROLINA IN CHARLESTON. I STEPPED DOWN AS CHAIR IN JUNE. I'M A MATERNAL FETAL MEDICINE DOCTOR IN THE DEPARTMENT, I SEE PATIENTS AND THOROUGHLY ENJOYED SHEDDING THE ADMINISTRATIVE RESPONSIBILITY. ALSO HAD THE VERY ENVIABLE JOB BEING CHAIR OF THE STEERING COMMITTEE FOR THE MATERNAL FETAL MEDICINE UNITS NETWORK AT THE NICHD. I WOULD LIKE TO BEGIN WITH A SPECIAL THANKS TO MEMBERS OF THE PANEL AND OUR SPEAKERS ALL WHOM ARE CONTRIBUTING THEIR TIME, THEIR INTELLECT AND EXPERIENCE TO THIS CONFERENCE, I'M ALSO GRATEFUL TO MEMBERS OF THE PLANNING COMMITTEE TO SUSAN OCOLA, OFFICE OF DISEASE PREVENTION WHO IS CAREFUL IN PATIENT STEWARDSHIP, HAS KEPT US ON TASK AND WELL INFORMED. LISA GEORGE GEORGERI FROM IQ SOLUTIONS TO MADE THE TRAVEL ARRANGEMENTS AN GETS US TO THE RIGHT PLACE AT THE SAME TIME. A LOT OF OTHERS PUT IN EFFORT TO MAKE THIS CONSENSUS CONFERENCE SUCCESSFUL. WE HOPE THAT THESE PROCEEDINGS AND FINAL REPORT WILL PROVIDE GUIDANCE FOR HEALTHCARE PROVIDERS. AND BENEFIT OUR PATIENTS. FINALLY THANKS TO ALL OF YOU FOR ATTENDING AND CONTRIBUTING TO THE DIALOGUE OF THE NEXT SEVERAL DAYS. DURING THE COURSE OF THIS CONFERENCE WE'LL EXPLORE THE CURRENT SCIENTIFIC KNOWLEDGE RELATING TO THE DIAGNOSIS OF GESTATIONAL DIABETES. WE WILL HEAR EXPERT OPINIONS RELATED TO THIS IMPORTANT ISSUE FOR WOMEN AND THEIR BABIES. THE FORMAT OF THIS CONFERENCE WILL ENCOURAGE AUDIENCE PARTICIPATION, IT WILL BE THE CHALLENGE FOR THE PANEL MEMBERS TO WEIGH QUALITY OF EVIDENCE PRESENTED AND DEVELOP SUMMARY RECOMMENDATIONS. THE PANEL WILL DRAFT A STATEMENT ADDRESSING THE FOLLOWING KEY QUESTIONS WHICH WE DEVELOP NOW ALMOST TWO YEARS AGO AT OUR PLANNING’}Q‡cu„ NUMBER ONE, WHAT ARE CURRENT SCREENING AND DIAGNOSTIC APPROACHES FOR GESTATIONAL DIABETES AND WHAT ARE THE GLYCEMIC THRESHOLDS FOR EACH APPROACH. HOW WERE THE THRESHOLDS CHOSEN. WHAT THE AFFECTS OF GESTATIONAL DIABETES SCREENING AND DIAGNOSTIC APPROACHES FOR PATIENTS, PROVIDERS, AND U.S. HEALTHCARE SYSTEMS. NUMBER 3, IN THE ABSENCE OF TREATMENT, HOW DO HEALTH OUTCOMES OF MOTHERS WHO MEET VARIOUS CRITERIA FOR GESTATIONAL DIABETES AND OFFSPRING COMPARE WITH THOSE WHO DO NOT. NUMBER FOUR, DOES TREATMENT MODIFY THE HEALTH OUTCOMES OF MOTHERS WHO MEET VARIOUS CRITERIA FOR GESTATIONAL DIABETES THE AND OFFSPRING? FIVE, WHAT ARE HARMS OF GESTATIONAL DIABETES AND DO THEY VARY BY DIAGNOSTIC APPROACH? NUMBER 6, GIVEN THE ABOVE WHAT DIAGNOSTIC APPROACHER APPROACHES FOR GESTATIONAL DIABETES SHOULD BE RECOMMENDED IF ANY? FINAL L NUMBER 7, WHAT ARE THE KEY RESEARCH GAPS IN THE DIAGNOSTIC APPROACH OF GESTATIONAL DIABETES MELLITUS? ON WEDNESDAY THE FINAL DAY OF THE CONFERENCE, WE WILL READ THE PANEL DRAFT STATEMENT AND INVITE COMMENTS AND QUESTIONS. THE ENTIRE PANEL WILL BE ON STAGE AT THAT TIME TO RESPOND TO COMMENTS AND QUESTIONS THAT ARISE. WE WILL REQUEST COMMENTS FROM THE AUDIENCE QUESTION BY QUESTION AS I HAVE JUST OUTLINED AS PREVIOUSLY MENTIONED THE STATEMENT WILL REPRESENT OUR VIEWS AS INDEPENDENT PANEL AN NOT AN OFFICIAL POSITION OF THE NIH OR FEDERAL GOVERNMENT. AND PANEL NOT ADVISORY BODY TO THE NIH. I WANT TO TAKE A FEW MOMENTS TO OUTLINE THE CONFERENCE PROCESS THE SPEAKERS FOR EACH SESSION WILL PRESENT THEIR DATA AND SEQUENCE NOTED IN THE AGENDA BOOK, QUESTIONS AN DISCUSSION WILL BE RESERVED UNTIL THE SPEAKERS FOR A GIVEN SESSION HAVE FINISHED THEIR PRESENTATIONS. FOLLOWING EACH SET OF PRESENTATIONS, THE SPEAKERS WILL ASSEMBLE ON STAGE, THE PANEL AND MEMBERS OF AUDIENCE WILL HAVE AN OPPORTUNITY TO ASK QUESTIONS. GIVEN THE LARGE AMOUNT OF MATERIAL THAT MUST BE COVERED I ASK THE SPEAKERS PLEASE KEEP THEIR REMARKS WITHIN THE ALLOTTED TIME, THERE WILL BE LIGHT SYSTEM TO GIVE A THREE MINUTE WARNING AND THEN A RED LIGHT WHEN YOUR TIME HAS ENDED. FOR THE AUDIENCE, THERE ARE MICROPHONES THAT ARE SET UP IN THE AISLES, BEFORE MAKING COMMENTS PLEASE IDENTIFY YOURSELF AND YOUR INSTITUTION. IF DUE TO TIME CONSTRAINTS YOU'RE UNABLE TO GET TO THE MICROPHONE WE ENCOURAGE YOUR COMMENTS IN WRITING ON LAPTOPS WHICH ARE SET UP OUTSIDE THE CONFERENCE HALL, AND THEY'LL BE DISTRIBUTED FOR THE PANEL REVIEW. NOW I WOULD LIKE TO INTRODUCE OUR ESTEEMED PANEL AND LIKE THEM TO TELL THE US WHO THEY ARE, WHERE THEY'RE FROM AND IN GENERAL THEIR AREA OF EXPERTISE. >> MY NAME IS WILLIAM DODD SON, I'M THE VISION DIRECTOR FOR END COUNTRY NOL AND INFERTILITY COLLEGE OF MEDICINE PENN STATE UNIVERSITY. >> >> I'M MARK (INDISCERNIBLE) DEPARTMENT OF BIOSTATISTICAL SCIENCES AT WAKE FOREST SCHOOL OF MEDICINE, CLINICAL TRIALIST, STATISTICIAN AND EPIDEMIOLOGIST. >> I'M BILL GROVEMAN PROFESSOR OF MA TERM FETAL MEDICINE NORTHWESTERN UNIVERSITY, CHICAGO. >> (INDISCERNIBLE) I'M PROFESSOR IN THE DEPARTMENTS OF OBGYN PUBLIC HEALTH AND MEDICAL INFORMATICS OHIO HEALTH AND SCIENCE UNIVERSITY. >> I'M BRIAN MERCER, I'M A PROFESSOR OF REPRODUCTIVE BIOLOGY CASE WESTERN RESERVE UNIVERSITY AND CHAIRMAN OF OBSTETRICS AN GYNECOLOGY IN MEDICAL HEALTH CENTER IN CLEVELAND. >> I'M HOWARD MINCOFF PROFESSOR OF OBSTETRICS AND GYNECOLOGY AT (INDISCERNIBLE) MEDICAL CENTER. >> BRENDA POINDEXTER, PROFESSOR PEDIATRICS INDIANA UNIVERSITY AND NEONAY TOLL GIST AT RILEY HOSPITAL FOR CHILDREN. >> I'M LOUISE PROFESSOR FROM THE UNIVERSITY OF MICHIGAN, EVALUATING THE EFFECTIVENESS OF CHILDHOOD HEALTH INTERVENTIONS. >> I'M GEORGE (INDISCERNIBLE) PROFESSOR OF OBSTETRICS GYNECOLOGY AND REPRODUCTIVE SCIENCES, BIOSTATISTICS AT UNIVERSITY OF CALIFORNIA SAN FRANCISCO. >> I'M JIM SCOTT, PROFESSOR AND FORMER CHAIR OF DEPARTMENT OF OBSTETRICS AND GYNECOLOGY, UNIVERSITY OF UTAH, ALSO EDITOR OF OBSTETRICS AN GYNECOLOGY ALSO KNOWN AS RANGER. >> BOB SILVER, I'M A MATERNAL FETAL MEDICINE DOC, UNIVERSITY OF UTAH. >> LISA SMITH, VOLUNTEER AT THE AMERICAN DIABETES ASSOCIATION P IN SHUL TA, OKLAHOMA. >> I'M ALICE THOMAS, PERINATAL NUTRITION CONSULTANT AT ST. YOU RECEIVES MEDICAL CENTER, PATTERSON, NEW JERSEY. >> I'M ALAN AT A TIMER, I'M MSM CLINICIAN AS WELL AS RESEARCHER AND PERINATAL EPIDEMIOLOGIST AT THE UNIVERSITY OF ALABAMA BIRMINGHAM. >> OKAY. THANKS TO PANELISTS, I THINK YOU'LL AGREE WE HAVE A WIDE RANGE OF EXPERTISE AND I LOOK FORWARD TO WORKING WITH ALL OF THEM OVER THE NEXT SEVERAL DAYS. PANELISTS IF YOU WILL TAKE YOUR SEATS IN THE FRONT CENTER AISLES. WE HAVE GOT A FULL AGENDA SO LET'S GET STARTED. THE FIRST SPEAKER THIS MORNING WILL GIVE US AN OVERVIEW ON THE SUBJECT OF GESTATIONAL DIABETES. IT WILL BE PRESENTED BY MY CLOSE FRIEND AND COLLEAGUE, DR. CATHERINE SPONG, RECENTLY ASSOCIATE DIRECTOR OF EXTRAMURAL PROGRAMS AT THE EUNICE KENNEDY SHRIVER N ICHD. CATHY. >> THANK YOU SO MUCH, DR. VAN DORS THETEN. I WANT TO WELCOME Y'ALL TO THIS CONSENSUS CONFERENCE ON DIAGNOSING GESTATION MELLITUS. IT'S BEEN A LONG TIME COMING AND THRILLED TO HAVE IT HAPPENING TODAY. WHAT I WOULD LIKE TO DO OVER SEVERAL MINUTES IS GIVE AN OVERVIEW OF THE PROBLEM. DIABETES AND EXPLAIN HOW WE GOT HERE, WHY WE HAVE A CONSENSUS CONFERENCE ON THE TOPIC OF DIAGNOSING GESTATIONAL DIABETES. GESTATIONAL DIABETES IS DEFINED AS A CARBOHYDRATE INTOLERANCE WITH ONSET OR IDENTIFICATION OCCURRING DURING PREGNANCY, HENCE THE NAME GESTATIONAL. VERY COMMON COMPLICATION IN PREGNANCY. IN THE UNITED STATES USING THE CURRENT DIAGNOSTIC CRITERIA, ESTIMATED TO AFFECT 7% OF ALL PREGNANCIES AND WITH THE ENHANCED SURVEILLANCE AND ENHANCED MEDICAL INTERVENTIONS ASSOCIATED WITH THE DIAGNOSIS OF GESTATIONAL DIABETES, IT'S ESTIMATED TO HAVE AN ECONOMIC BURDEN OF ABOUT $636 MILLION ANNUALLY. AGAIN, USING THE CURRENT DIAGNOSIS. DIAGNOSTIC CRITERIA. THE DIAGNOSIS OF GDM, THAT CRITERIA WAS ESTABLISHED 30 TO 40 YEARS AGO. IT WAS DESIGNED TO IDENTIFY WOMEN WHO WERE AT RISK OF DEVELOPING DIABETES AFTER PREGNANCY, OR BASED ON NON-PREGNANT WOMEN. IT WAS NOT A DIAGNOSIS TO IDENTIFY WOMEN WHO WOULD BE AT RISK OF HAVING AN ADVERSE PREGNANCY OUTCOME. SIMPLY TO IDENTIFY THOSE WOMEN WHO LATER WOULD DEVELOP DIABETES. IF YOU LOOK AT HOW DIABETES IS DIAGNOSED AND SCREENED FOR, INTERNATIONALLY AS WELL AS IN THE UNITED STATES, A BIT OF A DIFFERENT APPROACH. OUTSIDE THE UNITED STATES TYPICALLY GESTATIONAL DIABETES IS DEFINED USING A TWO HOUR 75-GRAM ORAL GLUCOSE LOAD. WHEREAS IN THE UNITED STATES TYPICALLY THERE'S A 2 TIERED APPROACH. INITIALLYe1 A ONE HOUR 50-GRAM ORAL GLUCOSE LOAD IS GIVEN. IF THE PATIENT'S VALUE IS OVER 135-MILLIGRAMS PER DECALITER, YOU UNDERGO A 3 HOUR 100-GRAM ORAL GLUCOSE LOAD. IF TWO VALUES ARE ABNORMAL, THEY'RE DIAGNOSED WITH GESTATIONAL DIABETES. WHY HAVE A CONSENSUS CONFERENCE ON THE DIAGNOSIS OF GESTATIONAL DIABETES? ONE ELEMENT OF A CONSENSUS CONFERENCE SIT MUST BE OF PUBLIC HEALTH IMPORTANCE AND MUST BE A PUBLIC HEALTH PRIORITY. GESTATIONAL DIABETES IS INCREDIBLY COMMON IN PREGNANCY, AS ARE RATES OF OBESITY IN THE UNITED STATES INCREASE, THE RATES OF GESTATIONAL DIABETES WILL LIKELY INCREASE AS WELL. IN ADDITION, GESTATIONAL DIABETES RESULTS IN ADVERSE PREGNANCY OUTCOMES. IN ADDITION THE OUTCOMES FOR WOMEN AND CHILDREN LONG TERM, ARE AFFECTED BY HAVING GESTATIONAL DIABETES FOR MOM AND BABY. SOME OF THESE COMPLICATIONS INCLUDE PREECLAMPSIA, FETAL OVERGROWTH, BIRTH INJURY, MACROSOMEIA, CESAREAN DELIVERY AND NEONATAL SUCH AS HYPOBILIRUBINEMIA, RESPIRATORY STRESS SYNDROME AND MOTHER TYPE 2 DIABETES OCCURRING AFTER PREGNANCY. IN ADDITION TO HAVE A CONSENSUS CONFERENCE THERE MUST BE SOMETHING CONTROVERSEAL. UNFORTUNATELY FOR US WITH GESTATIONAL DIABETES THERE'S CONTROVERSIAL ASPECTS IN THIS TOPIC. IT'S CONTROVERSIAL HOW TO SCREEN WOMEN FOR GESTATIONAL DIABETES. WE HAVE LIMITED INFORMATION ON THE BENEFITS OF TREATMENT OF GESTATIONAL DIABETES DURING PREGNANCY. THE THIRD CONTROVERSY WE HAVE IS NEW CRITERIA PROPOSED FOR THE DIAGNOSIS OF GESTATIONAL DIABETES. I WOULD LIKE US TO WALK THROUGH SOME OF THESE CONTROVERSIES AN SPECIFICALLY IDENTIFY WHAT WE'RE GOING TO BE FOCUSING ON TODAY FOR THE CONSENSUS CONFERENCE ON THE DIAGNOSIS OF GESTATIONAL DIABETES. SO FIRST LOOK AGENT CONTROVERSY OF SCREENING. UNIVERSEAL SCREENING, SCREENING AUTISM WOMEN VERSUS TARGETED SCREENING, HIGH RISK WOMEN, IS DEBATED. IN THE UNITED STATES THE DEFAULT BASICALLY IS TO SCREEN ALMOST ALL PREGNANT WOMEN. THE U.S. PREVENTATIVE TASK FORCE LOOKEDDED THAT THE IN 2008 AND RECENTLY LAST OCTOBER AND WILL BE ISSUING NEW GUIDELINES ON THE SCREENING. THE 2008 GUIDELINES DIDN'T RECOMMEND ROUTINE SCREENING FOR ALL PREGNANT WOMEN. CURRENT EVIDENCE IS INSUFFICIENT TO ASSESS BALANCE BETWEEN BENEFITS AN HARMS SCREENING WOMEN FOR GESTATIONAL DIABETES EITHER BEFORE OR AFTER 24 WEEKS. THEY NOTED HARMS OF SCREENING INCLUDE SHORT TERM ANXIETY, INCONVENIENCE TO WOMEN AND MEDICAL PRACTICES BECAUSE MOST POSITIVE SCREENING TESTS ARE LIKELY FALSE POSITIVES. THIS GROUP IS RECONVENED INCOLLIDING THE NEW EVIDENCE THAT CAME OUT AND THEY'LL COME OUT SHORTLY WITH ADDITIONAL INFORMATION ON THIS QUESTION OF SCREENING ITSELF. WE ALSO MENTION LIMITED EVIDENCE ON EFFECTIVENESS OF TREATMENT. PRIOR TO 2005, WE HAD NO EVIDENCE THAT TREATMENT OF GESTATIONAL DIABETES IMPROVED OUTCOME. SINCE THAT TIME WE HAVE TWO LARGE RANDOMIZED TRIALS PUBLISHED IN NEW ENGLAND JOURNAL OF MEDICINE LOOKING AT WOMEN WHO HAD MILD GESTATIONAL DIABETES, AND IDENTIFIED THAT SCREENING AND TREATMENT OF MILD GESTATIONAL DIABETES DID HAVE AN IMPACT AND LOWERED MACROSOMEIA OR ENLARGED GESTATIONAL INFANTS AS WELL AS SHOULDER DISTOTIA. SO WE HAVE SOME EVIDENCE THAT TREATMENT AFFECTS OUTCOME. THERE'S LARGE DATA SET FROM DEMONSTRATING HYPERGLYCEMIA IS A CONTINUUM. THIS STUDY OF OVER 25,000 WOMEN INTERNATIONALLY SHOWED A CONTINUOUS ASSOCIATION BETWEEN GLUCOSE LEVELS AND ADVERSE PREGNANCY OUTCOMES. SO AS A WOMAN IS FASTING ONE HOUR OR TWO HOUR GLUCOSE LEVEL ROSE. SO WAS AN ASSOCIATION WITH HIGHER BIRTH WEIGHTS, PEPTIDE LEVELS, BUT THERE WAS NO CLEAR CUT POINT, NO CLEAR PLACE THAT WE COULD DIVIDE AND SAY THIS IS WHERE WE SHOULD MAKE THAT DETERMINATION THIS THIS IS ABNORMAL AND THIS IS NORMAL. IT WAS A CONTINUUM AS SHOWN ON THIS GRAPH. BASED ON THAT DATA, NEW CRITERIA FOR GDM PROPOSED. IT WAS BASED ON PREGNANCY OUTCOME WHICH IS VERY DIFFERENT IN THE CRITERIA WE CURRENTLY USE FOR THE DIAGNOSIS OF GESTATIONAL DIABETES. AGAIN, THAT WAS BASED ON EITHER NON-PREGNANT WOMEN OR ON WOMEN IDENTIFYING THEIR RISK FOR DEVELOPING DIABETES LATER IN LIFE. THIS CRITERIA IS BASED ON PREGNANCY OUTCOME. THE CUT OFFS WERE DEFINED BY ADVERSE OUTCOMES ODDS RATIOS. THIS WAS PROPOSED AND HAS BEEN ENDORSED BY THE AMERICAN DIABETES ASSOCIATION. IF THIS NEW CRITERIA IS ADOPTED IT WILL BASICALLY DOUBLE THE DIAGNOSIS OF GESTATIONAL DIABETES TO ABOUT 18%. WHAT WILL THAT IMPACT BE ON HEALTHCARE RESOURCE UTILIZATION? EXPENDITURES ESTIMATED $2.5 BILLION ANNUALLY. MORE IMPORTANTLY, WE DON'T HAVE EVIDENCE THAT TREATMENT USING THIS NEW CRITERIA, THESE NEW DIAGNOSTIC CRITERIA WILL IMPROVE OUTCOME. WE ON THE RECENTLY HAVE EVIDENCE THAT TREATMENT WITH THE OLD CRITERIA COULD IMPROVE OUTCOME AND IT WAS ONLY LIMITED OUTCOME MEASURE. G LOTS OF THOUGHTS ARE CIRCULATING IN THE LITERATURE WHAT WE SHOULD DO WITH THIS NEW DIAGNOSTIC CRITERIA. WE'RE GOING TO HEAR A LOT ABOUT THAT OVER THE NEXT DAY AND A HALF. SO I WANT TO TALK FIRST ABOUT WHAT THIS CONFERENCE WILL NOT ADDRESS. AS I MENTIONED, THERE'S LOTS OF CONTROVERSIES IN GESTATIONAL DIABETES. WHETHER HE NOT BE ADDRESSING WHETHER SCREENING SHOULD ACT OCCUR. THE U.S. PREVENTATIVE TASK FORCE WILL BE ADDRESSING THAT ISSUE. WE ALSO ARE NOT ADDRESSING WHAT IS THE OPTIMAL MONITORING MANAGEMENT AND TREATMENT OF GESTATIONAL DIABETES. WE WOULD HAVE TO BE HERE AT LEAST A WEEK OR MONTH OR MAYBE A YEAR IF WE WANTED TO COVER ALL THOSE TOPICS. INSTEAD WE ARE GOING TO ADDRESS THE DIAGNOSIS OF GESTATIONAL DIABETES. WHAT SHOULD THE DIAGNOSTIC THRESHOLD OR GDM BE AND SHOULD THE DIAGNOSTIC CRITERIA BE CHANGED? DR. VAN DORSTEN DID A WONDERFUL JOB GOING THROUGH THE SEVEN QUESTIONS THAT WILL BE SPECIFICALLY DRESSED BUT THE ESSENCE IS SIMPLY, WHAT SHOULD THE DIAGNOSTIC THRESHOLD BE AND SHOULD THE DIAGNOSTIC CRITERIA BE CHANGED. WHY HOLD A CONSENSUS CONFERENCE ON THIS TOPIC? WE NEED TO RAISE AWARENESS OF THESE VERY COMPLICATED ISSUES AND WE LACK OF CLARITY ACROSS THE PUBLIC AND PROVIDERS WHAT THE DIAGNOSTIC THRESHOLD SHOULD BE. WE FELT BY HOLDING A CONSENSUS CONFERENCE WE COULD ALLOW RIGOROUS EVALUATION OF THE EXISTING EVIDENCE AND LOOK AT IMPLICATIONS OF THE NEW PROPOSED THRESHOLDS. AND THEN THE PANEL COULD DEVELOP A STATEMENT THAT ADVANCES THE UNDERSTANDING FOR HEALTHCARE PROFESSIONALS AND THE PUBLIC. OUR GOAL AT THE NATIONAL INSTITUTES OF HEALTH AND NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT ARE HEALTHY CHILDREN, HEALTHY MOTHERS AND HEALTHY FAMILIES. I LOOK FORWARD TO HEARING PANEL DELIBERATIONS OVER THE NEXT DAY AND A HALF. I WOULD NOW LIKE TO WELCOME DR. BILL CALLAHAN FROM THE CDC WHO WILL BE SPEAKING ON THE EPIDEMIOLOGY OF GESTATIONAL DIABETES. [APPLAUSE]‡£h >> GOOD MORNING. I WOULD LIKE TO THANK THE ORGANIZERS OF THIS CONFERENCE FOR ASKING ME TO PRESENT AND SPECIFICALLY LIKE TO THANK THE PANEL IN ADVANCE FOR THE DIFFICULT CHARGE THAT WE HAVE OVER THE NEXT FEW DAYS. SO I HAVE TO TALK ABOUT THE EPIDEMIOLOGY, THIS IS A FAIRLY STANDARD DEFINITION OF EPIDEMIOLOGY, THE STUDY OF THE DISTRIBUTION AND DETERMINANTS OF HEALTH-RELATED STATES OR EVENTS IN A SPECIFIC POPULATIONS AND APPLICATION OF STUDY OF THESE EVENTS TO THE CONTROL OF HEALTH PROBLEMS. SO EPIDEMIOLOGY ASSESSES BURDEN, LOOKING AT INCIDENCE AND TRENDS AND BURDENS, IT'S AN ENTERPRISE INVOLVED IN COUNTS AND RATES AND HOW THINGS CHANGE OVER TIME. IT ALSO LOOKS AT CAUSES AND RISK FACTORS, THE NATURAL HISTORY AND PROGNOSIS OF DISEASE, AND LASTLY IN A CLINICAL WAY EFFECTIVENESS OF TREATMENT AND PREVENTION STRATEGIES. TODAY I'M GOING TO CONCENTRATE FOR THE NEXT FEW MINUTES ON THE ISSUE OF DISEASE BURDEN AND STRENGTHS AND LIMITATIONS OF OUR ESTIMATES. THERE ARE A LOT OF OTHER PEOPLE HERE THAT WILL ADDRESS SPECIFICS OF NATURAL HISTORY AND PROGNOSIS THOUGH I HAVE BEEN ASKED TO BRIEFLY ADDRESS THE IMPLICATIONS OF GDM BEYOND PREGNANCY. SO TALK ABOUT GESTATIONAL DIABETES, WE NEED A CASE DEFINITION. PUBLIC HEALTH SURVEILLANCE THE BASIS OF POPULATION EPIDEMIOLOGY RELIES ON DEFINING CASES. THIS PRETTY MUCH STANDARD DEFINITION OF GDM, CARBOHYDRATE INTOLERANCE OF VARYING SEVERITY THAT BEGIN OR FIRST RECOGNIZED DURING PREGNANCY. AS WE WILL SEE, HOW GDM IS DEFINED AND DIAGNOSED AFFECTS WHAT IT IS THAT WE COUNT. AS I SAID I'M GOING TO SHOW EXAMPLES OF DATA FOR TRENDS AND PREVALENCE IN TRENDS BOTH ON NATIONAL BASIS BUT ALSO USE EXAMPLES IN SMALLER POPULATIONS. GDM PREVALENCE VARIES BY POPULATION AND AS E SEE CHANGES IN POPULATIONS AN CHANGES IN TESTING WILL AFFECT TRENDS WE SEE OVER TIME. AND ALSO GIVE INFORMATION ABOUT RISK FACTORS AND GDM BEYOND PREGNANCY. THESE ARE SOME DATA FROM NATIONWIDE INPATIENT SAMPLE. THIS DATA SET IS PART OF THE AGENCY FOR HEALTHCARE RESEARCH QUALITIES HEALTHCARE COST AND UTILIZATION PROJECT. A 20% SAMPLE OF HOSPITALS IN THE UNITED STATES. THESE ARE WOMEN DURING THEIR DELIVERY HOSPITALIZATION HAD AN ICD CODE, NATIONAL DISEASE CODE 68.8 AT TIME OF DISCHARGE, 648.8. THE GENERIC DEFINITION IS ABNORMAL GLUCOSE TOLERANCE DURING PREGNANT SANE WIDELY INTERPRETED ADS GESTATIONAL DIABETES. THESE ARE DATA THAT SANDRA ALBRECT PUBLISHED A FEW YEARSING BACK AND RECENTLY UPDATED. USING THIS DATA SET WHICH SHOWS AN GDM INCIDENCE OF ALMOST 6% AND THUS AFFECTS SOMEWHERE NORTH OF 200,000 WOMEN PER YEAR. ANOTHER INCREASINGLY STILL POTENTIAL SOON TO BE ACHIEVEED WAY OF LOOKING AT NATIONAL PREVALENCE OF GESTATIONAL DIABETES, IS THE BIRTH CERTIFICATE. IN 2003 THE U.S. STANDARD BIRTH CERTIFICATE WAS REVISED AND HAS A FIELD FOR GESTATIONAL DIABETES. THIS REPRESENTS INFORMATION FROM 2008 WHICH IS THE MOST RECENT YEAR WHICH THE ANCILLARY FIELDS ON THE BIRTH CERTIFICATE WERE AVAILABLE, IT IS ABOUT 27 STATES SEEN HERE IN BLUE. AND ENCOMPASSESÖ ABOUT 65% OF ALL BIRTHS IN THE UNITED STATES. YOU CAN SEE BASED ON THE 2008 GDM PREVALENCE ABOUT 4 PERCENT WHICH IS SOMEWHAT LESS THAN WHAT WE SEE IN HOSPITAL DISCHARGE DATA. AND I WILL TALK ABOUT THAT IN A MINUTE. BY JANUARY 2011, 36 STATES IN THE DISTRICT COLUMBIA THIS INFORMATION WHICH ENCOMPASSES 76 OF ALL BIRTHS SO WE'RE APPROACHING A TIME WHEN HOPEFULLY GESTATIONAL DIABETES ON THE BIRTH CERTIFICATE WILL BECOME NATIONALLY REPRESENTATIVE. ALSO NATIONAL AND LOCAL EFFORTS TO IMPROVE INFORMATION ON BIRTH CERTIFICATES AND HOPEFULLY HAVE ANOTHER MEANS OF GDM SURVEILLANCE. WHETHER WE'RE USING BIRTH CERTIFICATES OR HOSPITAL DISCHARGE DATA THESE ARE ESSENTIALLY ADMINISTRATIVE DATA. AN EDITORIAL IN JAMA THIS YEAR, WE NEED TOWNS HOW IT IS THAT CODES AND CHECK BOX GET FROM THE CLINICAL RECORD INTO DATA SETS WE USE FOR MONITORING. AS WE LOOK AT STRENGTHS AND LIMITATIONS OF THESE DATA THEY ARE REASONABLY SENSITIVE BUT WE KNOW WE'RE ALWAYS UNDERCOUNTING. FAIRLY GOOD SPECIFICITY, MANY HAVE SHOWN THAT. WE LIKELY UNDERESTIMATE THE TRUE PREVALENCE OF ANYTHING WHEN LOOKING AT THESE DATA AND GDM IS LIKELY NO EXCEPTION. AND HOSPITAL DISCHARGE DATA ON THE MAIN, GENERALLY MORE SENSITIVE THAN BIRTH CERTIFICATES. HOWEVER LOOKING AT TRENDS SCREENING PRACTICES DO NOT CHANGE, THESE ARE BIG IFs AND DIAGNOSTIC THRESHOLDS DON'T CHANGE AND CODING IS NOT BIASED, LIKELY REASONABLE ESTIMATES OF TRENDS. I'M GOING TO SHOW THOSE ASSUMPTIONS MAY NOT BE TRUE. AT THE END OF THE DAY WE'RE UNABLE TO KNOW THE CRITERIA RESULTING IN SOMEBODY GETTING A DIAGNOSIS CODE. WHEN A CODE GOES THROUGH A MEDICAL RECORD, IT IS ESSENTIALLY A BLACK BOX AND COMES OUT AS A CODE. WE HAVE NO IDEA WHAT METHODS WERE USED TO TEST THAT WOMAN. SO THOUGH I AM AN EPIDEMIOLOGIST AND I WORK WITH SUMMARY DATA, I FREELY DISCLOSE SUMMARY DATA MAY CONCEAL RATHER THAN REVEAL. OFTENTIMES IN MANY DATA WE HAVE LIMITED AVAILABILITY OF RISK FACTOR DATA FOR STRATIFICATION FOR WHAT'S GOING ON, ON A LEVEL CLOSER TO GROUND THAN THE 30,000-FOOT LEVEL THAT WE'RE LOOKING AT HERE. SO WE'LL LOOK AT VARIATION. VARIES BY POPULATION SUBGROUPS. THIS IS A PAPER BY SUE CHU USING AVAILABLE BIRTH CERTIFICATES FOR 2005, 2006. SO A LIMITED SAMPLE, WHERE THERE WAS A FIELD FOR F DIABETES. GESTATIONAL DIABETES. THEY WERE INTERESTED IN THE PACIFIC ISLANDER GROUP BUT ALSO OTHER SUBGROUP VARIATION. AS YOU CAN SEE WE'LL SEE DEPENDING ON WHAT AGE YOU ARE, GESTATIONAL DIABETES IS DIFFERENT, IT INCREASES WITH AGE. IT ALSO VARIES WITH RACE, AS YOU CAN SEE FROM GOING FROM WHITE NON-HISPANIC, BLACK NON-HISPANIC SIMILAR TO ONE ANOTHER, IN THESE DATA HISPANIC ARE NOT HIGHER BUT AS YOU'LL SEE THAT'S NOT PARTICULARLY TRUE IN MOST OTHER DATA SETS. AMERICAN INDIAN POPULATION, ASIA-PACIFIC ISLANDER. I HIGHLIGHT THIS BECAUSE OF HOW WE LOOK AT THINGS BY RACE. AMONG ASIAN PACIFIC ISLANDERS ARE VERY DIFFERENT. AS HIGH AS 8% IN ASIAN INDIAN FOLKS AND THEN AS LOW AS THREE AND A HALF PERCENT IN JAPANESE. SO EVEN WITHIN RACES THERE ARE APPEAR TO BE IMPORTANT DIFFERENCES. THEY EVEN PUT IT A LITTLE BIT DIFFERENT AND LOOK AT COUNTRY OF NATIVITY. AND WHEN THEY LOOK AT THAT, THERE WERE DIFFERENCES AND EVEN DIFFERENCES WEREN'T ENTIRELY CONSISTENT IN GENERAL FOREIGN BORN HAD HIGHER INCIDENCE OF GESTATIONAL DIABETES BUT THE DIRECTION OF THE RISK WAS NOT ENTIRELY CONSISTENT. ANOTHER EXAMPLE VARIATION BY. LATION COMES FROM THE STUDY THAT HAPOS DID USING THE INTERNATIONAL ASSOCIATION OF DIAGNOSE BEE TEASE AN PREGNANCY STUDY GROUP CRITERIA, THE OVERALL FREQUENCY OF GDP WAS 17.8 BUT IT RANGED AS HIGH AS 25% IN SOUTHERN CALIFORNIA TO LESS THAN 10% IN ISRAEL. THESE ARE DATA FROM KEISER PERMANENTE FROM 1995 TO 2005. GDM DIAGNOSED BY THREE ORAL GLUCOSE INTOLERANCE TEST USING CARPENTER FOR ABOUT 83% POPULATION FOLLOWED BY 75-GRAM OTTT AND RARELY BY FASTING GLUCOSE OR RANDOM GLUCOSE SOME THEY SET IT OUT IN HIERARCHICAL ORDER. THE FIRST THING WE SEE IS THE MONOTONIC INCREASE WITH AGE THAT WE SAW IN OTHER DATA. WE LOOK AT TRENDS INTERESTINGLY INVESTIGATORS DID NOT SEE THE INCREASE WE SEE NATIONALLY. THE INCIDENCE OVER TIME WAS STABLE, WHEN STRATIFIED ON AGE. WE LOOK AT RACE ETHNICITY DATA WE CAN SEE AGAIN WHEN ADJUSTED FOR AGE NON-HISPANIC, WHITE HISPANIC, BLACK, ASIAN PACIFIC ISLANDERS SHOW THE SAME SOURCE OF THINGS WITH THE MORE COMMONLY REPORTED INCREASE HISPANIC POPULATION. AGAIN WHEN LOOKED AT RACE ETHNICITY ADJUSTED FOR AGE, THERE WAS LITTLE DIFFERENCE IN TERMS OF SECULAR TRENDS. SO WE'RE HERE TO MAKE DECISIONS ABILITY HOW TO DIAGNOSE GDM AND IMPLICIT IN THESE DECISIONS IS THE FREQUENCY GDM DEPENDS HOW IT'S DIAGNOSED. AS YOU CAN SEE USING TESTING CUT OFFS FOR THE NATIONAL DIABETES DATA GROUP CARPENTER CUSTAN GROUP AND CRITERIA RATHER AND THE INTERNATIONAL ASSOCIATION OF DIABETES AND PREGNANCY STUDY GROUPS, THESE ARE THE CUT POINTS THAT HAVE BEEN USED AND ARE CURRENTLY PROPOSED. WHEN WE USE ADMINISTRATIVE DATA TO ESTIMATE DISEASE BURDEN WE RARELY KNOW WHAT TESTS OR TESTS WERE USED TO SIGN THE DIAGNOSIS. SO THIS TABLE DISPLAYS FREQUENCY OF GM ACCORDING TO TESTING CUT OFFS IN A VARIETY OF STUDIES. USING CARPENTER CUSTAN CRITERIA THE PREVALENCE CLUSTERS AROUND 5. NATIONAL DIABETES DATA GROUP A LITTLE MORE THAN 3 AND THE INTERNATIONAL ASSOCIATION OF DIABETES AND PREGNANCY STUDY GROUP, ALMOST 18%. BUT AGAIN, AS SAW IN PREVIOUS SLIDE THERE'S CONSIDERABLE VARIATION BY SITE. THE DEGREE TO WHICH THESE HAVE BEEN USED CONSISTENTLY OR HAVE CHANGED OVER TIME IS UNKNOWN. BUT LIKELY THOSE CHANGES HAVE INFLUENCED THE TRENDS THAT WE'RE SEEING AT THE POPULATION LEVEL. THESE REPORT DATA ACCORDING TO BMI THERE HAVE BEEN TWO RECENT META ANALYSIS, THOUGH POINT ESTIMATES ARE SOMEWHAT DIFFERENT BECAUSE OF SLIGHTLY DIFFERENT METHODOLOGIES. THERE'S A CLEAR DOSE RESPONSE EFFECT OF BODY MASS ON GDM. IN ADDITION WE KNOW OBESITY IS HIGHLY PREVALENT, ONE IN FIVE WOMEN ENTER PREGNANCY OBESE NOW. IN ADDITION OF PAPER BY SHIN KIM IN OUR SHOP LOOKED AT DATA FROM PREGNANCY RISK MONITORING SYSTEM IN 7 STATES LINKED TO BIRTH RECORDS AND CALCULATED A POPULATION ATTRIBUTABLE FRACTION OF NEARLY OBESITY, POPULATION FRACTION CAN BE INTERPRETED IF WE MAKE THE ASSUMPTION THAT BODY MASS IS CAUSEAL IN GDM WHAT FRACTION OF THE PROBLEM, WHAT FRACTION OF GDM COULD BE PREVENTED IF NOBODY WAS OVERWEIGHT OR OBESE. I THINK THE CAUSEAL ASSUMPTION IS RELATIVELY IMPORTANT TO CONSIDER HERE BUT I THINK WE CAN MAKE A CASE FOR THAT. FOR SOMETHING TO BE CAUSEAL IT MUST PRECEDE THE DISEASE, OBESITY PRECEDES GDM. NEED TO BE A STRONG ASSOCIATION, THESE ARE STRONG ASSOCIATIONS AS OBESITY INCREASES. THERE NEEDS TO BE A DOSE RESPONSE EFFECT. WE SEE DOSE RESPONSE EFFECT STRONGLY HERE. STUDIES NEED TO BE REPLY CASH BALANCE AND OVER AN OVER WE HAVE SHOWN OBESITY IS RELATED TO GDM. BIOLOGIC PLAUSIBILITY WITH INSULIN RESISTANCE OF ATTENDANT TO OBESITY MAKES SEN. WE HAVE TO CONSIDER WHETHER CONFOUNDING HAS BEEN ADDRESSED IN MOST GRANULAR STUDIES FOLKS HAVE I DRESSED CONFOUNDING SO I THINK THE CAUSEAL ASSUMPTION IS ROLE THRIVETIVELY -- RELATIVELY FIRM AND WE CAN ASSUME THAT OBESITY IS MAKING AN OVERWHELMING CONTRIBUTION TO GESTATIONAL DIABETES. THIS IS JUST TO REMIND YOU OF TRENDS IN OBESITY BECAUSE IT'S NOT GOING AWAY. AND ESPECIALLY WHAT WE KNOW ABOUT POPULATION ATTRIBUTABLE FRACTION. THIS IS OBESITY OVER THE PAST 20 YEARS FROM BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM. AS YOU CAN WATCH COLORS CHANGE, I REMIND YOU THIS IS 15 TO 19% HIGHEST STATES ON THIS. AND COLORS KEEP CHANGING AND THEY KEEP CHANGING AND NOW WE HAVE THE TO KEEP COMING UP WITH NEW COLORS AND THE OLD COLORS GO AWAY. THE OTHER THING TO ADD THAT I DID NOT HAVE A SLIDE FOR WAS A RECENT PAPER BY BARDENHIDER THAT USES STATEWIDE IN PATIENT DATA FOR 23 STATES. THESE STATES HAD RACE ETHNICITY DATA. THEY DID NOT HAVE OBESITY DATA BUT THEY USED STATE LEVEL OBESITY DATA AS ECOLOGIC VARIABLE AND DID MULTI-LEVEL MODELING WHERE THEY CAN USE HIGHER ORDER VARIABLE FOR THE STATE OBESITY LEVEL AND TRY TO EXPLAIN VARIABILITY BY STATE SO THEY HAD 23 STATES, PREVALENCE OF GDM WAS VARIED FROM THREE AND A HALF TO OVER 7%. THEN THEY MODELED THAT VARIABILITY. THE MOST IMPORTANT EXPLANATORY VARIABLE WAS STATE LEVEL OBESITY THAT WAS FOLLOWED BY AGE, RACE ETHNICITY, AND INTERESTINGLY A VARIABLE FOR HOSPITAL. BUT I THINK CONFIRMS WHAT WE HAVE BEEN TALKING ABOUT HERE WHEN WE LOOK AT OBESITY, AGE, RACE ETHNICITY, AND PERHAPS WHILE WE CAN SPECULATE ABOUT THAT, THE HOSPITAL IS A PROXY HOW GDM IS DIAGNOSED ON LOCAL LEVEL. SORRY. IN SUPPORT OF THE NATIONAL TRENDS, THESE ARE LOCAL POPULATION STUDIES, THEY USE DIFFERENT DECEMBER SOURCES, DIFFERENT DIAGNOSTIC CRITERIA AND THEY ARE REPORTING FREQUENCY IN SPITE OF WHAT WE ASSUME EXPECTED DIFFERENCES IN POINT ESTIMATES BASED ON DIFFERENT WAYS OF DIAGNOSING AND DIFFERENT YEARS OF STUDY. SO LAST FEW MINUTES I WANT TO TALK ABOUT GDM BEYOND PREGNANCY. AND DISKISS IMPLICATIONS FOR GDM AS SHE MOVES FORWARD THROUGHOUT THE LIFE COURSE. I DON'T NEED TO REMIND PEOPLE HERE, CATHY ALREADY HAS ABOUT ORIGINAL WORK OF O'SULLIVAN AND MAY HAHN, GDM WAS DEFINED BY ASSESSING CUT POINTS PREDICTING TYPE 2 DIABETES IN THE DIVISION OF REPRODUCTIVE HEALTH WE HAVE BEEN PARTICULARLY INTERESTED. SOMEWHERE BETWEEN 25th VERSE OF WOMEN WITH GDM WILL DEVELOP TYPE 2 DIABETES FIVE TO TEN YEARS AFTER DELIVERY AND ONE-THIRD OF WOMEN TESTED POST PARTUM WILL HAVE SOME DISTURBANCE OF GLUCOSE HOMEOSTASIS IMPAIRED FASTING GLUCOSE OR IMPAIRED GLUCOSE TOLERANCE. IN RECENTLY THIS HAS HIT HARD, THERE ARE -- INCREASING AWARENESS IN THE PUBLIC AND MEDICAL COMMUNITY WE NEED TO PAY ATTENTION TO THESE WOMEN IN THE IMMEDIATE POTTS PARTUM AND AFTERWARDS. -- POST PARTUM AND AFTERWARDS. THESE ARE DATA THAT P PATTY DEITS PUBLISHED AD FEW YEARS BACK. THESE ARE DATA THAT CAME FROM WORK THAT WE ARE DOING WITH KEISER PERMANENTE NORTHWEST AND PORTLAND CENTER FOR HEALTH RESEARCH. NOTE OVER TIME THERE WAS AN INCREASE IN DIABETES TESTING. BUT IT'S INTERESTING, THIS ACTUALLY BEKNOWNGST TO US AT THE TIME WE INITIATED WE DID NOT KNOW THERE WAS INCREASED EFFORT ON INITIATION TO MAKE CLINICIANS AWARE OF TESTING. THIS IS A NATURAL HISTORY UNINTENDED NATURAL HISTORY STUDY. WE SAW INCREASES BOTH IN PHYSICIANS ORDERING TESTS AND IN COMPLETED TESTS BUT IT'S IMPORTANT TO NOTE IN SPITE OF THIS RAISING AWARENESS ONLY ABOUT 50% OF TESTS WILL HAVE COMPLETED SO WE'RE NOT HITTING THE MARK WELL. THESE ARE SOME OTHER STUDIES SHOWING RATES OF POSTPARTUM TESTING AND AGAIN DURING THE SAME TIME PERIOD SHOWED SIMILAR RATES OF TESTING, HARBORING IN THE 50% RANGE. SO AS I REFLECT WE CAN SEE PREVALENCE OF GDM USING SCREENING AND TESTING METHODS IS BETWEEN 5%, 6%, PERHAPS 7% NATIONALLY BUT VARIATION BY POPULATION RISK, TESTING STRATEGIES AN GLUCOSE CUT OFFS. TREND INCREASING BUT THE RATE OF INCREASE APPEARS TO BE LEVELING WHEN WE EYE BALL THAT TYPE 2 DIABETES AND PREGNANT IS INCREASING AND AS WE DIAGNOSE MORE TYPE 2 PRIOR TO PREGNANCY, WE MAY BE DECREASING AMOUNT OF GDP WE DIAGNOSE. RISE IN OBESITY MAYBE SLOWING BUT IT'S HIGH AND NOT GOING AWAY. THE CUT POINTS PROPOSED WILL RESULT IN DRAMATIC INCREASE IN PREVALENCE. THIS IS INCREASED BURDEN DELIVERY P SYSTEM DURING PREGNANCY WE NEED TO ADDRESS. WE NEED NEW IMPROVED STRATEGIES FOR FOLLOW-UP OF WOMEN FOR ABOUT FORMALITIES OF GLUCOSE. THE ISSUE OF BURDEN, AS I WAS FINISHING UP I BECAME MORE UNCOMFORTABLE WITH THE TERM TO BE SURE THE MORE GDM THERE IS, THE MORE RESOURCES EXTENDED. HOWEVER, IT MAY BE MORE IMPORTANT TO FRAME IN TERMS OF VALUE OBTAINED FOR RESOURCES EXPENDED. I THINK THAT'S WHAT WE'RE HERE TO TALK ABOUT. AND THANK YOU. [APPLAUSE] >> THANK YOU, BILL AND CATHY. I THINK WE CERTAINLY SET THE STAGE AND NOW TURN ATTENTION TOWARD THE QUESTIONS THE FIRST QUESTION RELATES TO THE CURRENT STATUS OF SCREENING AND DIAGNOSIS, AND NO ONE IS BETTER ABLE TO PRESENT THAT. THAN MY CLOSE FRIEND DONALD COUSTAN, PROFESSOR OF OBGYN AT BROWN AND CARD CARRYING MEMBER OF THE DIVISION OF MATERNAL FETAL MEDICINE AT WOMEN'S HOSPITAL RHODE ISLAND. DON. >> THANK YOU, PETER. I WOULD LIKE TO THANK THE NECHD FOR PUTTING ON THIS CONFERENCE AND ALSO IN PARTICULARLY THE PANEL IT'S OBVIOUSLY INTENSIVE AND THANKLESS TASK YOU'RE ABOUT BUT IT'S AN IMPORTANT ONE. HOW DO I ADVANCE? SO ONE OF MY ASSIGNMENTS WAS TO TALK ABOUT THE CURRENT STATE OF AFFAIRS AND THE CURRENT DIAGNOSTIC CRITERIA FOR GESTATIONAL DIABETES. AND THIS IS A VERY LIMITED DEPICTION. THERE ARE MORE THAN 20, 30 DIFFERENT SETS OF CRITERIA AROUND THE WORLD. I CHOSE SOME OF THE MORE COMMONLY USED ONES AN POINT OUT AGAIN WHAT CATHY SPONG POINTED OUT INITIALLY, TWO SETS OF CRITERIA, THE FIRST TWO ARE BASED ON THE O'SULLIVAN CRITERIA VALIDATED BY THEIR PREDICTIVE VALUE OF SUBSEQUENT DIABETES. THE WORLD HEALTH ORGANIZATION CRITERIA ARE SIMPLY THE SAME AS NON-PREGNANT INDIVIDUALS. ADIPS THE AUSTRALIAN ASIAN DIABETES AND PREGNANCY SOCIETY CAME AT THEIR CRITERIA BY CONSENSUS THOUGH THEY HAVE RECENTLY SWITCHED TO THE IDPSG CRITERIA. THE CANADIAN DIABETES ASSOCIATION WAS CONSENSUS AND THEN THE IADPSG CRITERIA WERE BASED ON PREGNANCY OUTCOME. LET'S LOOK AT THOSE VARIOUS CRITERIA. I'M GOING TO BE FOCUSING MAINLY ON THOSE IN COMMON USE IN THE UNITED STATES BUT I WANT TO TAKE A MINUTE TO TALKNB ABOUT SIMILARITIES AN DIFFERENCES. SO THE TWO BASED ON O'SULLIVAN CRITERIA NATIONAL DIABETES DATA GROUP AND ONES MARSHALL CARPENTER AND I PROPOSE USE 100-GRAM GLUCOSE CHALLENGE THE WORLD HEALTH ORGANIZATION, ADIPS I SHOULD SAY, CANADIAN AND IADPSG USES 75-GRAM CHALLENGE SO THERE'S ONE BASIC DIFFERENCE. SOME STUDIES HAVE SHOWN THAT AT LEAST IN NON-DIABETIC INDIVIDUALS THERE'S NOT MUCH DIFFERENCE BETWEEN THE RESULTS WITH THOSE TWO CHALLENGES. LET'S GO DOWN TO THE BOLED LINE BECAUSE THEY HAVE IN COMMON A TWO HOUR VALUE, A TWO HOUR PLASMA GLUCOSE VALUE, WE CAN COMPARE THE CUT OFFS. WE'LL TALK LATER ABOUT THE DIFFERENCE BETWEEN FIRST TWO SETS OF CRITERIA BUT LET'S USE 155 WHICH IS MORE COMMONLY USED IN THIS COUNTRY. THE WORLD HEALTH ORGANIZATION USES CUT OFF OF 140 SO THAT IS CONSIDERABLY LOWER. ADIPS USED 144, CANADIANS 160 AND NEW PROPOSED IDPSG CRY TIER USED 153. I WANT TO POINT OUT HERE THE PROPOSAL OF THE IADPSG IS NOT TO LOWER THE CUT OFF, PEOPLE TALK ABOUT LOWING THE DIAGNOSTIC CRITERIA. THAT'S NOT THE CASE. THE IADPSG CRITERIA MAY BE MARGINALLY LOWER THAN ONES IN THIS COUNTRY BUT THEY'RE HIGHER THAN THE WORLD HEALTH ORGANIZATION CRY CRITERIA. THE REAL DIFFERENCE IS USE OF ONE ELEVATED VALUE RATHER THAN TWO. THAT'S WHAT ACCOUNTS FOR MOST OF THE INCREASE IN PREVALENCE WITH THESE NEW CRITERIA. THE DIFFERENT CRITERIA ALSO HAVE A DIFFERENT NUMBER OF STEPS IN THEIR SCHEME. SO THE NATIONAL DIABETES DATA GROUP AND CNC CRITERIA ARE A TWO STEP PROCESS AS YOU HAVE HEARD WITH A 50-GRAM CHALLENGE AND 100-GRAM GTT. THE WORLD HEALTH ORGANIZATION, ADIIPS ARE ONE STEP PROCESS T CANADIANS USE A TWO STEP PROCESS IADPSG IS A ONE STEP PROCESS. SO THERE ARE DIFFERENCES AND PEOPLE COMPAREDDED THOSE PROCESSES AND I'M SURE WE'LL DO SO AS THE PROGRAM UNFOLDS. SO LET'S FOCUS HOW WE GO TO WHERE WE ARE IN THIS COUNTRY. THE MOST COMMON CRITERIA IN THIS COUNTRY ARE THE TWO THAT I MENTIONED. BOTH BASED ON O'SULLIVAN AND MAHAN CRITERIA. BEFORE THEY DID THEIR WORK, THE FIRST MENTION IS JAY MATTHEWS DUNCAN IN 1882 WHO SAID DIABETES MAY COME UNDER IN PREGNANCY, MAY OCCUR ONLY IN PREGNANT SANE MAY CEASE WITH TERMINATION OF PREGNANCY. THAT WAS THE FIRST MENTION WHAT WE CONSIDER GESTATIONAL TIE BEE TEASE. IN 1952 JACKSON POINTED OUT A HIGH LIKELIHOOD OF PREVIOUS STILLBIRTH IN MACROSOMEIA IN PREVIOUS PREGNANCIES IN WOMEN WHO DEVELOP DIABETES. IN 1957, ELSIE REED CARINGTON USED THE TERM IN PRINT, GESTATIONAL DIABETES. BEFORE O'SULLIVAN, THE COMMON DIAGNOSTIC CRITERIA FOR DIABETESES IN COUNTRY THE U.S. PUBLIC HEALTH SERVICE CRITERIA, I WON'T GO OVER THE DETAILS EXCEPT TO SAY THEY USE 100-GRAM THREE HOUR GTT AND THEY WERE COMPLICATED. THIS IS THE ONLY PICTURE I COULD FIND OF SEAN O'SULLIVAN LOANED TO ME BY DAVID HADDON. I KNOW HE WAS HERE IN OCTOBER WHEN THE CONFERENCE WAS CANCELED, I DON'T THINK HE'S HERE TODAY. O'SULLIVAN IS ONE ON THE LEFT. DAVID IS ONE OPT RIGHT. PREGNANCY CHANGES CARBOHYDRATE METABOLISM AND ORAL GLUCOSE TOLERANCE MAYBE ALTERED BY PREGNANCY AND NON-PREGNANT NORMS MAY NOT BE VALID DURING PREGNANCY. THEY PUBLISHED A STUDY OF 752 UNSELECTED PREGNANT WOMEN WHO HAD 100-GRAM THREE HOUR GTTs, MEASURED GLUCOSE IN VENOUS WHOLE BLOOD USING THE SUE MOW G. NELSON METHOD, I'LL GET TO THAT IN A MINUTE AND THEY DERIVE THRESHOLDS 1, 2, 3 STANDARD DEVIATIONS ABOVE THE MEAN FOR EACH OF THE FOUR L VALUES. SO THEY TRIED THOSE ON FOR SIZE. POTENTIAL CUT OFFS OF 1, 2, 3 STANDARD DEVIATIONS WERE APPLIED RETROSPECTIVELY TO THE SECOND SET OF GLUCOSE TOLERANCE TESTS IN 1300 PLUS PREVIOUS PREGNANT WOMEN. THESE HADe9sI UNDERGONE PERIODIC GTTs IN THE UNITED STATES SO THEY CAN DETERMINE HOW LIKELY THEY WERE TO DEVELOP DIABETES. THEY SETTLED ON THE USE OF TWO STANDARD DEVIATIONS WHICH GAVE 1.9% PREVALENCE OF GESTATIONAL DIABETES AND WAS ASSOCIATED WITH A 22% RISK OF SUBSEQUENT DIABETES WITHIN SIX YEARS. THESE WERE THE NUMBERS. THE UNROUNDED NUMBERS WERE WHOLE BLOOD, SUE MOW G. NELSON TECHNIQUE. YOU WILL SULLIVAN WAS AN INTERNIST AND HIS VIEW OF AN OBSTETRICIAN WAS SOMEBODY WHO COULDN'T REMEMBER NUMBERS NOT DIVISIBLE BY FIVE SO HE ROUNDED OFF TO THE NUMBERS YOU SEE. THE RATIONALE THAT O'SULLIVAN GAVE FOR USING TWO STANDARD DEVIATIONS WAS THE PREVALENCE WOULD BE 2% F YOU USE ONE STANDARD DEVIATION IT WOULD BE 16%. HE WAS CONCERNED ABOUT THE POTENTIAL PSYCHOLOGICAL EFFECT OF OVERDIAGNOSIS. AND THE 2% PREVALENCE WAS SIMILAR TO THE THE PREVALENCE OF DIABETES IN A NON-PREGNANT IMMUNITY AT THE TIME. A VERY INTERESTING STUDY WHERE HE WENT OUT AND TESTED EVERY -- AS CLOSE AS POSSIBLE TO EVERY INHABITANT OF SMALL TOWN IN MASSACHUSETTS TO GET PREVALENCE OF DIABETES. AT THAT TIME THEY'RE USING A STEROID MODIFIED GLUCOSE TOLERANCE TEST TO SEE WHO WAS AT RISK FOR DIABETES AN THOSE NUMBERS WERE SIMILAR TO ONES FROM THEIR TEST. WHY USE TWO ABNORMAL VALUES? THIS IS CRITICAL, THE BIGGEST CHANGE IN THE PROPOSED CRITERIA IS GOING FROM TWO ABNORMAL VALUES TO ONE ABNORMAL VALUE. THIS IS WHAT HE SAID. CONSIDEREDDED EXPEDIENT TO REQUIRE TWO OR MORE VALUES TO BE MET OR EXCEEDED. MISCLASSIFICATION DUE TO LABORATORY ERROR OR OCCASIONAL SINGLE HIGH PEAK RESULTING FROM UNUSUALLY RAPID ABSORPTION OF GLUCOSE COULD BE AVOIDED. PURELY TO MAKE SURE YOU WESTERN MAKING A DIAGNOSIS ON A SINGLE LABORATORY TEST. AND I THINK THE LABORATORIANS THAT WE WORK WITH THESE DAYS ARE MORE CONFIDENT IN THE RESULTS OF A SINGLE TEST BUT THAT WAS THE REASON O'SULLIVAN CHOSE TO DO THIS. WHEN FOLLOWED UP PATIENTS FOR AN AVERAGE OF 20 YEARS USING TWO DIFFERENT CRITERIA FOR DIABETES IN THE NON-PREGNANT STATE, THE NDDG ISN'T THE PREGNANCY VALUES, IT'S NON-PREGNANT STATE AND I WOULD JUST POINT OUT THAT CURRENTLY THE WHO CRITERIA ARE BASICALLY SAME AS ONES, THE NDDG RECOMMENDS AND ADA RECOMMENDS FOR DIABETES. 61% PREVIOUS GESTATIONAL DIABETES PATIENTS WOULD HAVE DIABETES WITHIN 20 YEARS COMPARED TO 14% OF CONTROLS WITH NORMAL GLUCOSE TOLERANCE AND PREGNANCY. NOW, AFTER THOSE STUDIES WERE PUBLISHED. EVERYTHING TAKE AS LONG TIME. SO 1964 WAS WHEN THOSE WERE PUBLISHED. EIGHT YEARS LATER ACOG PUBLISHED ALTERNATIVE DATA NOT SETTLING ON A PARTICULAR ONE. FOUR YEARS AFTER THAT, THE USUAL TEXTBOOK OF OBSTETRICS, WILLIAMS OBSTETRICS INCLUDING O'SULLIVAN MAY HAHN CRY TIERIA. THAT WAS 12 YEARS AFTER PUBLICATION. TWO YEARS LATER, ACOG RECOMMENDED THE O'SULLIVAN AND MESSMAN CRITERIA, ANOTHER SET. IF 1979 THE NATIONAL DIABETES DATA GROUP PUBLISHED THEIR CONVERSION OF O'SULLIVAN, MAYHAN'S CRITERIA. TO CONVERT, THEY -- BECAUSE MOST SWITCHED FROM WHOLE BLOODS TO PLASMA OR SERUM T NDDG TOOK THE ROUNDED O'SULLIVAN NUMBERS, HE ROUNDED THEM OFF TO MAKE EASY FOR OBSTETRICIANS, THEY TOOK THE ROUNDED NUMBERS, ADDED 15% AND GOT THE NUMBERS 105160 AND 1455. IN 1980, THE FIRST INTERNATIONAL WORKSHOP CONFERENCE ON GESTATIONAL DIABETES, THERE'S A SERIES OF CONFERENCES EVER SINCE ENDORSED THE NDDG CRITERIA, ADDITIONAL ADJUSTMENTS MAYBE NECESSARY AND AMERICAN DIABETES ASSOCIATION ENDORSED THOSE CRITERIA. TWO YEARS LATER, WE P PUBLISHED OUR CRITERIA WHICH WERE BASED ON TWO THINGS THE SUE MOW G. NELSON TO ENZYMEATIC METHODS, SO IT MEASURED REDUCING SUBSANSES OTHER THAN GLUCOSE SO IT OVERESTIMATED GLUCOSE. THEN CORRECTION TO PLASMA. WE STARTED WITH THE UNROUNDED O SULLIVAN NUMBERS, MORE REASONABLE THING TO DO. AND MADE CORRECTIONS, GOT 95, 180, 155, 140. WHICH ARE ARE CORRECT? DAVID IS SITTING HERE TODAY, DID A COMPARATIVE STUDY, HE RECREATED O'SULLIVAN'S ORIGINAL METHODOLOGY AND RAN THE SAME SAMPLES BOTH WITH WHOLE BLOOD SUE MOW G. NELSON AND PLASMA GLUCOSE OXIDASE AND FOUND THOSE VALUES WITH AN ASTERISK WERE WITHIN 95% CONFIDENCE INTERVALS OF WHAT HE WOULD HAVE GOTTEN ON THE CONVERSION. THAT CONVINCED US FURTHER CRITERIA WE WERE USING ON THE FAR RIGHT WERE REASONABLE. IN 1986 ACOG ENDORSED THE NDDG CRITERIA AND BY 1994 ACOG RECOMMENDED EITHER SET OF CRITERIA. WHICH THEY STILL DO TODAY. THE WORLD HEALTH ORGANIZATION RECOMMENDED A 75-GRAM 2 HOUR GTT. OTHER STUDIES WE'RE USINGING A 50-GRAM GTT. SO IN 1992, THE NICHD HAD A WORKSHOP ON ADVERSE PERINATAL OUTCOMES AND SAID QUESTIONS ABOUT EFFORTS TO DIAGNOSE AN TREAT GESTATIONAL DIABETES TO PREVENT ADVERSE PERINATAL EFFECTS CANNOT BE RESOLVED WITHOUT ADDITIONAL STUDIES. IT WILL ENABLE INVESTIGATORS TO CORRELATE VARYING GLUCOSE INTOLERANCE. THIRD INTERNATIONAL WORKSHOP CAME AND POINTED OUT INTERNATIONAL AGREEMENT, WE COULDN'T COMPARE PREVALENCE FROM ONE COUNTRY TO ANOTHER. AND SAID SINCE THE 75-GRAM CHALLENGE IS WHAT'S UNIVERSEALLY USED AROUND THE WORLD FOR DIAGNOSING DIABETES IN THE NON-PREGNANT SATE, EVENTUALLY IT WOULD BE USE IN THE PREGNANT STATE. THEY POINTED OUT WHAT YOU HAVE HEARD TODAY, O'SULLIVAN CRITERIA ARE BASED ON TWO STANDARD DEVIATIONS, THE WORLD HEALTH ORGANIZATION CRITERIA ON NON-PREGNANT VALUES AND NONE WERE BASED ON PREGNANCY OUTCOMES. FOURTH INTERNATIONAL WORKSHOP CONFERENCE SAME FINDINGS AND SAID WE NEED HIGHER PRIORITY ON DEVELOPING INTERNATIONAL CONSENSUS. BY 1999, THE AMERICAN DIABETES ASSOCIATION RECOMMENDED WITH CNC CRITERIA, HA BECOMEO STARTED IN -- ENDED IN 2008 AND IN 2010 THE IADPSG RECOMMENDATIONS WERE PUBLISHED. BY 2011 ADA REPD THE AIDPSG CRITERIA AND ACOG CONTINUES TO RECOMMEND EITHER NDDG OR CNC CRITERIA. I WANT TO SPEND A MOMENT ON THE EVOLUTION OF THE TWO STEP PROCESS. THAT IS ANOTHER IMPORTANT ISSUE IN SCREENING AND TESTING. IN 1973 O'SULLIVAN DESCRIBED THE SCREEN. VENOUS WHOLE BLOOD, ONE HOUR AND GOT A CUT OFF HE RECOMMENDED OF 130 WHICH IDENTIFIED 79% OF GESTATIONAL DIABETIC PATIENTS IN HIS COHORT. IN 1982, WE CONVERTED THAT 130 TO 143 FOR PLASMA AND GLUCOSE OXIDASE BUT FOUND IT WAS STILL NOT VERY SENSITIVE OR SENSITIVE AS WE LIKE IT TO BE. AND WE DEMONSTRATED THAT LOWERING THE THRESHOLD TO 130 INCREASE SENSITIVITY TO NEAR 100% AND 140 IT WOULD BE 90%. THE TRADE OFF WAS THAT IF YOU USE 130, 21% OF THE POPULATION REQUIRE FULL GTT. AS 140 ONLY 14% DID SO. 1986 ACOG RECOMMENDED 50-GRAM ONE HOUR SCREEN FOR WOMEN AGE GREATER THAN OR EQUAL TO 30 YEARS OR YOUNGER WOMEN WITH HISTORIC RISK FACTORS. AND I JUST WANT TO STOP FOR A MINUTE AND SAY VARIOUS RECOMMENDATIONS FROM ACOG TEND TO BE LEVEL 3. THE OPINIONS OF EXPERTS. THERE WAS NOT A LOT OF DATA. IN 2001, I SAY THAT I WROTE MANY OF THEM BUT THEY WERE LEVEL 3. ACOG PRACTICE BULLETIN REAFFIRMED IN 2010 RECOMMENDED UNIVERSEAL 50-GRAM ONE HOUR SCREENING EXCEPT IN LOW RISK WOMEN. I HAVEN'T SEEN ONE OF THESE LOW RISK WOMEN. THEY HAVE TO BE LESS THAN AGE 25 IN NON-HIGH RISK RACIAL OR ETHNIC GROUP, BMI UNDER 25, NO HISTORY OF ABNORMAL GLUCOSE TOLERANCE, NO FIRST DEGREE RELATIVE WITH DIABETES. WHERE ARE WE NOW? ACOG SAYS EITHER OF THE TWO SETS OF CRITERIA FOR THE 100-GRAM GTT WITH TWO ELEVATED VALUES, UNIVERSEAL 50-GRAM SCREEN TWO STEP PROCESS EXCEPT LOW RISK WOMEN AND ADA RECOMMENDS THE IADPSG CRITERIA WITH ONE ELEVATED VALUE INSTEAD OF TWO, ONE STEP PROCESS. ADDITIONALLY TESTING HIGH RISK WOMEN AT FIRST VISIT FOR PRE-EXISTING DIABETES, SOMETHING I DON'T THINK WE'LL BE GETTING INTO IN THIS CONFERENCE. SO I WANT TO SHOW YOU AGAIN DIFFERENT SETS OF CRITERIA. THE NEWLY RECOMMENDED CRITERIA ARE SOMEWHERE IN THE MIDDLE BETWEEN THE WORLD HEALTH ORGANIZATION AND CNC AT LEAST FOR THE TWO HOUR VALUES. AND WHEN PEOPLE HAVE SAID THERE ARE NO DATA THAT INTERVENTION WILL PREVENT ADVERSE OUTCOMES I THINK THAT'S NOT ENTIRELY TRUE. SINCE THE A CHOICE STUDY USED THE WORLD HEALTH ORGANIZATION 140 SINGLE ABNORMAL VALUE OVER 140 AND FOUND INTERVENTION SIGNIFICANTLY PREVENT ADVERSE PERINATAL WITHOUT COMES. SO WHETHER PEOPLE DIAGNOSE BY FASTING OR ONE HOUR VALUE SIMILARLY BE HELPED IS WHAT'S NOT SO CLEAR. IF THE IADPSG CRY TIER QUA ARE ADOPTED THE BIGGEST CHANGE IS NOT THE NEW THRESHOLDS. THEY'RE SIMILAR TO THE OLD ONES. IT'S A TRANSITION FROM TWO ELEVATED VALUES TO ONE ELEVATED VALUE. IN THE HAPLO DATA SET, WHEN DAVID P PUBLISHED THE -- YOU SAW A SLIDE EARLIER ON THE DIFFERENT CENTERS IN THE PREVALENCE, HE ALSO SHOWED HOW MANY PATIENTS WOULD BE IDENTIFIED BY PARTICULAR VALUE? THAT DATA SET 64% GDMs ARE DIAGNOSED ON SINGLE ABNORMAL VALUE, DIDN'T HAVE TWO VALUES. WHAT THAT TELLS US IS THAT THAT'S THE BIG CHANGE. THAT'S THE BIG CHANGE THAT'S BEING RECOMMENDED. SO LET ME STOP THERE. THANK YOU. [APPLAUSE] >> THANK YOU, DON. IT'S FUN TO LOOK BACK AND SEE HOW WE GOT WHERE WE'VE GOTTEN. THAT'S PART OF THE PROBLEM. LET'S NOW TURN TO QUESTION 2, WHAT ARE AFFECTS OF VARIOUS GESTATIONAL DIABETES SCREENING AND DIAGNOSTIC APPROACHES FOR PATIENTS, PROVIDERS AND U.S. HEALTHCARE SYSTEMS. OUR FIRST SPEAKER ON THAT TOPIC IS WANDA NICHOLSON WHO IS DIRECTOR OF DIABETES AND OBESITY CARE IN THE CENTER FOR WOMEN'S HEALTH RESEARCH. AND ALSO ASSOCIATE PROFESSOR IN OBGYN DEPARTMENT, UNIVERSITY OF NORTH CAROLINA. WANDA. >> I WANT TO THANK THE NATIONAL INSTITUTES OF HEALTH SPECIFICALLY DR. KATHERINE SPONG AN DR. GUTTMACHER FOR INVITING ME HERE TODAY. ALSO WANT TO THANK THE OFFICE OF DISEASE PREVENTION AND THE PANEL. SO MY OBJECTIVES TODAY ARE JUST A FEW OBJECTIVES. ONE, TO EMPHASIZE HEALTHCARE UTILIZATION WITH DIFFERENT DIAGNOSTIC THRESHOLDS. SECOND, TO DESCRIBE THE CHANGE IN THE PROCESS AND CARE THAT WOULD BE REQUIRED FOR ANY CHANGE IN CRITERIA. TO OFFER A FEW IMPLEMENTATIONS STRATEGIES. AND THEN PROVIDE A HYPOTHETICAL MODEL OF RESOURCE USE. AND FINALLY LEAVE YOU WITH A FEW THOUGHTS TO PONDER. SO JUST BRIEFLY GESTATIONAL DIABETES IS GLUCOSE INTOLERANCE FIRST RECOGNIZED OR DIAGNOSED IN PREGNANCY. NORMALLY DIAGNOSED AFTER 24 WEEKS OF PREGNANCY, WE KNOW IN GENERAL THERE'S A WIDE RANGE OF PREVALENCE FROM 2 TO 10% IN GENERAL A RANGE OF 5 TO 7%. BASED ON DIAGNOSTIC CRY CRITERIA AND DEMOGRAPHICS. WE HAVE BEEN SEEING INCREASE IN PREVALENCE GESTATIONAL DIABETES WHICH PARALLELS THE RISE IN OBESITY AND TYPE 2 DIABETES IN THE US. CYCLE OF GESTATIONAL DIABETES WE REFER TO IS IMPORTANT BECAUSE IT CAN BE ONGOING CYCLE FOR MOTHERS AND OFFSPRING. WITH DIAGNOSIS OF GESTATIONAL DIABETES, THERE ARE IMPLICATIONS FOR INFANTS AS WELL AS MOTHERS. IT'S ASSOCIATED WITH HYPERGLYCEMIA AND THAT IS ASSOCIATED WITH INCREASE IN GESTATIONAL WEIGHT GAIN. SUBSEQUENTLY, IF YOU LOOK HERE TO THE LEFT, YOU'LL SEE SHORT TERM ADVERSE OUTCOMES THAT MAY OCCUR IN INFANT. WE CAN SEE ACCELERATED INFANT GROWTH AND INFANT -- THAT CAN OCCUR IN PARALLEL WITH INCREASE AMOUNTS OF POSTPARTUM WEIGHT AND RETENTION IN THE MOTHER. CERTAINLY FROM OBSTETRICAL STANDPOINT WE'RE CONCERNED ABOUT LONG TERM ADVERTS OUTCOMES IN THE INFANT. CHILD OBESITY, DEVELOPMENT EARLY DEVELOPMENT INCREASING BODY MASS INDEX AND LONG TERM OBESITY AN DIABETES. INFANTS ULTIMATELY WE'RE CONCERNED WITH PRE-DISPOSITION TO ADULT OBESITY WHICH IN ANY SUBSEQUENT PREGNANCY PARTICULARLY FEMALE INFANT TO PUT THAT MOTHER AT RISK FOR PRESENTENING PREGNANCY IN ADULTHOOD AD TYPE 2 DIABETIC OR ULTIMATELY OVERWEIGHT, OBESE OR RISK OF DEVELOPING GESTATIONAL DIABETES. SO THIS INFINITE CYCLE OF BRINGS US TO CONTEMPLATE THE CRITERIA FOR DIAGNOSING GESTATIONAL DIABETES. OUR GOAL HERE IS TO REDUCE SUBSEQUENT ADVERSE OUTCOMES, SHORT AND LONG TERM IN THE INFANT. AND AS A RESULT WE HAVE AN EVOLVING SCREENING CRITERIA. I WON'T BELABOR THIS POINT, IT'S BEFORE COVERED BY DR. COURSE STAN, JUST TO EMPHASIZE -- COUSTAN. IN THE U.S. OUR SCREENING HAS BEEN A TWO STEP PROCESS. CERTAINLY THE OBSTETRICIANS ARE FAMILIAR WITH THIS METHOD OF SCREENING AND DIAGNOSING DIABETES. USING 50-GRAM SCREENING TEST FOLLOWED BY THREE HOUR ORAL GLUCOSE TOLERANCE TEST. HERE I LISTED THE THRESHOLD OR CUT OFFS IN THE COUSTAN MODEL. AS DR. COUSTAN EMPHASIZED, TWO OR MORE ELEVATED VALUES ARE USED AND REQUIRED FOR DIAGNOSIS. BUT THE NEWLY PROPOSED CRITERIA, AGAIN, LISTED THE THRESHOLDS HERE, I WON'T BELABOR BUT THE KEY ISSUE BEING WE'RE LOOKING AT ONE OR MORE ELEVATED VALUES, THE KEY TO DIAGNOSTIC CHANGE. JUST QUICKLY THE SCREENING STRATEGY FOR OVERT DIABETES IS FASTING PLASMA GLUCOSE ABOVE 126 OR A 1C ABOVE AVENUE 1/2 PERCENT. WHY IS THIS CHANGE IMPORTANT? WHAT BRINGS US TO DISCUSS AN CONTEMPLATE? THE HAPLO STUDY WHICH FINDINGS SUGGEST THERE WOMEN -- THERE ARE MANY WOMEN WHO HAVE OVERT DIABETES BUT RECOGNIZED AS BEING DIABETIC. GLUCOSE LEVELS BELOW THOSE THE CURRENT THRESHOLD CAN BE ASSOCIATED WITH INFANT COMPLICATIONS. NOTABLY A HIGHER BIRTH WEIGHT WHICH LEADS TO SHORT AND LONG TERM OUTCOMES THAT WERE LISTED IN THE EARLIER DIAGRAM OPT CYCLE AND LONG TERM METABOLIC ALTERATIONS IN FETUS ELEVATEDDED BY C PEPTIDE LEVELS. BUT KEY TAKE HOME POINT IS PREVALENCE CHANGE, THAT INCREASES FROM 5 TO 7% WE'RE ACCUSTOMED TO IN THE U.S., 18% WHICH REPRESENT AS THREEFOLD CHANGE. A LOT OF CONTROVERSY, A LOT OF DEBATE. WE'RE HERE TO LOOK AT EVIDENCE AND WEIGHT THE EVIDENCE AND WEIGHING EVIDENCE IS L CHALLENGING. PERCEPTIONS OF BENEFIT AND HARMS VARY. ALL OF US IN THE HEALTHCARE SYSTEM HAVE CONCERNS ABOUT IMPLEMENTATION. WE CHANGE SCREENING STRATEGIES OR DIAGNOSTIC CRITERIA, HOW DO WE THEN TRANSITION THIS INTO OUR DAY TO DAY CARE OF PATIENTS AND HOW MIGHT THE HEALTH SYSTEM INFRASTRUCTURE NEED TO BE CHANGED. CHANGE IS HARD. THIS DEBIT OR CONTROVERSY IMPLEMENTING THIS, BEWE BEGAN THE DISCUSSION BEFORE THIS BEGAN. WE TALK ABOUT IMPLICATION OF INCREASED FREQUENCY. AND THEN YOU SEE DR. CUNDY WHO WILL BE HERE PRESENTING THE AFTERNOON WHO IN HIS REVIEW ARTICLE PROMPTED US FOR PAUSE FOR THOUGHT. WE HAVE BEGUN THIS CONVERSATION ALREADY. THE CONVERSATION, THIS SERVES AS A FRAMEWORK FOR MY TALK MOVING FORWARD, A FRAMEWORK OF LOOKING AT THE BALANCE OF BENEFITS AND HARM. IN MANY CASE LOOKING AT BENEFITS AND HARMS WE'RE THINKING ABOUT RISK AS WELL AS ADVANTAGES. ADVANTAGES OR DISADVANTAGES. BUT IN THE FRAMEWORK OF MY PRESENTATION, WHAT I WANT TO TAKE A FEW MINUTES TO PONDER, IS HOW DO WE LOOK AT THE BALANCE OF BENEFIT AND HARM AS IT RELATES TO HEALTHCARE UTILIZATION. OUR GOAL IS TO IMPROVE NEWBORN HEALTH, DECREASE DELIVERY COMPLICATIONS AND IDENTIFY OVERT DIABETES. SO WE HAVE THE BALANCE THAT WITH WHETHER WE'RE MOVING TO A SITUATION WE MIGHT BE OVERT IN AREA OF OVERDIAGNOSES AN SERVICES OR PROVIDING MORE SERVICES TO WOMEN, AND WE ALSO HAVE TO LOOK AT IT IN TERMS OF HEALTHCARE SYSTEM AND GREATER RESOURCES REQUIRED. THAT BRINGS US TO THE PRIMARY QUESTION, POSEDDED WITH QUESTION 2, HOW DO WE IMPLEMENT THIS IN A REAL WORLD SETTING. WHAT ARE AFFECTS OF VARIOUS SCREENING AND DIAGNOSTIC APPROACHES? I THINK TO GET A FULL FRAMEWORK OR FULL VIEW OF THAT WE HAVE TO LOOK AT THE MULTIPLE STAKE HOLDERS THAT ARE INVOLVED. 4 MILLION WOMEN DELIVER IN THE UNITED STATES. WHATEVER STRATEGY WE DECIDE TO PROCEED WITH. SECOND ARE PROVIDERS. THIS INCLUDES A WIDE RANGE. OBSTETRICIANS, MIDWIVES, PRIMARY CARE PHYSICIANS AN PEDIATRICIANS. FINALLY INCLUDES DIVERSE CLINICAL SETTINGS WHICH ALL WORTH WHETHER PRIVATE PRACTICE IN A RURAL COMMITTEE, TERTIARY CARE CENTER OR LOCAL HEALTH DEPARTMENT. THE PRIMARY AREAS TO FOCUS ON ARE TIME. POTENTIAL PSYCHOSOCIAL HE WANTS AND HEALTHCARE RESOURCES. THE THREADED CLOCK. LOOK AT TIME AND COMPARE THE ONE STEP VERSUS THE TWO STEP PROCESS, AGAIN. THE TWO STEP IS THE 50-GRAM PATH THAT EVERY WOMAN WOULD BE SCREENED WITH FOLLOWED BY THE ONE HOUR -- 100-GRAM THREE HOUR TEST THOSE WHO INITIALLY SCREEN POSITIVE. ONE ADVANTAGE OF THE CURRENT PROTOCOL IS WE HAD THE ABILITY THE SCREEN WITH SHORTER TASK ONE HOUR COMMITMENT FEWER THAN ONE HOUR TASK. YOU WILL IN PRACTICE ADMIT IT'S RELATIVELY EASY TO ADMINISTER. ONE DOWN SIDE IS IT REQUIRES TWO VISITS POTENTIALLY NEEDED. IN SOME CASES PARTICULARLY WHEN LOOKING AT LOW RESOURCE SETTINGS AND LOW INCOME WOMEN AND DELAY DIAGNOSIS. COMPARING TO THE ONE STEP PROCESS, IN GENERAL WE HAVE DIAGNOSIS WITH ONE TASK, IT IN TERMS OF U.S. MAKE US MORE IN LINE WITH IN OTHER COUNTRIES. ONE POTENTIAL DISADVANTAGE IS IT REQUIRES ALL PATIENTS TO PRESENT IN FASTING STATE SO FROM THE PATIENT PERSPECTIVE AS WELL AS HEALTH SYSTEM PERSPECTIVE, THIS WOULD BE A REAL CHALLENGE TO CONSIDER. IN TERMS OF TIME FOR PATIENTS WE'RE LOOKING AT POTENTIAL OF MORE -- IF YOU LOOK AT STUDIES BY YOUTHER FROM 2005 PRESENTED IN SUMMARY LATER TODAY, THERE ARE A HIGHER NUMBER OF PRE-NATAL VISITS AMONG WOMEN TREATED WITH GESTATIONAL DIABETES. MORE VISITS AND MORE TESTS. ADDITIONAL TIME IS REQUIRED FOR GLUCOSE ASSESS AS WELL AS AVERAGE ONE HOUR NUTRITIONAL COUNSELING APPOINTMENT. THEN THE DOWNSTREAM CONSEQUENCES THAT RESULTS IN INCREASE IN FETAL TESTING, NON-STRESS TEST AND OTHER EVALUATIONS. WITH THAT CAUSE US TO BE IMPLEMENT OBSTETRICAL ULTRA SOUND TO ASSESS FETAL GROWTH? AND WHAT ARE DOWNSTREAM CONSEQUENCES, MANY CASES MIGHT BE UNDERSTAND NECESSARY TESTING THAT LEADS TO IMPOSSIBLE INCREASE INDUCTION OF LABOR OR CESAREAN DELIVERY. ANOTHER OUTCOME VIEWED AS RELATED TO HEALTH RELATED QUALITY OF LIFE PSYCHOSOCIAL OUTCOME. IN GENERAL THERE'S LIMITED DATA ON THIS WITH REGARD TO DATA. 2005 CROUTHER CONDUCTED A CLINICAL TRIAL COMPARING OUTCOME OF WOMEN SCREENING POSITIVE FOR GESTATIONAL DIABETES AND TREATED COMPARED TO A GROUP DIAGNOSED WITH UNTREATED. -- BUT UNTREATED. THREE POINTS ALONG THE COURSE OF THE TRIAL. LOWER RATES OF DEPRESSION IN WOMEN DIAGNOSED AND TRADITIONALLY TREATED FOR GESTATIONAL DIABETES AT THREE MONTHS POST PARTUM. SO AGAIN, LIMITED DATA ON PSYCHOSOCIAL EFFECTS OF DIAGNOSIS AND TREATMENT BUT WHAT WE DO HAVE SUGGESTS BENEFITS WITH TREATMENT RESOURCE OF DELIVERY. IN GENERAL, WHEN MANY CLINICAL CIRCUMSTANCES LABOR INDUCTION FOR GESTATIONAL DIABETICS THAT OCCUR AT 39 OR 40 WEEKS OF PREGNANCY. BUT WE KNOW CESAREAN DELIVERY RATES IN THIS GROUP VARY ACROSS THE U.S. AND THERE'S MULTIPLE DECISIONS, AND FACTORS THAT CONTRIBUTE TO THE DECISIONS FOR CESAREAN DELIVERY, PHYSICIAN CONCERN, OVER DIAGNOSIS OF GESTATIONAL DIABETES AND THAT MAY IN FACT AFFECT HOW TO INTERPRET LABOR OR FETAL STATUS DURING LABOR. ALSO THE ISSUE OF AVAILABILITY OF OTHER HOSPITAL PERSONNEL INCLUDING HIGH RISK NURSES OR IN HOUSE ANESTHESIA. THEN AS ALWAYS PATIENT AND FAMILY EXPECTATIONS WHENEVER THERE'S ADDITIONAL DIAGNOSIS. SO OUR SECOND KEY GROUP, PERMISSIONS OF STAKEHOLDERS AGAIN LOOKING AT TIME, PERSONNEL AN IMPLEMENTATION STRATEGIES. TIME IS MORE VIVID ON THE PART OF CLINICIANS. ADDITIONAL APPOINTMENT FOR LARGER NUMBER OF WOMEN WHO NOW HAVE THIS DIAGNOSIS, ADDITIONAL TIME FOR ASSESSMENT AND RECOMMENDATIONS AROUND GLUCOSE LEVELS, PROVIDING OFFICE PRACTICE FOR A COMMUNITY SETTING THAT CAN NOW BROAD PEN WASES TO PROVIDE NUTRITIONAL COUNSELING NEEDED BY HIGH NUMBER OF WOMEN AND DIABETIC EDUCATION. WILL WE NEED TO PROVIDE MORE AVAILABILITY OF NURSES CERTIFIED TO PROVIDE EDUCATION AND TEACHING. ANOTHER KEY POINT ABOUT PERSONNEL HAS TO DO WITH NUTRITIONAL COUNSELING AND DR. LANDON WILL CERTAINLY BE SPEAKING TODAY BUT I WANT TO QUOTE HIS ARTICLE: THIS WAS A TRIAL OF MILD GESTATIONAL DIABETES, 958 WOMEN WERE RANDOMIZED TO ON GOING NUTRITIONAL COUNSELING DURING THE COURSE OF PREGNANCY VERSUS USUAL CARE. AS YOU CAN SEE THE MAIN RESULTS HERE INTERVENTION VERSUS USUAL CARE GROUP LOWER RATES OF CESAREAN DELIVERY IN THE TREATED GROUP, LOWER INFANT BIRTH WEIGHT AND LESS HYPERTENSIVE DISEASE IN THOSE WHO RECEIVED NUTRITIONAL COUNSELING. CERTAINLY THE DATA WE HAVE AVAILABLE SUGGESTS THAT MAKING THIS AVAILABLE AND MAKING THESE CHANGES WOULD BE PRUDENT. WHEN IT COMES TO PROVIDERS, IMPLEMENTATION, HOW WE BROADEN OURSELVES TO PROVIDE MORE TREATMENT. WOULD WE THEN HAVE TO LOOK INTO OPPORTUNITIES TO PROVIDE CARE IN BETWEEN THE INTERVALS FOR PRE-NATAL APOINTMENTS. ONE OPTION THAT MIGHT BE AVAILABLE WE HAVE BEEN DOING INITIAL STUDIES ON IS USING OR DEVELOPING ELECTRONIC PROGRAMS THAT ASSISTS PHYSICIANS IN MANAGING GLUCOSE LEVELS AND FOLLOWING UP PATIENTS OUTSIDE ROUTINE APPOINTMENTS. I'LL2xw ALLUDE TO THIS ONE CURRENTLY TESTED AT MY HOME INSTITUTION, KNOWN AS THE GOOD MOM STUDY, A GESTATIONAL DIABETES MANAGEMENT SYSTEM. AS PART OF THIS SYSTEM, WE ADVOCATED AS AN ELECTRONIC PATIENT PROVIDER TOOL. AS YOU CAN SEE HERE, THERE ARE OVER THE COURSE OF PREGNANCY THERE ARE WEEKLY LESSONS, ALSO ONLINE SELF-MONITORING OF GLUCOSE AND WEIGHT AND ALSO TIPS AND EDUCATIONAL PIECES THAT HELP WOMEN BETTER MANAGE GESTATIONAL DIABETES. THESE ARE TOPICS THAT MIGHT HAVE TO BE LOOKED AT IF WE EXPAND THE CRITERIA. IF WE HAVE EVER INCREASING NUMBER OF WOMEN WITH THIS TIGHT KNOWSIS, WE HAVE -- DIAGNOSIS WE HAVE TO IMPLEMENT CHANGES THAT PROVIDE OPPORTUNITY FOR PHYSICIANS TO PROVIDE ONGOING CARE BUT CARE THAT MAY NOT BE ABLE TO TAKE PLACE IN THE TRADITIONAL OFFICE PRACTICE. THEN PROMOTING CARE AFTER DELIVERY. AGAIN DILEMMA FOR US CLINICIANS. THIS GETS TO THE AREA OF POSTPARTUM SCREENING, ENTERCONCEPTION CARE, AN COLLABORATIVE MODELS FOR US TO LOOK AT FOR CARE. AGAIN, OUR GOAL LOOK AT CRITERIA, TO EMPHASIZE NEWBORN OUTCOMES BUT CURRENT ISSUE WE DEAL WITH IS THAT OUR POSTPARTUM RATES FOR SCREENING FOR PERSISTENT GLUCOSE INTEL P ANSWER ARE LOW, ONLY-OF PATIENT WHOSE NEED TO BE SCREENED AT 6 TO 12 WEEKS ARE ACTUALLY SCREENED. SO WHEN WE LOOK AT CURRENT HEALTHCARE MODEL, THIS IS AN AREA CURRENTLY BEING DISCUSSED IN THE LITERATURE AND AN AREA THAT NEEDS ADDITIONAL ATTENTION AND GROWTH. SO I THINK WE HAVE TO LOOK CRITICALLY WITHIN OUR CURRENT SYSTEM HOW IT WAS THEN DEVELOPED TO ENGAGE A THREEFOLD INCREASE IN WOMEN WITH GESTATIONAL DIABETES WHO NOW NEED TO PRESENT POST PARTUM SCREENING AND TESTING. SOME OF THE BARRIERS HERE THAT MOST WOMEN ARE NOT PREVENTING IN A FASTING STAGE. THERE CAN BE POOR COMMUNICATION BETWEEN PATIENTS AND PROVIDERS ABOUT THE NEED FOR TESTING. THERE IS SOMETIMES CROSS TALKS BETWEEN OBSTETRICIANS AN PRIMARY CARE PROVIDERS AS WE TRANSITION WOMEN FROM OB CARE TO PREPARE CARE. THERE'S LITTLE DATA ON THE PEDIATRIC APPROACH TO OFFSPRING OF GESTATIONAL DIABETICS. HOW DO WE MOVE FORWARD IN THIS AREA AFTER DELIVERY? ONE PROCESS, DO WE LOOK AT INTEGRATING INTERCONCEPTION CARE MORE TO OBSTETRICAL PACKAGES OF INFORMATION THIS GETS BACK TO OUR CORE PRINCIPAL HERE OF HEALTHCARE UTILIZATION AND INCREASING SERVICES. DO WE DEVELOP MODELS TO IMPROVE LIFESTYLE INTERVENTIONS IN WOMEN AFTER DELIVERY COMPLICATED BY GESTATIONAL DIABETES? WE HAVE TO LOOK AT WHAT POTENTIAL FINANCIAL IMPACT WOULD BE ON HEALTHCARE COVERAGE. DO WE CONSIDER EXTENDING THE PERINATAL PERIOD TO SIX MONTHS OR ONE YEAR TO BETTER ACCOMMODATE WOMEN AND REDUCE RISK OF PROLONGED METABOLIC ADVERSE EVENTS AND HOW DO WE MOVE FORWARD IN IMPROVING OVERALL OUTCOMES FOR THIS MOTHER CHILD DYAD, HOW DO WE PROCEED TARGETING THE GROUP AFTER DELIVERY. ONE OPTION IS A COLLABORATIVE MODEL OF CARE, AND IN GENERAL, WE ARE PRACTICING A COLLABORATIVE MODEL OF CARE, WE HAVE OBSTETRICIANS WHO INTERACT WITH PRIMARY CARE PROVIDERS AND DIABETIC EDUCATORS, PROMOTE SELF-MANAGEMENT IN PATIENTS, WE PROMOTE PATIENT PROVIDER COMMUNICATION AN DECISION SUPPORT. BUT HOW DO WE GET THIS TO WORK TOGETHER ON ALL CYLINDERS FOR LARGER GROUP OF WOMEN? HOW DO WE MAKE PATIENTS MORE PROACTIVE IN CARE AN LEAD TO BETTER OUTCOMES WE WANT FOR MOMS AND OFFSPRING. FINALLY HOW WE LOOK AT THE HEALTH SYSTEM AS STAKEHOLDER. HOW DO WE CHANGE PRACTICE. ACCOMMODATE LABORATORY VOLUME ASSOCIATED WITH DIFFERENT TESTING TECHNIQUE AND AGAIN, WE'RE BACK TO THE BASIC CONCEPT OF RESOURCE UTILIZATION. SCREENING IN GENERAL, HOW DO WE GET THE MESSAGE OUT? HOW DO WE GET THE MESSAGE OUT TO WOMEN PRESENTENING PREGNANCY THAT YOU NEED TO PRESENT IN THE FASTING STATE NOR YOUR GLUCOSE EVALUATION. LABORATORY WORKLOAD, WE LOOK AT LABS, WE NEED POTENTIAL INCREASE IN LABORATORY PERSONNEL TO ACCOMMODATE A TEST OVER TWO HOUR PERIOD RATHER THAN THE INITIAL SCREENING PERIOD. THIS IS AGAIN PARTICULARLY IMPORTANT IN LOW RESOURCE SETTINGS. HOSPITAL BASED CLINICS OR HEALTH P DEPARTMENTS, CROSS TALK BETWEEN LABORATORY AND PRACTITIONERS. MY COLLEAGUES WILL COME LATE TORE TALK ABOUT COST EFFECTIVENESS LOOKING AT DIFFERENT SCREENING MODALITIES BUT ANOTHER POINT THE TO MAKE CLEAR IS HOW TO THE LOOK AT ISSUES OF COST AND e BURDEN TO LABORATORIES AND HOW TO COMPARE THAT COST AND BURDEN TO THE OVERALL POTENTIAL INCREASE AND IMPROVEMENT IN OUTCOME. FINALLY THE LEAVE WITH A BROADER FRAMEWORK OF RESOURCE UTILIZATION, I WANT US TO LOOK AT A HYPOTHETICAL MODEL. THIS IS USING A PREVALENCE OF 6% PREVALENCE RATE IN THE US. THIS CORRELATES TO 240,000 WOMEN WITH GDM, 180,000 NUTRITIONAL COUNSELING. 1.2 MILLION PRE-NATAL VISITS. 67,000 CESAREAN DELIVERIES AN UP TO 240,000 EPISODES OF POSTPARTUM SCREENING. IF WE LOOK AT TRANSITIONING TO A HIGHER PREVALENCE RATE, SAY WE SKIP HERE TO THE LAST ROW OF 18%, YOU SEE A THREEFOLD INCREASE ACROSS THE BOARD. LOOKING ABOUT 720,000 WOMEN WITH DIAGNOSIS OF GESTATIONAL DIABETES. OVER 540,000 NUTRITIONAL COUNSELING SESSIONS. 3.6 MILLION VISITS, OVER 200,000 INDUCTIONS OR CESAREAN DELIVERIES. WHEN WE LOOK AT THIS FRAMEWORK OF RESOURCE UTILIZATION, IT DOES CAUSE US TO PAUSE FOR THOUGHT. SO IN CLOSING, FUTURE DIRECTIONS I WOULD HYPOTHESIZE SEVERAL AREAS WE NEED TO FOCUS ON FOR IMPLEMENTATION RESEARCH. ONE DEVELOPING PROTOCOLS THAT WORK ACROSS SETTINGS. DEVELOPING INNOVATIVE APPROACHES TO ASSIST PROAID VIEWERS COMMUNICATING WITH PATIENTS AND CREATING EFFECTIVE MODELS FOR ADHERENCE TO POSTPARTUM SCREENING AFTER DELIVERY. SO RATHER THAN LEAVING YOU WITH A LIST OF CONCLUSIONS I WANT TO LEAVE YOU WITH KEY POINTS TO PONDER. AS WE MOVE FORWARD DISCUSSING DIAGNOSTIC CRITERIA, WE HAVE TO LOOK AT ADVANTAGES OF TWO STEP PROCESS VERSUS ONE, ARE THERE HARMS IN OVERTREATMENT, HIGHER RESOURCE UTILIZATION AND MORE TIME FOR DIAGNOSIS AN MANAGEMENT AND HOW WE MOVE FORWARD WITH PATIENT CENTERED CARE DURING PREGNANCY AND BEYOND. USING OUR ROUTINES AND USING COLLABORATIVE MODELS FOR CARE. THANK YOU. [APPLAUSE] >> THANK YOU, WANDA, WE'RE DOING WELL WITH TIME. CAN I ASK THE FIRST FOUR SPEAKERS TO COME TO THE PODIUM? REMEMBER FIRST WE'LL SOLICIT QUESTIONS FROM OUR PANELISTS AND THEN AFTER THEIR QUESTIONS WE'LL TAKE QUESTION FROM THE AUDIENCE. Q. CATHY, I HAD A QUESTION WHILE THEY'RE COMING TO THE MIC. WHEN YOU TALK ABOUT CURRENT COST OF 636 MILLION CONTRASTED WITH THE NEW COST OF 2 BILLION PLUS, DOES THAT INCLUDE EXTRA TESTING ULTRASOUND, ALL THESE PERSONNEL CONSIDERATIONS THAT WANDA ALLUDED TO? >> THOSE ESTIMATES ARE BASED ON MANY DIFFERENT ASSUMPTIONS. WE'RE GOING TO HAVE ADDITIONAL TALKS LATER IN THE PRESENTATIONS ABOUT IMPLICATIONS OF THESE DIFFERENT TESTING REGIMENS. WHAT I QUOTED WERE SOME OF THE INFORMATION THAT'S AVAILABLE BUT I THINK YOU'LL GET ADDITIONAL INFORMATION AS THE CONFERENCE PROGRESSES. >> BILL. >> QUESTION FOR DR. NICHOLSON. YOU HAD A SLIDE FROM CAROLYN CROWDERs STUDY ABOUT DECREASE IN DEPRESSION. BUT I WANT TO BE CLEAR ABOUT SOMETHING. THAT WAS FOR WOMEN ACKNOWLEDGEED TO HAVE GDN ON THE BASIS OF WHETHER OR NOT THEY WERE TREATED OR IF NOT, COULD YOU CLARIFY EXACTLY WHO HAD LESS DEPRESSION? >> I KNOW THE EPC WILL PRESENT MORE SPECIFICS ABOUT THAT IN THEIR TALK BUT THESE ARE WOMEN WHO SCREEN POSITIVE AND RANDOMIZED TREATED FOR GESTATIONAL DIABETES OR NOT TREATED FOR GESTATIONAL DIABETES. AND WITH THE POINT BEING THAT IN THOSE WOMEN WHO ARE DIAGNOSED, AND TREATED FOR GESTATIONAL DIABETES, THERE APPEARS LESS DEPRESSION AN ANXIETY IN THREE MONTH POSTPARTUM PERIOD BUT THEY WERE SCREENED DECKED AND TREATED. >> BOTH GROUPS WERE AWARE OF THEIR -- >> NO. >> I'M SORRY. >> I'M TRYING TO GET AT, BOTH GROUPS AWARE OF THEIR GDM STATUS AND THEY WERE ALLOCATED DIFFERENT TREATMENT GROUPS OR IS ONE GROUP GDM ACKNOWLEDGED GDM, THE OTHER GROUP WAS NOT TREATED BUT WASN'T AWARE -- >> WAS THE LATTER, THE OTHER GROUP WAS NOT AWARE THEY HAD GDM. I MISSPOKE THAT. >> HELEN. >> (INDISCERNIBLE) THANK YOU TO THE PRESENTERS. DO WE HAVE CURRENTLY SUFFICIENT INFORMATION TO RECOMMEND SPECIFIC CUT OFF OR ONE HOUR SCREEN, 130, 135, 140, WHAT DO YOU THINK? >> GREAT QUESTION. >> LET ME TAKE A CRACK AT THAT. WE HAVE PLENTY OF INFORMATION. THE QUESTION IS WHAT IS THE TRADE OFF BETWEEN SENSITIVITY AND SPECIFICITY IF YOU WILL. THAT'S INFORMATION THAT AT 1:30 YOU PICK UP THE VAST MAJORITY, I CAN'T EVER SAY 100% BUT CLOSE TO IT. BUT YOU END UP HAVING TO DO GLUCOSE TOLERANCE TESTS ON 21% OF THE POPULATION. AT 140 YOU LOSE 10% AND A COUPLE OF STUDIES HAVE SHOWN THAT OF GDM BUT YOU ONLY HAVE TO DO GLUCOSE TOLERANCE TESTS ON 14 PEST OF THE POPULATION. SO YOU PAY YOUR MONEY AND YOUR TAKE YOUR CHOICE. >> DON, AS I WAS GETTING READY FOR THE CONFERENCE, I KEPT SEEING ILLUSIONS TO TESTING PATIENTS, RETESTING PATIENTS IN CLOSE PROXIMITYpz VARIATIONS IN THE RESULTS. I CAN'T REMEMBER WHETHER IT WAS IN THE GLUCOSE CHALLENGE TEST OR TOLERANCE TEST BUT IT'S CONCERNING TO KNOW IF WE GET SOMEBODY THREE DAYS LATER WE MAY GET NORMAL RESULTS. >> THAT'S TRUE. THE GLUCOSE TOLERANCE IS NOT STABLE, FASTING GLUCOSE IS PRETTY STABLE BUT THE OTHER THREE CAN HAVE VARIABILITY. THAT'S TRUE WHETHER YOU'RE TALKING NON-PREGNANT PATIENTS OR PREGNANT PATIENTS. FROM Z >> FIRST THANKS TO THE SPEAKERS, I LEARNED A LOT BUT WANT TO FOLLOW-UP ON YOUR COMMENTS, YOU PAY YOUR MONEY, YOU TAKE YOUR CHANCES, USUAL CASUAL SAYING YOU WOULD LOSE 10% IN EXCHANGE NOT HAVING TO TEST 24% OF PEOPLE. BUT AREN'T WE ASKING THAT QUESTION TODAY IF WE LOSE A CERTAIN -- HOW MUCH HARM ARE WE DOING BY LOSING THOSE? YOU'RE SAYING LOSE 10%, YOU'RE SOUNDING LIKE THAT'S NOT A TERRIBLE THING, 10% GO UNDIAGNOSED IN EXCHANGE FOR SPARING PEOPLE UNNECESSARY 3 HOUR GTTs. I'M ASKING IF WE DON'T PICK UP ADDITIONAL GROUP BY ADDING NECESSITY FOR A SINGLE ABNORMAL VALUE ARE WE KNOWINGLY DOING HARM BY NOT COLLECTING THAT GROUP? >> I WOULD PUT IT IN THE OPPOSITE TERMS. I THINK -- FIRST OF ALL, I DIDN'T MEAN TO IMPLY I DIDN'T CARE IF WE LOST 10%, I WAS SIMPLY ANSWERING THE QUESTION. BUT YOU WILL STILL PICK UP THAT SEVERE GROUP IF YOU DO -- IF YOU REQUIRE ONLY ONE ELEVATEDDED VALUE THEY'LL HAVE A VERY ELEVATEDDED VALUE. YOU WILL PICK UP AN ADDITIONAL PERCENTAGE OF PATIENTS WHERE YOU HAVE AN OPPORTUNITY TO PREVENT ADVERSE OUTCOMES. THAT'S WHAT THIS CONFERENCE WILL BE ABOUT AND I SUSPECT PROBABLY THAT'S NOT WHAT E WANT TO GET INTO THIS MORNING. I DON'T THINK YOU WOULD MISANYTHING BY GOING TO ONE ELEVATED VALUE. >> DON, YOU IMPLIED THAT REALLY WAS A LOT OF DIFFERENCE BETWEEN THE 100-GRAM AND 75-GRAM. I'M NOT AWARE THERE HAVE BEEN ANY HEAD TO HEAD COMPARISONS. YOU'RE SUGGESTING BECAUSE TWO HORAL IS SIMILAR >> THERE ARE SOME STUDIES ON THAT, ONE IS DONE BY PROFESSOR (INAUDIBLE) IN AUSTRIA YEARS AGO WHERE HE LOOKED AT 100-GRAM, 50-GRAM AND ONE GRAM PER KILOGRAM. AND IN NORMAL PATIENTS THERE WAS LITTLE DIFFERENCE. IT LOOKED LIKE THE 100-GRAM MIGHT BE OVERKILL FOR THE THIN PATIENTS AND THE 50-GRAM MIGHT BE NOT QUITE ENOUGH FOR THE OBESE PATIENTS BUT IN GENERAL THE -- IN NORMAL PATIENTS, THE FASTING ONE TWO HURDLE VALUES WERE QUITE SIMILAR. >> SO IF THERE'S BEEN INTERNATIONAL PLEA FOR STANDARDIZATION OF THE TEST, WHY HAVEN'T YOU CHANGED THE TEST? THAT'S WHY WE'RE HERE, ISN'T IT? >> IT IS BUT IT'S TAKEN SEVERAL YEARS. THERE'S OOH BEEN -- >> LOOK HOW MANY YEARS IT TOOK TO HAVE THE O'SULLIVAN CRITERIA RECOGNIZED IN THIS COUNTRY. IF YOU LOOK BACK AT THE SLIDES, IT'S LIKE 10, 20 YEARS BEFORE IT WAS -- THAT'S THE WAY IT IS. >> CHANGE IS TOUGH AS WANDA SAYS. >> GEORGE SALIAN. THIS IS FOR DO COUSTAN. MOVE HERE SO I CAN SEE YOU. I'M WONDERING IF -- WHAT THE CURRENT THOUGHTS ARE ABOUT BEING ABLE TO CAPTURE THE CONVENIENCE OF A SINGLE VISIT BUT ALSO CHANGE PROPORTION POSITIVE FROM 18 BY SACRIFICING SOMEOM SENSITIVITY SINCE WE SEEM TO BE WILLING TO SACRIFICE SOME SENSITIVITY BETWEEN 130 AND 140 AS CUT OFF SO BOTH SEEM TO BE ACCEPTABLE. SO I'M WONDERING ABOUT THE ANSWER POTENTIALLY LYING SOMEWHERE IN BETWEEN, WHAT WE HAVE HEARD SO FAR AND WHAT INFORMATION OR EVIDENCE WE HAVE TO GUIDE US TO OPTIMIZING AN ANSWER THAT BALANCES BENEFITS AN HARMS >> FIRST OF ALL, WE USE 130 BECAUSE I DON'T WANT TO LOSE THOSE 10% SO I DON'T WANT TO GIVE TIM PRESENTATION THAT I THINK THEY'RE EQUAL. I'M SAYING THAT'S WHAT ACOG IN ITS INFINITE WISDOM RECOMMENDED. I THINK THE QUESTION OF CUT OFFS ONE SHOULD USE I KNOW DR. METSGER WILL GET INTO THAT IN MORE DETAIL TOMORROW BUT BASED ON ODDS RATIOS. WHEN THE GROUP LOOKED AT 1.5, 1.75 AND 2.0 ODDS RATIOS, YOU COULD HAVE USED 2.0 AND HAD FEWER CASES DIAGNOSED BUT THE RISK OF ADVERSE OUTCOMES WAS NOT DIFFERENT BETWEEN 2.0 AND 1.75. THE ARGUMENT, IF IT'S WORTH DIAGNOSING WHATEVER IT WAS, 12%, MAKING THIS UP, 12% OF THE POPULATION, TO PREVENT THEIR ADVERSE OUTCOMES THAT NEXT 6% HAS SIMILAR ADVERSE OUTCOMES AND CAN BE PREVENTED BUT IT WAS ARBITRARY. IT WAS REALLY A DECISION BY A LARGE GROUP OF INDIVIDUALS FROM AROUND THE WORLD AS TO WHAT MADE THE MOST SENSE. IT'S ARGUABLE CERTAINLY. Q. TO WE HAVE QUESTIONS FROM THE AUDIENCE? >> MIKE LIPKUS FROM BAILOR HOUSTON. REGARDING EPIDEMIOLOGY I HAVE AN OBSERVATION FROM THE HAPLO TRIAL THAT SAID, I'LL MENTION WE DO UNNOTED SEEM TO HAVE AN EPIDEMIC OF DIAGNOSIS, NOT DISEASE. I WAS HEARD GESTATIONAL DIABETES IS DEFINED NOW AS ABNORMAL GLUCOSE I WERE TOLERANCE OR TOLERANCE RATHER THAN HYPERGLYCEMIA RECOGNIZED IN PREGNANCY. THE HAPLO TRIAL DESCRIBED THE SAME DESCRIPTION OF FASTING RESULT THAT O'SULLIVAN TRANSLATED VALUES BY THE NDDG DESCRIBED 50 YEARS PRIOR. SO NOT THAT MEASURE OF GLYCEMIA AT ALL. THE OTHER THING I FIND MISSING THIS THIS DISCUSSION THUS FAR IS ATTRIBUTABLE RISK. AND SOME CONFUSION ABOUT ADVERSE PREGNANCY OUTCOMES AND MORBIDITY. LARGE BABIES ARE NOT A MORBIDITY AND ATTRIBUTABLE RISK IF WE CAN GET RID OF GLYCEMIC EFFECTS HOW WELL WOULD WE ADDRESS THE QUOTE PROBLEM OF LARGE BABIES? OBESITY ACCOUNTS FOR A FAR LARGER NUMBER AND NEITHER HYPERFLY SEEMIA NOR OBESITY ACCOUNT FOR ALL THE LARGE BABIES. SO THAT'S A PROBLEM WE NEED TO READDRESS THE STRATEGY I BELIEVE OR SUGGEST. WHAT'S THE ATTRIBUTABLE RISK IN THE CONTEXT, WHAT'S -- WHAT TO WE HOPE TO GAIN IN TERMS OF IMPACT ON LARGE BABY OUTCOME. >> GOOD POINT. >> FIRST OF ALL, THERE WAS NO HA POE TRIAL. THAT WAS AN OBSERVATIONAL STUDY. THERE WAS NO INTERVENTION SO TO CALL IT A TRIAL IS THE DIFFERENCE IN RISK ATTRIBUTABLE TO OBESITY AND INDEPENDENT RISK OF GLUCOSE. I CAN TELL YOU THEY ARE INDEPENDENT. WELL, THEY ARE EACH -- THEY EACH CONTRIBUTE RISK. I WOULDN'T HAVE TO SAY THEY'RE INDEPENDENT. BUT IT'S NOT ALL OBESITY. AND I THINK THAT'S KIND OF THE DISCUSSION AS THE MEETING GOES ALONG, I DON'T THINK IT'S ANYONE'S GOAL TO ELIMINATE ALL MACROSOMIC BABIES. I THINK MACROSOMIC BABIES OF DIABETIC MOTHERS ARE DIFFERENT IN MANY WAYS FROM MACROSOMIC BABIES OF NON-DIABETIC MOTHERS. SO I WANT TO GET RID OF THE SHOULDERS, INCREASE RISK OF OBESITY AND AND SO ON. IF OUR GOAL IS TO ELIMINATE BIG BABIES LET'S STOP THE CONFERENCE NOW. >> IF I CAN RESPOND, YOUR POINT IS WELL TAKEN TRYING TO UNDERSTAND THE RELATIONSHIP BETWEEN DIABETES AND ATTRIBUTABLE RISK OF WHAT YOU CAN TREAT WITH TREATING GESTATIONAL DIABETES VERSUS WHAT IS UNDERLIENING THE WOMAN VERY IMPORTANT ONE. AS FAR AS LARGE BYE-BYES OR MACROSOMEIA I THINK PART OF THE CONFERENCE ITSELF IS LOOKING AT SHOULD WE DIAGNOSE GESTATIONAL DIABETES BASED ON OBSTETRICAL OUTCOMES OR SHOULD WE CONTINUE WHERE WE HAVE IT RIGHT NOW, WHERE CRITERIA ARE BASED ON SOMEONE DEVELOPING IT LATER IN LIFE. WE DIDN'T HAVE A LOT OF DATA TO SAY THAT ACTUALLY TREATING GESTATIONAL DIABETES IMPACT NED OUTCOMES IN PREGNANCY. AND WE HAVE SOME DATA, MACROSOMEIA IS ONE THAT PLAYED OUT. WHEN YOU LOOK AT THE CROWDER TRIAL THE MAJOR COMPONENT THAT SHOWEDDED THE IMPROVEMENT IN TREATMENT WAS THAT REDUCTION OF SHOULDER DISATTORNEYIA. FOR THEM THE MATERNAL NETWORK TRIAL T COMPOSITE OUTCOME WHICH INCLUDE AD NUMBER OF FACTORS WAS NOT DIFFERENT BETWEEN THE TWO, LOOKING TO ADDRESS WHAT YOU ACTUALLY SAID AS THE QUESTION, WHICH IS REALLY REAL MORBIDITY ASSOCIATED WITH DIABETES. IF YOU LOOK AT SECONDARY OUTCOMES SUCH AS HE WILL MACROSOMEIA, THAT IMPACT WAS REDUCED BY 50% WITH TREATMENT BUT THAT WAS NOT THE PRIMARY OUTCOME OF THE THE TRIAL. SO I THINK YOUR POINTS ARE WELL TAKEN. FROM Z EVEN IN CONCERT OBESITY AND GESTATIONAL DIABETES PROBABLY ONLY ACCOUNT FOR ABOUT 25%. OF MACROSOMEIAS SO OBVIOUSLY OTHER THINGS ARE AT WORK. YES, SIR. >> >> THIS QUESTION FOR DR. COUSTAN. AT THE END OF THE TALK I THOUGHT I HEARD YOU SAY THE HAPO CRITERIA DIAGNOSED 64% OF THE DIABETICS WHICH SOUNDS LIKE A LOSS COMPARED TO THE TWO STEM SYSTEM WHERE AT ONE-THIRD OR EVEN 140 YOU WOULD IDENTIFY 90%. SO IS THERE -- DID I MISUNDERSTAND, WAS THAT A REAL DIFFERENCE? I I'M SURE I MISSPOKE. I WAS TRYING TO SAY THERE ARE NO HAPO CRITERIA. THAT OF 100% OF PATIENTS WITH GDP BY THE AIPGSP CRITERIA, 64% WERE FOUND BY ONE ABNORMAL VALUE. THE OTHER 36% HAD TWO MORE ABNORMAL VALUES. I WAS TRYING TO MAKE THE POINT THE BIGGEST CHANGE, IF THOSE WERE ADOPTED IS CHANGE FROM 2 TO 1 ELEVATED VALUE. NOT THE ACTUAL CUT OFFS. >> (INDISCERNIBLE) HARVARD MEDICAL SCHOOL. WANT TO MAKE THE POINT A LOT OF ISSUES COMING UP RIGHT NOW BUT TWO IN PARTICULAR. ONE IS, AGAIN, TO REITERATE DECISION MAKING IS BETTER DONE ON BASIS OF ATTRIBUTABLE RISK THAN BASIS OF RELATIVE RISK. WE'RE STARTING THE TALK ABOUT THAT WITH SENSITIVETIVE AND SPECIFITY OUTCOMES. BUT SECOND THING IS TO CONSIDER WHETHER RAISING -- SUPPOSE WE ALL AGREE 75-GRAM ONE CUT POINT WAS THE WAY TO GO. WHAT ARE TRADE OFFS OF INCREASING THE CUT POINTS TO 150 OR 160, OR SOMETHING EVEN HIGHER. WHERE YOU GET MORE SPECIFICITY, YOU HAVE FEWER PEOPLE BUT THEY MAY HAVE BETTER OUTCOMES. AND COST EFFECTIVENESS MAYBE GREATER. SO A FEW COMMENTS ABOUT THIS IN MY TALK LATER WHEN I'M NOT SUPPOSED TO. BUT I THOUGHT I WOULD RAISE THE ISSUE THIS MORNING. >> I THINK DR. METSGER WAS TALKING ABOUT THAT EXACT POINT -- WERE YOU GOING OVER THAT? >> AND ALSO TO >> THAT RAISE IT IS POINT THAT WE DOCTORS FOCUS ON FALSE NEGATIVES BECAUSE WE DON'T WANT TO MISS THEM. AS SOON AS WE LOWER FALSE NEGATIVES WE INCREASE THE FALSE POSITIVES. HOWEVER YOU WANT TO DEFINE IT. >> MICHELLE QINLON UCSD. WHEN YOU WERE TALKING ABOUT THE HU GUIDELINES THE SLIDE SAID THAT THE FASTING WAS 126 FOR THE CUT OFF. IS IT TRUE THAT EXCEPTION OF PEOPLE USING IADPSG AUSTRALIA THEY ALLOW FASTING OF 126 OR 125 OR LESS TO BE NORMAL AND DOES THAT LEAVE OUT IMPAIRED FASTING GLUCOSE PEOPLE IN >> WORLD HEALTH ORGANIZATION VALUES THE 126 OR ABOVE FOR DIABETES. SO IN ORDER IN THE A CHOICE STUDY THEY STIPULATED YOU HAD TO HAVE -- NOT NORMAL -- FASTING -- BELOW 140 BECAUSE THAT WAS THE CUT OFF AT THE TIME. TWO HOUR VALUE BETWEEN 140 AND 200. IN FACT, THOUGH, THE AVERAGE FASTING GLUCOSE IN THOSE PATIENTS WAS 86. SO I THINK IT GETS CONFUSING BECAUSE THEY'RE USING THE NON-PREGNANT NORMS SAYING YES, SIRRATIONAL DIABETES IS SOMEONE WHO DOESN'T MEET CRITERIA FOR OVERT DIABETES BUT HAS TWO HOUR VALUE WITH GLUCOSE TOLERANCE 140 TO 200. PERHAPS SOMEONE IS FAMILIAR WITH THE CURRENT WHO CRITERIA TO SAY IF THEY HAVE COME AROUND TO HAVING IMPAIRED GLUCOSE OR NOT. >> SO USING A)W< SCREENING PROCESS WHERE YOU ONLY DO ONE HOUR ACTUALLY WOULD ALSO LEAVE OUT IMPAIRED FASTING GLUCOSE PEOPLE? >> THE 50-GRAM ONE HOUR SCREEN DONE IN THIS COUNTRY? >> THAT'S CORRECT. >> SURE BUT THE FACT IS THAT FASTING GLUCOSE IS NOT I DID DENT OF THAT ONE HOUR VALUE SO WHILE IT PROBABLY WOULD MISS A FEW PATIENTS ABOVE THE 92 CUT OFF, THE VAST MAJORITY WHO HAVE AN ELEVATED 50-GRAM SCREEN THAT WOULD PICK UP MOST PEOPLE WHO HAVE AN ELEVATED FASTING. >> I'LL P PUT MY TWO SENTENCE IN TO SAY I LIKE THE FASTING TEST. >> ME TOO. >> IN THE BACK. >> I'M A MEDICAL ENDOCRINOLOGIST FROM KEISER PERMANENTE NORTHWEST IN PORTLAND. TWO QUICK COMMENTS. THEN WELCOME TO SEE ANY 2008 EVIDENCE REVIEW FOR THE TASK FORCE. WHAT THAT MEANS BY DESIGN WITH TASK FORCE IN DOING SO IS THE TASK FORCE DECIDES THE QUESTIONS PEOPLE IN THE REVIEW DO AND ALSO NO INPUT INTO RECOMMENDATIONS BY DESIGN. I THINK COUPLE OF COMMENTS TO MAKE ABOUT THAT REVIEW, QUESTIONS CHOSEN DIDN'T INCLUDE MACROSOMEIA. AS WE CONSIDER HOW TO DIAGNOSE GESTATIONAL DIABETES, WE NEED TO THINK ABOUT WHETHER THE IMPORTANT OUTCOMES WE CARE ABOUT WITH DIAGNOSING GESTATIONAL DIABETES BECAUSE IT DIDN'T INCLUDE -- ALSO DID NOT INCLUDE LONG TERM OUTCOMES IN THAT REVIEW. THE SECOND COMMENT, THE GOOD NEWS SINCE THAT REVIEW IS WHY WE HAVE THIS CONTROVERSY TODAY, IMPORTANT EVIDENCE DEVELOPED SINCE THAT TIME MATERNAL FETAL NETWORK. RANDOMIZED TRIAL AS WELL AS HAPLO DATA, AN IMPORTANT THING TO CONSIDER THIS EVIDENCE TO ALSO THINK ABOUT THOSE TRIALS IN THE -- IT WAS UNETHICAL RECRUIT WOMEN WITH SEVERE GDM EVIDENCE IS BASED ON MILD GDM SO AS WE CONSIDER SPECTRUM OF DIAGNOSIS, I HOPE THE COMMITTEE CONSIDERS THAT PIECE TOO. >> YOUR POINT IS WELL TAKEN. ONE COMMENT I WOULD MAKE THAT WAS MENTIONED MT. BEGINNING WE HAVE NO DATA FOR THE TREATMENT FOR PATIENT WHO MEET THE NEW CRITERIA PROPOSED BY THE IADPSG CHANGES YOU COME. THE HAPO STUDY SHOWS WHAT'S SEEMINGLY A CONTINUUM. THE DIFFICULTY IS HOW TO PICK THE CUT OFF AND WHAT EVIDENCE DO WE HAVE TREATING THE NEW CUT OFF CHANGES AN OUTCOME. SO WE HAVE SOME EVIDENCE TRIALING MILD PATIENTS WILL IMPROVE OUTCOME. WE DON'T HAVE EVIDENCE IN THIS HAPO COHORT. >> FIRST OF ALL THANK YOU FOR THE SHIELD TO PROTECT ME. SECONDLY, WITH REGARD TO THE 50-GRAM GLUCOSE TEST, THIS QUESTIONS TO THE PANEL WHOEVER WANTS TO FIELD IT BUT IF YOU LOCK BACK TO THAT 64 PAPER O'SULLIVAN GAVE THE GLUCOSE SCREEN ON THE AFTERNOON REGISTRATION AND 100-GRAM GTT. BUT DOES IT TEST WITH REGARD TO DAYTIME AFTER THE LAST MEAL. AND IN 1982 PREPPER IT SHOWED IT DOES VARY WITH REGARD TO TIME AFTER THE LAST MEAL, THIS WAS SUBSEQUENTLY SUPPORTED BY DATA FROM THE TORONTO HOSPITAL STUDY, WITH REGARD TO TIME OF DAY, PAPER CAME OUTLOOKING AT 100-GRAM GTT AND GDN AND FOUND THAT INDEED THE POST GLUCOSE CHALLENGE VALUE IS HIGHER IN THE AFTERNOON THAN IN THE MORNING. WE LOOKED AT REPRODUCIBILITY OF THE TEST AND FOUND SOMETHING LIKE 30 WOMEN WITH GDM THAT 27% WERE BELOW THE 135-MILLIGRAM PERCENT SCREENING THRESHOLD ON ANY ONE OF TWO DAYS WHICH THEY REPRODUCE THEIR ACTIVITY CAME IN AT THE SAME TIME OF DAY SO WE HAVE A TEST WE'RE USING AS A SCREENING TEST THAT VARIES WITH TIME OF DAY, TIME AFTER LAST MEAL AN POORLY REPRODUCIBLE AS MOST GLUCOSE CHALLENGE TESTS. HAS THE TIME ARRIVED FOR US TO ABANDON THE 50-GRAM TEST AND GO THROUGH A DEFINITIVE TEST, WHATEVER DEFINITIVE TEST WE CHOOSE. >> THANK YOU. COMMENTS FROM THE SPEAKERS? >> JUST THAT I THINK THAT'S WHAT WE'RE HERE TO DO. THAT ISxa, IMPLICIT IN IF WE ARE CHOOSING TO ADOPT THIS NEW RECOMMENDATION THAT DOES NOT HAVE A SCREENING TEST. >> ALSO GOES TO WANDA'S POINT SHE MADE HOW DOES THAT IMPACT THE PRACTICE AND THE PATIENT. FOR THEM TO COME IN FOR A FASTING LEVEL. IN SOME WAYS THAT DOES HAVE IMPACT HOW THIS TEST IS ADMINISTERED. MAYBE YOU WANT TO COMMENT. >> IT'S A GREAT POINT. I AGREE, PART OF WHAT WE'RE HERE TO DO IS TO LOOK AT THAT. PART IS LOOKING AT THE SCREENING TESTING IN AND OF ITSELF LOOKING AT THE. PARAMETERS OF SENSITIVITY SPECIFICITY. THAT'S WHAT YOU'RE ALLUDING TO. WHAT I'M ALSO TRYING TO PRESENT IS A PART B. PART OF WHAT WE HAVE TO DO IS MAKE THE DECISION ABOUT WHICH IS THE BEST STRATEGY TO USE. BUT WE CAN'T FORGET THE IMPLEMENTATION SIDE OF THATTER WHATEVER STEPS NECESSARY TO FULLY IMPLEMENT TO ACHIEVE THE OUTCOME THAT WE WANT TO GAIN BY MAKE MAKING ANY CHANGING CRITERIA, THEY HAVE TO GO HAND IN HAND. >> ONE POINT THAT I FAILEDED TO MAKE WAS THERE ARE A COUPLE WHO SHOW THE WOMEN WITH ELEVATED SCREENING TEST VALUES AND FAILED NEWS DOSE TOLERANCE TESTS AS WELL. >> I WOULD LIKE TO ADD A LITTLE SOMETHING TO THE MATHEMATICS. AS I HAVE BEEN SITTING HERE THINKING ABOUT WHAT'S THE ADDITIONAL TIME COMMITMENT THAT THEY WERE TALKING ABOUT FOR TWO HOUR GTT FOR EVERYONE RATHER THAN TWO STEP PROCESS. IF YOU THINK ABOUT THE FACT THAT 100% OF PATIENTS SPEND AN HOUR DOING THAT 50-GRAM SCREEN, AND P YOU USE 130 AS CUT OFF AS WE DO, IT'S 23%, GTT. SO 20 AZUREAN NUMBER. 20 TIMES THREE HOURS IS 60 HOURS. SO ADDITIONAL 60 HOURS AFTER THAT UNIVERSEAL ONE HOUR FOR THE SCREEN. EVERYBODY FOLLOW ME SO FAR? IF 100% OF PEOPLE DO A TWO HOUR TEST THAT'S ADDITIONAL HUNDRED HOURS. IF THEY WERE DOING THE OLD WAY THEY SPEND 100 HOURS TO THE ONE HOUR TEST SO THEY ALL SPEND ANOTHER HOUR. THE INCREMENTAL NUMBERS OF HOURS PATIENT TIME IS 40 PER 100 PATIENTS OR WHATEVER IT COMES TO, .4 PER PATIENT. .4 OF AN HOUR IS 25 MINUTES. NOT AS HUGE A DIFFERENCE AS ONE MIGHT EXPECT BUT THE BIGGEST DIFFERENCE IS THEY HAVE TO BE FASTING. >> I AGREE. THIS GETS BACK TO THE LOGISTICS OF IMPLEMENTATION. AND YOU'RE RIGHT. WHEN YOU WEIGH THE TIME FRAME, PARTICULARLY DEPENDING WHAT YOUR -- IF YOU USE CURRENT TWO STEP APPROACH, WHAT YOUR INITIAL CUT OFF IS FOR THE 50-GRAM, IN FACT YOU WOULD HAVE A BETTER CORRELATION WITH TIME THAT WOULD BE REQUIRED. I THINK IT IS TIME AND ALSO FASTING STATE. ALLUDE TO POSTPARTUM TESTING AND GETTING WOMEN TO COME IN IN FASTING STATE, AREA WE DO HAVE WORK TO DO. AS BASIS OR REFERENCE POINT POW FOR THAT. NOT TO SAY THAT WOULDN'T BE POSSIBLE BUT WE HAVE TO LOOK HOW WE CHANGE CURRENT HEALTHCARE SYSTEM AND MODELS OF CARE TO ACCOMMODATE THE NEED TO BE FAST AND ACHIEVE CHANGING CRITERIA. >> (INAUDIBLE) UCLA. I BASICALLY HAVE A COMMENT WHEN THE IADPS GROUP WE'RE TRYING TO PICK A NUMBER AND WE DID HAVE THE CHOICE BETWEEN 1.5, 1.75, OR TWO AS RATIO OF RISK. AND WE COST 1.75, HAVE WE CHOSE 1.5, A LOT LESS DEMANDING OR MORE DEMANDING, WE WOULD HAVE GOT -- THAT'S WHAT THEY HAVE BEEN USING. AT THAT 1.5 RISK RATIO, BASICALLY PEOPLE THAT DO WHO TESTS, THE FASTING VIRTUALLY NEVER DIAGNOSIS ANYTHING, IT'S THE TWO HOUR VALUE BECAUSE FASTING IS SO HIGH. SO FUNCTIONALLY ALL THE PEOPLE DIAGNOSED ON ONE VALUE, THAT'S THE STUDY RIGHT THERE. IN A WAY WE HAVE DATA THAT TELLS US AT 1.75, WE WOULD PROBABLY GET MORE PEOPLE THAN IF WE LEAVE SAY AT TWO. SOME PEOPLE WANTED TO DO ODDS RATIO OF TWO, CANADIAN NUMBERS EFFECTIVELY. SO I JUST TO SAY THAT AS DR. KUSTAN HAS BEEN POINTING OUT NUMBERS THEMSELVES ARE NOT THAT TIGHT, WHETHER YOU USE ONE OR TWO VALUES AND EVEN WITH ONE WE HAVE SOME DATA THAT TELLS US IT MAKES A DIFFERENCE. >> IN THE BACK. >> MELINDA SKULLLY, SAN FRANCISCO. I WILL LIKE TO RAISE THE POINT OF THE SERVICES UTILIZED. MOST PEOPLE IN THE ROOM FEEL LIKE TO SOME DEGREE THIS IS SPLITTING HAIRS OVER WHICH TEST YOU USE BUT IT COME IT IS UTILIZATION OF DIETARY STAFF. AS PHYSICIANS VERY FEW OF US ACTUALLY KNOW ANYTHING ABOUT DIETARY SERVICES. AND I COME FROM A FAIRLY SOPHISTICATED CITY WITH A WELL HEALED POPULATION WITH RESOURCES SO APPLYING THIS TO REST OF THE COUNTRY WHERE EVEN MANY OF MY PATIENTS DONE HAVE COVERAGE FOR NUTRITION SERVICES IS WHAT IS CONCERNING HERE. EFFORT PREGNANT WOMAN SHOULD HAVE DIETARY SERVICES REGARDLESS WHETHER THEY HAVE THE LABEL OF DIABETES THE. BECAUSE 95 PLUS% DO THE FOOD SHOPPING. SO THAT IS SOMETHING WE NEED TO ADDRESS SOMEHOW NOT SPECIFICALLY IN THIS CONFERENCE BUT ALLUDE TO IT BECAUSE THAT IS THE HEART OF THE ISSUE, GETTING PEOPLE TO UNDERSTAND FOOD CHOICES. >> POINT WELL TAKEN. I THINK IT'S CLEAR ONCE YOU DIAGNOSE SOMEONE WITH GESTATIONAL DIABETES, THE HEALTHCARE RESOURCES UTILIZATION DRAMATICALLY GO UP ANTI-PARTUM SERVICES YOU WILL RA SOUND, MONITORING AND FOLLOWING SUGARS, TIMING DELIVERY ALL THAT, NEONATAL SERVICES ARE ALL INCLUDED IN THAT, WE WILL BE TALKING ABOUT THAT OVER THE NEXT DAY AND A HALF. I APPRECIATE YOUR BRINGING IT UP. >> ONE FINAL QUESTION THEN WE NEED TO GET BACK ON OUR AGENDA. >> KATHERINE, I'M CLINICIAN IN BALTIMORE, MARYLAND, I'M FACULTY AT SHENANDOAH WHAT UNIVERSITY WINCHESTER, VIRGINIA. MY QUESTION HOPEFULLY IS SIMPLE. IS THERE A ROLE FOR THE HEMOGLOBIN A 1C? IF SO, WHAT IS IT? >> FOR DIAGNOSIS OF GESTATIONAL DIABETES? >> YEAH, THE WHOLE THING WITH DIAGNOSIS AND WHO IS PRE-GESTATIONALLY A DIABETIC AND HOW DOES THAT IMPACT ON PROGRESS OF THE PREGNANCY AND THE OUTCOMES. IS THERE A ROLE FOR THAT? >> PART OF THE DIFFICULTY DIFFICULTY OF THIS CONFERENCE IS FIGURING OUT WHAT WE CAN READILY ADDRESS IN A DAY AND A HALF. THE ROLE OF THE HEMOGLOBIN A 1C IN SCREENING FOR OR DIAGNOSIS OF GESTATIONAL DIABETES IS NOT CLEAR. WHAT WE'RE TRYING TO FOCUS ON TODAY IS THE DIAGNOSIS OF GESTATIONAL DIABETES. IADPSG CRITERIA INCLUDE AS ONE ELEMENT HEMOGLOBIN A 1C BUT THERE ISN'T A LOT OF DATA ON HEMOGLOBIN A 1C ALONE AS DIAGNOSTIC MEASURE. CERTAINLY THEY CAN WEIGH IN ON THAT IF THAT WAS THE BEST WAY TO DIAGNOSE IT BUT WE CAN'T TACKLE EVERYTHING TODAY. >> IF I COULD JUST POINT OUT THAT THE IADPSG RECOMMENDATIONS DID NOT RECOMMEND A 1C TO DIAGNOSE GESTATIONAL DIABETES. THE RECOMMENDATION FOR A 1C OR FASTING WAS DIAGNOSE PRE-EXISTING DIABETES EARLY IN PREGNANCY. THERE IS AN A 1C CATEGORY FOR PRE-DIABETES BUT THAT'S NOT THE SAME AS GESTATIONAL DIABETES. PEOPLE HAVE MISTAKENLY SAID 5.7, THAT MUST BE GESTATIONAL DIABETES, THAT'S NOT THE CASE. SO I DON'T THINK AT THIS MOMENT IT HAS ROLE DIAGNOSING GESTATIONAL DIABETES. >> THANK YOU, MORNING SPEAKERS. [APPLAUSE] >> MOVING RIGHT ALONG THE QUESTION 3. IN THE ABSENCE OF TREATMENT HOW DO HEALTH OUTCOMES OF MOTHER WHOSE MEET VARIOUS CRITERIA FOR GESTATIONAL DIABETES AN OFFSPRING COMPARED WITH THOSE WHO DO NOT. AFTER WE FORMULATED THE QUESTIONS AT OUR PLANNING SESSION NEARLY TWO YEARS AGO THE FIRST ORDER OF BUSINESS WAS TO LOOK AT AVAILABLE DATA. AND THE EVIDENCE BASED PRACTICE CENTER AT THE UNIVERSITY OF ALBERTA DID THAT FOR US. IT'S A LONG DRAWN OUT PROCESS. BUT THAT BECAME THE FOUNDATION FOR OUR EARLY DELIBERATIONS. WE'RE FORTUNATE TO HAVE TWO SPEAKERS, LEWIS DONOVAN, A CLINICAL A -- LOIS DONOVAN, ASSOCIATE MEDICAL DIRECTOR OF DIABETES PREGNANCY DIVISION OF ENDOCRINOLOGY METABOLISM DEPARTMENT OF OBGYN UNIVERSITY OF CALGARY AND SECOND LISA HARTLINGS PROFESSOR O PEDIATRICS AND DIRECTOR OF ALBERTA EVIDENCE BASED PRACTICE CENTER. THEY WILL TALK TO US A LITTLE BIT THIS MORNING ABOUT THAT QUESTION 3 AND EVIDENCE THAT LOOKS AT IT. LOIS AND LISA. THANK YOU. >> I'M LISA, NOT LOIS. ISLE BE SPEAKING FIRST. SO I'M DIRECTOR OF THE UNIVERSITY OF ALBERTA EVIDENCE BASED PRACTICE CENTER AND I'M A METHODOLOGIST SO I CAN SPOKE TO OUR APPROACH AND METHODS WE USE IN THE REVIEW AND THEN PASS;q TO LOIS AND THEN PASS TO LOIS TO PRESENT RESULTS. OUR KEY QUESTION WE WERE ASKED TO ADDRESS IS IN THE ABSENCE OF TREATMENT HOW HEALTH OUTCOMES OF MOTHERS WITH VARIOUS CRITERIA FOR GDM AND OFFSPRING COMPARE TO THOSE WHO DO NOT MEET VARIOUS CRITERIA. WE CONDUCT AD COMPREHENSIVE SEARCH, UP TO DATE Z OF MAY 2012. WE HAD MEDICAL LIBRARIAN WITH EXPERIENCE IN FIRST SYSTEMATIC REVIEWS. 16 ELECTRONIC DATABASE, GRAY LITERATURE WEBSITES TRIAL REGISTRIES AN REFERENCE LIST OF RELEVANT STUDIES. WE USE STANDARDS SYSTEMATIC REVIEW METHODS, I WON'T GO INTO DETAIL WITH THESE IN TERMS OF STUDY SELECTION, ASSESSING THE METHODOLOGICAL QUALITY OF STUDIES WE INCLUDED. STANDARD METHODS DATA EXTRACTION WE REPORTED RISK RATIOS WITH 95% CONFIDENCE INTERVALS USING A RANDOM EFFECTS MODEL. THE INCLUSION CRITERIA FOR THIS QUESTION IN THE REVIEW, WE LOOKED AT PRIMARY RESEARCH PUBLISHEDDED IN ENGLISH FROM 1995 ONWARD. WE AIM TO INCLUDE RANDOMIZED CONTROL TRIALS, RANDOMIZED CONTROL TRIALS OR COHORT STUDIES. INTERESTED IN WOMEN WITH NO HISTORY OF PRE-EXISTING DIABETES. AND INTERESTED IN COMPARING WOMEN WHO MET VARIOUS GDM THRESHOLDS AND AGAIN, WE WERE LOOKING FOR STUDIES WHERE WOMEN HAD NOT RECEIVED TREATMENT. WE LOOKED FOR SHORT TERM AND LONG TERM OUTCOMES IN MOTHER AS WELL AS THE OFFSPRING. WE INCLUDED STUDIES WITH ANY DURATION O FOLLOW-UP AND ANY STUDY SETTING. SO FOR THIS QUESTION WE IDENTIFIED 38 RELEVANT STUDIES, THE MAJORITY WERE CONDUCTED IN THE UNITED STATES WITH A VARIETY CONDUCTED IN OTHER REGIONS. THEY WERE ALL COHORT STUDIES OR THE UNTREATED GROUPS FROM OUR CTs AGAIN BECAUSE WE WERE INTERESTED IN THE ABSENCE OF TREATMENT. MOST OF THE COHORT STUDIES WERE RETROSPECTIVE. ONLY FIVE STUDIES WERE BLINDED AND BY WHAT I MEAN BY THAT IS THAT THE CAREGIVERS WERE BLINDED TO THE RESULTS OF THE ODT TESTS. THERE WERE A VARIETY OF CRITERIA, EXAMINED ACROSS THE STUDIES. AS YOU CAN SEE THERE MOST COMMONLY THE STUDIES USE THE CARPENTER CUSTAN CRITERIA. I'LL PASS YOU ON TO LOIS TO GET TYPE THE DETAILS OF WHAT WE FOUND. >> THIS SLIDE IS PROVIDED AS A REMINDER HOW THE DIAGNOSTIC CRITERIA COMPARE WITH EACH OTHER. DR. COUSTAN HAS TAKEN US THROUGH THIS. BUT I'LL JUST REVIEW THIS BRIEFLY. THE TOP BAR REPRESENTS HOW FASTING GLUCOSE THRESHOLDS COMPARE TO DIFFERENT CRITERIA. BOTTOM BAR SHOWS POST GLUCOSE CRITERIA COMPARE BY VARIOUS DIFFERENT CRITERIA. FOR EXAMPLE YOU CAN SIGH FASTING GLUCOSE THRESHOLD THE LOWEST ONES, THE LOWEST LEVELS ARE IN THE GREEN SIDE AND HIGHEST RED SIDE OF THIS FIGURE. YOU CAN SEE IADPSG HAVE LOWEST FASTING GLUCOSE THRESHOLD AT 92-MILLIGRAMS PER DECALITER AND THE WHO CRITERIA, THE HIGHEST FASTING GLUCOSE THRESHOLD AT 110-MILLIGRAMS PER DECALITER. THE BOTTOM BAR AS I SAID IS POST GLUCOSE VOLUME THRESHOLD, NOT ENTIRELY COMPARABLE BECAUSE DIFFERENT GLUCOSE WERE USED. 75 OR 100-GRAM LOAD. I'LL JUST POINT OUT, ALREADY NOTED, WHO HAS THE HIGHEST FASTING GLUCOSE THRESHOLD FOR CRITERIA FOR GDM, IT HAS THE LOWEST POST GLUCOSE LOAD THRESHOLD. THE KEY OUTCOMES WE'RE REPORTING ON TODAY ARE LISTED HERE. MACROSOMEIA, LGA, SHOULDER DISSTOW SHAH, MORTALITY AND CHILDHOOD OBESITY L. THERE ARE MORE OUTCOMES AND COMPARISONS LISTED IN FULL REPORT AND WE RECOGNIZE NOT ALL THESE OUTCOMES ARE DIRECT OUTCOMES BUT INDIRECT PREDICTORS OF MORE DIRECT OUTCOMES. WE IDENTIFIED THREE METH LOGICALLY STRONG PROSPECTIVE‡HhÖQ – STUDIES, H HAPO TRY HOSPITAL IN SAX 1995 PAPER THAT SHOWED A CONTINUOUS POSITIVE RELATIONSHIP BETWEEN INCREASING GLUCOSE LEVEL AND FREQUENCY OF A NUMBER OF ADVERSE PREGNANCY OUTCOMES. THE REMAINING STUDY CATEGORIZEDDED WOMEN IN GESTATIONAL DIABETES ABOVE OR BELOW SPECIFIED CRITERIA. SO FOR THE REMAINING DATA THAT I WILL SHOW YOU, THEY WILL BE GROUPED AS SUCH. FOR THE OUTCOME OF MACROSOMEIA, WE PRESENTED OUR -- THE RISK RATIOS FOR MACROSOMEIA HERE. THESE ARE INDIRECT COMPARISONS FROM DIFFERENT STUDIES OR DIFFERENT GROUPING OF STUDIES. AND ALONG THE X AXIS, THIS IS NOT A LINEAR X AXIS, IT INDICATEDDED THE CRITERIA BY WHICH WOMEN WERE DIAGNOSED WITH GESTATIONAL DIABETES. I ORDERED THIS INCREASING FASTING GLUCOSE ALONG THE X AXIS AS ALREADY DISCUSSED YOU COULD ADVOCATE DIFFERENT ORDERING IF YOU USE POST GLUCOSE LOAD THRESHOLD. THERE IS A SIGNIFICANT INCREASE RISK RATIO FOR MACROSOMEIA AT ALL CRITERIA EXCEPT FOR IADP SG CRITERIA. THERE MAYBE A NUMBER OF REASONS FOR THEM. CERTAINLY SAMPLE SIZE, DIFFERENCES IN SAMPLE SIZE, MOST CAME FROM THE (INDISCERNIBLE) CRITERIA. THERE'S A NUMBER OF OTHER EXPLANATIONS AS WELL. WE GET BACK TO THE RED GREEN DIAGRAM, WE PUT UP FASTING GLUCOSE THRESHOLD. TWO STUDIES COMBINED FOR THE META ANALYSIS ON MACROSOMEIA, BY THE IADPSG CRITERIA, USE DIFFERENT HIGH CUT OFFS. WHAT I MEAN IS THE STUDY WAS ONE THAT WAS INCLUDED IN THIS POOL AIDNALSIS THAT COMPARED WOMEN ABOUT THE LOW CRITERIA BUT DID NOT INCLUDE WOMEN THAT WOULD HAVE BEEN DIAGNOSED WITH GESTATIONAL DIABETES BY CARPENTER AND CUOSTAN CRITERIA. IT DID NOT HAVE SIGNIFICANT FINDING. WHEREAS THE (INAUDIBLE) STUDY HAD A SIGNIFICANT FINDING BUT IT DIFFERED IN STUDY DESIGN IN THAT IT INCLUDED -- COMPARED WOMEN BELOW IADP AS CHIEF CRITERIA AND WOMEN ABOVE THE CRITERIA THAT INCLUDE SOME WOMEN THAT MET CRITERIA FOR CARPENTER COUSTAN AND NDDG CRY TIER YUM. THIS TABLE IS ORGANIZED WITH LOWEST FASTING GLUCOSE THRESHOLD AT THE TOP AND HIGHEST THRESHOLD AT THE BOTTOM. THIS SHOWS THE RISK RATIOS AGAIN BUT ALSO THE SIZE OF THE POOLED ANALYSIS THAT WE WERE ABLE TO PERFORM. IN ADDITION TO THIS WE PROVIDE AD BASELINE RISK OF MACROSOMEIA BY VARIOUS CRITERIA, AND WHAT DIFFERENCE IN RISK BETWEEN THOSE WOMEN THE BASELINE RISK OF MACROSOMEIA RANGED FROM 6% TO 22% AND THE RISK DIFFERENCE BETWEEN WOMEN WHO MET THESE CRITERIA AND WOMEN WHO FELL BELOW THE CRITERIA RANGE FROM 5 TO 12%. THIS IS DATA FOR LGA. THERE WAS SIGNIFICANT INCREASE RISK OF LGA BY ALL CRITERIA USED TO DEFINE GESTATIONAL DIABETES. THIS TABLE SHOWS THE NUMBER OF PARTICIPANTS IN EACH POOLED ANALYSIS AND RISK RATIOS ARE BOLDED BECAUSE SIGNIFICANT. AND YOU CAN SEE THE BASELINE RISK OF LGA VARIED FROM 13%, TO 19% USED BY VARIOUS DIFFERENT CRITERIA RANGE FROM 5 TO 10%. THIS IS OUR DATA FOR SHOULDER DISSTOW SHAH. AS YOU CAN SEE CRITERIA HAD A SIGNIFICANTLY INCREASED RISK RATIO FOR SHOULDER DISTOCIA. THERE APPEARS TO BE A STEP UP IN SHOULDER DISTOCIA AT AND ABOVE CAN'T TEAR AND COUSTAN CRITERIA FOR DIAGNOSING GESTATIONAL DIABETES. ALMOST A THREEFOLD INCREASE RISK OF SHOULDER DISTOTIA BY THOSE CRITERIA. HOWEVER BECAUSE IT IS A RARE EVENT WITH BASELINE RISK GENERALLY 2 TO 5%, RISK DIFFERENCE BETWEEN VARIOUS CRITERIA AND THE GROUPS THAT DID NOT HAVE GESTATIONAL DIABETES WAS ONLY 1 TO 2%. BECAUSE NDDG GROUP WITH A SMALL NUMBER OF PARTICIPANTS, WE ALSO PROVIDED DIFFERENT COMPARISONS OF GDM FALSE POSITIVES BY NDDG CRITERIA VERSUS KNOWN GESTATIONAL DIABETES WHICH WOULD THE RESULTS BE INTERMEDIATE BETWEEN CARPENTER AND COUSTAN AND NDDG CRITERIA. THIS SHOWS OUR DATA FOR CESAREAN DELIVERY. ALL WAYS OF DIAGNOSING GESTATIONAL DIABETES ARE ASSOCIATED WITH ABOUT 30% INCREASE RISK OF CESAREAN DELIVERY. THE BASELINE RISK FOR CESAREAN DELIVERY RANGED FROM 18% TO 50% WITH RISK DIFFERENCE BETWEEN DIAGNOSIS OF F DIABETES AND NOT DIAGNOSED WITH GESTATIONAL DIABETES, BY VARIOUS CRITERIA RANGING FROM 5 TO 12%. THIS PLOT SHOWS SOME OF THE DATA THE INTO THE MAKING OF THOSE TABLES. THIS IS THE DATA FOR CESAREAN DELIVERY BY CARPENTER AND CRITERIA DIAGNOSING GESTATIONAL DIABETES. I WANT TO POINT OUT A COUPLE OF POINTS. OVERALL THERE IS A 30% INCREASE IN WOMEN WITH CARPENTER AND COUSTAN CRITERIA GESTATIONAL DIABETES. THE ONLY TRIAL IN THE GROUP BLINDED WAS THE NAYLOR TRIAL. THE OTHER TRIAL PROSPECTIVE NOT BLINDED WAS THE RICCART STUDY. NO DIFFERENCE IN INFANT MORE L IT WILLTY BY DIFFERENT CRITERIA USED FOR DIAGNOSING GESTATIONAL DIABETES. WE IDENTIFIED ONLY ONE STUDY THAT LOOKED AT LONG TERM OUTCOMES, THE OUTCOME OF CHILDHOOD OBESITY. THIS WAS THE 2007 PAPER, A RETROSPECTIVE COHORT OF MOTHER, CHILD PARENT AND LOOKED AT CLOSE TO 10,000 MOTHER CHILD PAIRS. THEY DEMONSTRATED MORE CASES OF CHILDHOOD OBESITY FOR WOMEN, FOR NOT TREATED UNMET CRITERIA FOR CARPSER AND COUSTAN FOR GESTATIONAL DIABETES VERSUS WOMEN NOT GESTATIONAL DIABETES. HOWEVER BECAUSE THEY WERE UNABLE TOED ADJUST MATERNAL BMI WHICH IS IS ONE OF THE BEST KNOWN PREDICTORS OF CHILDHOOD OBESITY, RESULTS OF THESE STUDIES NEED TO BE INTERPRETED WITH CAUTION. SO IN SUMMARY, WOMEN WITH HAD SIGNIFICANTLY MORE MACROSOMEIA EXCEPT IADPSG. LGA SHOULDER DISTOCIA AND SECTIONS. THE HIGHER THRESHOLD DID NOT CONSISTENTLY DEMONSTRATE GREATER RISK OF POOR OUTCOMES, HOWEVER THERE DID APPEAR A STEP UP FOR SHOULDER DISTOCIA AT AND ABOVE CARPENTER COUSTAN DIAGNOSING FOR GESTATIONAL CASE. >> THANK YOU. [APPLAUSE] >> LOIS, I SAT IN ON THESE CONFERENCE CALLS, THE AMOUNT OF WORK THAT WAS DONE AND VOLUME OF DATA ANALYZED WERE PHENOMENAL. THANK YOU SO MUCH FOR VERY IMPORTANT FOUNDATION. NEXT RELATIVE HYPERGLYCEMIA AND HEALTH OUTCOMES FOR THE MOTHER, PAT CATALANO, PROFESSOR IN REPRODUCTIVE BIOLOGY, DIRECTOR OF THE CENTER FOR REPRODUCTIVE HEALTH OBGYN DEPARTMENT, IN CASE WESTERN, ANOTHER FORMER CHAIRMAN, PATRICK.. >> THANK YOU, PETER AND THANKS TO THE ORGANIZERS. I THINK YOU HAVE A VERY LARGE TASK AHEAD OF YOU. THERE'S SO MUCH DATA THAT I THINK IT WILL TAKE A LITTLE BIT OF TIME. WE APPRECIATE YOUR INPUT AND THE EFFORT YOU HAVE DONE. SO WHAT I WANT TO TALK ABOUT IS THESE ISSUES RELATING TO RELATIVE HYPERGLYCEMIA AND OUTCOMES FOR THE MOTHER. IF YOU TAKE THE STANDARD CRITERIA, THE CARPENTER COUSTAN, THE QUESTION IS, WHAT DO WE KNOW, WHERE IS THE DATA RELATIVE TO THE OUTCOME FOR LESS THAN WHAT WE CONSIDER GESTATIONAL DIABETES. I DIDN'T THINK THERE WAS MUCH DATA WHEN I LOOKED AT IT BUT WE'LL START WITH A CONCEPT AND I'LL END WITH A CONCEPT AT THE END. THIS IS A CONCEPT OF WHAT HAPPENS OVER TIME TO INSULIN RESISTANCE. THE FACTORS RELATED TO IT IN ALL ARE TWO FACTORS. BETA CELL FUNCTION. SO OVER TIME UNFORTUNATELY WE DEVELOP INCREASED INSULIN RECESS STANCE. WE LOOSE LEAN BODY MASS, DEVELOP MORE FAT MASS, AND AS A RESULT OF THAT WE BECOME MORE INLYNN RESISTANT. DURING PREGNANCY THERE'S A 60% INCREASE IN INSULIN RESISTANCE. THIS IS ACROSS THE BOARD. MAKES NO DIFFERENCE IF NORMAL, OBESE, IF YOU HAVE NORMAL GLUCOSE TOLERANCE, GESTATIONAL DIABETES OR TYPE 1 DIABETES. PREGNANCY GOES FORWARD BUT BIG CHANGE INSULIN RESISTANCE. THIS IS WHAT WE'RE HERE TODAY TO TALK ABOUT WE DRAW A LINE TO SAY THERE IS CUT OFF GESTATIONAL DIABETES WHICH WE'LL SHOW LATER. ALSO WHAT WE CALL LATER IN LIFE, TYPE 2 DIABETES. THE KEY TO MENTION IS THAT THIS CHANGE HAPPENS OVER TIME AND THIS DELTA DIFFERENCE IS THAT WHERE YOU GO UPND AGAIN, THIS IS FOR ILLUSTRATIVE PURPOSES, PROBABLY REPRESENTS THOSE 75% WOMEN OF WEIGHT GAIN. THIS IS ONE FACTOR RELATED TO PARODY AS OUTCOME FACTOR FOR TYPE 2 DIABETES. THE REAL KEY IS WHEN YOU START. IF YOU START HERE, AGAIN, THIS BEING ARBITRARY, YOU HAVE A CHANGE IN YOUR GLUCOSE INSULIN RESISTANCE DURING PREGNANCY. 60% CHANGE. AND YOU MAY COME BACK DOWN TO BASELINE AND IF YOU DON'T LOSE THAT WEIGHT YOU WILL BE MORE INSULIN RESISTANT BUT UNLESS YOU LIVE TO BE 120 CHANCES ARE YOU WON'T DEVELOP DIABETES IN THE FUTURE. MY POINT THAT I'M TRYING TO MAKE IS THERE'S AN UNDERLYING FACTOR WHICH WILL BEGIN THE PREGNANCY WITH WHICH DETERMINES YOUR LONG TERM RISK OF DEVELOPING, AND PREGNANCY WHAT WE CALL GESTATIONAL DIABETES AND TYPE 2 DIABETES. PREGNANCY IS UNIFORM EFFECT ON METABOLISM IN GENERAL. THESE ARE MY OBJECTIVES, TALK ABOUT THE CRITERIA AND ACTUALLY I'LL SPEND LITTLE TIME ON THIS BECAUSE THE PREVIOUS SPEAKER VERSUS. RELATIVE HYPERGLYCEMIA RELATING TO PERINATAL OUTCOMES IN WOMEN WITH LESS THAN GESTATIONAL DIABETES. FOLLOW-UP RISK FOR MOTHER, ONE, FIVE AND 20 YEARS DATA AND BACK TO PATHOPHYSIOLOGY, BACK TO THE CONCEPT RELATIVE RISK OF DEVELOPING DIABETES AND WHAT CAN WE DO AS IT RELATES TO CRITERIA THAT ARE LESS SEVERE THAN WE NOW CALL GESTATIONAL DIABETES, IS THERE ANY BENEFIT OF KNOWING THIS, WHAT THE POTENTIAL BENEFIT FOR SOMETHING WE HAVEN'T TALKED A LOT ABOUT CALLED PREVENTION. THESE ARE CRITERIA, YOU HAVE SEEN THEM ALL BEFORE, I WON'T SPEND A LOT OF TIME ON THIS EXCEPT FOR WHAT ALREADY SAID. THESE ARE THE CRITERIA ELEVATED RELATIVE TO THE IADPSG CRITERIA. AND PEOPLE SAID THIS IS THE ONE CRITERIA WHICH IS LESS. THE POINT DR. COUSTAN AND OTHERS MADE IS THE ISSUE TALKING ABOUT ONE OR TWO ABNORMAL VALUES. AND FROM -- I WANT TO REITERATE A POINT THAT DR. COUSTAN MADE, THE WAY WE MEASURE IT TODAY IS MUCH DIFFERENT THAN THE WAY DR. O'SULLIVAN MEASURED IT 60, 70 YEARS AGO. WE USE PLASMA OR SERA. WE DON'T USE SAMOGI NELSON METHOD WE USE GLUCOSE OXIDASE METHOD. THIS METHOD DOG FOR GLUCOSE HAS CO-EFFICIENT VARIATION OF 2%. VERY REPRODUCIBLE RELATIVE TO WHAT WE HAD BEFORE. IN MY MIND WHAT WE'RE LOOKING AT IS ONE ABNORMAL VERSUS TWO IS REALLY GOING TO BE KEY. WHEN YOU DIAGNOSE DIABETES FROM IMPAIRED GLUCOSE TOLERANCE WHEN NOT PREGNANT, ONE VALUE THAT YOU -- THAT CAUSES DIABETES THAT GIVES YOU DIAGNOSIS, NOT TWO, SO WHEN NOT PREGNANT ONE ABNORMAL VALUE GIVES YOU DIAGNOSIS. IF YOU'RE PART OF THE CANADIANS THEY HAVE SOMETHING CALLED IMPAIRED GLUCOSE TOLERANCE WHICH I WILL SPEND TIME ON BECAUSE SOME OF THE STUDIES TALKING ABOUT COME FROM CANADA. WHAT IS THE RELATIVE RISK OF HYPERGLYCEMIA, LESS THAN GESTATIONAL DIABETES COMPARED THE PERINATAL OUTCOMES. FIRST IS THE DR. LANDON STUDY AT THE RELATIONSHIP BETWEEN ETERNAL GLYCEMIA AND PERINATAL OUTCOMES TESTIMONY BOTTOM LEFT SIDE YOU CAN SEE LEGENDS. , OPEN BOX REPRESENTS PEOPLE WITH 50-GRAM GLUCOSE CHALLENGE LESS THAN 120 WHICH MOST WOULD CONSIDER NORMAL. NOT 100% BUT NORMAL. B, REPRESENTS 50 GLUCOSE CHALLENGE GREATER THAN 135, C REPRESENTS 50-GRAM GLUCOSE CHALLENGE GREATER THAN 135 BUT ONE ABNORMAL VALUE. D, THOSE PEOPLE CONSIDER GESTATIONAL DIABETES WITH TWO OR MORE. IN THE PRINCIPLE OF THIS SLIDE IS TO SHOW YOU THAT WHETHER YOU LOOK AT COMPOSITE OUTCOME HERE, ELEVATED C PEPTIDE, SHOULDER DISTOTIA OR GESTATIONAL DIABETES OF PREECLAMPSIA, THERE'S INCREASED RISK OF PERINATAL OUTCOMES DEPENDING HOW NORMAL GLUCOSE TOLERANCE IS. SO HE DID SECOND ASPECT OF ANALYSIS AND COMPARED WITH ONE ABOUT NORMAL VALUE VERSUS TWO OR GESTATIONAL DIABETES AND SHOWING WHETHER YOU'RE LOOKING AT COMPOSITE, AT THE RISK OF LGA, ELEVATED C PEPTIDE, OR HYPERTENSIVE DISORDERS IN PREGNANCY, NO SIGNIFICANT DIFFERENCE IF YOU HAD GESTATIONAL DIABETES BY STANDARD CRITERIA, TWO ABNORMAL VALUES OR ONE ABNORMAL VALUE. THIS SLIDE IS SHOWN BEFORE ALSO. HAPO ASSOCIATIONS IN GLUCOSE WITH ABNORMAL OUTCOMES. BIRTH WEIGHT GREATER THAN 90 PERCENTILE, PERCENT BODY FAT GREATER THAN 90th PERCENTILE AND C PEPTIDE. THE POINT I WANT TO LOOK ON THIS SLIDE, WHAT YOU CAN SEE IS THAT IN BLUE, FASTING GLUCOSE HAS THE STRONGEST CORRELATION. AS MENTIONED PREVIOUSLY, WE KNOW THAT COMING IN FASTING FOR ALL PATIENTS IS A BURDEN. THE QUESTION, IF CAN YOU LOOK AT THIS DO WE NEED TO DO FASTING GLUCOSE ON EVERYBODY? AT THE ADA MEETING IN 2010. THESE LOOKING AT OUTCOMES WE HAVE BEEN TALKING ABOUT WHETHER BIRTH WEIGHT GREATER THAN 90 PERCENTILE, LGA, PEPTIDE, PAUCITY, CLINICAL HYPOGLYCEMIA, PRIMARY C-SECTION, PREMATURITY OR PREECLAMPSIA. IF YOU LOOK AT THE OVERALL HAPO GROUP THESE ARE PERCENTAGES ASSOCIATED WITH ADVERSE OUTCOMES. THEY SEEM TO MAKE SENSE. KEEP IN MIND THAT THE MEAN FASTING GLUCOSE IN THE HA POE STUDY WAS 81-MILLIGRAMS PER DECALITER. THE IF YOU TOOK PEOPLE WITH FASTING BLOOD SUGAR LESS THAN 80, NO QUESTION IT WAS LOWER, WHAT IS THE RISK OF SOME OF THESE ADVERSE OUTCOMES IF YOU DIDN'T HAVE THAT FASTING OR IF YOU KNEW THE FASTING WAS LESS THAN 80. HERE IT IS. ONE HOUR LESS THAN 80, TWO HOUR LESS THAN 153, WITHOUT COMES OF INTEREST WERE NOT SIGNIFICANTLY BUT LESS THAN WHAT WE SAW IN OVERALL HAPO STUDY GROUP. C PEPTIDE WAS 4.8 VERSUS 8.4, INFOS GREATER THAN 90th PERCENTILE, # .6 VERSUS 9.6, SO FORTH. TAKE THE WOMEN AND WENT TO THE NEXT STEP, FASTING GLUCOSE LESS THAN 80 BUT HAD ONE HOUR GREATER THAN 180 OR TWO HOUR GREATER THAN 153, WE CONSIDER IADPSD CRITERIA FOR GDM. SOME OF THESE CRITERIA DON'T CHANGE THAT MUCH. BIRTH WEIGHT GREATER THAN 90 PERCENTILE IS THE SAME. WE DO SEE THAT'S STILL A SIGNIFICANT INCREASE IN C PEPTIDE GREATER THAN 90 PERCENTILE, PRE-TERM DELIVERY. SO EVEN IF YOU HAVE NORMAL FASTING GLUCOSE LESS THAN MEAN FOR WHOLE 125,000, ONE AND TWO HOUR INCREASE RISK FOR ADVERSE OUTCOME AS COMPARED TO THE OVERALL POPULATION. BUT IS IT ENOUGH? REALLY THE KEY IS THIS LAST SLIDE. WHEN YOU LOOK AT GDM OVERALL, YOU NEED TO HAVE THAT FASTING GLUCOSE INVOLVED BECAUSE YOU CAN SEE VALUES HERE ARE ALL SIGNIFICANTLY GREATER THAN WHAT YOU HAVE EVEN IN THOSE PEOPLE WITH JUST ABNORMAL ONE AN TWO HOUR FASTING LESS THAN 80. SO SOME OF THE FOLLOW-UP. WHAT IS DATA ON FOLLOW-UP RISK OF DEVELOPING METABOLIC DYSFUNCTION, ONE YEAR FIVE AND 20 YEARS AFTER DIAGNOSIS OF DIABETES AN PREGNANCY. THESE ARE RECOMMENDED ASSESSMENTS AFTER GDP BY THE FIFTH INTERNATIONAL WORKSHOP CONFERENCE ON GDM IN 2007. THIS ALLUDED TO PREVIOUSLY, POST DELIVERY THE FIRST FEW DAYS CHECK FASTING RANDOM PLASMA GLUCOSE TO DETECT FOR OVERT DIABETES. IN THE POSTPARTUM PERIOD AROUND 6 WEEK FOLLOW-UP VISIT, CONSIDER A 75-GRAM TWO HOUR GTT TO DIAGNOSE DIABETES OUTSIDE OF PREGNANCY OR GLUCOSE TOLERANCE. ONE YEAR LATER A 75-GRAM TWO HOUR GTT TO ASSESS GLUCOSE NEOTAB HIM ANNUALLY FASTING GLUCOSE. TRIANNUALLY ANOTHER 75-GRAM AND PRIOR TO SUBSEQUENT PRE-EXISTING DIABETES, 75-GRAM TWO HOUR GTT. THIS IS DATA BY CATHY KIM WITCH WHICH HAS BEEN ALLUDED TO THE BEFORE, LOOKING AT STUDIES FIST FIVE YEARS AFTER DIAGNOSIS OF GESTATIONAL DIABETES IS A SIGNIFICANT INCREASE RISK OF DEVELOPMENT OF ABNORMAL GLUCOSE TOLERANCE CLOSE TO 30% OF THE POPULATION. FOLLOWING TO TEN YEARS IS A LITTLE LESS STEEP, CLOSE TO 50 TO 60%. AGAIN, VARIATIONS INCLUDE ETHNICITY, BMI, SO FORTH. THESE ARE DATA FROM (INDISCERNIBLE), THIS IS DATA FROM THE UNIVERSITY OF TORONTO. LOOKING AT WOMEN WHO PROGRESSED, WHO DEVELOPED PRE-DIABETES AND DIABETES 12 MONTHS POSTPARTUM. WHAT HE STUDIED, THE CODE IS DOWN HERE ALONG THE LEFT. THOSE WOMEN WITH NORMAL GLUCOSE CHALLENGE TEST. SECOND IS WOMEN WITH ABOUT NORMAL GLUCOSE CHALLENGE TEST BUT NORMAL GLUCOSE TOLERANCE TEST. GIGT I MENTIONED BEFORE WHICH IS BASICALLY ONE ABNORMAL VALUE ON GLUCOSE TOLERANCE TEST USING CANADIAN CRITERIAND GDM USING CANADIAN CRITERIA. THE POINT IS, IS THAT AT THREE MONTHS ALL THESE WOMEN HAD NORMAL GLUCOSE TOLERANCE TEST. SO THE THEY CAME IN FOR THE SIX TO 8 WEEKS CHECK UP, THEY WERE FINE, AND THE QUESTION IS SHOULD WE FOLLOW THESE CRITERIA THAT WE HAVE BEEN TALKING ABOUT. WHAT RAVI HAS SHOWN IS IF YOU HAD GESTATIONAL DIABETES IN PREGNANCY YOUR RISK OF HAVING ABNORMAL GLUCOSE TOLERANCE TEST OR PRE-DIABETES TO DIABETES WAS CLOSE TO 17% AT ONE YEAR. POINT OF FACT, HERE WHICH WE DON'T SPEND A LOT OF TIME, ONE ABNORMAL VALUE OR ABNORMAL GLUCOSE CHALLENGE TEST MAY RISK HAVING PRE-DIABETES OR DIABETES WAS CLOSE TO 10%, TWO TO FIVE TIMES GREATER THAN NORMAL GLUCOSE CHALLENGE TEST SO POINT OF FACT USING THE CANADIAN CRITERIA THAT YOU DIAGNOSE GDM, ONE YEAR RATER WITH NORMAL GTT THREE MONTHS HAD SIGNIFICANT INCREASE RISK OF GLUCOSE INTOLERANCE. CAN YOU LOOK AT PEOPLE TO FIND OUT WHAT ARE WITH RISK FACTORS, WHAT CAN WE TELL THAT SAYS DO YOU KNOW, MR. MRS. SMITH, YOU'RE AT RISK. IF I'M A CLINICIAN, LET'S LOOK AT THE OGT DURING PREGNANCY. WHAT YOU CAN SEE WHETHER LOOKING AT AGE, GESTATIONAL WEAK IT WAS DIAGNOSED WAS DIFFERENT. IT WAS OBVIOUSLY SIGNIFICANT. BUT CLINICALLY DOES IT MAKE A DIFFERENCE GESTATION IN HOW ABOUT ETHNICITY IN ONE THING THAT STANDS OUT IS HERE ONE ABNORMAL VALUE WITH GIGT GROUP YOU HAVE SIGNIFICANTLY MORE PEOPLE ASIAN. FAMILY HISTORY DIABETES, STILL TALKING 40, 50% OF THE POPULATION. PRE-PREGNANCY BMI WHERE THE MONEY WOULD BE, BMI BETWEEN 23 AND 25 AND HOW WE DEAL THAT SEEING PATIENTS IN A BUSY OFFICE. PRE-PREGNANCY BMI, THERE IS A TREND AS YOU WORK UP BUT EVEN WITH LARGE NUMBERS IT BARRY REACHES SIGNIFICANCE. SO WHEN YOU LOOK AT THIS DATA, IF YOU HAVE ANYTHING LESS THAN GDM THESE ARE PEOPLE WITH A 10% RISK OF ABNORMAL GLUCOSE TEST ONE YEAR OUT. EVEN WITH NORMAL TEST OF THREE MONTHS. HOW ABOUT THE THREE MONTHS POSTPARTUM VISIT? EVERYONE COMES BACK, YOU HAVE A NORMAL TEST, IS THIS SOMETHING ABOUT THE WOMAN CLINICALLY THAT YOU'RE IN YOUR OFFICE, YOU HAVE SEEN THE PATIENT, AND YOU CAN SAY YOU'RE INCREASED RISK. MONTHS POSTPARTUM DIDN'T MAKE A DIFFERENCE. SURPRISINGLY FOR ME, CURRENT BREAST FEEDING MAKES NO DIFFERENCE. MOST WOMEN WERE BREAST FEEDING. SYSTOLIC BLOOD PRESSURE WAS SIGNIFICANTLY HIGHER IN PEOPLE WHO HAD GDM BUT IN YOUR OFFICE YOU TELL A DIFFERENCE BETWEEN 108 AND 111? DIASTOLIC WAS THE SAME. BMI NOT DIFFERENT. ALL HAD A BMI AROUND 25. WASTE CIRCUMFERENCE I CAN'T IMAGINE CLINICALLY BUT THEORETICALLY FOR RESEARCH PURPOSES WAS NOT THAT MUCH DIFFERENT. IF YOU THINK 10% RISK OF ABNORMAL GLUCOSE TOLERANCE IS IMPORTANT, MY CONTENTION IS, IS THAT A LOT OF CLINICAL CRITERIA THAT MAY HAVE STATISTICCAL SIGNIFICANCE MAY NOT BE AS HELPFUL TO YOU KNOWING THEY HAD ABNORMAL GLUCOSE TEST DURING PREGNANCY, LESS SEVERE THAN GESTATIONAL DIABETES. WE TALK ABOUT GLUCOSE. KEEP IN MIND GESTATIONAL DIABETES IS GLUCOSE PART OF THE ICEBERG ABOVE THE WATER LINE. IT ALSO INVOLVES LIPID METABOLISM AND HERE IS DATA FROM RAVI WHO SHOWED THERE'S A LONGITUDINAL PROGRESSION IN ISSUES RELATED TO LIPID METABOLISM THAT WE TALK ABOUT. WHETHER TOTAL CHOLESTEROL, INCREASED, YOU CAN SEE THE P VALUES BELOW, THEY'RE ALL SIGNIFICANCE, DECREASE IN HDL CHOLESTEROL, INCREASE IN LDL CHOLESTEROL AND TRIGLYCERIDES AN RISK FACTOR HAVING GIGT, ONE ABOUT NORMAL VALUE WAS SIGNIFICANT RELATIVE TO TOTALRYK OF CHOLESTEROL LDL. A LATER LIFE. EXCUSE ME. THIS IS DATA FROM DR. DUNN. THIS IS THE ATLANTIC DIABETES AND PREGNANCY STUDY. SHE WAS NICE ENOUGH WHEN I WENT TO POSTER AT THE ADA TO GIVE HER SLIDES. SO THINK SHE SHOULD BE HERE, THANK YOU AGAIN. HOPEFULLY I PRESENTED YOUR DATA CORRECTLY. WHAT IT IS, IN THIS PARTICULAR STUDY DIAGNOSIS WAS MADE ONLY USING THE IADPSG CRITERIA. WHAT SHE LOOKED AT IS SHE FOLLOWED THE WOMEN OUT APPROXIMATELY FOUR TO FIVE YEARS AND LOOKED AT THE CUMULATIVE PROBABILITY OF DEVELOPING ABNORMAL GLUCOSE TEST. WHAT YOU CAN SEE USING THE IADPSG CRITERIA LESS THAN STANDARD IN THIS COUNTRY, IT WAS A SIGNIFICANTLY HIGHER RISK OF DEVELOPING GLUCOSE INTOLERANCE IN THIS POPULATION COMPARED TO NORMAL GLUCOSE TEST. FACTORS WAS FASTING GLUCOSE, 100-MILLIGRAMS PER DECALITER, USE OF INSULIN IN PREGNANCY, EARLY WEAK DIAGNOSIS OF GESTATIONAL DIABETES, COMPONENTS OF METABOLIC SYNDROME AND HEMOGLOBIN A 1C ELEVATEDDED. VERY INTERESTENING THIS STUDY, MATERNAL BMI WAS NOT A RISK FACTOR, I THINK WHAT THE SUMMARY WAS AT LEAST IN A POPULATION IN IRELAND, 30% HISTORY BY IADGSD GLUCOSE TOLERANCE AT MEAN OF 2.5 YEARS. A WOMAN WITH NORMAL GLUCOSE TOLERANCE USING SAME CRITERIA, 3.3% PROGRESS TO ABNORMAL GLUCOSE TOLERANCE. THE RISK FACTORS I MENTIONED, HIGHER FASTING INSULIN USE, EARLIER DIAGNOSIS AND OTHER RISK FACTORS I MENTIONED, ATP CRITERIA FOR METABOLIC SIN CHROME AND A 1C. THIS IS A SENATE STUDY BY CRARATO ET AL IN ITALY. LOOKING AT FOLLOW-UP OF WOMEN WITH GESTATIONAL DIABETES AND DEVELOPING ABNORMAL GLUCOSE TOLERANCE. THE NGT IS NORMAL GLUCOSE TOLERANCE, OAV IS ONE ABNORMAL VALUE. AND GDM WITH STANDARD TWO ABOUT NOR VALUES. WHAT WE'RE CALLING ABNORMAL GLUCOSE TOLL BACK THE TO THE POINT EARLIER IMPAIRED FASTING GLUCOSE, GLUCOSE TOLERANCE AT THE TWO HOUR VISIT OR TEST, AND IMPAIRED FASTING OR IMPAIRED GLUCOSE TOLERANCE OR DIABETES. IT WAS A SIGNIFICANT DIFFERENCE WITH ONE ABNORMAL VALUE OR GESTATIONAL VALUE COMPARED THE WOMEN SEVEN YEARS EARLIER WITH NORMAL TOLERANCE. ONE ABNORMAL VALUE THAT WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO RELATIVE RISK DEVELOPING ABNORMAL GLUCOSE TOLERANCE SEVEN YEARS OUT. IN THIS PARTICULAR STUDY BMI WAS A SIGNIFICANT CO-VARIABLE. HOW ABOUT THIS DATA FROM SEATTLE. THIS IS DARCY (INAUDIBLE) DATA PUBLISHED IN DIABETES IN 2008. WHAT IS THE RISK OF DIABETES POST ORAL GLUCOSE CHALLENGE TEST IN NORMAL VALUE. THE TOP REPRESENTS ABNORMAL GLUCOSE CHALLENGE TEST, THESE ARE THE QUARTILES, LESS THAN 97, SO FORT, DOWN THE LIST GETTING DOWN THE DR. COUSTAN'S 130, WHAT YOU CAN SEE IS THAT YOUR RISK OF DEVELOPING DIABETES NINE YEARS AFTER WAS SIGNIFICANTLY INCREASED DEPENDING DOWN THE QUARTILE. SECOND QUARTILE, THIRD QUARTILE, TOP QUARTILE, BOTTOM BEING REFERENCE. IF YOU WEPT AHEAD AND DID A GTT, ASSUME NO ABNORMAL VALUES NORMAL GLUCOSE L TOLERANCE, YOUR RISK OF DEVELOPING DIABETES PER 100,000 PERSON YEARS. ONE ABOUT NORMAL VALUE. NOT GDM, YOU HAVE A TWOFOLD HIGHER HAZARD RATIO DEVELOPING DIABETES NINE YEARS OUT. FINALLY, NOT FINALLY, COUPLE L MORE, THIS IS THE DIGEST STUDY, OUT OF FRANCE, 15 CENTERS IN FRANCE AT RISK OF DEVELOPING ABNORMAL GLUCOSE TOLERANCE. NORMAL GLUCOSE TOLERANCE GROUP WERE HERE AN OPEN BAR IS STRIPED BAR REPRESENTS ONE ABOUT NORMAL VALUE, SOLID BARS REPRESENT GDM WITH TWO OR MORE VALUES AND POINT IS WHETHER YOU HAVE GDM, ONE ABNORMAL VALUE, YOUR RISK OF HAVING ABOUT ABNORMAL TOLERANCE NINE YEARS OUT IS SIGNIFICANTLY GREATER COMPARED TO THE CONTROL GROUP. FINALLY, IF YOU HAVE A A HISTORY OF CARDIOVASCULAR DISEASE, THIS IS A 20 YEAR FOLLOW-UP STUDY, CARDIOVASCULAR DISEASE IS ATHEROSCLEROTIC DISEASE, STROKE, MAJOR ABNORMALITY. WHAT YOU CAN SEE HERE IS THAT IN USING HBA 1C QUARTILE PREGNANCY, BY THE TIME YOU GET TO THE FOURTH QUARTILE, 25% OF PATIENTS WITH HEMOGLOBIN A 1C YOU CONSIDER IN THE GENERAL NORMAL RANGE THEY HAD A SIGNIFICANTLY HIGHER RELATIVE RISK ADJUSTED FOR RISK OF CARDIOVASCULAR DISEASE. SO I'LL END TALKING ABOUT THE PATHOPHYSIOLOGY OF DIABETES, WHAT IS THE BENEFIT OF LOOKING AT THESE PEOPLE WHO MAY HAVE LESS THAN WHAT WE CONSIDER GESTATIONAL DIABETES. I'M GOING TO THANK TOM BUCHANON, WHAT IS THAT UNDERLYING PATHOPHYSIOLOGY DEVELOPING TYPE 2 DIABETES. ON THIS AXIS WE LOOK AT INSULIN SENSITIVITY INCLUDING LIVER AND SKELETAL MUSCLE. INSULIN SECRETION ON THIS SIDE OVER HERE, THERE'S YOUR PANCREAS. THIS IS A HYPERBOLL RELATIONSHIP. WHAT THIS REPRESENTS, AS YOU BECOME MORE INSULIN SENSITIVE, THE AMOUNT OF INSULIN YOU NEED TO SECRETE TO MAINTAIN NORMAL TOLERANCE DECREASES. TOM DID THIS. WHEN YOU BECOME PREGNANT AND YOU HAVE THAT 60% DECREASE IN INSULIN SENSITIVITY, OR INCREASE IN RESINCE STANCE, IF YOUR' NORMAL YOU GO UP THIS CURVE BUT YOU MAINTAIN GLYCEMIA. THE PROBLEM COMES WITH LIKE THE OXYGEN HEMOGLOBIN DISSOCIATION CURVE, IF YOUING SHIFT TO THE LEFT YOU INCREASE YOUR RISK OF IMPAIRED GLUCOSE TOLERANCE OR DEVELOPING DIABETES OR TOPIC TODAY IS GESTATIONAL DIABETES. THE POINT IS HERE, THOSE PEOPLE WHO ARE ON THIS PARTICULAR CURVE WHO MAY DEVELOP GESTATIONAL DIABETES SAME LEVEL OF INSULIN SENSITIVITY OR DECREASED INSULIN -- INCREASED INSULIN RESISTANCE OR DECREASED SENSITIVITY, THE DELTA DIFFERENCE HERE AT LEVEL OF INSULIN SENSITIVITY IS INABILITY TO PANCREAS TO MAKE ENOUGH INSULIN TO KEEP NORMAL GLYCEMIC. WHEN TOM LOOKED AT ISSUES HE FOLLOWED UP WOMEN OVER TIME, IF YOU LOOK AT THE FASTING GLUCOSE, THESE ARE WOMEN WHO DIED NOT DEVELOPDE DIABETES, AND DIABETES IS DEFINED CROSSING THIS SLIDE HERE. THESE ARE THE WOMEN WHO HAVE DISPOSITION INDEX. DISPOSITION INDEX IS THE PRODUCT OF THE INSULIN SENSITIVITY TIMES INSULIN RESISTANCE. IT'S A NUMERICAL FIGURE TO LOOK AT. THE POINT IS HERE, WHEN YOU HIT THIS PART OF THE CURVE YOUR INSULIN RESINCE ANSWER GETS WORSE, MAYBE YOU'RE GETTING FATTER AND THE PANCREAS DOESN'T WORK AS WELL. AS A RESULT YOU GET CLOSER TO THIS THRESHOLD. MY ARGUMENT WOULD BE THAT AS YOU LOOK HERE, THESE MAYBE BE PEOPLE WHO HAD GESTATIONAL DIABETES WHO DIDN'T GET BACK TO PRE-PREGNANCY WEIGHT. THESE MAY BE PEOPLE WHO HAD ONE ABNORMAL VALUE. THESE MAY BE PEOPLE WITH ABNORMAL GLUCOSE CHALLENGE TEST. IT'S A CONTINUUM. THE SAME CONTINUUM IS HERE WHETHER YOU LOOK AT TWO HOUR GLUCOSE TOLERANCE TEST, NORMAL PEOPLE HERE, DISPOX INDEX GETS WORSE BASED ON YOUR INCREASING INSULIN RESINCE TRANSAND INABILITY TO MAKE BETA CELL RESPONSE. WHAT GOOD IS IT? WHAT'S THE BENEFIT OF KNOWING THAT? THE BENEFIT OF THAT IS DOING SOMETHING ABOUT IT, GETTING BACK TO PREVENTION. THIS IS THE DATA FROM THE DPP. SHOWING THAT BELIEVE IT OR NOT, AS MANY OF YOU MAY KNOW, LIFESTYLE IN PEOPLE WHO ARE INCREASED RISK FOR DEVELOPING DIABETES, DECREASE RISK BETTER THAN USING DRUG LIKE METFORMAN AND HAVING PLACEBO. KNOWING SOMEONE IS AT RISK YOU CAN DO SOMETHING ABOUT IT. WE STALK ABOUT RISK BUT WE HAVE TO THINK LONG TERM AS WELL AS SHORT TERM. WHAT ARE WE INVESTING WHEN WE MAKE DIAGNOSIS. IF YOU WANT TO LOOK AT PEOPLE WHO HAD THE DIAGNOSIS OF GESTATIONAL DIABETES, NOT A DIAGNOSIS, NOT EVERYBODY ELSE, SAME PRINCIPLE APPLIES HERE. COMPARED TO METFORMAN GROUP AN MUCH LESS THAN PLACEBO GROUP. FINAL SLIDE, WE TALK OBESITY, IT'S INTERTWINED WITH WHAT WE TALK ABOUT WITH DIABETES, IN MY MIND, BASED ON STUDIES, IN MY MIND TREATMENT OF OBESITY HAVE BEEN ABLE TO IMPROVE AVOIDANCE OF EXCESSIVE GESTATIONAL WEIGHT GAIN. HOWEVER YOU DON'T HAVE MUCH AN EFFECT ON THE RISK OF FETAL OVERGROWTH, MACROSOMEIA, GESTATIONAL DIABETES, HYPERTENSIVE DISORDERS. WHEN WE TREAT WOMEN WITH GESTATIONAL DIABETES WE'RE ALSO TREATING EXCESSIVE GESTATIONAL WEIGH GAIN. 75% IS STILL GETTING MUCH GREATER. BUT WE ARE GETTING ADDITIONAL BANG FOR OUR BUCK BY LOOKING AT EXCESSIVE WEIGHT GAIN THAT'S A SIDE EFFECT BENEFIT. SO WE THINK IN THOSE WOMEN WITH HYPERGLYCEMIA LESS SEVERE THAN WE CONSIDER GESTATIONAL DIABETES CURRENTLY, INCREMENTAL INCREASE IN ADVERSE PERINATAL OUTCOMES, THREE MONTHS POSTPARTUM, INCREASE IN METABOLIC DYSFUNCTION NOT ONLY CARDIAC DYSFUNCTION LIPID METABOLISM 3 TO 20 YEARS OUT. THERE ARE INTERVENTIONS THAT WORK. WHETHER MEDICATIONS, YOU CAN PREVENT POTEEN IMPLICATIONS FOR LONG TERM. THANK YOU FOR YOUR ATTENTION. [APPLAUSE] >> THANKS, THAT'S A BEAUTIFUL TALK. OUR LAST SPEAKER TALKING RELATIVE HYPERGLYCEMIA AND HEALTH OUTCOMES FOR THE FETUS, DR. DAVID PETITT, SENIOR SCIENTIST, SANSOM DIABETES RESEARCH INSTITUTE. >> THANK YOU VERY MUCH. AS WITH THE OTHERS, I HAVE NO RELATIVE FINANCIAL CONFLICTS HERE. MY TASK WAS TO LOOK AT CHILDREN OF WOMEN WHO WERE NOT TREATED DURING LEGACY, RELATIVE HYPERGLYCEMIA. I WILL START OFF SHOWING DATA FROM AUSTRALIAN A CHOICE STUDY BROUGHT UP EARLIER. USING THE OLD WHO CRITERIA, WOMEN WITH FASTING GLUCOSE AS HIGH AS 139 COULD HAVE BEEN INCLUDED IN THIS STUDY RANDOMIZED TO NO TREATMENT. MILD GESTATIONAL DIABETES BECAUSE THE TWO HOUR HAD TO BE UNDER 200. AND THEY WERE RANDOMIZED EITHER TO TREATMENT OR NO TREATMENT. THE PRIMARY OUTCOME WAS ANY SERIOUS COMPLICATION. AND YOU CAN SEE COMPLICATIONS HERE. DEATH, NEONATAL DEATH, THERE WERE FIVE IN THIS UNTREATED GROUP, SHOULDER DISTOTIA BONE FRACTURE OR NERVE PALSY OR BEING ADMITTED TO THE NEONATAL INTENSIVE CARE UNIT OR JAUNDICE REQUIRING PHOTO THERAPY. THESE ARE PRIMARY OUTCOMES. 4% UNTREATED WOMEN HAD ONE OF THESE SERIOUS COMPLICATIONS, YOU'LL HEAR THIS AFTERNOON ABOUT THE EFFECT OF TREATMENT GESTATIONAL DIABETES ON OUTCOME. WE'LL POINT OUT IN THE TREATED GROUP NO NEONATAL DEATHS AND MANY LESS SERIOUS COMPLICATIONS. SECONDARY OUTCOMES INCLUDE ALL THE INDIVIDUAL ELEMENTS OF THE COMPOSITE SCORE OF THE SERIOUS OUTCOMES IN ADDITION TO BIRTH WEIGHT AND LGA AND MACROSOMEIA AND OTHERS THAT WE ARE USED TO THINKING ABOUT. BIRTH WEIGHT OVERALL WAS NOT PARTICULARLY ABNORMAL, IT WAS ABOUT 7 1/2 POUNDS YOU CAN SEE HERE BUT THAT WAS LESS WHAT WAS HIGHER THAN IN THE TREATED GROUP. THE LGA OVER 90th PERCENTILE OCCURRED AT 22% POPULATION. WE EXPECT IT TO BE 10% NORMAL POPULATION. MACROSOMEIA AS YOU CAN SEE, 4-KILOGRAMS MOST OF THE WOMEN LGA HAD BABIES -- MOST BABIES LGA MACROSOMIC. SGA DID NOT SEEM OUT OF LINE. HYPOGLYCEMIA IV THERAPY TO OCCURRED IN 5% WHICH IS CERTAINLY HIGHER THAN YOU EXPECT NORMAL. UNFORTUNATELY ALTHOUGH THEY COLLECTED DATA ON NORMAL WOMEN DURING THIS THIS STUDY THEY DID NOT PUBLISH THE NORMAL DATA. THE OTHER RANDOMIZED TRIAL, MILD GESTATIONAL DIABETES IS ONE SPONSORED BY THE CHILD HEALTH INSTITUTE. IT USED STANDARD U.S. CRITERIA WITH O'SULLIVAN -- WITH THE CARPENTER COUSTAN CRITERIA ON DIAGNOSIS OF GESTATIONAL DIABETES. THE BIG DIFFERENCE WAS THESE HAD MILD GESTATIONAL DIABETES, NUMBER HAD FASTING HYPERGLYCEMIA, FASTING GLUCOSE HAD TO BE POLO 95. AGAIN, BROKEN TO TWO GROUPS ONE WAS TREATED, THE OTHERS WITHER -- WERE NOT TREATED. THE OUTCOME WAS A COMPOSITE END POINT, HYPOGLYCEMIA, C PEPTIDE OVER THE 95TH PERCENTILE WITH HAPO STUDY LOOK AT 90th PERCENTILE, SO THAT WAS DIFFERENT. THAT WAS EXTERNALF EXTERNAL C PEPTIDE NORM THEY WERE USING TO DECIDE THE 95TH PERCENTILE SHOULD BE. STILLBIRTH NEONATAL DEATH WHICH THERE WERE NONE IN THE UNTREATED GROUP OR FIRST BIRTH TRUE MAVMENT YOU SEE GESTATIONAL AGE AVERAGE, 39 WEEKS, SO IT WAS FAIRLY NORMAL. SECONDARY OUTCOMES THEY HAD ALSO INCLUDED THE MACROSOMEIA AS WE LOOKED AT BEFORE. BIRTH WEIGHT WAS ABOUT THE SAME AS IT WAS IN THE A CHOICE STUDIES, 7 1/2 POUNDS OR SO, LGA OCCURRED IN 14 1/2 PERCENT OF THE KIDS AN AS YOU CAN SEE MOST OF THEM WERE MACROSOMIC WITH BIRTH WEIGHT OVER FOUR KILOGRAMS. FAT MASS ALSO HIGH AND ALL THESE WERE APPROVED WITH TREATMENT. PRE-TERM DELIVERY IN 11%, ABOUT WHAT YOU EXPECT. SG&A WAS WHAT YOU WOULD EXPECT. AD HIS TO ICU IS HARD TO PUT IN AS GLOBAL OUTCOME, SO MUCH DEPENDS ON WHAT THE CENTER IS DOING MUCH LOWER THAN A CHOICE STUDY BUT BOTH WOULD BE NORMAL. IV GLUCOSE TREATMENT IS HIGHER THAN YOU EXPECT IN TREATED POPULATION, NORMAL POPULATION OF WOMEN THAT DID NOT HAVE GESTATIONAL DIABETES. DR. CATALANO SHOWED YOU THIS EARLIER SO I DON'T NEED TO GO THROUGH THAT WHAT THEY MEAN BUT BECAUSE THEY HAVE THE NORMALS PUBLISHED HERE, GIVES A CHANCE WHAT TO EXPECT NORMAL POPULATION DID NOT HAVE GESTATIONAL DIABETES. CATEGORY A OPT LEFT IS A GROUP OF WOMEN WITH A NORMAL GLUCOSE, 50-GRAM GLUCOSE SCREEN WITH ONE HOUR LESS THAN 120 FOR COMPOSITE SCORE THAT WAS NOT SIGNIFICANTLY DIFFERENT FROM UNCRETE TREATED GDM THOUGH YOU CAN SEE THERE IS A TREND IN COMPOSITE SCORE FROM NORMAL TO ABNORMAL SCREEN, ONE ABNORMAL, TWO ABNORMAL GLUCOSE CONCENTRATIONS. BUT OTHER FACTORS SHOWS WHAT WE SHOULD BE EXPECTING IN TERMS OF LGA. THIS IS NORMAL WOMEN, THIS IS PROBABLY ABOUT THE BEST WE CAN EXPECT IN A POPULATION, WHAT WE SHOULD BE SHOOTING FOR WITH OUR TREATMENT. OF COURSE MUCH HIGHER LGA SHOULD EVERY DISTOTIA OFFSPRING OF WOMEN WITH UNTREATED THAN IN THE NORMALS. THE GPS CRITERIA, THE NUMBERS POINTED OUT BEFORE ARE NOT DIFFERENT THAN NUMBERS IN THE OTHER, SINGLE GLUCOSE THAT REALLY MAKES THE DIFFERENCE IN THE NUMBER OF WOMEN DIAGNOSED WITH GESTATIONAL DIABETES. THIS IS NOT THE SLIDE YOU HAVE SEEN BEFORE HERE, LOOKING JUST AT FASTING GLUCOSE, BIRTH WEIGHT, BODY FAT AND CORE PEPTIDE OVER THE 90th PERCENTILE. THAT'S DERIVED FROM DISTRIBUTIONS THE CENTER FOR SPECIFIC DISTRIBUTIONS OF WOMEN THAT WERE IN THE HAPLO STUDY SO THESE ARE HAPO SPECIFIC NUMBERS SO WE EXPECT OR WE KNOW BY DEFINITION 10% OF THE BABIES WERE OVER 90 PERCENTILE. 10% HAD BODY FAT OVER THE 90th PERCENTILE. FOR FASTING GLUCOSE, POINT WHICH WE SEE 10% IS IN THIS CATEGORY HERE WHERE WE HAVE GLUCOSE OF 81 TO 85%, THIS IS WHERE WE SEE 10% OR MORE. SO ANYBODY ABOVE THIS, ANY WOMAN ABOVE THIS SHIER THAN 10% RISK OF HAVING CHILD WITH HIGH BIRTH WEIGHT. THE CUT POINT FOR THE IDPSG IS 92. SIMILARLY FOR THE ONE HOUR 10% POINT 133 TO 135. CUT POINT IS 180. FOR THE TWO HOUR, 10% POINT WAS 110 AND 124 AND CUT POINT FOR DIAGNOSIS AND GESTATIONAL DIABETES IS 133. SO HERE FROM THE HAPO STUDY, HIGH ADPSG RETRO SPECK TESTIFILY APPLIED ON THE -- RETROSPECTIVELY APPLIED ON THE ENTIRE WOMEN AND CHILDREN TO COME UP WITH THESE NUMBERS. SO WE CAN SEE WITH WOMEN THAT ARE BELOW THE CUT POINT, ALL THREE POINTS, WE HAVE GOT A LGA RATE OF 8.3%. THE POPULATION AS A L WHOLE AT 10% AND IF ANY ONE OF THE THREE VALUES OVER THE CUT POINT RATE OF WAS DOUBLE. FOR PERCENT BODY FAT, HALF A PERCENT, IF THEY WERE OVER, IF THE WOMAN HAD GESTATIONAL DIABETES, THE RATE WAS DOUBLED. C PEPTIDE 6.7%, TWO AND A HALF TIMES, THE OTHER HAD GESTATIONAL DIABETES. YOU CAN SEE FOR ALL THE OTHER PARAMETERS THEY HAVE GOT HERE, WE DON'T HAVE GOOD NORMS FOR OTHER POPULATIONS BUT WE CAN SEE WHAT TO EXPECT IN WOMEN NORMAL BY SG CRITERIA, EVERY PACE IT WAS SIGNIFICANT INCREASE IN PARAMETER WITH GESTATIONAL DIABETES INCREASE 25 TO 50%, EACH ONE OF THESE PARAMETERS. ANOTHER STUDY LOOKED AT -- HERE WHERE SANDY WAS HELPFUL; THIS WAS PUBLISHED IN JANUARY, I WOULDN'T HAVE SHOWN IN IN OCTOBER. BUT THE KEISER PERMANENTE GROUP IN SOUTHERN CALIFORNIA USED UNIVERSEAL 75-GRAM LOAD FOR A NUMBER OF YEARS. THEY DIAGNOSED GESTATIONAL DIABETES BY THE CRITERIA WHICH YOU SEE THERE, THIS WAS A RECOMMENDATION, LATER INTERNATIONAL WORKSHOPS THAT YOU COULD GO AHEAD AND USEM-M UNIVERSEAL 75-GRAM MODE. TWO OR MORE ABNORMAL VALUES TO DIAGNOSE GESTATIONAL DIABETES. THEY FOUND 1900 WOMEN LOOKING RETROSPECTIVELY WHO MET THE IADPSG CRITERIA FOR GESTATIONAL DIABETES BUT THEY HAVE NOT MET THE PREVIOUS CRITERIA, THEY HAD IN THE BEEN TREATED SO YOU HAVE A GROUP OF WOMEN THEY CAN LOOK AT AND SEE WHAT THE OUTCOME WAS. AND THEY WERE PARTICULARLY INTERESTED IN LOOKING AT THE RATES OF LDA. THIS PAPER ALSO FOCUSED ON MATERNAL OBESITY, THAT WAS A BUSINESS RISK FACTOR. WE TALKED ABOUT THAT BEFORE. I WANT TO START BY SHOWING YOU THE EFFECT OF OBESITY ON THIS. LATION. NORMAL WEIGHT LIMIT, NOT OBESE, OVER WEIGHT WOMEN WHO DID NOT HAVE GESTATIONAL DIABETES. RATES OF LGA WERE ABOUT 7 1/2% OR SO. IF THE WOMAN WAS OBESE THESE WERE ESSENTIALLY DOUBLED IN THIS STUDY THEY LOOKED AT. THIS IS IMPORTANT BECAUSE THERE ARE MORE OBESE WOMEN THAN THERE ARE WOMEN WITH GESTATIONAL DIABETES BUT THEY LOOKUPS POPULATION STRATIFIED BY OBESITY AND SEE THE EFFECT OF GESTATIONAL DIABETES BY THE NDD CRITERIA. YOU CAN SEE NORMAL WEIGHT WOMEN, WHO DID HAVE GESTATIONAL DIABETES RATES OF LGA WERE DOUBLE. ABOUT THE SAME. A LITTLE HIGHER THAN OBESITY. IN THE OBESE WOMEN WHO ALSO HAD GESTATIONAL DIABETES, YOU CAN SEE THE EFFECT WAS DOUBLING OVER 20% OF THE OFFSPRING OF THESE WOMEN. AND GESTATIONAL -- HAD LARGE FOR GESTATIONAL AGE IF A WOMAN HAD GDM AND LESS OBESE. KEEP IN MIND, WOMEN WHO HAD A ONE HOUR GLUCOSE OVER 180 OR TWO HOUR GLUCOSE OVER 160 WERE NOT INCLUDED IN THIS STUDY. SO THIS IS RELATIVELY MILD CRITERIA SHOWING EFFECT OF BOTH OBESITY AND GDM. SUMMARY OF FINDINGS FROM THESE VARIOUS STUDIES, EVERYBODY LOOKED AT RATES OF LGA AND THEY VARIED FROM 14% UP TO 22%. THE HAPO STUDY BASED ON WOMEN IN THE HAPO STUDY, ABOUT 16% OF THE BIRTHS OF THE WOMEN (INDISCERNIBLE) CRITERIA WERE LGA IN THE USE, THE CRITERIA FROM KEISER SOUTHERN CALIFORNIA GROUP RATES VARIED FROM 13 TO 22% DEPENDING ON OBESITY. THOSE THAT LOOKED MOST (INDISCERNIBLE) BEFORE THAT. SHOULDER DISTOTIA WAS SIGNIFICANT IN ALL FAIRNESS THE DEFINITION OF GESTATIONAL DIABETES, ELEVATED C PEPTIDE, THIS IS ABOVE THE 95TH PERCENTILE IN THE CHILD HEALTH INSTITUTE STUDY. 90th PERCENTILE FOR THE HAPO STUDY. YOU CAN SEE THE BIRTH WEIGHTS UP THERE. LONG TERM FOLLOW-UP FOR THE KIDS. THE KIDS ARE BEING FOLLOWED, THEY HAVE PUBLISHED THE DATA FOR THE 4 TO 5-YEAR-OLDS 26% ABOVE THE 80th PERCENTILE, 4 TO 5 YEARS OF AGE. THE CHILDREN WERE ABOVE THAT PERCENTILE. YOU EXPECT 15% TO BE ABOVE BUT IT WAS 27%. THIS DIDN'T SEEM EFFECTIVE BY TREATMENT. NOT SIGNIFICANTLY DIFFERENT BETWEEN TREATED AND UP TREATED IN THIS POPULATION. THE KIDS OF WOMEN IN HAPO STUDY, WERE LOOKED ATLANTA AGE 2 AND AT THAT AGE THERE WAS NO ASSOCIATION BETWEEN THE MOTHER GLUCOSE DURING PREGNANCY AND OBESITY IN THE CHILDREN. THIS IS IN KEEPING WITH OTHER STUDIES, LOOKED AT OFFERING DIABETIC WOMEN AND FOUND THAT AT TWO YEARS THERE ISN'T MUCH EFFECT OF MOTHER GLUCOSE THOUGH THEY WERE BIG AT BIRTH AND GOT OBESE LATER ON, ONE OR TWO YEARS OF AGE, THEY WEREN'T DIFFERENT A NUMBER OF STUDIES USING ARCCOG CRITERIA TAKE ADVANTAGE OF THE FACT THE 50-GRAM SCREEN IS UNIVERSEAL. ALL THE WOMEN HAVE THE 50-GRAM SCREEN SO THAT'S A RISK FACTOR FOR WEIGHT IN THE CHILDREN LATER ON. THIS STUDY OUT OF NORTH CAROLINA LOOKED AT WOMEN WHOSE ONE HOUR 50-GRAM GLUCOSE WAS OVER 130 WHICH WAS THEIR DIAGNOSIS OF ABNORMAL AND COMPARED THEM WITH WOMEN WHOSE ONE HOUR SCREEN WAS BELOW 100 AND FOUND IF WOMAN HAD ABNORMAL SCREEN AT THEE THERE WAS A SIGNIFICANTLY HIGHER SCORE THAN KIDS. I DON'T KNOW ABOUT THE KIDS WHOSE MOTHERS HAD GLUCOSE IN BETWEEN THESE HERE. LIKEWISE IN KEISER PERMANENTE NORTHWEST, THEY LOOKED AT THE 50-GRAM SCREEN AND LOOKED AT KIDS 5 TO 7. LISTEN WAR ASSOCIATION BETWEEN ONE HOUR, 50-GRAM GLUCOSE IN BOTH RISK BEING OVERWEIGHT AND RISK OF BEING PIECE IN THE CHILDREN. INTERESTINGLY THOSE CHILDREN WHOSE MOTHERS HAD GDM THAT WAS TREATED WERE LESS OBESE THAN THOSE WHOSE WERE NOT TREATED OR WHO HAD SIMILAR 50-GRAM GLUCOSE LOAD. THIS IS THE ONLY DATA I KNOW THAT SUGGESTS THAT TREATING A WOMAN'S GDM DURING PREGNANCY MAY HAVE AN EFFECT ON OFFSPRING WEIGHT LATER ON. IT IS A RETROSPECTIVE NON-RANDOMIZED OBSERVATIONAL STUDY BUT ENCOURAGING TO THINK WHAT WE'RE DOING WITH WOMEN MAY HAVE AN EFFECT ON CHILD OBESITY LATER ON. THERE'S LINEAR ASSOCIATION BETWEEN MOTHER GLUCOSE DURING PREGNANCY AND CHILD WEIGHT AND CHILD GLUCOSE WHEN WE LOOK AT THEM LATER IN LIFE. JUST AS AN EXAMPLE, I WANT TO SHOW YOU KIDS AT AGE 10 TO 12. HERE WE LOOK AT THE AGE AND SEX SPECIFIC RELATIVE WEIGHT FOR HEIGHT IN THE CHILDREN. PLOTTEDDED ACCORDING TO MOTHER GLUCOSE DURING PREGNANCY. TWO HOUR GLUCOSE DURING DIAGNOSTIC GTT. YOU CAN SEE A LINEAR ASSOCIATION BETWEEN MOTHER GLUCOSE AN CHILD WEIGHT. THIS PERSISTS THROUGH AGE 20. IF YOU LOOK AT CHILD GLUCOSE, THERE'S A LINEAR ASSOCIATION BETWEEN MOTHER GLUCOSE DURING PREGNANCY AND CHILD GLUCOSE AND THIS PERSISTS AT LEAST UNTIL THE MID 30s AS WE HAVE LOOKED AT IT THERE. SO I WANTED TO CONCLUDE AND SAY THAT'S LINEAR ASSOCIATION DURING PREGNANCY AN ADVERSE OUTCOMES WE LOOK AT. THE CUT POINT WE USE TO PICK DIAGNOSE GDM DEPENDS WHAT WE'RE WILLING TO ACCEPT AS A COMPLICATION IN THE KID. IT'S ALWAYS DECIDED BY CONSENSUS, IT ALWAYS WILL BE DECIDED BY CONSENSUS WHICH IS WHY WE'RE HERE TODAY. THE GDM CRITERIA THAT LIMIT THE DIAGNOSIS TO HIGHER GLUCOSE CONCENTRATIONS HAVE SMALLER NUMBER AND HIGHER RATES OF ADVERSE OUTCOMES. SO IF IF YOU INCLUDE WOMEN LESS DEGREES OF GLUCOSE ABOUT NORMALITY YOU'LL HAVE -- ABNORMALITY YOU'LL -- A LOT WILL BE LESS THAN OVERALL RATE OF GDM COME MYCATIONS LESS THAN POPULATION. THANK YOU. [APPLAUSE] >> SO CAN I ASK PATRICK TO COME UP AND LISA AND LOIS. WE'LL START AGAIN WITH QUESTIONS FROM THE PANEL. >> MARK. >> THIS MIC DOESN'T SEEM TO BE WORKING. >> THERE IT IS. WONDERFUL PRESENTATION. I LEARNED MUCH. I REALLY APPRECIATE THINGS. I HAVE GOT THREE QUESTIONS. AND MAYBE I'LL LET YOU ANSWER IN TURN FIRST FOR DR. CATALANO, FROM YOUR DIAGRAM LOOKED LIKE GESTATIONAL DIABETES WAS ON THE SAME CONTINUUM AND PROCESS AS INSULIN RESISTANCE, SO I WOULD LIKE TO UNDERSTAND BETTER HOW THE EPIDEMIOLOGY OF GESTATIONAL DIABETES DIFFERS FROM EPIDEMIOLOGY OVINES LINS RESISTANCE OR DISPOSITION INDEX. AND ALSO MOST COMPLICATIONS OCCUR IN PREGNANCIES THAT DON'T INVOLVE GESTATIONAL DIABETES AND WONDERING WHAT WE'RE MISSING FROM PREDICTION MODELS. THIRD IS LOOKING AT CONTINUING DRUG SUBGROUP PREGNANCIES WHERE PARTICULARLY IMPORTANT CUT POINT IS DRAWN. CUTS HAVE STEEPER SLOPES, CONVERSELY ARE THEY SUBGROUPS WHICH IT DOESN'T MATTER MUCH WHERE CUT POINT IS. >> TRY TO ANSWER THE FIRST QUESTION SINCE YOU PUT MY NAME TO IT. THE CURVES FOR INSULIN RESISTANCE GDM ARE NOT THE SAME. PART OF THE PROBLEM IS WE DON'T MEASURE INSULIN RESISTANCE WELL. AS SUCH WE END UP USING AHOMA WHICH AREN'T GOOD. AND THE OTHER PART IS THAT WE DON'T REALLY MEASURE BETA CELL FUNCTION VERY GOOD. YOU CAN LOOK AT FASTING INSULIN, AREA UNDER THE CURVE, ET CETERA, BUT I THINK THAT THE VARIABLE IS HOW GOOD A PANCREAS YOU HAVE RELATIVE TO DEGREE OF INSULIN RESTANCE. -- RESISTANCE. THERE'S DATA THAT SAYS YOU CAN BE HEALTHY AND OBESE AND YOU CAN BE THIN AN METABOLICALLY DYSFUNCTIONAL. ALL WE HAVE TO GO BY IS CRITERIA WE'RE USING. RIGHT NOW IT'S A CLINICAL CRITERIA WHAT A GLUCOSE IS AFTER A LOAD WHICH IS THE VERY REASON WE TALKED ABOUT. BUT ONE THING, AS YOU GET OLDER, AS WE PROGRESS, ALL STUDIES HAVE SHOWN THIS, THAT THIS INCREASE IN OBESITY, IN WEIGHT FOR WOMEN WHO HAD GDM WITH ABNORMAL GLUCOSE VALUE DOES INCREASE THAT RISK OF DEVELOPMENT OF GLUCOSE INTOLERANCE OR HYPERLIPIDEMIA RELATED. METABOLIC SYNDROME. YOU CAN PURPORT A MECHANISM BECAUSE OF CYTOKINES AN INFLAMMATION. SO WHATEVER CUT OFF YOU USE, YOU HAVE TO LOOK NOT ONLY AT THAT POINT BUT WHERE I WILL BE IN FIVE YEARS, FROM THE DATA DAVID PRESENTED HE NEEDS TO LOOK AT OFFSPRING AS WELL. Q. YOU DIDN'T GET AN ANSWER TO YOUR SECOND QUESTION. >> I DID. >> REPEAT IT. >> SECOND QUESTION, MOST OUTCOMES COMPLICATIONS OCCUR IN PREGNANCIES THAT DON'T INVOLVE GESTATIONAL DIABETES. SO WHAT ARE WE MISSING FROM PREDICTION MODELS HERE? >> GO AHEAD, PATRICK. >> YOU CAN LOOK AT SOME PREDICTION MODELS THAT THERE ARE OTHER VARIABLES. THERE'S INDEPENDENT EFFECTS OF OBESITY, GLUCOSE INTOLERANCE RELATIVE TO MACROSOMEIA. THAT'S PART. GENETIC FACTORS HOW WE MEASURE AN OUTCOME IS ANOTHER VARIABLE, THAT WE TEND TO USE WEIGHT BECAUSE WE DEVELOP SCALES THAT ARE ACCURATE. I THINK AS YOU LOOK AT THESE THERE AREN'T VERY MANY VALUES THAT GO ON. CHANGES HAVE OCCURRED WITH EPIGENETIC CHANGES THAT MAY NOT BE MANIFEST UNTIL 5, 10, 20 YEARS OUT. WE DID INCLUDE ETHNICITY IN DISCUSSIONS. THAT'S GETTING TO THE THIRD TWEE QUESTION, WHAT GROUPS HAVE STEEPER SLOPE. TO THE CURVE. SO THAT MAYBE ANOTHER VARIABLE THAT YOU WANT TO LOOK AT. HOW MUCH OF THAT IS INDEPENDENT FACTOR? IF YOU ARE THIN WITH POOR DIET DOES THATTEN CREASE YOUR RISK? EXCESSIVE WEIGHT GAIN LEADS TO DEVELOPMENT OF DIABETES, BY WHATEVER CRITERIA. SO I THINK IT AS PHYSICIANS WE LOCK FOR SILVER BULLETS, I THINK THE LOAN RANGER RODE OFF TO THE SUN SET MANY YEARS AGO. AS A RESULT WE HAVE TO LOOK AT MULTI-FACTORALLY, GENETICALLY, ENVIRONMENTALLY, EPIGENETICALLY AND MOVE CLOSER TO THE ANSWER TO YOUR QUESTIONS. >> THIRD QUESTION YOU MENTIONED RACE ETHNICITY AS A PARTICULAR SUBGROUP WITH THE SLOPE IS INCREASED. OTHERS. THANK YOU. >> CERTAINLY THERE ARE CERTAIN ETHNIC GROUPS MUCH HIGHER RATES OF DIABETES. IT'S NOT TREATABLE. MUCH LIKE THE OBESITY IS VERY DIFFICULT TO TREAT WE CAN PREVENT WEIGHT GAIN. THIS CONFERENCE IS ABOUT GLUCOSE. WE KNOW IT'S TREATABLE AND THAT WE TREAT THEM WHETHER THERE'S GLUCOSE WE CAN GREATLY REDUCE COMPLICATIONS AT BIRTH. AND POSSIBLE REDUCE P COMPLICATIONS LATER ON, OTHER THINGS ARE VERY DIFFICULT TO ADDRESS AND ARE REALLY NOT SUBJECT OF THIS PARTICULAR CONFERENCE BUT DOESN'T HELP DECIDE HOW TO MAKE A CUT POINT FOR GDM. >> PATRICK, MAKE A VERY COMPELLING ARGUMENT THAT ONE ABNORMAL VALUE, HOWEVER DETERMINES CONFERS GLUCOSE INTOLERANCE AND LIPID ABNORMALITIES LATER. IS THERE COMPELLING EVIDENCE THAT YOU CAN DO ANYTHING ABOUT IT? YOU SHOWED A STUDY COMPARING PLACEBO, METAPHORMAN, LIFESTYLE, WE CAN'T EVEN GET PATIENTS TO COME BACK FOR SIX WEEK CHECK UP MUCH LESS A GLUCOSE TOLERANCE TEST. >> THAT'S TRUE BUT DOESN'T MEAN IT HAS TO BE TRUE IN THE FUTURE. 20, 30 YEARS AGO WE WOULD BE TALKING SMOKING AN PREGNANCY, MAYBE THROW OUR HANDS UP THE SAME WAY. BECAUSE IT IS NOT JUST YOU WITH YOUR PATIENT AND ME WITH MY PATIENT, PUBLIC HEALTH ISSUE. IT'S A GOVERNMENTAL ISSUE. AND I THINK THAT IT'S A PUBLIC ISSUE. AND I THINK THAT UNTIL WE'RE READY TO RECOGNIZE IT, PEOPLE WILL TAKE ISSUES IN THEIR OWN HANDS, I THINK THAT WE'RE GOING TO SAY WE CAN'T DO ANYTHING ABOUT IT. WE CAN'T LET THAT GOOD TRYING TO DO SOMETHING GET IN THE WAY OF PERFECT. WE WON'T HAVE EVERYONE COME BACK BUT IF WE HAVE SOME PEOPLE COME BACK IT'S BETTER THAN NONE. >> YES, SIR. >> MATT GILMAN HARVARD MEDICAL SCHOOL, QUESTION FOR DAVID AND LISA. IT COMES ABOUT IN MY QUEST TO SEPARATE APPLES AND ORANGES AND LOOK AT ORANGES SEPARATELY FROM APPLES SO WE HAVE A TYPE OF TEST, TWO STEP, 50-GRAM, 100-GRAM. WE HAVE A ONE STEP TEST WITH 75-GRAMS. WE ALSO HAVE NUMBERS OF CUT POINTS, ONE VERSUS TWO AND WE ALSO HAVE LEVEL OF GLUCOSE. SEEM AS LOT OF STUDIES ARE CONFLATTING THOSE THINGS. I WOULD LIKE TO ASK IN THE META ANALYSIS THAT YOU HAVE DONE OR AT LEAST THE REVIEW OF THE LITERATURE, ARE THERE ENOUGH STUDIES WITH INDIVIDUAL LEVELS THAT YOU CAN LOOK WITHIN THE GROUP OF 75 GRANTS APT DIFFERENT LEVELS AND DIFFERENT CUT POINTS TO SEE NUMBER ONE, DIFFERENT NUMBERS OF PEOPLE THAT YOU IDENTIFY, WE CAN PROBABLY PREDICT THOSE BUT ARE THEY DIFFERENT OR ARE THEY THE SAME PEOPLE? IT COULD BE DIFFERENT PEOPLE. BECAUSE NOT ONLY DO YOU CHANGE FASTING CRITERIA, YOU ALSO CHANGE POST PARENTAL CRITERIA. AND WHAT ARE THE RISKS ASSOCIATED WITH THE DIFFERENT CRITERIA WITHIN THE SAME POPULATION? DOES DOES THAT MAKE INNOCENCE I THINK WHAT YOU WERE SHOWING IS DIFFERENT TESTING STRATEGIES IN DIFFERENT POPULATIONS. NOT DIFFERENT CUSTOMER STRATEGIES WITHIN THE SAME POPULATIONS. THEN THE SAME THING FOR DAVID, I DIDN'T KNOW THAT PAPER FROM KEISER'S SOUTHERN. DID THEY LOOK AT THE OLD VERSUS THE NEW CUT POINTS USING THE 75-GRAM TO SEE IF IT IDENTIFY DIFFERENT PEOPLE AND IF THE RISKS -- HOW DIFFERENT WERE THE RISKS DEPENDING ON WHETHER YOU IDENTIFY THE SAME PEOPLE OR DIFFERENT PEOPLE? D]%?– THAT MAKE SENSE IN >> IT MAKE AS LOT OF SENSE. A COUPLE OF AUTHORS ARE HERE, WE MAY HEAR SOMETHING FROM THEM. IN THAT PAPER THEY DIDN'T INCLUDE ANY OF THE WOMEN THAT HAD BEEN DIAGNOSED BY THE OLD CRITERIA. IT WAS ONLY THE MILD ONES BY THE IADPG CRITERIA THAT'S WHAT THEY WERE LOOKING AT. THEY HAVE THE DATA TO SEE, CERTAINLY JUST BY DEFINITION ALL OF THE WOMEN THAT HAD BEEN IDENTIFIED OLD CRITERIA WOULD BE IDENTIFYD BY NEW CRITERIA. BUT I DON'T KNOW WHAT THE RATES OF WILL LGA WAS IN THE OLD CRITERIA IN WOMEN DIAGNOSED BY OLD CRITERIA. BUT THEY WERE ALL TREATED SO NOT COMPARABLE. >> I COULDN'T TELL WHETHER IT'S A SUBSET OR OVERLAPPING DIAGRAM BECAUSE THEY WERE DIFFERENT FASTING AND POST (INAUDIBLE). >> THEY USED THE SAME 75-GRAM OGGT FOR A NUMBER OF YEARS. AND THEY LOOKED AT THAT WOMEN THAT HAD THAT TEST OVER THE YEARS. WHO DIDN'T MEET OLD CRITERIA AND THEREFORE SAY THESE ARE NORMAL BY CRITERIA, THESE WOULD HAVE BEEN DIAGNOSED DIABETES BY THE DESCRIPTION AND THAT'S ALL THAT'S INCLUDED IN THE PAPER. >> YOU CAN SEE THE OTHER COLUMN OF THE 2 BY 2 TABLE. THE OTHER L COLUMN OF THE 2 BY 2 TABLE WHICH SAYS THIS IF THEY WERE DIAGNOSED THEY WOULDN'T BE BY -- >> IF THEY WERE DIAGNOSED BY THE OLD CRITERIA, THEY WOULD BE DIAGNOSED BY NEW CRITERIA. BUT ELIMINATING THEM BECAUSE THEY'RE TREATED. WE WERE LOOK AT UNTREATED. >> I'LL SPEAK TO YOUR FIRST QUESTION. MOST STUDIES COMPARED WOMEN ABOVE AND BELOW A DIFFERENT CUT POINT. YOU'RE QUITE CORRECT MOST COMPARISONS WE SHOWED WERE BETWEEN DIFFERENT STUDIES. THOSE STUDIES THAT REPRESENTED DATA IN A CONTINUOUS POSITIVE RELATIONSHIP THE HAPO STUDY, 1995 PAPER AND THE TORONTO HOSPITAL PAPER DO HAVE THE ABILITY TO CUT AT DIFFERENT CUT POINTS AND MAKE THEM MUTUALLY EXCLUSIVE. THE DATA WE INCLUDED FOR A NUMBER OF DEVELOPMENT OF OUR RISK RATIOS, INCLUDED THE HAPO DATA FOR SYSTEM OF THOSE OUTCOMES WHERE IT WAS AVAILABLE BUT IT'S IMPORTANT TO NOTE THE THEY INCLUDED WOMEN THAT MET THE I E. CXFCG. CXFCDPASG CRITERIA. ABOVE THAT WHICH WOULD HAVE INCLUDED WOMEN AT HIGHER CUT POINTS BUT THE DATA IS THERE. COULD BE ANALYZED IN THAT FASHION BY THE GROUPS THAT DEVELOPED IT. >> HI, THANK YOU. THE POINT ABOUT THIS BEING GLYCEMIA, IS WELL MADE. BUT WE'RE IN MULTI-FACTORIAL WORLD IF YOU'LL PARDON ME. WE CAN'T SEPARATE IT OUT. CONFOUNDER OF OBESITY AND WEIGHT GOES THROUGH AN PERMEATES EVERY TRIAL. IT AFFECTS HOW WE INTERPRET OUR TRIALS TOO. THE NETWORK TRIAL WERE ALL VOLUNTEERS. THE NET GAIN OF FAIRLY INTENSIVE TREATMENT GROUP IS 100-GRAMS IN BIRTH WEIGHT. THAT RESULTS IN SECONDARY INFLUENCES OF LGA PERCENTAGES BUT THAT 100-GRAM PUSHED A CONSIDERABLE PORTION OVER THE EDGE SO 100-GRAM DIFFERENCE IN BIRTH WEIGHT. C-SECTION REDICTION, DIRECT RESULT IT IS WAY THE STUDY WAS DONE AND THE FACT PEOPLE WITH WERE ALERTED THIS IS A STUDY PATIENT THAT'S BEEN TREATED, ET CETERA. SO TYPE OF STUDY IS IMPORTANT. COHORT STUDIES ARE IMPORTANT TO GET RID OF THE VOLUNTEER AFFECT. I RECALL A TRIAL THAT I DON'T BELIEVE I HAVE SEEN BECAUSE OF THE NUMBERS, IT INVOLVES PATIENTS AT DIFFERENT SITES ALL MANAGED BY MAY TRIA WITH A MINIMUM OF 21 NURSE CONTACT VISITS DAILY FOR 21 DAYS. MANY OF THEM THROUGHOUT TO END OF PREGNANCY DEPENDING ON THEIR NEED, ONE-THIRD OF 3,000 WOMEN, FAILED TO GET CONTROL AND STILL HAD BIGGER BABIES THAN TARGETED. THOSE WITH THAT HIGHER FASTINGS AND HEAVIER. SO THOSE -- THAT KIND OF DATA REALLY IS IMPORTANT, IT ILLUSTRATES THE IMPORTANCE OF THESE RELATIONSHIPS ALL PERTAIN, GLUCOSE EFFECTS BABY SIZE BUT IT DOESN'T MEAN WE'LL BE ABLE TO DO ANYTHING ABOUT IT. >> ALAN. >> I GUESS THAT WAS THE QUESTION. >> I TRIAL IT AS A COMMENT. ALAN. THANK YOU. >> JUST A QUICK FOLLOW-UP ON THE CUT OFFS FOR THE ONE HOUR GTT, I WAS INTRIGUED BY DATA PRESENTED FROM UNC AND I THINK ONE OF THE (INAUDIBLE) SUGGESTING THAT CUT UP, VALUES GREATER THAN 130 WOULD BE WITH INCREASE IN OBESITY OF ONE AND PERHAPS FIVE YEARS OR SO. CAN YOU TELL US OR SHARE REFERENCES THAT WOULD BE GREAT BUT DID THEY LOOK AT DIFFERENT CUT OFFS AT BOTH 130 FOR EXAMPLE BETWEEN 130 AND 135 BETWEEN 135 AND 140 TO SEE WHETHER THAT IMPACT WAS RESTRICTED TO A CERTAIN CATEGORY. FOR EXAMPLE, IS IT JUST 135 AND ABOVE? OR ALL THE WAY FROM 130? >> THAT'S CERTAINLY SOMETHING THEY OUGHT TO DO. THAT WASN'T IN THE T PAPER THAT I SAW FOR ONE REFERENCE. THE OTHER GROUP IN KEISER PERMANENTE NORTHWEST LOOKED AT THE 50-GRAM SCREEN RESULT AS CONTINUUM AND SAW A LINEAR ASSOCIATION BETWEEN THAT, WITH NO OBVIOUS CUT POINT. >> THANK YOU. >> DAVID SAX FROM DEPARTMENT OF LABORATORY MEDICINE CLINICAL CENTER AT THE NIH. NO RELATION TO THE OTHER DAVID SAX WHO SPOKE EARLIER THOUGH SOMETIMES WE GET CONFUSED AT A TA MEETINGS. DESPITE THE FACT I HAVE MORE HAIR THAN HE DOES. I HAVE A COMMENT, NO QUESTION. I JUST WANTED TO TALK ABOUT THE GLUCOSE ASSAY WHICH HAS IMPROVED CONSIDERABLYP SINCE STUDIES WERE DONE. PARTICULARLY REPRODUCIBILITY WHICH WAS MENTIONED EARLIER. SO IF YOU RUN THE SAME PATIENT SAMPLES SEVERAL TIMES ON THE SAME INSTRUMENT YOU'LL GET CLOSE TO THE SAME RESULT. BUT TWO IMPORTANT FACTORS THAT HAVE TO BE CONSIDERED, ONE IS SOMETHING CALLED BIAS, WHICH MEANS SOME INSTRUMENTS MIGHT MEASURE A DIFFERENT RESULT TO ANOTHER INSTRUMENT. SO IF PATIENT TRUE GLUCOSE IS 100, IF THE INSTRUMENT HAS 5% BIAS'S HIGH, IT WILL GIVE YOU A RESULT OF 105, ANOTHER WILL GIVE YOU THE RESULT OF 100. THE SECOND IMPORTANT ISSUE, NOTHING CAN BE DONE ABOUT CURRENTLY IS GLYCOLYSIS THAT HAPPENED AFTER THE SAMPLE IS COLLECTED FROM THE PATIENT. AND PEOPLE BELIEVE GRAY TOP TUBES STOP GLYCOLYSIS AND THAT'S TRUE BUT ONLY AFTER FOUR HOURS. SO IF FIRST FOUR HOURS EVEN IF SAMPLES, GLYCOLYSIS OCCURS SO YOU CAN GET DECREASE IN GLUCOSE CONCENTRATION. THE HAPO STUDY WAS DESIGNEDDED IN TERMS OF THIS AND I CAN SAY THAT BECAUSE I HAVE NOTHING TO DO WITH THE DESIGN OF THE STUDY. BUT THEY MADE SURE SAMPLES WERE COLD AND IMMEDIATELY AND SIERRA FROM PLASMA WAS SEPARATED, WHICH IS CURRENTLY THE ONLY WAY TO STOP GLYCOLYSIS. THERE IS A TUBE AVAILABLE YOU CAN INHIBIT GLYCOLYSIS IMMEDIATELY BUT IT'S NOT COMMERCIAL LIVABLABLE IN THE US. SO I WANTED TO ADD THOSE -- AVAILABLE IN THE U.S. SO WANTED TO ADD THOSE COMMENTS TO THE PANEL. >> YOU'RE GOING TO BLOW OUR MINDS. WE HAVE ENOUGH CONFOUNDERS TO WORRY ALREADY. NOW WHICH GOT TO WORRY ABOUT TUBES AND BIAS IN AN INSTRUMENT. GOLLY. >> IT'S NOT MY FAULT. >> >> (INDISCERNIBLE) MONTREAL. I HAVE A SET OF I'M EMBARRASSED IS NOT PUBLISHED PUBLISHED BUT IT IS A PROSPECTIVE RANDOMIZED CONTROL TRIAL WHERE ONE GROUP HAD A 50-GRAM AND 100-GRAM TEST WITH N THEGG CRITERIA FOR DIAGNOSIS AN THREE, THE OTHER IS 50-GRAMS IN THE CANADIAN DIABETES TREATMENT AND THE THIRD GROUP HAD 75-GRAM DTT ALL OF THEM. WE LOOKED AT OUTCOMES IN PATIENTS TREATED WITH GDM BY SAME GROUP OF PEOPLE IN THE SAME HOSPITAL SAME METHODS. WHAT WE SAW WAS THE FAST -- THE NEDD CRITERIA, THE NUMBERS CLOSEST TO GIVING 75-GRAM NUMBERS THAT WERE COMPARABLE IN THE SAME RATES OF DIAGNOSIS OF WHAT WE CALL GDM WITH ABNORMAL SCREEN OR TWO ABNORMAL VALUES WAS THE SAME AS IDDPSG. SO WE'RE COMPARING NUMBERS, ACCORDING TO MY DATA THAT SAY THE DATA AND NEW NUMBERS ARE COMPARABLE. WE'RE NOT GOING EVEN TO CARPENTER AND COUSTAN NUMBERS. WE GET HIGHER NUMBERS IF WE DID THAT. I WOULD BE HAPPY TO LET ANYBODY WORK WITH MY DATA BECAUSE I DON'T KNOW WHEN I'LL GET IT OUT THERE. 1770 WOMEN IN EACH GROUP. SO I THINK THERE IS A PERSPECTIVE RANDOMIZED CONTROL TRIALS DONE, THERE'S A LOT OF INFORMATIONNA MAYBE HELPFUL BUT NEDD TO IADPSD NUMBERS FROM 100 TO 75, BASICALLY IDENTICAL. AND CURIOUSLY ENOUGH WE HAD STATISTICALLY POOR OUTCOMES IN THE NORMAL WOMEN IN GROUP 3. SO GROUP 3, THE CANADIAN NUMBERS TWO RISK RATIO WITH HAPO NUMBERS OF 2, THAT POPULATION HAD STATISTICALLY DIFFERENT POORER OUTCOMES COMPARED TO 50-GRAM SCREEN, 100-GRAM NIDDC OUTCOMES. SO AS I SAID, I WOULD BE HAPPY TO SHARE THIS DATA AT THIS POINT. BECAUSE I THINK IT MIGHT BE HELPFUL. >> REMEMBER WE HAD TO READ THIS IN LESS THAN 48 HOURS. >>LINDA BAR BOAR, UNIVERSITY OF COLORADO. THANK YOU FOR THE PRESENTATION. WANTED TO MAKE A COMMENT AND QUESTION. IN TERMS OF THE COMMENT ABOUT LONG TERM OUTCOMES OF CHILDREN WHICH ARE INCREDIBLY IMPORTANT AND WHAT RESULTED MACROSOMEIA OTHER THAN GLUCOSE OR OBESITY, THERE'S A COUPLE OF PAPERS, ONE BY SCHAFER GRAPH AND SHOWENING WELL CONTROLLED WOMEN WITH GESTATIONAL DIABETES WAS MATERNAL TRIGLYCERIDES, HIGHER PREDICTOR OF ADIPOSITY. AND WE ALSO PUBLISHED IN OBESE WOMEN PUTTING THEM ON A CONTROLLED DIET AND LOOKING AT GLYCEMIC PATTERNS. OBESE WOMEN HAVE HIGHER GLYCEMIC PATTERNS THAN NORMAL WEIGHT WOMEN USING CONTINUOUS GLUCOSE MONITORING AND ON A CONTROLLED DIET. IT WAS THE MATERNAL TRIGLYCERIDES THE HIGHEST PREDICTOR OF FETAL FAT ACCRETION. SO WE TALK ABOUT IT BEING PART OF THE EQUATION. THE A CHOICE TRIAL DIDN'T SHOW MILD GLUCOSE INTOLERANCE USING A 2 HOUR 140 CHANGED ADIPOSITY OF FOUR TO FIVE YEARS OF AGE WHEN YOU REALLY THINK THAT'S WHEN YOU START SEEING THAT OBESITY EFFECT GO UP. SECOND IS A QUESTION. WHEN I WAS AT IDBASG THEY LOOKED HOW MANY SUBJECTS THEY COULD ACTUALLY MAKE DIAGNOSIS OF GDM, BASED ON FASTING APPROXIMATE ONE HOUR. EXCLUDING THE TWO HOUR. AND TO MY RECOLLECTION, 95% OF ALL THE WOMEN WITH WITH GESTATIONAL DIABETES COULD BE DIAGNOSED BY FASTING AND ONE HOUR. IF THAT WOULD SAVE, A LOT OF TIME AND RESOURCES WITH A THIRD GLUCOSE BEING DONE, I WOULD WONDER, IF MAY BE DISCUSSED BY DR. MES,TSGER AND OTHERS BY CONSIDERING ADOPTING A TWO STEP THAT INCLUDES FASTING AND ONE HOUR. >> RIGHT ON QUEUE, DR. METSKER. >> I THOUGHT PERHAPS I WOULD ADDRESS THAT QUESTION. THE FIGURE OF PEOPLE WHOSE DIAGNOSIS MADE WITH FASTING AND ONE HOUR IDDPSG CRITERIA IS ABOUT 85% BUT THERE'S CENTER TO CENTER VARIATION IN HONG KONG TWO HOUR VALUE IS DIAGNOSTIC IN OVER 30% SO I DON'T THINK ONE CAN GENERALIZE STRATEGY APPLYING FASTING AND ONE HOUR TESTING WITHOUT FURTHER EVALUATION OF THAT. THERE'S ALSO A LOT OF POSSIBILITY APPLYING FASTING GLUCOSE ONLY. HIGH RATES OF DIABETES. IT'S BEEN LOOKED AT IN AN ARAB POPULATION, UNITED ARAB EMIRATES AND FASTING GLUCOSE ALONE COULD RULE IN AND OUT HIGH PROPORTION OF POSITIVE AND NEGATIVE PATIENT TS. IF WE HAVE STANDARDIZED SET OF CRITERIA WE CAN LOOK AT WAYS TO STREAMLINE OR MAKE OUR TESTING MORE COST EFFECTIVE BUT I THINK DECIDING ON CRITERIA IS THE FIRST BIG STEP. THEN ONE GOES AT WHAT'S BEST WAY TO DETECT THAT. >> THANKS, ROY. ANY OTHER COMMENTS? IF YOU DIDN'T GET TO THE MICROPHONE AND WANT TO DO SO, FEEL FREE TO USE COMPUTERS IN THE LOBBY TO QUERY THE SPEAKERS AND LET THE PANEL KNOW YOUR THOUGHTS. I THINK WE HAVE HAD A GREAT SESSION THIS MORNING, THANKS TO ALL THE SPEAKERS AND DISCUSSANTS. LOOK FORWARD TO SEEING YOU THIS AFTERNOON. [APPLAUSE] WE'RE NOW ADDRESSING QUESTION FOUR, DOES TREATMENT MODIFY HEALTH OUTCOMES OF MOTHERS WHO MEET VARIOUS CRITERIA FOR GESTATIONAL DIABETES AND THEIR OFFSPRING. FIRST OFF, WE'RE GOING TO HEAR FROM THE EVIDENCE BASE PRACTICE CENTER BENEFITS OF TREATMENT OF GESTATIONAL DIABETES ON MATERNAL FETAL HEALTH OUTL COMES LOIS AND LISA. >> I THINK WE HAVE JUST HEARD THE QUESTION, DOES TREATMENT MODIFY HEALTH OUTCOMES OF MOTHERS WHO MEET VARIOUS CRITERIA AND OFFSPRING. THAT'S THE QUESTION WE'RE FOCUSING ON IN THIS PRESENTATION. GOING TO GO THROUGH THESE IN DETAIL, SAME SLIDE I PRESENTED THIS MORNING, STEMS FROM THE EVIDENCE WORK WE DID THROUGH AHRQ. WE DID A COMPREHENSIVE SEARCH SYSTEMATIC REVIEW METHODS AND POOLING THE DATA FROM THE INDIVIDUAL STUDIES IN THE FORM OF A META ANALYSIS. SO FOR THIS QUESTION OUR EXCLUSION CRITERIA WERE RESEARCH PUBLISHED IN ENGLISH IN 1995 ONWARD. WE WERE INTERESTED IN RANDOMIZED CONTROL TRIALS, NON-RANDOMIZED CONTROL TRIALS AND COHORT STUDIES. WE WERE INTERESTED IN WOMEN WITH NO HISTORY AND ANY TREATMENT VERSUS NO TREATMENT. WE WERE INTERESTED IN SHORT AND LONG TERM OUTCOMES AMONG’M MOTHERS AN OFFSPRING AND WE INCLUDE STUDIES OF ANY DURATION OF FOLLOW-UP AND ANY STUDIES. FOR THIS WE WE FOUND FIVE RANDOMIZED CONTROL TRIALS AND SIX RETRO PECKTIVE COHORT STUDIES. THEY USED A VARIETY OF GLUCOSE INCLUSION CRITERIA. LOIS WILL SPEAK ABOUT THAT IN A MINUTE. ALL STUDIES COMPARED NO TREATMENT, DIETARY -- WHEN IT WAS REPORTED IN STUDIES, GLUCOSE TESTING OCCURRED AFTER 24 WEEKS AND SEVERAL STUDIES THAT INFORMATION WAS NOT REPORTED I'LL PASS YOU ON TO LOIS FOR MORE DETAILS. >> SO THE GLUCOSE INCLUSION CRITERIA USED BY THESE TREATMENT STUDIES RANGE FROM WOMEN THAT HAD A POSITIVE 50-GRAM SCREEN WITH A NON-DIAGNOSTIC ORAL GLUCOSE TOLERANCE TEST TO WOMEN WHO MET CRITERIA FOR JUSSATIONAL DIABETES BY NDDG CRITERIA. WE WANT TO FOCUS ON INCLUSION CRITERIA FOR THE TWO LARGEST RANDOMIZED CONTROL TRIALS THAT DRIVE MOST OF THE FINDINGS. SO FOR THE SHOW BY CARUTHER AT ALL THEY USED THE CRITERIA TO IDE IF IN MY STUDY. ON FASTING GLUCOSE LESS THAN 95-GRAMS PER DECALITER. BACK TO THE GREEN DIAGRAM TO SHOW HOW THESE COMPARED DESPITE ENTRY CRITERIA INTO THE STUDIES, THERE WAS A REMARKABLY SIMILAR MEAN FASTING GLUCOSE FOR THE MF MU STUDY AND THE -- MEAN FASTING GLUCOSE OF 86 ONE STANDARD DEVIATION ABOVE AND BELOW THE MEAN FASTING GLUCOSE. SO MATERNAL FETAL MEDICINE UNITS WANTED A FASTING GLUCOSE LESS THAN 95 BUT I CHOSE ACROTERIA, SO THOUGH THEY HAD A SIMILAR MEAN INCLUDING WOMEN WITH ONE STANDARD DEVIATION OF THEIR WOMEN UPPER LIMIT WAS ONE STANDARD DISEASEIATION WAS 99 -- DEVIATION WAS 99. YOU SEE HOW THEY COMPARE IN TERMS OF TWO HOUR POST GLUCOSE LOAD NUMBERS. THE MEAN WAS 155 FOR TWO HOURS POST LOAD AND THE INTRACORE TILE RANGE SHOWN UP TO 167-MILLIGRAMS PER DECALITER. FOR MATERNAL FETAL MEDICINE UNITS TRIAL THE MEAN FASTING GLUCOSE WAS HIGHER THAN THE OTHER TRIAL BUT KEEP IN MIND THEY USED A 100-GRAM LOAD AND THE AHCHOS USED A 75-GRAM LOAD. THE MEAN FELL WITHIN THE TWO CRITERIA THAT WAS ABOVE THE CUT OFF FOR THE NDDG CRITERIA AND THE BARS THAT I HAVE SHOWN HERE ONCE AGAIN REPRESENT ONE STANDARD DEVIATION OF THE TWO POWER POST GLUCOSE LOAD NUMBER SO THE KEY OUTCOMES WE'RE REPORTING ON TODAY ARE LISTED HERE. MORE IN THE FULL REPORT. LGA SHOULDER DISTOTIA, PREECLAMPSIA, MATERNAL WEIGHT GAIN, LONG TERM METABOLIC OUTCOME. THIS IS THE PLOT FROM -- THIS FOREST PLOT AND ONES THAT FOLLOW ARE ARRANGED WITH A RANDOMIZED CONTROL TRIAL POOLED RESULTS AT THE TOP. AND THE COHORT STUDY POOLED RESULTS AT THE BOTTOM. AS YOU CAN SEE, FOR THE RANDOMIZED CONTROL TRIALS, THERE WAS ABOUT A 50% REDUCTION WITH TREATMENT IN MACROSOMIA. THIS TREND BECAUSE OF A BASELINE RISK OF ABOUT 19% THIS RESULTS IN RISK REDUCTION OF 6% WITH NUMBER NEEDED TO TREAT OR PREVENT ONE CASE OF 18. THIS SLOT SHOWS DATA FOR LGA. RESULTS ARE SIMILAR. THERE WAS ABOUT A 50% REDUCTION IN LGA BY RANDOMIZED ROLL CONTROL TRIALS AND COHORT STUDIES. WHICH BASELINE RISK OF 14 1/2% AND ABSOLUTE RISK REDUCTION OF 5.7% ALSO TRANSLATES INTO A NUMBER NEEDED TO TREAT OF 18 TO PREVENT ONE CASE OF LGA. THESE ARE FINDINGS FOR SHOULDER DESTOTIA. AS YOU CAN SEE THERE'S A # 0% -- 60% REDUCTION BUT BECAUSE THIS IS SUCH A RARE EVENT WITH A MEDIAN BASELINE RISK OF 4% THE ABSOLUTE RISK REDUCTION IS ONLY 2% WITH NUMBER NEEDED TO TREAT OF 50 TO REDUCE ONE CASE OF SHOULDER DISTOTIA. HERE IS OUR FININGS FOR PREECLAMPSIA. THERE'S A 40% REDUCTION IN POOL AIDNALSIS FOR PREECLAMPSIA. THE BASELINE MEDIAN RISK IN THE POPULATIONS OF THE COMBINED STUDIES WAS 5.35%. -- 5.5%. ABSOLUTE RISK REDUCTION OF 3.5% WITH NUMBER NEEDED TO TREAT OF 29 TO PREVENT ONE CASE OF PREECLAMPSIA. THE PLOT FOR MATERNAL WEIGHT GAIN AND SUBSTANTIAL HETERO GENICITY, THESE RESULTS WERE NOT PULLED. FROM FOR STUDIES THAT MET INCLUSION CRITERIA FOR THIS QUESTION THAT WE WERE TASKED TO ANSWER THERE WAS NO DATA FOR MATERNAL YOU COMES FOR TYPE 2 DIABETES, OBESITY OR HYPERTENSION. THERE WAS DATA FROM TWO DIFFERENT STUDIES ON FOLLOW-UP OF CHILDREN BY DIFFERENT MEASURES OF OBESITY. THE FIRST WE REPORT HERE WAS A FOLLOW-UP OF THE GARDENER STUDY THAT FOLLOWED CHILDREN 7 TO 1 # YEARS AFTER -- 11 YEARS AFTER MOTHERS WERE PART OF THE RANDOMIZED CONTROL TRIAL FOR TREATMENT OF GESTATIONAL DIABETES. AND THEY FOUND NO DIFFERENCE IN IMPAIREDDED GLUCOSE TOLERANCE IN THOSE CHILDREN AT 7 TO 11 YEARS. TYPE 2 DIABETES OR BMI GREATER THAN 95th PERCENTILE. THE SECOND STUDY WE REPORT ON IS FOLLOW-UP OF A SUBGROUP OF CHILDREN FROM THE ODD SHOW STUDY FOUR THE FIVE YEARS OF AGE AT TIME OF THERE WAS NO DIFFERENCE IN BMI GREATER THAN 85TH PERCENTILE DESPITE CLEAR DIFFERENCES IN MACROSOMEIA BETWEEN THESE GROUPS AT BIRTH. 5% IN THE TREATMENT GROUP, ABOUT 22% IN THE NON-TREATMENT GROUP. WHEN TWO STUDIES WERE POOLED, FOR THE OUTCOME OF BMI GREATER THAN 85TH PERCENTILE, AND ALSO NO DIFFERENCE OVERALL. IN SUMMARY TREATMENT OF GESTATIONAL DIABETES RESULTS IN FEWER CASES OF MACROSOMEIA, LGA, SHOULDER DISTOTIA AND PREECLAMPSIA. DIFFERENT TREATMENT RESPONSES BASED ON VARIOUS DIAGNOSTIC GLUE CO-THRESHOLD WAS NOT APPARENT BETWEEN STUDY. RESEARCH PRIORITIES THAT WE IDENTIFIED WERE LONG TERM FOLLOW-UP ANOTHER OFFSPRING FROM RANDOMIZED CONTROL TRIALS. RANDOMIZING WOMEN TO DIFFERENT TREATMENT TARGETS AND RANDOMIZED YOU TRIALS COMPARING DIFFERENT FETAL SURVEILLANCE AND DELIVERY PLAN. THANK YOU. [APPLAUSE] >> THANK YOU. NEXT UP IS MARK LANDON, WE HAVE HEARD HIS NAME OFTEN TODAY. THE ARCHITECT OF THE MFMU STUDY. MARK IS CURRENTLYvJTT‡‡Ju AND CHAIRMAN, DEPARTMENT OF OBGYN AT THE OHIO STATE UNIVERSITY. MARK. >> THANK YOU, PETER. GOOD AFTERNOON. LIKE EVERYTHING ELSE I HAVE NO CONFLICTS NO FINANCIAL INTERESTS AND WON'T BE DISCUSSING ANY OFF LABEL USE. I WOULD LIKE TO THE THANK THE ORGANIZING COMMITTEE FOR INVITING ME AND NICHD, DR. SENIOR AND IN PARTICULAR DR. KATHERINE SPONG WHO DID SO MUCH AS CHIEF OF PREGNANCY PERINATOLOGY TO ENSURE SUCCESS OF MFMU AND IN PARTICULAR DELVE INTO THIS CONFERENCE THE RANDOMIZED CONTROL TRIAL FOR TREATMENT OF MILD GESTATIONAL DIABETES. SO THANKS ONCE AGAIN, CATHY. I THINK IT'S WELL ACCEPTED AND YOU HEARD UNDERSCORED BY OTHERS THAT GESTATIONAL DIABETES REPRESENTS A HETEROGENEOUS GROUP OF WOMEN WITH WIDE SPECTRUM METABOLIC ABNORMALITIES AN THUS VARYING DEGREES OF PREGNANCY ASSOCIATED RISK. WITH CONTROVERSY VONNING THE THE APPROPRIATE THRESHOLDS FOR THE DIAGNOSIS OF GESTATIONAL DIABETES AS WELL AS VALUE OF TREATMENT, ATTENTION HAS BEEN PAID PRIMARILY TO PERINATAL OUTCOMES PARTICULARLY IN EVALUATION OF THE HAPO STUDY AND TWO LARGE RANDOMIZED CONTROL TRIALS. A A RECENT SYSTEMATIC REVIEW IN META ANALYSIS FROM OR VAT PUBLISHED IN THE BRITISH MEDICATIONAL JOURNAL, DIABETES IS ASSOCIATED WITH SHOULDER DISTOTIA AND MACROSOMEIA. AMONG MATERNAL OUTCOMES THIS REPORT FAILED TO SHOW REDUCTION IN CESAREAN DELIVERY WITH TREATMENT AND MOST IMPORTANTLY THE AUTHORS OF THIS META ANALYSIS FAILED TO CONSIDER PREECLAMPSIA OR GESTATIONAL HYPERTENSION IN THE ANALYSIS AND SUMMARY CONCLUSIONS. DURING THIS PRESENTATION, I WILL ADDRESS TWO IMPORTANT MATERNAL OUTCOMES RELATED TO GESTATIONAL DIABETIC PREGNANCIES MAINLY PREECLAMPSIA, PREGNANCY INDUCED HYPERTENSION OR AND CESAREAN DELIVERY. WILL BRIEFLY REVIEW THE FREQUENCY OF THESE COMPLICATIONS, WHAT IS KNOWN ABOUT THE RELATIONSHIP TO GLYCEMIA AND PREGNANCY. ALONG WITH EXISTING EVIDENCE REGARDING THE BENEFIT OF TREATMENT ON THESE OUTCOMES. THERE IS GENERAL AGREEMENT PREECLAMPSIA AND GESTATIONAL HYPERTENSION ARE MORE COMMON IN PREGNANCY COMPLICATED BY PRE-EXISTING DIABETES COMPARED TO NORMAL POPULATION. MOST AUTHORS HAVE CONCLUDED THAT SUCH IS THE SAME FOR GESTATIONAL DIABETES WITH FREQUENCIES VARYING BETWEEN 5 AND 22% FOR TREATED GESTATIONAL DIABETES, PREGNANCIES COMPARED TO 4.9 TO 10.5% FOR CONTROLS. IMPORTANTLY, NOT ALL STUDIES CARFULLY ADJUSTED FOR CONFOUNDING VARIABLES SUCH AS OBESITY, IN ASSESSING THE COMPARATIVE RATES OF THESE DISORDERS. TWO STUDIES, NAMELY JENSON AND ROACH STUDIES WITH MATCHED CONTROLS FOR AGE AND PARODY AND BODY MASS INDEX REVEALED SIGNIFICANTLY HIGHER RATES SPECIFICALLY APPROXIMATELY A TWOFOLD INCREASE RISK FOR PREECLAMPSIA AND OTHER HYPERTENSIVE DISORDER. MOST RECENTLY PAT CATALANO AND COLLEAGUES REPORTED SECONDARY ANALYSIS FROM THE HAPO STUDY AN FOUND BOTH MATERNAL OBESITY AN JUSSATIONAL DIABETES ARE INDEPENDENTLY ASSOCIATED WITH PRE-ECLAMPSIA. GESTATIONAL DIABETES IN LEAN WOMEN WAS ASSOCIATED WITH 5.9% ECLAMPSIA, COMPARED TO 3.5 PEST IN CONTROLS. FROM Z OBESE WOMEN WITHOUT GESTATIONAL DIABETES HAD 13.3% FREQUENCY. FREQUENCY OF HYPERTENSIVE DISORDERS ROSE TO 20.1% IF BOTH GESTATIONAL DIABETES AND OBESE FEW WERE PRESENT. -- OBESITY WERE PRESENT. WHAT INFORMATION EXISTS REGARDING RELATIONSHIP BETWEEN MATERNAL GLYCEMIC STATUS IN GESTATIONAL DIABETES AND HYPERTENSIVE DISORDERS. HERE YOU SEE DATA FROM A LARGE RETRO PECKTIVE STUDY WHICH INCLUDED OVER 800 GESTATIONAL DEE BITE PREGNANCIES, INCLUDING 174 CASES FOR 9.6% PREGNANCY PREECLAMPSIA, A FIGURE WHICH WAS HIGHER SIGNIFICANTLY HIGHER THAN THE 7 TO 8% FREQUENCY IN THE NON-TIE BETTIC POPULATION. IN THIS GRAPHIC YOU CAN SEE THAT THE RATE OF PREECLAMPSIA INCREASED PROGRESSIVELY WITH WITH FASTING GLUCOSE LEVEL ON DIAGNOSTIC ORAL GLUCOSE TOLERANCE TEST SUCH THAT A FASTING LEVEL LESS THAN 95 WAS ASSOCIATED WITH APPROXIMATE 7% FREQUENCY OF HYPERTENSIVE DISORDERS COMPARED WITH FREQUENCY EXCEEDING -- APPROACHING 20% WHEN THE FASTING GLUCOSE LEVEL ON THE OGTT WAS IN EXCESS OF 125-MILLIGRAMS PERCENT. IN A LOGISTIC REGRESSION MODEL ONLY PRE-PREGNANT BODY MASS INDEX AN SEVERITY GESTATIONAL DIABETES ACCORDING TO THE ORAL GLUCOSE TOLERANCE TEST WERE SIGNIFICANTLY ASSOCIATED WITH THE RISK OF PREECLAMPSIA, IN THE STUDY POPULATION. HERE IS MORE DATA FROM THE SAME PUBLISHED STUDY IN WHICH GLYCEMIC CONTROL ALSO APPEARED TO AFFECT RISK OF DEVELOPING PREECLAMPSIA. IN WOMEN WHO ACHIEVE FASTING GLUCOSE LEVEL LESS THERE WAS NO DIFFERENCE IN THE RATE OF PREECLAMPSIA EVEN IN SUBGROUP FASTING GLUCOSE ON THE DIAGNOSTIC ORAL GLUCOSE TOLERANCE TEST. IN LESS OPTIMALLY CONTROLLED WOMEN WITH FASTING GLUCOSE LEVELS GREATER THAN FOR EXAMPLE 126, A FOUR FEEL INCREASE IN RATE OF PREECLAMPSIA WAS OBSERVED CO. COMPARED TO IDEA GLUCOSE CONTROL GROUP WITH MEAN FASTING GLUCOSE LESS THAN 95. THOSE FASTING BETWEEN 106 AND 115, YOU CAN SO THAT THE ODDS RATIO WAS NEARLY TWO FOR DEVELOPMENT OF PREECLAMPSIA. IN THE HAPO STUDY, WHICH DEMONSTRATED SIGNIFICANT CONTINUOUS ASSOCIATION BETWEEN MATERNAL GLYCEMIA AND VARIOUS OUTCOME, SAME WAS OBSERVED FOR THE OUTCOME OF PREECLAMPSIA. THIS ANALYSIS OF 25,000 POST PREGNANCIES SHOWED FOR EACH ONE STANDARD DEVIATION, NAMELY THE FASTING FASTING VALUES ON 75-GRAM ORAL GLUCOSE TOLERANCE TESTS, ODDS RATIOS RANGE BETWEEN 1.21 AND 1.28. PAT SHOWEDDED SECONDARY ANALYSIS FROM OUR RRT, WE DEMONSTRATED A MONOTONIC RELATIONSHIP BETWEEN MATERNAL GLYCEMIA AND RISK FOR PREECLAMPSIA AND/OR GESTATIONAL HYPERTENSION. WE USE THE THREE HOUR GLUCOSE TOLERANCE TEST AND A SIGNIFICANT TREND WAS PRESENT FOR POST GLUCOSE LOAD LEVELS AND HYPERTENSIVE DISORDERS OF PREGNANCY. HOWEVER, LOGISTIC REGRESSION ANALYSIS CONTROLLING FOR BODY MASS INDEX PARODY AND RACE FAILED TO DEMONSTRATE ELEVATED RISK FOR FASTING LEVELS IN THE TOP LINE LESS THAN 95 PILL GRAMS PERCENT. FOR THE ONE HOUR AND THREE HOUR VALUES EMPLOYING THRESHOLDS BELOW THOSE CURRENTLY EMPLOYED THERE WERE SOME SIGNIFICANT INCREASED RISK AS BOLDED IN THE YELLOW COMPARED TO REFERENCE GROUPS. HERE YOU SEE THE RISK OF GESTATIONAL HYPERTENSION PRE-ECLAMPSIA FROM THE SAME ANALYSIS ACCORDING TO THE VARIOUS GLUCOSE GROUPINGS WITH GROUP A THOSE WOMEN WITH NORMAL 50-GRAM SCREEN AND B IN THE RED, THOSE WITH ABNORMAL 50-GRAM SCREEN BUT COMPLETELY NORMAL ORAL GLUCOSE TOLERANCE TEST SEE THE GREEN, ONE ABNORMAL VALUE AND TWO ABNORMALVALUES, AS PAT SHOWED WITH RESPECT TO DIFFERENT OUTCOME, SIMILAR RATES OF PREECLAMPSIA AND/OR GESTATIONAL HYPERTENSION BETWEEN WOMEN WITH ONE ABNORMAL VALUE AND THOSE TWO ABNORMAL VALUES ON THE GLUCOSE TOLERANCE TEST. RECOGNIZING THAT A CLEAR ASSOCIATION EXISTS BETWEEN MATERNAL GLYCEMIA AND RISK FOR HYPERTENSIVE DISORDERS OR PREGNANCY, LODGELY LEADS TO THE QUESTION WHAT TREATMENT GESTATIONAL DIABETES IN FACT REDUCES THIS RISK. MOREOVER, GLUCOSE LEVELS WHICH EXCEED ESTABLISHED CLINICAL TARGETS AS NOTED APPEAR TO INCREASE THE RISK IN PREECLAMPSIA IN WOMEN TREATED FOR GESTATIONAL DIABETES FOR THE WORK. WHAT EVIDENCE THE TREATMENT CONFERS BENEFIT WITH RESPECT TO HYPERTENSIVE DISORDERS OF PREGNANCY. AND NOT TO BE REPETITIVE, BUT AGAIN, BOTH LARGE SCALE RANDOMIZED TRIALS FOR THE TREATMENT OF GESTATIONAL DIABETES HAVE SHOWN THE BENEFIT. HERE YOU SEE THE DATA FROM THE A CHOICE STUDY, YOU CAN SEE TREATMENT WAS ASSOCIATED WITH A 30% REDUCTION IN PREECLAMPSIA, 12% IN THOSE WOMEN TREATED COMPARED TO 18% CONTROL GROUP. IN THE MFMUn CLOUDS A MORE HETEROGENEOUS GROUP OF WOMEN, 950 OR SO RANDOMIZED WITH MILD RESCUESATIONAL DIABETES THAN THE A CHOICE STUDY REMEMBERING THE 93% OF WOMEN IN THE TRIAL WERE TREATED WITH DIETARY INTERVENTION ALONE. THE COMBINED RATE OF PREECLAMPSIA AND/OR GESTATIONAL HYPERTENSION WAS REDUCED IN 37% FROM 13.6% IN THE CONTROLS, COMPARED TO 8.6% IN WOMEN WITH MILD GESTATIONAL DIABETES WHO WERE TREATED. EVIDENCE THAT TREATMENT EFFECT LOWERING RATES OF HYPERTENSIVE DISORDERS OF THE PREGNANCY DEMONSTRATED IN TWO LARGE SCALE RCTs IS EVIDENCE IT CAN BE EXTENDED TO POPULATIONS WITH GLUCOSE LEVELS LOWER THAN THOSE MEETING MEETING THE ENTRY RYE TIERIA FOR THESE TWO TRIALS IS LACKING. OVER 20 YEARS AGO, LANGUAGER AND COLLEAGUES RANDOMIZED WOMEN WITH ONE ABOUT NORMAL OGTT VALUE TO TREATMENT VERSUS NO TREATMENT. WHILE BENEFIT OBSERVED IN STUDY IN TERMS OF REDUCTION, PERINATAL OUTCOMES SUCH AS MACROSOMEIA, SIMILAR RATES HYPERTENSIVE DISORDERS, 2 TO 3% WERE OBSERVED IN TREATED WOMEN COMPARED TO CONTROLS. LANGER IN A LARGER PROSPECTIVE POPULATION BASED STUDY OF OVER 2400 WOMEN INCLUDING ONE-THIRD OF SUBJECTS WITH JUST ONE ABNORMAL OGTT VALUE, REPORTED THAT TREATMENT FAILED TO REDUCE THE RATE OF PREECLAMPSIA. HOWEVER COMPARISON GROUP WAS A NONGDM POPULATION. A RECENT SECONDARY ANALYSIS NOW FROM THE HAPO STUDY WAS PERFORMED IN ORDER TO DETERMINE WHETHER ASSOCIATIONS EXISTED BETWEEN FASTING C PEPTIDE LEVELS, MATERNAL BMI, AND GLUCOSE FOR THE RISK OF PREECLAMPSIA. AS YOU CAN SEE HERE THERE WERE STRONG INDEPENDENT ASSOCIATIONS FOR C PEPTIDE AND BMI, HOWEVER WEAKER ASSOCIATIONS IN YELLOW FOR FASTING BLOOD GLUCOSE LEVELS AFTER ADJUSTMENT FOR CONFOUNDERS. MOST RECENTLY BOB NAROY AND COLLEAGUES PUBLISHED A JOURNAL IN VARIOUS OUTCOMES WOMEN MEETING THE CRITERIA NOT TREATED FOR GDM AND COMPARED TO NORMAL POPULATION. UNADJUSTED RATES OF PREECLAMPSIA SHOW A SIGNIFICANT DIFFERENCE AMONG THE GROUPS. AFTER CONTROLLING FOR RACE, PARODY AND BMI ONLY A TREND WAS OBSERVED. SO TOGETHER THESE RESULTS NOT SUGGEST A HIGH LIKELIHOOD OF TREATMENT AT LOWER LEVELS OF GLUCOSE THAN OPPORTUNITILY EMPLOYED BY CURRENT DIAGNOSTIC THRESHOLDS WOULD REDUCE FREQUENCY OF HYPERTENSIVE DISORDERS OF PREGNANCY. I WILL NOW MOVE TO CAESAREAN. THIS IS INCREASED IN GESTATIONAL DIABETES COMPARED TO NORMAL POPULATION. HERE ARE REPORTS FROM A DECADE AGO WHICH CITED ACROSS STUDIES HIGHER OVERALL C-SECTION RATES IN GESTATIONAL DIABETES. THE OUTCOME IS SUBJECT TO MANY CONFOUNDERS. DEMOGRAPHICS, PREFERENCES PHYSICIAN PRACTICE STYLE AND MISSOURI. THESE FACTORS CONTRIBUTE TO SUBSTANTIAL VARIATION IN C-SECTION RATES AND ON TOP OF THIS O ARE FACTORS UNIQUE TO BUY DIABETIC PREGNANCY, FETAL SIZE, CONCERN ABOUT NAMELY TRAUMATIC DELIVERY IN SETTING OF SUSPECTED LARGE FETUS. THIS CONCERN WAS HIGHLIGHTED 20 YEARS AGO BY NAYLOR AND COLLEAGUES THAT WHILE INFANT MACROSOMEIA WAS REDUCED FROM 33 TO 15% WITH TREATMENT AND BIRTH WEIGHS NORMALIZED WITH TREATMENT A CLEAR INCREASED RISK FOR CAESAREAN WAS OBSERVED IN WOMEN TREATED FOR GESTATIONAL DIABETES, 48% WHETHER MACROSOMEIA WAS PRESENT OR NOT. OTHERS HAVE SIMILARLY REPORTED CESAREAN RATES HIGHER IN TREATED GDM COMPARED TO THE GENERAL POPULATION. THUS RECOGNITION AND TREATMENT OF GESTATIONAL DIABETES MAY APPARENTLY LEAD TO LOWER BIRTH WEIGHTS AND REDUCED MACROSOMEIA WITH THRESHOLD FOR SURGICAL DELIVERY MAY BE ALTERED TO MITIGATE AGAINST BENEFITS OF TREATMENT AS STATED BY„E DR. NAYLOR IN HIS MANUSCRIPT. IN THE ABSENCE OF RANDOM ICED CONTROL TRIALS FOR GESTATIONAL DIABETES AT THE TIME, LANGER AND COLLEAGUES IN 2004 ADDRESSED THE CONSEQUENCES OF TREATING VERSUS NOT TREATING GESTATIONAL DIABETES IN A MATCH CONTROL STUDY OF 555 WOMEN NOT IDENTIFIED OR TREATED FOR GDM UNTIL 37 WEEKS GESTATION AND COMPARED WITH OVER A THOUSAND TREATED WOMEN AND OVER A THOUSAND NON-GDM CONTROLS. SOMEWHAT SIMILAR TO NAYLOR'S FINDINGS, LANGER AND COLLEAGUES FINDINGS WERE 17.7% CESAREAN RATES WERE NOT AFFECTED BY TREATMENT AND REMAIN CONSIDERABLY HIGHER THAN NORMAL POPULATION. OBESITY HAS BEEN IDENTIFIED AS CLEAR RISK FACTOR FOR CAESAREAN AND HAS BEEN TO BE CONSIDERED IN ANALYSIS OF THIS SUBJECT. HERE IS DATA FROM PAT CATALANOS SECONDARY ANALYSIS OF THE HAPO DATA WHICH PAT DEMONSTRATED AGAIN OBESITY INDEPENDENTLY INCREASED RISK FOR PRIMARY CAESAREAN SUCH THAT IF YOU WERE OBESE, WITHOUT GESTATIONAL DIABETES YOU HAD A MARKLY INCREASED RISK FOR CAESAREAN BUT IF YOU WERE BOTH GESTATIONAL DIABETIC AND OBESE THE RATE ROSE TO SOME 28.7% IN THIS GROUP. CROWDER AND COLLEAGUES REPORTED OVERALL CAESAREAN RATES WERE NOT LOWERED WITH TREATMENT OF GESTATIONAL DIABETES. 31 VERSUS 32%. IN CONTRAST IN THE NICHD TRIAL WE SUGGESTED TREATMENT OF GESTATIONAL DIABETES WAS ASSOCIATED WITH LOWER CAESAREAN RATES. CAESAREAN OCCURRED IN 29% TREATED VERSUS 33.8% CONTROLS. AFTER WE EXCLUDED FOR CASES OF ABNORMAL PRESENTATION, PRIOR CAESAREAN, OLIGOHIGH DRAMNIOS THE CAESAREAN RATE WAS STILL LOWER 13% SEARCH AND SEIZURE 19.7%, STATISTICALLY SIGNIFICANT. THE EXTENT TO WHICH REDUCTION OF LARGE FOR F AGE INFANTS CONTRIBUTED TO LOWER CAESAREAN RATE, UNKNOWN AND WE HAVE NOT -- WE NEVER ACTUALLY ANALYZED THAT. THE EVIDENCE, TREATMENT EFFECT FOR LOWERING C-SECTION RATES IN WOMEN WITH LOWER GLUCOSE VALUES THAN CARPETTER COUSTAN CRITERIA IS LACKING. RCT TREATMENT WITH ONE WITH ABNORMAL VALUE TREATMENT ASSOCIATED WITH PRIMARY CAESAREAN OF 10% COMPARED TO 11 PERCENT OF CONTROLS. THE STUDY IS UNDERPOWERED THE LOOK AT THIS PARTICULAR OUTCOME. NEW ENGLAND JOURNAL PAPER SHOWING RELATIONSHIP BETWEEN VARIOUS CATEGORIES AND THE RISK FOR PRIMARY OR RATE OF PRIMARY CAESAREAN SUCH THAT IN THE LOWEST UDŽ(jUt CATEGORY THE CAESAREAN RATES FROM 13% AND CLIMBED TO SOME 25% IN THE HIGHEST GLUCOSE CATEGORY. IN THE HAPO STUDY THE ODDS RATIO FOR CESAREAN DELIVERY INCREASED AMONG GLUCOSE CATEGORIES AND IN FACT WAS 1.86 WITH HIGHEST ONE HOUR GLUCOSE. THE RISK FOR CAESAREAN WAS MODESTLY INCREASED IN COMPARISON TO OTHER OUTCOMES. THE YOD ODDS RATIO WAS NOT SIGNIFICANTLY INCREASED IN HIGHER TWO HOUR CATEGORIES. YOU SEE FASTING CATEGORY AND PRIMARY CAESAREAN RATES WHICH RANGE FROM 13.3% IN LOWEST, FASTING GLUCOSE CATEGORY TO 27.9% IN THE HIGHEST CATEGORY. DIFFERENCES IN RATES WERE NOT VERY DIFFERENT CORRESPONDING BETWEEN FASTING LEVELS IN 81 AND 9, 90094 AND 94 TO 99 PERCENT RESPECTIVELY. GIVEN COMPARISONS AND LACK OF CONVINCING TREATMENT EFFECT ON CAESAREAN RATES EXCEPT THE NICHD TRIAL, IT FOLLOWS THAT LOWERING DIAGNOSTIC THRESHOLDS AND TREATMENT IS SUCH WOULD BE UNLIKELY ASSOCIATED WITH FURTHER REDUCTION IN CAESAREAN RATES. IN SUMMARY EMPLOYING EXISTING CURRENT CRITERIA FOR DIAGNOSIS OF GESTATIONAL DIABETES, TREATMENT IN FACT DOES RESULT IN REDUCE OR DECREASED RISK FOR GESTATIONAL HYPERTENSION AND PREECLAMPSIA. THIS IS AN IMPORTANT FINDING, ALMOST EVERY STRATEGY EMPLOYED TO DATE TO REDUCE PREECLAMPSIA HAS BEEN INEFFECTIVE. WITH RESPECT TO CESAREAN DELIVERY, SOME STUDIES SUGGEST WE ARE LABELING A WOMAN GESTATIONAL DIABETIC MAY DECREASE RISK FOR OPERATIVE DELIVERY, NOTWITHSTANDING THE MFMU NETWORK TRIAL FINDING RESULTS, IT BECOMES LESS CLEAR WHETHER TREATMENT HAS BENEFICIAL EFFECT ON THE OVERALL CAESAREAN RATE. THANK YOU VERY MUCH. [APPLAUSE] >> NEXT, BENEFITS OF TREATMENT ON FETAL AND INFANT HEALTH YOU COMES DR. MATT GILMAN, DIRECTOR OF OBESITY PREVENTION PROGRAM AND PROFESSOR IN THE DEPARTMENT OF POPULATION MEDICINE AT HARVARD. >> THANKS VERY MUCH TO ORGANIZERS AND TO THE COMMITTEE FOR HAVING ME SPEAK TODAY. TESTING OUT THE -- HOW DO WE GO FORWARD. THIS IS MY ONLY PEON TO HURRICANE SANDY. I LIKE TO THANK MY COLLEAGUES IN OBESITY PREVENTION PROGRAM HARVARD MEDICAL SCHOOL, WHO DO A LOT OF WORK THAT I REPORT ON. AND ALSO TO FUNDERS OVER THE MANY YEARS. THE QUESTIONS TODAY ARE TO WHAT EXTENT DOES TREATMENT EFFECT HEALTH OUTCOMES AND OFFSPRING AND PREVENTION SCREENING AND DIAGNOSIS. TODAY I'M GOING TO REVIEW EFFECTIVE TREATMENT OF MILD MODERATE GDM ON MOSTLY NEONATAL OUTCOMES. DR. LANDON TALKED MATERNAL. SAY SOME WORDS ABOUT TREATMENT IN THE CONTEXT OF SCREENING AND DIAGNOSIS, END WITH GESTATIONAL EFFECT ON CHILDHOOD OBESITY. IT'S BEEN SINCE BEFORE THE DISCOVERY OF INSULIN THAT WE KNEW THERE WAS SOMETHING ABOUT GESTATIONAL DIABETES THAT MIGHT HAVE AN EFFECT ON THE FETUS. NOW WE THINK A NUMBER OF INTERGENERATIONAL CYCLES THAT HAVE BEEN PRESENTED BEFORE IN BOTH MOTHER AND OFFSPRING THAT LEAD FROM PRE-NATAL FACTORS INCLUDING GESTATIONAL DIE BOW TEASE TO POST PARTUM RETENTION IN THE MOTHER, SHE HAS PREGNANCY, OBESE AND GOES THROUGH THE CYCLE AGAIN AND ALTERED FETAL GROWTH METABOLISM TO INFANT CHILDHOOD OUTCOMES AND IF SHE'S FEMALE AND BECOMES PREGNANT WHEN SHE GROW US UP, IT GOES THROUGH THE CYCLE AGAIN. HOW DO WE INTERRUPT IT.5 TODAY WE'RE INTERESTED IN F DIABETES ON EARLY INFANT AND LATER CHILDHOOD OUTCOMES. AND WE'LL START WITH INFANT OUTCOMES. EVERYONE HAS SEEN VERSIONS OF THESE STUDIES, A CHOICE STUDY AN MSMU STUDY. I'M GLAD THAT MY CONCLUSIONS WILL MATCH THOSE OF DR. LONDON AND AHRQ EVIDENCE BASED REVIEW. JUST TO REVIEW, WE HAVE HEARD ELIGIBILITY CRITERIA FOR BOTH STUDIES, CHOICE STUDY 75-GRAM OGGT, FASTING GLUCOSE AND 140 AND 198. FOR MSMU TWO STEP 50-GRAM GCT ABOVE 135 FOLLOWD BY THREE OUR WHO 100-GRAM OGGT WITH FASTING AN POST CHALLENGE CUT POINTS. OTHERWISE THE TRIALS WERE SIMILAR IN REGARDS TO ENROLLMENT PERIOD VERY SIMILAR WITH DIAGNOSING SELF-MONITORING WITH CHOICE STUDY. HAVING SLIGHTLY MORE SEVERE GDM, 20% INSULIN VERSUS 78% IN MU. HERE WE SEE PRIMARY OUTCOMES WITH SIMILARITIES AN DIFFERENCES. WE HAVE SEEN SOME RESULTS LIKE THIS SO I'LL GO QUICKLY THROUGH THEM. A REMIND TEAR CHOICE TREATMENT RESULTED IN DECREASE IN THEIR COMBINED OUTCOME OF ANY SERIOUS PERINATAL COMPLICATION. WE HAVE SEEN COMMENTS ABOUT SHOULDER DISTOTIA. THIS IS CONFUSING FOR ME AND OTHERS, THIS IS ADMISSION TO THE NEONATAL NURSERY. TWO-THIRDS OF THE KIDS WERE ADMITTED TO THIS SO CALLED NEONATAL NURSERY, THIS IS NOT ACTUALLY THE NEONATAL INTENSIVE CARE UNIT, IT'S A LEVEL 1.5 NURSERY AS FAR AS I CAN TELL FROM THE INVESTIGATORS IN THEIR CHOICE. THERE WAS INCREASE IN INDUCTION THIS AND LABOR AND NO CHANGE IN CAESAREAN. SECONDARY OUTCOMES, MICROSOMEIA WAS HALVED AS WOULD LGA AND THERE WAS NO DIFFERENCE IN THE SGA RATINGS. WE HAVE SEEN A NUMBER NEEDED TO TREAT MEDICAL ANALYSIS FROM THIS PARTICULAR TRIAL, NUMBER NEEDED TO TRIAL TREAT WAS 34 COMPARED TO ONE SERIOUS PERINATAL COMPLICATION AND THE NUMBER NEEDED TO HARM WAS 11, INDUCTION LABOR ADMISSION TO NEONATAL NURSERY. WE DON'T KNOW WHAT THE FINAL MORBIDITY OUTCOMES WERE, RESULTING FROM INDUCTION OF LABOR, NOR CAN WE GENERALIZE I THINK THE NICU SETTING FROM THE NEONATAL NURSERY SO JUST TO PUT THOSE INTO CONTEXT. THE MAIN FINDINGS IN MSMU YOU HEARD THIS FROM MARK AND OTHER SPEAKERS BEFORE, NO CHANGE IN COMPOSITE END POINT. THERE WAS REDUCTION IN MACROSOMEIA AS WELL AS FOR LGA. AND ONE THING I WANT TO POINT OUT IS DIFFERENCE IN FAT MASS. SO IT'S IMPORTANT NOT ONLY TO LOOK AT WEIGHT RELATED BUT BODY COMPOSITION OUTCOME, SUBSEQUENT STUDY SHOWED THIS AFFECT WAS GREATER IN MALES THAN FEMALES. THERE WAS NO REAL CHANGE IN THE RATE OF SGA. SO I THINK FROM THESE TWO STUDIES E WE SEE BROAD AGREEMENT ON THE REDUCTION IN LGA AND MACROSOMEIA. SHOULDER DISTOTIA IS NO DIFFERENCE IN CHOICE BUT THERE WAS HAVING OF A RATE SO WHEN YOU PUT THAT INTHE TO A POOLED ANALYSIS THERE'S REDUCTION. AND WE HAVE HEARD ABOUT THE REDUCTION IN PREECLAMPSIA. IF YOU COMBINE THE TRIALS WITH THE AHRQ REVIEW AND META ANALYSES THAT HAVE COME OUT RECENTLY WE CAN CONCLUDE TREATMENT OF MILD TO MODERATE GDM RESULTS IN REDUCEDDED RISK OF PREECLAMPSIA, SHOULDER DISTOTIA AND LGA OR MACROSOMEIA. IT DOESN'T APPEAR THE RAISE THE RATE OF SGA. AND WE HAVE UNCLEAR RESULTS ON PRE-TERM CAESAREAN BIRTH TRAUMA, AND OTHER FORMS OF NEONATAL MORBIDITY AND PERINATAL DEATH, NEONATAL MORTALITY. THESE SUPPORT DIAGNOSIS OF MILD TO MODERATE GDM IN PREGNANCY. THEY DON'T ADDRESS INITIAL SCREENING WHICH IS REALLY ASSUMED HERE IN THIS CONFERENCE, THEY DON'T SHOW EFFECTS ON INFANT MORBIDITY AND MORTALITY BECAUSE OF SMALL NUMBERS. AND THEY DON'T INCLUDE LONG TERM FOLLOW-UP. ONE QUESTION IS MILDER FORMS OF GLUCOSE INTOLERANCE. WE HEARD MANY TIMES THE HAPO RESULTS SHOW MONOTONIC INCREASES IN GLYCEMIC LEVEL WITH REGARD TO NUMBER OF OUTCOMES. SO NUMBER OF THRESHOLDS IDENTIFIED WITHIN HAPO THAT HELP US CREATE CUT POINTS. I TRIED TO SUPERIMPOSE THE RANGES OF GLUCOSE THAT WERE ENTRY CRITERIA TO BOTH THE MFMU AND ORANGE AND CHOICE STUDIES IN GREEN. I THINK NOW WE HAVE QUESTIONS ABOUT SLIGHTLY LOWER FORMS OF GLUCOSE INTOLERANCE AND IN PASSING THE MILDER FORMS CAN COME NOT ONLY FROM THE ACTUAL CUT POINTS BUT LOWERING THE NUMBER OF CUT POINTS WE CAN GET INTO STUDIES WITH. THAT'S POINTED OUT BY PREVIOUS SPEAKERS. NOT A LOT OF DATA ON INTERVENTIONS AND NOT MEETING GDM CRITERIA. COCHRAN DID A SYSTEMATIC REVIEW, PUBLISHED A YEAR AGO, OF THESE FOUR STUDIES. YOU CAN SEE ELIGIBILITY CRITERIA HERE. TWO REQUIRED ABNORMAL GCT WITH NORMAL 100-GRAM OGGT, ONE REQUIRED ONE ABNORMAL OGGT, IMPAIRED GLUCOSE TOLERANCE BY PREVIOUS SPEAKERS, IMPAIRED GLUCOSE TOLERANCE OR GDM. THE OTHER WAS 75-GRAM. YOU CAN SEE SAMPLE SIZES IN THESE ARE RELATIVELY SMALL ADDING TO ONLY 500 PARTICIPANTS ALTOGETHER. HIGH RISK OF BIAS SO TO LOOK QUICKLY ON MATERNAL OUTCOMES, CAESAREAN, POOLED RATIO IS .93 BUT HAS A WIDE CONFIDENCE INTERVAL. FOR PREECLAMPSIA THERE'S TWO VERSUS ONE CASE SO WE CAN'T CONCLUDE VERY MUCH. FOR GESTATIONAL AGE AT BIRTH WE SEE A SUGGESTION OF LOWERING. SO THAT CERTAINLY NEEDS TO BE FOLLOWED UP. FOR MACROSOMEIA AND SGA WE SEE EVEN WITH THIS NUMBER OF PEOPLE, WE SEE A STRONG SIGNAL FOR REDUCTION OF MACROSOMEIA. ON THE OTHER HAND THAT'S A SUGGESTION OF INCREASE IN RISK OF SG&A. SO I THINK THE CONCLUSION HERE IS THAT FOR INTERVENTIONS FOR HYPERGLYCEMIA NOT MEETING GDM CRITERIA WE NEED MORE BETTER RCT DATA AND I'M AWARE OF A COUPLE OF TRIALS THAT ARE ONGOING. SO MY NEXT FEW SLIDES ARE INTERPRETING TREATMENT FINDING IN CONTEXT OF OVERALL STRATEGIES, HERE WE MIGHT SAY SCREEN DIAGNOSE AND TREAT STRATEGIES. SO THE RATIONAL FOR TREATING LOWER RISK IS THAT EVEN INDIVIDUAL RISK OF ADVERSE OUTCOMES IS LOWER, THE POPULATION BURDEN IS HIGHER. LOWER RISK CAN DERIVE FROM HAVING FEWER CUT POINTS OR LOWER GLUCOSE AT ANY ONE OF THE TIME POINTS. BY ANALOGY, THIS KIND OF ISSUE HAS BEEN WELL KNOWN IN ADULT CARDIOVASCULAR DISEASE FOR A WHILE. HERE WE SHOW FOR CHOLESTEROL LEVELS AND BURDEN OF CARDIOVASCULAR DISEASE, INDIVIDUAL RISK GOES UP WITHOUT ANY THRESHOLD. BUT BECAUSE MOST PEOPLE ARE IN MODERATE LEVELS PERCENTAGE OF CARDIOVASCULAR DISEASE ATTRIBUTABLE TO THE MODERATE LEVELS IS GREATER THAN THAT ATTRIBUTED TO THE HIGHEST RISK. NOW WE HAVE EXPERIENCE WITH CARDIOVASCULAR RISK FACTORS, EXAMPLE ADULT PRIMARY PREVENTION WITH STATINS. THERE WAS INITIAL ENTHUSIASM BUT BENEFITS ARE HARDER TO DETECT IN THE LOW RISK AND THEN WE SEE ADVERSE WITH PREPONDERANCE AND LOWEST POPULATIONS. FOR EXAMPLE, STATINS CAUSE TYPE 2 DIABETES. MY WORK CHILDHOOD BLOOD PRESSURE AND LIPID SCREENING AND TREATING LOWER RISK. WE HAVE CAVEATS RELATIVE EFFECTIVENESS IS LOWER. MORE ADVERSE EVENTS PER BENEFIT INCREASE COST AND DECREASE IN COST EFFECTIVENESS. WE HEARSAY HAVE TO PUT THIS INTO THE CONTEXT OF OVERALL PREVENTION SCREENING OR HIGH RISK ONE WAY OF PREVENTING ADVERSE OUTCOMES. WHERE WE IDENTIFY AFFECTED INDIVIDUALS AN MODIFY RISK FACTORS THIS THEM THE OTHER GENERAL WAY OF PREVENTION IS POPULATION APPROACHES WHERE WE MODIFY RISK FACTORS IN ALL. BY ANALOGY WE PUBLISHED A LONG TERM BLOOD PRESSURE SCREENING, LOOKING AT EFFECTIVE BLOOD PRESSURE SCREENING AND ADOLESCENCE ON CARDIOVASCULAR DISEASE OUTCOMES. WHEN WE COMPARE POPULATION WITH SCREENING WE SEE THE POPULATION APPROACH DOMINATE. ALL THE SCREENS STRATEGIES ARE MORE COSTLY AND LESS EFFECTIVE THAN POPULATION WIDE APPROACHES. THE MOST COST EFFECTIVE IS IT TREATS ONLY HIGHEST RISK. I HAVE BEEN TRYING TO ARGUE THAT RAISING NOT LOWERING CUT POINTS IS THE WAY TO GO IN SCREENING EXERCISES AND LIKE US TO CONSIDER THAT AS WELL. THERE HAVE BEEN GDP SCREENING, COMMENTARIES AN SIMULATION MODELS. MY WAY TO READ THIS, HARD TO FERRET OUT WHAT THE RIGHT THING TO DO BECAUSE THEY CONFLATE THE TYPE OF SCREENING TESTS TWO STEP VERSUS ONE STEP CUT POINTS FOR TREATMENT, ONE VERSUS TWO CUT POINTS AND WHAT THE GLUCOSE LEVELS ARE. THEY REFLECT DECISION MAKING ON RELATIVE RISK WHERE WE NEED ABSOLUTE RISK AND RISK DIFFERENCES AND WE NEED TO PUT THIS IN CONTEXT OF SCREENING PROCESS COMPARING POPULATION APPROACHES. OFF THE SOAP BOX BACK TO DATA. WE'LL TALK ABOUT THE EFFECTIVE TREATMENT ON CHILDHOOD OBESITY. THERE HAVE BEEN REALLY NICE STUDIES IN OBSERVATIONAL LITERATURE. STARTING WITH SIB PAIR STUDY FROM DONNA DEBILIA SHOWING SIBLINGS EXPOSED TO DIABETES IN UTERO 9 TO 12 YEARS IN EARLY ADULT HAD HOOD HAD HIGHER BMI THAN THOSE NOT EXPOSED TO DIABETES IN OUTROW. THIS COMBINES GDM WITH PRE-EXISTING DIABETES. MORE RECENTLY A STUDY AMONG 147,000 SWEDISH MEN, THE GREAT THING YOU CAN DO WITH REGISTRIES IN NORDIC COUNTRIES AND 46,000 HAD A BROTHER IN A COHORT. WHAT SHE WAS ABLE TO SHOW IS DIABETES DURING PREGNANCY IS ASSOCIATED WITH HIGHER BMI IN THE SIBS. THIS IS NOT TRUE OF EARLY PRESENCE BMI. IT'S A COMBINATION OF GESTATION AL PRE-GESTATIONAL DIABETES, THE PREVALENCE WAS LOW AND THE PREVALENCE OF OBESITY OUTCOME AGE WAS ALSO LOW. WE LOOKED AT ODDS OF ADOLESCENT OBESITY FOR GESTATIONAL DIABETES VERSUS NO DIABETES WITHIN GROWING UP TODAY STUDY, THE SUNS AND DAUGHTERS OF NURSES AND SECOND NURSES HELP STUDY. AFTER MULTI-VARIABLE ADJUSTMENT YOU CAN SEE IT'S HARD TO SHOW ANY INCREASE IN ODDS OF OBESITY. AT AGE 9 TO 14. ARE THEY AWARE OF GESTATIONAL DIABETES AND GET BETTER TREATMENT, THE STUDY THERESA HILLIA DID HELPS MOVE IN THIS DIRECTION. SHE LOOKED AT RISK OF OBESITY AGE 5 TO 7. LOOK AT 85 PERCENTILE AND 95 PERCENTILE FOR WEIGHT, THEY DIDN'T HAVE HEIGHT IN THIS STUDY. LOOKING AT CATEGORIES OF GDM SCREENING WITH TWO STEP NORMAL GLYCEMIC CHALLENGE TEST, NORMAL OGGT, WITH NO TREATMENT GDM WITH QUOTE TREATMENT WHICH IS ACTUALLY A BIT OF A SECULAR CHANGE BECAUSE OF CHANGE IN CRITERIA FOR DIAGNOSIS. YOU CAN SEE A SUGGESTION THAT GESTATIONAL DIABETES WITH NO TREATMENT CONFERS A DOUBLING OF RISK ABOVE THE 95 PERCENTILE BMI AGE 5 TO 7. THIS CATEGORY THE SO-CALLED TREATMENT HAD ODDS RATIO ABOUT THE SAME AS THE IGT. SUGGESTING IT MIGHT HAVE A BENEFICIAL EFFECT ON OBESITY IN THE NEXT GENERATION. THESE ARE OBSERVATIONAL DATA AND CAN BE CON FOUNDED BY THINGS TALKED ABOUT BEFORE AS WELL AS SECULAR CHANGES IN DIAGNOSIS. SO THE BEST WAY TO LOOK AT THIS IS TO DO A CHILDHOOD FOLLOW-UP OF RAP DOCUMENTIZED CONTROL TRIAL TO TREAT GESTATIONAL DIABETES. THIS IS THE BEST WAY TO OVERCOME CONFOUNDING. IT HAS IMPLICATIONS FOR PRACTICE. IN THE CHOICE STUDY INTERVENTION REDUCED MACROSOMEIA RATE BY HALF FROM 21% TO 10%. SO I WAS DOING A MINI SABBATICAL IN SOUTH AUSTRALIA FOUR YEARS AGO AND WORKING WITH OTHER TRIALISTS THERE, AND THERE'S NO WAY WE'LL FOLLOW THE OFFSPRING OF THE STUDY BECAUSE WE RECRUITED OVER TEN YEARS AND E TRIED TO GET IN TOUCH WITH THEM AND THERE'S NO CHANCE. GOVERNMENT SOUTH AUSTRALIA DOES A STATEWIDE SURVEILLANCE OF HEIGHT AND WEIGHT AT AGES 4 TO 5. WE LINK THE TWO DATABASES WITH A SUBSET OF THOSE IN THE CHOICE STUDY. SO WE LIMIT TO SOUTH AUSTRALIA, 540, TWO-THIRDS PARTICIPATE IN THE SURVEILLANCE AND WE HAD STRICT LINKAGE CRITERION THAT REQUIRED DATE OF BIRTH, SEX, NAME AND ADDRESS SO WE LINKED 70% OF THOSE AND AFTER SOME EXCLUSIONS DUE TO MISSING IMPLAUSIBLE WEIGHTS AND TAKING OUT THE TWINS, WE HAD THE SAMPLE SIZE 199 TO LOOK AT OUTCOMES. SO WE LOOKED AT BASELINE CO-VARIANTS, IN THIS STUDY, AND ALSO AUSTRALIAN SUBJECTS IN THE CHOICE AND ALL SUBJECTS IN THE CHOICE. AND IT WAS GOOD TO KNOW THAT THE BASELINE CO-VARIANTS WERE EVENLY DISTRIBUTED. WE NEXT LOOKED AT NEONATAL OUTCOMES, THEY WERE ROUGHLY SIMILAR O THE WHOLE RCT. AS YOU CAN SEE HERE THE RATES OF SG&A WERE SIMILAR IN BOTH INTERVENTION AND CONTROL AND SIMILAR HERE AS THEY WERE HERE. THIS IS THE 21% TO 10% REDUCTION MACROSOMEIA WITHIN THE WHOLE TRIAL. P WITHIN THE SUBJECTS IN THIS STUDY IT WAS 22% TO 5%. HOWEVER, WHEN WE FOLLOWED UP THE KIDS AT AGE 4 TO 5 WE SAW NO EFFECT OF THE INTERVENTION ON BMI. IN FACT, IF ANYTHING, INTERVENTION HAD HIGHER BMI AND RELATIVE RISK OF OVERWEIGHT THAN THOSE IN THE CONTROL GROUP SO ADJUSTED TREATMENT EFFECT FOR BMIZ SCORE WAS .08 AND I JUST WANT TO POINT OUT THAT THE LOWER LIST -- LOWER LIMIT OF 95% CONFIDENCE INTERVAL WAS.-- NEGATIVE .3 WHICH MEANS WITH 95% CONFIDENCE WE COULD RULE OUT ANYTHING WITH A THIRD OF THE STANDARD DEVIATION OR MORE. SO WE THOUGHT THIS WAS PRETTY GOOD POWER. SO WE HAD A NUMBER OF HYPOTHESES ABOUT WHY WE SAW NO EFFECTIVE INTERVENTION ON BMI 4 TO 5 AND MOST STRIGGING IS THERE A LAYTANT PERIOD AND MAYBE BMI IS THE WRONG OUTCOME. AND BOARD METSKER'S GROUP PUBLISHED AN INTERRING PAPER 20 YEARS AGO, SUGGESTING THAT OFFSPRING OF MOTHERS WITH DIABETES ARE ACTUALLY HAVE HIGHER WEIGHTED BIRTH AND LATER CHILDHOOD BUT MAYBE NOT AT AGE 1, 2, 3, 4. WE RECENTLY SHOWED THAT GESTATIONAL DIABETES PREDICTS SLOWER GAIN IN WEIGHT FOR LENGTH IN EARLY INFANCY, THE FIRST SIX MONTHS OF LIFE. HERE YOU SEE A NEGATIVE COMPONENT, I HAVE SEEN PAT CATALANO SHOW SIMILAR THINGS FOR BODY COMPOSITION FOR FAT, AT AGE 3 IN OUR COHORT STUDY PROJECT VIVA WE SHOWED THAT GESTATIONAL DIABETES WAS ASSOCIATED WITH HIGHER SKIN FOLD THICKNESS, A DIRECT MEASURE OF ADIPOSITY AND HIGHER BLOOD PRESSURE BUT NOT HIGHER BMI. SUGGESTING THESE MIGHT HAVE MEASURING SLIGHTLY DIFFERENT THINGS. JUST TO SHOW YOU SOME GREG INTRIGUING FINDINGS FROM OUR SCHOOL AGE FOLLOW-UP FROM PROJECT DIVA, WE SEE A SEXUAL DIMORPHISM HERE SO WE MEASURE TOTAL FAT WITH SCAN AGE 7 TO 10 YEARS T. BOYS WE SHOWED THAT GDM WAS ASSOCIATED WITH HIGHER FAT MASS. BUT IN THE GIRLS NOT GDM BUT IGT IS ASSOCIATED WITH HIGHER FAT MASS. SO I DON'T KNOW IF THIS IS GOING TO BE REPLY CASH BALANCE BUT I HAVE SEEN INTERESTING RESULTS. I'M GOING TO SKIP THE MISTRIAL, LOVE THE ACRONYM FOR THE TWO YEAR FOLLOW-UP, ANYTHING TOFU BUT WE'LL HAVE TO DISCUSS IT SOMETIME ELSE. IN CONCLUSION, TWO MAJOR RANDOMIZED CONTROL TRIALS MILD TO MODERATE GESTATIONAL DIABETES AND META ANALYSES WHERE BROUGHT AGREEMENT ON THE BENEFITS AND RISKS FOR NEONATES. THERE ARE FEW DATA ON MILDER GLUCOSE INTOLERANCE. TREATMENT OF GDM DOES NOT APPEAR TO REDUCE OFFSPRING OBESITY AGE 4 TO 5 YEARS BUT FOLLOW-UP OF SUBSET OF ONLY RUN RANDOMIZED TROLL TRIAL. AND WE PUT THIS IN THE CONTEXT OF UNIVERSEAL AND SELECTIVE SCREENING BUT ALSO IN RELATION TO POPULATION APPROACHES. NEEDING TO SEPARATE THE TWO TEST AND THRESHOLD SCREENING TEST ITSELF, AS WELL AS TREATMENT THRESHOLD, NUMBER AND LEVEL, AND CREDENCE AND THOUGHT TO LOWERING CUT POINTS. THANK YOU VERY MUCH. [APPLAUSE] >> CAN I HAVE THE AFTERNOON SPEAKERS COME TO THE PODIUM? WE'RE LOOKING AT FOLLOW-UP IN THE MFMU TRIAL BUT THAT MAY BE WHAT, MARK, A YEAR AWAY? BILL. >> THE MIC ISN'T WORKING, BILL. >> I WANTED TO ASK A QUESTION, ABOUT THE NEEDED TO TREAT. WHAT NUMBERS SHOULD BE GETTING OUR ATTENTION? THOSE DON'T LOOK VERY DRAMATIC. PUSH THAT BUTTON. >> NUMBER NEEDED TO TREAT USUALLY CALCULATED AS RECIPROCAL OF ATTRIBUTABLE RISK. SO YOU'RE ASKING WHAT'S THE THRESHOLD FOR NUMBER NEEDED TO TREAT, THAT WOULD BE USEFUL IN DECISION MAKING. TO ME THERE'S NO STRICT CUT POINT BECAUSE IT REALLY DEPENDS ON THE BENEFITS, THE RISKS AND THE COSTS. AND I DON'T THINK YOU CAN HAVE A STRICT NUMBER NEEDED TO TREAT UNTIL YOU TAKE THOSE ALL INTO ACCOUNT. BUT NUMBER NEEDED TO TREAT IN THE HUNDREDS IS PRETTY BIG AND NUMBER NEEDED TO TREAT IN THE TENS IS SMALL. >> THANK YOU. MY FIRST SET OF QUESTIONS REFERS TO THE EFFECT OF TREATMENT OF GESTATIONAL DIABETES ON CESAREAN DELIVERY RATE. THERE WERE DISPARATE CONCLUSIONS. THE INFORMATION PRESENTED BY EPC WAS THAT THERE DEFINITELY WAS NO IMPACT OF TREATMENT ON CESAREAN DELIVERY RATE. ON THE OTHER HAND DR. LANDON INDICATED THAT IN HIS CONCLUSIONS THAT IT WAS UNCLEAR ABOUT WHETHER THERE WAS AN EFFECT. MY FIRST QUESTION IS TO DR.S DONOVAN AND HARTLING I NOTICED IN YOUR POOLED ESTIMATE YOU INCLUDE AD STUDY BY BONNOMO WHICH INCLUDED PATIENTS WHO WOULD NOT HAVE QUALIFIED FOR ANY DIAGNOSIS OF GESTATIONAL DIABETES. I WAS WONDERING WHAT JUSTIFICATION YOU USED TO INCLUDE THEM IN THE POOLED ESTIMATE WITH THE OTHER TRIALS? >> E RESERVED PRESENTATION OF CAESAREAN TO THE HARM, WE'LL BE PRESENTING THE DATA THERE. BUT FOR -- THERE WAS TWO STUDIES INCLUDED. ONE WAS A RANDOMIZED CONTROL TRIAL IN 2005 AND THE OTHER WAS COHORT STUDY. FROM 1997. ONE THING WE WERE TASKED AS DR. VAN DORSEN REFERRED TO PHONE CALLS WE HAD AND INPUT FROM THE TECHNICAL EXPERT PANEL ON THIS WAS THAT WE WERE REALLY TRYING TO SEE WHETHER DIFFERENT CRITERIA OR THRESHOLDS OF GLUCOSE ABNORMALITIES COULD BE IDENTIFIED THAT HAD DIFFERENT TREATMENT EFFECTS FOR THIS QUESTION. AND THAT'S WHY WE WANTED TO INCLUDE A SPREAD THAT WOULD HAVE HAD -- REFLECTED DIFFERENT GLUCOSE INCLUSION CRITERIA. YOUR POINT IS WELL TAKEN THAT SOME OF THE STUDIES INCLUDED ONLY HAD A POSITIVE 50-GRAM SCREEN. HOWEVER, IN THOSE STUDIES THE CUT OFF WAS NDDG CRITERIA. SOME PEOPLE THAT WOULD HAVE MET -- WOULD HAVE FAILED TO MEET NDDG CRITERIA WOULD HAVE MET CARPENTER COUSTAN CRITERIA I.E.PGS CRITERIA. THAT'S THE JUSTIFICATION FOR INCLUDING THOSE STUDIES, TO TRY TO GET A RANGE OF DIFFERENT GLUCOSE CRITERIA TO SEE IF WE WOULD BE ABLE TO PICK OUT WHETHER TREATMENT EFFECT WAS ONLY EVIDENT AT MORE SEVERE DEGREES OF GLUCOSE INTOLERANCE BUT UNFORTUNATELY THAT WE WERE ABLE TO DEMONSTRATE. >> FOR DR. LANDON, MY QUESTION IS ON THE SAME ISSUE IS WHETHER YOU FEEL THE POPULATIONS IN THE CRUOTHER AND LANDON STUDY WERE SIMILAR TO JUSTIFY A POOLED ANALYSIS. >> I'M GOING TO LET THOSE FOLKS ANSWER THAT QUESTION BECAUSE I DON'T DO META ANALYSIS AND I'M NOT NEARLY AS EXPERT AS THEY ARE IN TERMS OF THE -- WHETHER THAT'S FAIR TO COMBINE THOSE POPULATIONS. THEY'RE CLEARLY TWO DIFFERENT POPULATIONS ETHNICALLY AND SO FORTH. BUT THAT MIGHT ENRICH ANALYSIS. I WANT TO COME BACK TO CAESAREAN SPECIFIC QUESTION THAT YOU RAISED AND SIMPLY SAY THAT IF YOU LOOK ON SURFACE TWO RCT YOU MIGHT SAY THE CROUTHER STUDY DIDN'T SHOW A DIFFERENCE. THE MFMU STUDY SHOW YOU REDUCE CAESAREAN RATES SO CONCLUSION WOULD BE IDENTIFYING AND CRETE TREATING DOESN'T INCREASE THE CAESAREAN RATE, KIND OF THE CONCERN FROM THE TORONTO NAYLOR STUDY. HOWEVER, NOT SURE THAT'S FAIR THE ULTIMATE CONCLUSION SINCE THE CANADIAN ANALYSIS WAS ALL ENCOMPASSING AND I CAN'T SPEAK TOCOLON YOUTHERS POPULATION AND WHAT KIND OF OBSTETRICS PRACTICED IN THOSE CENTERS BUT WE'RE TALKING ACADEMIC CENTERS WHERE PEOPLE ARE PERHAPS A LITTLE MORE STRINGENT ABOUT CRITERIA FOR CAESAREAN OVERALL. TO SAY DIAGNOSIS DOESN'T PERHAPS INCREASE RISK FOR CAESAREAN MIGHT BE A NAIVE STATEMENT. >> MY LAST QUESTION, DR. LANDON, LAST YEAR IN DIABETES CARE WORKERNER AND ASSOCIATES PUBLISHED A MODEL DR. GILMAN REFERRED TO THAT LOOKED AT COST EFFECTIVENESS TESTING AND TREATMENT. OF GESTATIONAL DIABETES. THEIR CONCLUSION WAS THAT IT WAS COST EFFECTIVE IF YOU CONSIDER POST DELIVERY OUTCOMES THAT IF IF YOU WERE CONFINING THE ANALYSIS TO PERINATAL OUTCOMES THAT THE TREATMENT WAS NOT, THE DIAGNOSIS AN TREATMENT WAS NOT COST EFFECTIVE. MY QUESTION FOR YOU IS, IS THERE ANY INFORMATION OR ANY DATA THAT WOULD BE USEFUL AT GUIDEN THE PANEL TO CONSIDER WHETHER FREE DELIVERY ANTI-PARTUM TREATMENT WOULD AFFECT POST DELIVERY MATERNAL OUTCOMES. >> ARE YOU SPEAKING OF T LONG TERM MATERNAL OUTCOME? >> YES. >> NO. IN FACT IT WAS I THINK ON A PRESENTER SLIDE THIS AFTERNOON, ESSENTIALLY NOTHING TO ANSWER THAT SPECIFIC QUESTION. WE'RE DOING SOME MATERNAL FOLLOW-UP OFF OF THE NICHD TRIAL BUT THE PRIMARY FOLLOW-UP IS ON THE KIDS. BUT THAT IS A REAL VOID. >> THANK YOU. >> A BIT MORE ABOUT YOUR QUESTION AS TO WHETHER OR NOT IT WAS APPROPRIATE TO POOL THOSE STUDIES IN A META ANALYSIS. ONE THING WE DO IS LOOK AT STATISTICAL HETEROGENEITY ACROSS EFFECT ESTIMATES FROM DIFFERENT STUDIES. WE HAVEN'T PRESENTED OUR GRAPH ON CESAREAN DELIVERY YET BUT WE WILL. I HOPE YOU'RE INTERESTED AND SURPRISED WHEN WE PUT THAT UP IN 20 MINUTES. IT SHOWED 0 PERCENT HETEROGENEITY, MAYBE THERE WERE DIFFERENCES IN POPULATIONS BUT THAT'S NOT EXPLAINING ANY DIFFERENCES, THE DIFFERENCES WEREKo CONSISTENT DESPITE DIFFERENCES IN STUDY POPULATIONS. AND BONNOMO STUDIES EITHER ONE RCT OR COHORT STUDY TO CONTRIBUTE WAS WELL IN LINE WITH THE OTHER STUDY. >> (OFF MIC) >> AND CAUSE TROUBLE FOR THE MOTHER AND BABY AND THERE ARE CASES THAT ARE REALLY NOT THAT BIG A DEAL. AND DID YOU DO ANY SUBANALYSIS HOW SEVERE CASES OF PREECLAMPSIA WERE AND HOW MUCH TROUBLE YOU SAVED? >> NO, I DIDN'T, BOB. I DON'T HAVE THAT INFORMATION FOR YOU PER SE BUT I WOULD MAKE NOTE OF THE FACT THAT ONE OF THE LOSSES IN THE CROUTHER STUDY CONTROL ARM WAS A SEVERE PREE CLARK CLAM TICK WITH A GROWTH RESTRICTED FETUS. MEDICAL BENEFIT OF INCREMENTALLY INCREASING THE NUMBER OF PEOPLE WHO COME TO THE POOL TO BE TREATED, I THINK YOU'RE IN THE AWARE OF ANY EVIDENCE THAT THAT PARTICULAR GROUP WOULD BENEFIT FROM BEING ADDED TO THE CURRENT GROUP WHO ARE PARTICIPANTS IN YOUR STUDY OR IN THE LITERATURE, DID I HEAR YOU CORRECTLY? >> I THINK THE DATA THAT MOST DIRECTLY AFFECTS THAT QUESTION ARE THE SMALL TRIALS THAT THE INTERCRITERIA WHERE HYPERGLYCEMIA NOT MEETING THE THRESHOLD FOR GDM IT'S VERY HARD TO MAKE CONCLUSIONS FROM THOSE GIVEN THE SMALL ENAND RISK FOR BIAS. I ALSO THINK IT'S -- IT WILL BE HARD OTHERWISE TO TELL EVEN FROM SIMULATIONS BECAUSE OF THE -- WHAT I'M CALLING CONFLATION OF THE TYPE OF TEST, NUMBER OF THRESHOLDS AND THE GLUCOSE LEVEL AT THRESHOLDS. I THINK THOSE STUDIES MAY BE HELPFUL EVEN NOW. THEY'LL SHOW WHERE THE DATA ARE MISSING. >> DR. MINKOFF, I WOULD SAY I LIMITED MY CONCLUSIONS TO THE TWO OUTCOMES THAT I WAS ADDRESSING WITH CAESAREAN, PREECLAMPSIA, I'M REASONABLY CERTAIN THE CONVERSATION WILL BECOME GREATER AS THE AFTERNOON MOVES FORWARD AND TOMORROW MORNING ABOUT THE SPECIFIC OUTCOME OF LARGE INFANTS, HOW IMPORTANT THAT IS. EXTENDING DIAGNOSTIC CRITERIA WHICH SEEMS TO BE THOUGH A SECONDARY OUTCOME OF INTEREST MOST OBSTETRICIANS. >> GOING TO MAKE AN EDITORIAL COMMENT THAT THE NICHD TRIAL AND CHOICE FOR FAIRLY LARGE TRIALS THAT SHOWED DECREASES IN SOME IMPORTANT OUTCOMES BUT NOT IN OTHERS. PARTLY BECAUSE OF POWER BUT NOT ALWAYS. SO THERE'S A CONCERN THAT TREATMENT OF PEOPLE AT LOWER RISK WILL SHOW LOWER BENEFIT FROM THAT. >> IN THE BACK. >> (INDISCERNIBLE) NEW ZEALAND. IS IT FAIR TO CONFLATE GESTATIONAL HYPERTENSION PREECLAMPSIA AS ONE CONDITION? GESTATIONAL HYPERTENSION HAS A BENIGN OUTCOME AND PREECLAMPSIA NOT SO BENIGN. I WAS WONDERING META ANALYSTS HAVE SEPARATED THOSE OUT FROM THE STUDIES AND ALSO MY QUESTION, IS IT FAIR TO CONFLATE THE TWO? >> I'M ENDOCRINOLOGIST, THAT'S PROBABLY BETTER FOR OBSTETRICIAN BUT I WILL POINT OUT FROM THE CRUTHER STUDY THE DEFINITION -- THEIRS WAS BLOOD PRESSURE 140 OVER 90 TIMES TWO GREATER THAN FOUR HOURS APART. WHEREAS IN THE LANDON ET AL PAPER THE DEFINITION INCLUDEED INCLUDEED THAT BUT HAS HAD TO HAVE THE FOLLOWING. BLOOD PRESSURE MEDICATION, PROTONEUROIA, INCREASE IN AST OR DECREASE IN PLATELET COUNT. >> PROFESSOR, CERTAINLY NOT GOING TO ARGUE WITH YOU ABOUT OR TAKE EXEMPTION I SHOULD SAY WITH THE NOTION THAT GESTATIONAL HYPERTENSION IS MORE SERIOUS PERHAPS THAN PREECLAMPSIA. BUT I THINK NUMBERS IT IS A ACCEPTED DIAGNOSIS, DIAGNOSIS ACCEPTED WITH ATTACHED TO IT SOME MORBIDITY AND CERTAINLY RISK FOR INVOLVING THE PREECLAMPSIA AND RISK FOR OBSTETRIC INTERVENTIONS AS EVIDENCE THE WORK FROM THE NETHERLANDS THAT WE SHOULD BE INDUCING WITH Y HYPERTENSION. I THINK THE REAL DIAGNOSIS, I WOULD AGREE WITH YOU, IT'S NOT HELP SYNDROME. >> (INDISCERNIBLE) FROM BAILOR HOUSTON. I HAVE TWO QUESTIONS. ONE IS OBESITY FOLLOW-UP IN CHILDREN. DID I UNDERSTAND THIS CORRECTLY, MOST OF THOSE STUDIES DO NOT HAVE INFORMATION ON THE MOTHER STATUS? WHY NOT? IF WE KNOW THE BABY IS OBESE OR NOT, WHY DON'T WE KNOW WHAT THE MOTHER IS? I'LL ADDRESS THAT FROM THE CHOICE FOLLOW-UPENING BASED ON LINKAGE BETWEEN DATA SET OF HEIGHT AND WEIGHT THE STATE WAS DOING AND RANDOMIZED CONTROL TRIAL OF WOMEN. THAT WAS ONLY A CHILD FOLLOW-UP, THERE WAS NO MATERNAL FOLLOW-UP. >> MARK, I UNDERSTAND SECONDARY ANALYSIS OF THE NETWORK TRIAL ASSOCIATED WITH DECREASED WEIGHT GAIN DO YOU CONSIDER THAT A MUTE NOTION THAT WE MIGHT HAVE THE SAME EFFECT JUST DECREASEDDED WEIGHT GAIN? >> I DON'T THINK IT'S A MOOT OBSERVATION AT ALL. I THINK IT'S A TREATMENT EFFECT. BUT IF YOU'RE SUGGESTING THAT'S -- THAT SHOULD BE EXTENDED TO OTHER POPULATIONS, THAT MIGHT SO BE THE CASE. BUT THIS WAS A TRIAL OF GESTATIONAL DIABETES WHERE IT'S NOT A BENEFIT IN OBESE NON-GDM, I DON'T KNOW IF THAT'S WHAT YOU'RE SUGGESTING BUT I CAN ALSO TELL YOU, YOU KNOW THIS, IF YOU REMOVE THAT, OR CONTROL FOR THAT, OUTCOME, THERE'S STILL A TREATMENT EFFECT. >> I -- COUPLE OF COMMENTS, WITH REGARD TO NAYLOR STUDY CAESAREAN AND TORONTO TRIHOSPITAL STUDY, AS I REMEMBER IT N THAT STUDY, PATIENTS WHO MET CRITERIA WERE UNBLINDED AND PATIENT WHOSE ONLY MET C AND C CRITERIA WERE BLINDED. THE RESULT WAS THAT THE UNBLINDED PATIENTS WHO WERE TREATED, WHO HAD MORE SEVERE GESTATIONAL DIABETES, HAD LOWER RATE BIG BABIES AN STILL HAD THE HIGH CAESAREAN RATE AND THE CESAREAN SECTIONS WERE UNRELATED TO THE SIZE OF THE BABY, WHEREAS THE BLINDED PATIENTS WHO HAD MILDER GESTATIONAL DIABETES, ALSO HAD A HIGHER CAESAREAN RATE BUT CAESAREANS WERE RELATED TO THE SIZE OF THE BABIES, MEANING MORE BIG BABIES. THE LESSON FROM THAT STUDY ISN'T THAT GESTATIONAL DIABETES CAUSES CAESAREANS BUT OBSTETRICIANS BEING TOLD THEY HAVE GESTATIONAL DIABETES ARE MORE LIKELY TO PERFORM CAESAREANS SO WE SHOULDN'T LOOK UPON THAT AS DISADVANTAGE OF DIAGNOSING GESTATIONAL P, WE SHOULD LOOK AS AN OPPORTUNITY TO EDUCATE CAREGIVERS THAT IT DOESN'T NECESSARILY MEAN YOU HAVE TO DO A CAESAREAN. THE OTHER POINT I WANTED TO MAKE IS THAT THERE HAS BEEN A LOT OF DISCUSSION THAT THERE AREN'T STUDIES ON SINGLE ABNORMAL VALUE AT LOWER LEVELS AND I JUST WANT TO REMIND PEOPLE THAT THERE HAS BEEN ONE, IT WAS A LARGE STUDY, IT WAS CALLED A CHOICE. AND IT USED A TWO HOUR CUT OFF OF 140. SINGLE ABNORMAL VALUE AND DID SHOW A BENEFIT SO IT'S NOT QUITE TRUE TO SAY THERE HAVEN'T BEEN ANY STUDIES OF SINGLE ABNORMAL VALUE. THANKS. >> MY QUESTION IS ADDRESSED TO DR. LANDON. IN YOUR STUDY AND A CHOICE STUDY, THERE WERE A LOT OF SIMILARITIES, DECREASE IN LTA BABIES, BOTH SHOWED DECREASE IN PREECLAMPSIA. ALSO GOING INTO THIS STUDY THE, YOUR MEDIAN I THINK IT WAS ONE HOUR GLUCOSE SCREENING RESULTS TO THE OTHER MEAN, MAYBE I GOT THEM BACKWARDS, HOWEVER BOTH STUDIES SHOWED DECREASE IN MATERNAL WEIGHT GAIN IN COMPARISON WITH CONTROL GROUP. NEITHER STUDY REPORTED WHAT THE MATERNAL GLUCOSE WAS DURING PROCESS OF TREATMENT. SO MY QUESTION IS HOW DO WE DIFFERENTIATE WHETHER IT WAS DECREASE MATERNAL GLUCOSE OR WHETHER DECREASE MATERNAL WEIGHT GAIN THAT GAVE THE POSITIVE EFFECTS ON LGA AND PREECLAMPSIA. >> DAVID TO MY BEST KNOWLEDGE DR. CELESTE WOLF IN THIS AUDIENCE DID PUBLISH A SECONDARY ANALYSIS WHICH INCLUDE GLYCEMIC DATA FROM TREATMENT TRIAL. I DON'T BELIEVE WE LOOKED SPECIFICALLY AT VIRIOUS GLUCOSE THRESH HOLDS ATTACHED TO TREATMENT AND OUTCOMES PER SE WE DOCUMENTED THE FACT IN FACT GLUCOSE WAS LOWERED WITH TREATMENT. WE WERE CAREFUL TO DO THAT BECAUSE AS YOU KNOW WE FEAR THIS GIVES NEGATIVE STUDY AND PRIMARY CRITICISM BY FRIENDS AND COLLEAGUES, WE DIDN'T TREAT GESTATIONAL DIABETES ADEQUATELY SO UNLIKE CROUTHER WE SPEND A LOT OF TIME AND EFFORT MANY COLLECTING GLYCEMIC DATA PUBLISHED IN THE GREEN JOURNAL. >> FOLLOW UP WITH CORED BLOOD DATA, I THINK THE INTERVENTION GROUP OFF SPRING HAVE LOWER C PEPTIDE LEVELS THAN CONTROLS. >> I HAVE A COMMENT, SOMEBODY EARLIER SAID NO STUDIES LOOKING AT MOTHERS AN CHILDREN. THAT'S NOT ENTIRELY TRUE BECAUSE THIS STUDY WAS PUBLISHED WE WENT TO ADMINISTRATIVE DATA AND FOUND CASE MATCH CONTROLS THAT MATCH WITH PEOPLE WITH PROSPECTIVE INFORMATION FROM PREGNANCIES, 15 YEARS LATER. AND WE HAD 99 PEOPLE IN THE CASE POPULATION AND WE HAVE 100 PEOPLE IN THE CONTROL POPULATION. IN THE BRITISH JOURNAL OF ONG. DIABETIC MEDICINE, EGLIN AND MYSELF AUTHORED. BUT THE FACT IS THERE WAS A CORRELATION WITH DEGREE OF MATERNAL DIABETES IN THE FUTURE. OFFSPRING WITH BIGGEST WASTE CIRCUMFERENCES WERE OFFSPRING OF MOTHER WHOSE NOW HAD DIABETES. THERE WAS STILL A POPULATION OF MOMS THAT DIDN'T HAVE DIABETES. THERE SEEMS TO BE KIND OF -- THE WORST MOTHERS DIABETES THE BETTER THE CHANCE THEY WOULD BE GETTING IT IN TERMS OF HOW THEY HAD TO BE TREATED. AROUND WHETHER OR NOT OFFSPRING HAS METABOLIC SYNDROMES. NONE IN FACT HAD 15 YEARS WHICH IS ATYPICAL. HAD ANY GLUCOSE INTOLERANCE IN THAT POPULATION OF PATIENTS. THEY WERE SLIGHTLY MORE OBESE, THEY HAD METABOLIC SYNDROME THAT WAS TWICE THE OTHER POPULATION. BUT THERE WAS A LOT OF MOTHER/DAUGHTER CORRELATION. >> ANY OTHER QUESTIONS OR COMMENTS? >> IF YOU WANT, I CAN ADDRESS WHY I MAY NOT HAVE BEEN INCLUDEED THAT PARTICULAR STUDY. WAS IT A CASE CONTROL STUDY? CASE COHORT? IN THE PRESENTATION WE DID THIS MORNING THE INCLUSION CRITERIA WERE IN THE ABSENCE OF TREATMENT. IF THERE HAD BEEN TREATMENT IN ANY OF THOSE WOMEN IT WOULDN'T HAVE MET INCLUSION CRITERIA. IN THE PRESENTATION PRESENTED ON EFFECTIVE TREATMENT THERE HAS TO A NO TREATMENT GROUP. SO IT MAY NOT HAVE FIT INTO EITHER THE INCLUSION CRITERIA FOR EITHER OF THE QUESTIONS THAT WE WERE ASKED TO ADDRESS. >> OKAY. THANK YOU. [APPLAUSE] LOIS AND LISA. WE'RE ON TO QUESTION 5, HARMS OF TREATING GESTATIONAL DIABETES AND DO THEY VARY BY DIAGNOSTIC APPROACH? LOIS DONOVAN, LISA HART LING AGAIN. SKIM SUBSET OF WHAT WE PRESENTED. SIMILAR METHODS AND WE'LL GO OVER THEM. SIMILAR INCLUSION CRITERIA. IN TERMS OF HARMS WE WERE LOOKING FOR THOUGH WE DIDN'T FIND MOST OF THESE WE WERE LOOKING AT ANXIETY, HEALTHCARE SYSTEM ISSUE, BURDEN ON PRACTICER OFFICE, INCREASED INTERVENTIONS DUE TO TREATMENT BIAS, POSTPARTUM DEPRESSION, SMALL FOR GESTATIONAL AGE COST, WE WEREN'T LOOKING FOR COST EFFECTIVE ANALYSES, BUT IF THE STUDY MENTIONED COSTS, WE WOULD HAVE EXTRACTED THAT AND RESOURCE ALLEGATIONS. SO THESE WERE A SUBSET OF STUDIES WE PRESENTED AROUND BENEFITS OF TREATMENT SO FIVE RANDOMIZED CONTROL TRIALS AND SIX RETROSPECTIVE COHORT STUDIES THAT MET ELIGIBILITY CRITERIA THOUGH NOT ALL PRESENTED ON WHAT WE CLASSIFY AS HARMS. A VARIETY OF O INCLUSION CRITERIA WERE USED AND ALL HAD TO HAVE A KNOWN TREATMENT ARM VERSUS INTERVENTION ARM DIET MODIFICATION, GLUCO MONITORING AN INSULIN AS NEEDED. OVER TO LOIS AGAIN. SO THESE ARE SIMILAR TO THE BENEFITS OUTCOME. THE GLUCOSE INCLUSION CRITERIA, 5-GRAM SCREEN WITH A NON-DIAGNOSTIC ORAL GLUCOSE TOLERANCE TEST TO WOMEN WHO MET NADG CRITERIA FOR GESTATIONAL DIABETES. ONCE AGAIN, THE TWO LARGE RANDOMIZED CONTROL TRIALS AS YOU KNOW USED CARPENTER COUSTAN CRITERIA LESS THAN 95-MILLIGRAMS PER DECALITER. THIS SHOWS AGAIN THE MEAN FASTING GLUCOSE FOR BOTH MATERNAL FETAL MEDICINE UNITS AND CHOICE WAS REMARKABLY SIMILAR WITH GREATER SPREAD OF ONE STANDARD DEVIATION IN THE ACHOS TRIAL, POST GLUCOSE LOAD THRESHOLDS ONCE AGAIN, ON 75-GRAM TEST OR LOWER FOR ACHOS. WITH WIDESPREAD ONE STANDARD DEVIATION AN HIGHER MATERNAL FETAL MEDICINE UNITED STATES KEEPING IN MIND THAT WAS # HUNDRED GRAM CHALLENGE, TWO HOURS COMPARE WITH EACH OTHER. THE KEY OUTCOMES REPORTING ON TODAY ARE LISTED HERE. MORE IN THE FULL REPORT. INDUCTION OF LABOR, NUMBER OF PRE-NATAL VISITS, DEPRESSION AN ANXIETY. SMALL FOR GESTATIONAL AGE, ADMISSION TO NICU AND NEONATAL HYPOGLYCEMIA. THIS IS NOW SHOWING CESAREAN DELIVERY DATA AND AS YOU CAN SEE THERE WAS OVERALL THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN CESAREAN DELIVERY FOR POOLED RANDOMIZED CONTROL TRIALS. AS HAS BEEN POINTED OUT BY DR. LANDON, THERE WAS LESS CESAREAN DELIVERY IN HIS TRIAL AND THIS DIFFERS FROM THE OTHER LARGE RANDOMIZED CONTROL TRIAL. BOTH OF THESE TRIALS TRY THE BLIND BY NOT ADDING GESTATIONAL DIABETES IN THEIR CONTROL GROUP BUT BOTH TRIALS, I UNDERSTAND THEM CORRECTLY, HAD -- THE CARE PROVIDERS DID KNOW THEY HAD GESTATIONAL DIABETES. SO WHETHER PRACTICES DIFFERENCES, BETWEEN THOSE TWO CENTERS IN TERMS OF HOW THESE PEOPLE ARE MANAGED FOR DELIVERY HAS IMPACT ON THE DIFFERENCES BETWEEN THESE TWO TRIALS. NOT CLEAR BUT THAT -- HYPOTHESIZE THAT MIGHT BE ONE SO BASELINE FOR POOLED ANALYSIS WAS 30% WITH ABSOLUTE RISK REDUCTION OF 3% RESULTING IN A NUMBER NEEDED TO TREAT OF 32 TO REDUCE ONE CESAREAN DELIVERY IF THIS HAD BEEN A POSITIVE -- WE PROVIDEED THAT FOR YOU THOUGH IT WAS A SIGNIFICANT -- WAS P SIGNIFICANT BECAUSE THE CONFIDENCE INTERVAL CROSSED 1.01. BUT KEEP IN MIND THIS WAS NOT SIGNIFICANTLY DIFFERENT. HERE ARE THE RESULTS FOR INDUCTION OF LABOR. THEY COME FROM TULLIAN DOCUMENTIZED CONTROL TRIALS. AS YOU CAN SEE THOUGH THE POOLED RESULTS SHOW KNOW DIFFERENCE THE CARUTHER STUDY SHOWED INCREASE RISK OF LABOR. WHETHER THIS WAS BECAUSE CARE PROVIDERS WERE AWARE OF THE PEOPLE WHO HAD THE LABEL OF GESTATIONAL DIABETES IN THE TREATMENT GROUP OR NOT WE CAN ONLY SPECULATE. THE NUMBER OF PRE-NATAL VISITS, THERE'S DETAILS LISTED ON SLIDES BASEBALLLY WOMEN DIAGNOSED WITH -- BASICALLY BUT WOMEN TREATED WITH GESTATIONAL DIABETES HAD MORE PRE-NATAL VISITS. THERE WAS ONLY ONE STUDY THAT MET INCLUSION CRITERIA FOR THIS QUESTION. THAT LOOKED AT DEPRESSION AND ANXIETY. THAT WAS A FOLLOW-UP OF SUBGROUP OF PARTICIPANTS IN THE CARRUTHER STUDY. THEY LOOKED AT DEPRESSION AND ANXIETY THREE MONTHS POSTPARTUM. THERE WAS NO DIFFERENCES IN ANXIETY IN EITHER TIME POINT BUT TREATED GROUP HAD LESS DE DEPRESSION THREE MONTHS POST PARTUM. HERE IS THE FOREST PLOT FOR SMALL FOR GESTATIONAL AGE. AS YOU CAN SEE THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN TREATMENT AND UNTREATED GROUPS. AN OVERALL EFFECT ON MALL FOR GESTATIONAL AGE. NICU ADMISSION, OVERALL POOLED RESULT OF RANDOMIZED CONTROL TRIALS SHOWED NO DIFFERENCE IN NICU ADMISSION BUT IT'S POINTED OUT THERE WAS DIFFERENCE BETWEEN TWO LARGE RANDOMIZED CONTROL TRIALS BEEN AN EFFECT OF TREATMENT OF INCREASING NICU ADMISSION RATE BUT NOT IN THE LANDON STUDY. I DON'T KNOW WHETHER THERE WAS ANYBODY INVOLVED MANY THE STUDY, IF THEY CAN EXPLAIN WHY SUCH A HIGH RATE OF NICU ADMISSION. I WOULD PRESENCE IT HAD TO BE DIFFERENT THAN NICU. HAVING CURB SIDE SOMEONE INVOLVED IN THIS STUDY AT A MEETING PREVIOUSLY HE DID MAKE NOTE THERE WAS A DIFFERENT PAYMENT SCHEME MIGHT HAVE INFLUENCED THIS SUCH THAT BABIES THAT GO TO NICU IN THAT SETTING RESULTED IN A BETTER PAYMENT TO THE DOCTOR. HERE IS THE DATA FOR NEONATAL HYPOGLYCEMIA, THE OVERALL POOLED RESULTS AS WELL AS COHORT STUDIES SHOWED NO INCREASE RISK OF NEONATAL HYPOGLYCEMIA, TREATMENT OF GESTATIONAL DIABETES IS ASSOCIATED WITH INCREASE ASSOCIATION OF CARE. POTENTIAL HARMS WERE NOT REPORTED IN LITERATURE TO TELEPHONE OUR ANALYSIS TO. THERE WAS INADEQUATE POWER TO SOME OUTCOMES AND NO DIFFERENCES SHOULD BE DETERMINED AS EQUIVALENTS BETWEEN GROUPS AS FURTHER RESEARCH MAY CHANGE THE RESULTS. AN EXISTING CONCLUSIONS ABOUT OUTCOMES AND HOW THEY WERE ASSESSED. (INDISCERNIBLE) RESEARCH PRIORITIES WE IDENTIFY RANDOMIZED CONTROL TRIALS THAT RANDOMIZE WOMEN TO DIFFERENT TREATMENT TARGETS AS WELL AS RANDOMIZED CONTROL TRIALS COMPARING DELIVERY MANAGEMENT FOR GESTATIONAL DIABETES WITH AND WITHOUT INSULIN OR ORAL DIABETES MEDICATIONS ARE NEEDED. THANK YOU. [APPLAUSE] >> NEXT UP DR. TIM CUNDY, PROFESSOR OF MEDICINE PROFESSOR OF MEDICINE UNIVERSITY OF AUKLAND, WHO WILL TALK ABOUT TREATMENT OF GESTATIONAL DIABETES MELLITUS AND RELATIONSHIP TO DIAGNOSTIC THRESHOLD. I DON'T THINK ANYBODY HAS COME FURTHER. >> THANK YOU FOR THE INTRODUCTION. THANK YOU VERY MUCH, LIKE THE THANK THE ORGANIZERS VERY MUCH FOR THE GREAT HONOR BEING ASKED TO COME AND SPEAK HERE I DON'T HAVE RELEVANT FINANCIAL RELATIONSHIPS OR COMMERCIAL INTERESTS. THANKS TO HURRICANE SANDY, I GOT AS FAR AS SAN FRANCISCO LAST TIME. I WENT UP FROM SILVER TO GOLD STATUS IN NEW ZEALAND. I DO THANK YOU FOR THAT. SO I HAVE BEEN ASKED TO LOOK AT HARMS OF TREATMENT OF GESTATIONAL DIABETES IN RELATIONSHIP TO DIAGNOSTIC THRESHOLD. ONE DISADVANTAGE OF TALKING LATE IN THE AFTERNOON IS MOST OF ONE'S SLIDES HAVE BEEN SHOWN BY OTHER PEOPLE BUT THAT HASN'T STOPPED ANYBODY ELSE HERE I GO. I THINK WE'RE GOING TO UNDERSTAND HOW PEOPLE TALKED ABOUT THIS IS GESTATIONAL DIABETES AS CURRENTLY DEFINED DIABETES ONSET FIRST RECOGNITION PREGNANCY COMPRISES A HETEROGENEOUS GROUP OF PEOPLE AT THE TOP END OF THIS PYRAMID OF GLUCOSE TOLERANCE IN THE COMMUNITY, UNRECOGNIZED TYPE 2 DIABETES. SO PEOPLE, GOT WOMEN UNRECOGNIZED TYPE 2 DIABETES. IN A SECTION BELOW WE HAVE PRE-DIABETES AND VARIABLE PROPORTION OF UPPER END OF NORMAL. DEBATE WE'RE HAVING NOW IS HOW MANY OF THESE PEOPLE SHOULD WE INCLUDE, HOW FAR DOWN THE THRESHOLD SHOULD GO. AS POINTED OUT EARLIER, BY ELIMINATING TWO STEP TESTING, FACING DIAGNOSIS ON SINGLE BLOOD GLUCOSE RESULT IT IS NUMBER OF WOMEN IN THIS GO UP 2 TO 3 FOLD. IN OUR COUNTRY LOWERING GLYCEMIC THRESHOLD WILL ALSO HAVE THAT EFFECT. IT'S IMPORTANT TO UNDERSTAND FETAL RISK IN GESTATIONAL DIABETES ARE NOT EQUAL ACROSS THE WHOLE SPECTRUM OF GESTATIONAL DIABETES. WE LOOK AT CONGENITAL ANOMALIES, PERINATAL MORTALITY, I'LL SHOW YOU DATA IN A SECOND LARGELY RESTRICTED TO WOMEN AT THE TOP END OF THAT PYRAMID WITH UNDIAGNOSED GESTATIONAL DIABETES. TO UNDIAGNOSED DIABETES. LESSER DEGREES GLYCEMIA THAN IN FETAL ANALYSIS. AND THE MILD DEGREES WE'RE LOOKING FOR AT SURROGATE MEASURES LIKE BIRTH WEIGHT, LARGE FOR GESTATIONAL AGE. THIS IS DATA PUBLISHED A LONG TIME AGO NOW. WHICH WE LOOKED AT PERINATAL MORE TAIL RATE AT OUR HOSPITAL WITHOUT DIABETES. WOMEN WITH TYPE 1 DIABETES, PARTICULARLY GOOD 12 YEARS. WE HAVE HAD A FEW SINCE THEN. BUT AND WOMEN WITH KNOWN TYPE # DIABETES FOUND A SIGNIFICANTLY HIGHER PERINATAL MORTALITY RATE. WOMEN WITH GESTATIONAL DIABETES WE OPERATED OUT THOSE WITH UNRECOGNIZED TYPE 2 DIABETES AND WE QUESTION FINED AS HAVING A POSITIVE GGP SIX WEEKS POSTPARTUM AND WE ASSUMED THEY HAD IT BEFORE ATHAT THE PREGNANT. THE PERINATAL MORTALITY IS THE SAME FOR KNOWN TYPE 2 DIABETES. FOREST OF THE GESTATIONAL DIABETES GROUP WAS NO DIFFERENT. SAME FOR MAJOR CONGENITAL ANOMALIES, WE SEE 5 OR 6% IN TYPE 1 DIABETES AND KNOWN TYPE 2 DIABETES. WHEN WE SPLIT GESTATIONAL DIABETES GROUP UP INTO UNKNOWN THEY GOT THE SAME CONGENITAL ANOMALY RATE. PEOPLE AT THE TOP END OF THE SPECTRUM REALLY HAVE SIGNIFICANT PROBLEMS. VERY IMPORTANT TO DETHE FINE. WHEN WE'RE GETTING DOWN TO LESSER DEGREES OF GLYCEMIA, THINGS LIKE FETAL BIOCHEMICAL ABNORMALITIES AN BIRTH WEIGHT. WHICH SEEM TO BE OUTCOMES OF INTEREST. BY DEFINITION THE PEEP PEOPLE IN THIS GROUP ARE LOW RISK PREGNANCIES HI NUMBERS AND PROBLEMS ARE DISCUSSED. POTENTIAL HARMS TAKING A BROAD VIEW OF POTENTIAL HARMS SO REPETITION LOOK AT FIVE HEADINGS, LACK OF UTILITY MEDICALIZATION OF PREGNANCY. LOOK OF UTILITY WE HEARD ABOUT ALREADY BUT THINKING ABOUT POTENTIAL BENEFITS, SHORT TERM BENEFITS FOR THE MOTHER, PERHAPS DECREASE IN C-SECTION RATE, DECREASE IN ASSOCIATED HYPERTENSION, SHORT TERM EFFECT TO FETUS, DECREASED BIRTH WEIGHT, SHOULDER DISTOTIA HYPOGLYCEMIA AND THERE'S THE LONG TERM ISSUES I'LL COME TO IN A SECOND. WE HAVE DISCUSSED A LOT ALREADY SO I WON'T GO THROUGH THEM AGAIN THIS IS THE BMG ANALYSIS TESTIMONY DATA WE HEARD TODAY MORE OR LESS AGREE WITH THIS. THAT ME IS A ANALYSES DID NOT SHOW SIGNIFICANT DIFFERENCES FOR MOST SINGLE END POINTS JUST TO BE DIRECT CLINICAL IMPORTANCE. THE SURROGATE END POINT OF LARGE FOR GESTATIONAL AGE INFANTS IS AFFECTED AND BECAUSE WE CAN MAKE BABIES SMALLER WITH TREATMENT THERE IS REDUCTION IN SHOULDER DISTOTIA THOUGH NOT A COMMON COMPLYCATION. WE DISCUSSED THE REDUCTION IN HYPERTENSIVE DISORDERS IN PREGNANCY AS WELL. LONG TERM ETCHES OF THE MOTHER PREVENT OBESITY, TYPE 2 DIABETES IN THE BABY, IN THE INFANT OR AS THEY GROW UP. THE ANSWER IS PROBABLY WE DON'T HAVE ANY DATA THAT THAT'S TRUE, THAT WE CAN PREVENT DEVELOPMENT OF OBESITY AND LATER TYPE 2 DIABETES. AS THEY GROW UP. THIS DATA IS REFERRED TO A FEW TIMES, FOLLOW-UP AND ACHO FOLLOW-UP THOUGH TREATMENT MACROSOMEIA AT BIRTH DIDN'T RESULT IN CHANGE OF GUY MASS INDEX AGE 4 OR 5 AND SIMILAR DATA, NO RELATIONSHIP WITH MATERNAL GLUCOSE AND OBESITY IN CHILDREN AGE 2. NOT (INAUDIBLE) EITHER. THAT'S NO CONVINCING EVIDENCE THERE INTERVENTION REDUCE IT IS THE RISK OF OBESITY AND TYPE 2 DIABETES AN OFFSPRING. I SUSPECT WE'RE NOT GOING TO FIND THAT. THIS IS QUITE PER WAYSIVE FROM THE MUNICH GROUP. CHILDREN AGE 2, 8, 11, OFFSPRING OF NON-DIABETIC PREGNANCIES, MOTHERS WITH Y DIABETES, 230 OF THEM, OFFSPRING OF MOTHERS WITH TYPE 1 DIABETES, 750. WITH GESTATIONAL DIABETES AND TYPE 1 DIABETES WE KNOW THESE BABIES ARE BORN A BIT FAT AND STILL A BIT FAT AT AGE 2. BY AGE 8 OFFSPRING OF WOMEN WITH TYPE 1 DIABETES NO DIFFERENCE TO NON-DIABETES WOMEN. AND BY AGE 11, BOTH A LITTLE ON THE FAT SIDE BUT NO DIFFERENT CONTROLS. IN CONTRAST, THE OFFSPRING OF WOMEN GESTATIONAL DIABETES A LITTLE FATTER TO AND GETTING FATTER AFTERWARDS. HOW DO WE INTERPRET THE DATA? I INTERPRET THIS FOR SURE OFFSPRING OF WOMEN GESTATIONAL DIABETES ARE AT RISK OF GETTING FAT AS THEY GET OLDER TESTIMONY PROXIMATE CAUSE OF THAT IS NOT EXPOSURE TO SUGAR IN UTERO. IF SO, SHOULD BE ONLY DETERMINIC OF OBESITY IN ONSET TYPE 2 DIABETES AND THERE ISN'T. SO MOVE ON TO THE DIAGNOSTIC TESTS. WE HAVE DISCUSSED THIS BEFORE BUT THIS IS THE DATA. DR. VAN DORSTEN YOU WERE ASKING ABOUT, TWO STUDIES WITH 100 WOMEN WITH REPEAT GLUCOSE TOLERANCE TESTS WITHIN A COUPLE OF WEEK, FIRST IN PREGNANCY AND QUARTER CHANGED DIAGNOSTIC CATEGORY WITH THE SAME PROPORTION GOING FROM NORMAL TO ABNORMAL -- NORMAL TO ABNORMAL. SO IT'S GNAT PARTICULARLY GOOD TEST. THAT IS BASED ON THESE RESULTS HAVING TWO ABNORMAL RESULTS ON THE GTT. WHEN WE GET TO ONE TEST, THEN THERE'S QUITE A BIT MORE NOISE, IT'S NOT A PARTICULARLY GOOD TEST, AN IMPORTANT PRINCIPLE IN ANY SCREENING PROGRAM IS DIAGNOSTIC TEST SHOULD BE ROBUST AND REPRODUCIBLE AND DEFINE A HIGH RISK GROUP WITH PRECISION. I DON'T THINK THAT THIS TEST DOES. ANOTHER PROBLEM IS I THINK SOMEONE ALSO TOUCHED ON, WE GET ONE SIZE FITS ALL TEST, EVERYONE GETS 75-GRAMS OR 100-GRAMS OR WHATEVER, IRREASON ACTIVE OF WHAT YOUR BODY WEIGHT IS SO IT DOES MATTER WHAT GLUCOSE LOAD YOU GET GIVEN, DOES AFFECT THE POST PARANDIAL LEVELS, AND DOES TOUCH THE RECOMMEND TO TEST IDENTIFIES DIFFERENT POPULATIONS TO DIFFERENT CONTACTTITION AND DIFFERENCE PLACES -- CHARACTERISTICS AND DIFFERENT PLACES. THAT MAYBE IN THE CHINESE WOMEN TEND DIAGNOSED KILOGRAM BODY WEIGHT. MAYBE IDENTIFY DIFFERENT PEOPLE. WE DISCUSSED THIS, BE U COMPARING THE TWO BIG TRIALS, MFMU TRIAL RUNNING THROUGH THE CHOICE TRIAL SIGNIFICANTLY INCREASED NUMBER OF CLINIC VISITS ON AVERAGE FIVE EXTRA VISITS TO CLINIC DURING THAT TRIAL. IN THE MFU TRIAL. THEY WERE OBVIOUSLY MORE EFFICIENT, TWO EXTRA VISITS ON TOP O OF WHAT THEY ALREADY HAD TO DO. MATERNAL HYPOGLYCEMIA, NOT REPORTED IN EITHER STUDY THOUGH IN THE MFU STUDY FEW WOMEN WERE ON INSULIN. PROBABLY NOT PARTICULARLY HIGH. INDUCTION OF LABOR INCREASED NO DIFFERENCE IN -- CAESAREAN WE DISCUSSED A LOT. NO DIFFERENCE THERE.g4r A SMALL REDUCTION HERE I'LL TALK ABOUT IN A SECOND. AND NEONATAL NURSERY ADMISSIONS WE HAVE ALSO BEEN DISCUSSING PROBABLY MEANING DIFFERENT THINGS IN DIFFERENT PLACES. NO DIFFERENCE IN THE MFMU TRIAL BUT SIGNIFICANT DIFFERENCE THERE. INCREASE IN RESPIRATORY DISTRESS SYNDROME. SO THOSE -- THIS IS IN THE CONTEXT OF CLINICAL TRIALS. PEOPLE REFER TO THIS BUT WHEN WE GO OUTSIDE THE CLINICAL TRIALS, TO THE WILD WORLD, NO DOUBT THE LABEL OF GESTATIONAL DIABETES DOES PERSUADE OBSTETRICIANS AND THEY ARE HUMAN AFTERALL THEY INTERVENE. THE STUDY PEOPLE HAVE TALKED ABOUT THIS, STUDY OF NAYLOR IN JANA A -- IN JAMA TEST AS LONG TIME AGO. NEGATIVE GGT. POSITIVE CHALLENGE POSITIVE BY THE COUSTAN CRITERIA AND NDD CRITERIA. THE OBSTETRICIANS WERE BLINDED TO THIS POSITIVE RESULT BUT THEY KNEW ABOUT THIS ONE. SO THESE PEOPLE WERE TREATED, AND BIRTH WEIGHS WERE HIGHER IN THE COUSTAN GROUP, AS ONE MIGHT EXPECT, EFFECTIVE TREATMENT BROUGHT LEVEL DOWN TO JUST OVER 11% BUT IT DID NOTHING TO THE CAESAREAN RATE SO WE MADE THE BABIES SMALLER BUT STILL OPERATED ON THEM. THIS IS A PAPER OF DR. DONOVAN FROM LAST YEAR, DOING SIMILAR THINGS LOOKING AT NON-DIABETIC WOMEN, WOMEN GESTATIONAL DIABETES LIFESTYLE, MANAGED WITH INSULIN. THE TREATMENT, LIFESTYLE OR GDM, PRODUCE MACROSOMEIAL RATE SIMILAR TO THE -- BUT IT DIDN'T STOP CESAREAN DELIVERIES AND NEONATAL INTENSIVE CARE SO TO ME THIS IS ABSOLUTELY CLEAR ONCE WE APPLY THE LABEL GESTATIONAL DIABETES, IS GOING TO AFFECT HOW PREGNANCIES ARE MANAGED. THE NEXT SPEAKER WILL BE ADDRESSING COST EFFECTIVENESS SO I'LL BE VERY QUICK THERE BUT COUPLE OF COST EFFECTIVE ANALYSES HERE, ONE OF VERNA WHICH PUT THE COST QUALITY AT OVER HALF A MILLION U.S. DOLLARS. AND ONLY BECOME COST EFFECTIVE IF WE COULD DEFINITELY REDUCE THE INCIDENCE OF TYPE 2 DIABETES IN THE MOTHERS, AND THEY CONCLUDED BEFORE ADOPTING AGGRESSIVE NEW CRITERIA, THERE'S A PRESSING NEED NOT ONLY TO CONFIRM EFFECTIVENESS IN IMPROVING PERINATAL OUTCOMES BUT ALSO DEVELOP AND TEST POST PARTUM STRATEGIES TO AMELIORATE RISK. THE OTHER ONE BY MISSION -- I THINK IT'S OUT NOW, IT WASN'T WHEN I MADE THAT SLIDE. THIS WAS BASED ON THE IDEA THE DATA IN THE MFU TRIAL PERHAPS WE COULD REDUCE CAESAREAN, THAT WOULD MAKE IT COST EFFECTIVE. IF WE WERE UNABLE TO REDUCE THE RATE IT CEASED TO BECOME COST EFFECTIVE. WHAT IS IT REALISTIC? IS IT REALISTIC TO EXPECT WE CAN REDUCE CAESAREAN RATES? I DOUBT IT. THIS IS WHAT'S HAPPENED TO CAESAREAN RATES IN YOUR COUNTRY AND MINE OVER THE LAST 40 YEARS OR SO. IT'S GONE UP FROM ABOUT FIVE FOLD IN THE US. WE'RE ABOUT 15 YEARS MIND BUT ON THE SAME TRACK. AGAINST THIS BACKGROUND PRESSURE TO DO CAESAREAN, I THINK IS TRUE FROM A NUMBER OF DIFFERENCE CAUSES, IT'S VERY DIFFICULT TO SEE FOR ME TO BELIEVE THAT DIAGNOSING MORE WOMEN WITH MILD GESTATIONAL DIABETES IS GOING TO REDUCE CAESAREAN. SO I MOVE TO THE LAST POINT TO MAKE, MEDICALIZATION PREGNANCY. MOST SPEAKERS TODAY HAVE BEEN MEN. MY WIFE WOULD HAVE HAD SOMETHING TO SAY ABOUT THAT. THE MEDICALIZATION, TRANSFORMATION OF NORMAL LIFE DEPEND ON PATHOLOGISTS. AND FOCUSES THE SOURCE ON THE INDIVIDUAL RATHER THAN SOCIAL ENVIRONMENT. PREGNANCY IS A TIME WHEN WOMEN ARE PARTICULARLY SENSITIVE TO HEALTH, VERY5 RECEPTIVE TO CHANGES AND SUGGESTIONS. VERY VULNERABLE TO STRESS, ANXIETY AND GUILT. I THINK THIS -- WE HAVE ALL EXPERIENCEDDED THIS IN DIABETES PREGNANCY CLINICS, WOMEN FEEL VULNERABLE ANXIOUS, GUILTY, VERY KEEN TO DO THINGS TO HELP. I THINK THEREFORE IT'S VERY IMPORTANT THAT WE HAVE GOOD EVIDENCE THAT WE ARE GOING TO HELP. PREVENTATIVE MEDICAL INTERVENTIONS IN IN ASIMILAR THE TOMATIC WOMEN MUST BE BASED ON HIGHEST LEVEL, ALSO ON OBSERVATIONAL DATA FOR MISGUIDED ATTEMPTS TO DO GOOD. I DON'T BELIEVE YET WE HAVE THAT EVIDENCE. SO WE CAN JUST SUMMARIZE STUFF TALKED ABOUT TODAY, WE CAN LOOK AT HARM AND HARM FROM THE MOTHER, HARM TO OFFSPRING, FETUS. AND LATER GROWNUP CHILD AND SOCIETAL HARM. WE TALKED ABOUT NUMBER OF CLINIC VISITS, NUMBER OF INTERVENTIONS OBSTETRIC AND MEDICAL POSSIBLE NEED FOR NEONATAL ADMISSION DEPENDING WHERE YOU ARE. I HAVEN'T TALKED ABOUT THIS BUT I THINK IT ISEN ISSUE WE NEED THE THINK ABOUT. WE TREAT MORE WOMEN. DO WE KNOW WHICH NEED TO BE TREATED? IF SOMEONE HAS A SLIGHTLY HIGHER BLOOD SUGAR BUT SMALL FETUS TO WE IMMEDIATE TO TREAT THEM? DO WE KNOW WE'RE GOING TO DO MORE GOOD THAN HARM? MEDICALIZATION OF PREGNANCY AND COSTS DISCUSSED LONG TERM OBVIOUSLY RISK OF REPEAT CAESAREAN ONCE YOU HAVE HAD ONE. I DON'T THINK WE KNOW HARM FOR OFFSPRING BUT I DON'T THINK THERE'S CLEAR EVIDENCE OF BENEFIT. I THINK THIS IS SOMETHING WE DO CONSIDER AND FOR THOSE OF US WHO LIVE IN A YEAR OF CONSTRAINT BUDGETS THAT'S PROBABLY ALL OF US. THIS IS GOING TO COST A LOT IF WE DIAGNOSE MORE PEOPLE. IN MY COUNTRY THAT MEANS RESOURCES HAVE TO BE DIVERTED FROM SOMEWHERE ELSE. AND EVOKE A ROBUST DEBATE WHERE THAT MIGHT COME FROM. SO I WOULD LIKE TO THANK YOU FOR YOUR ATTENTION. FLOSS [APPLAUSE] >> THANK YOU FOR MAKING THE SECOND TRIP. OUR NEXT SPEAKER IS AARON CAUGHEY, PROFESSOR AND CHAIR IN THE DEPARTMENT OF OBGYN OREGON HEALTH AND SCIENCE UNIVERSITY TALKING TO US ABOUT ECONOMIC IMPLICATIONS OF ALTERING GDM DIAGNOSTIC CRITERIA. >> THANK YOU, DR. VAN DORSTEN AND THE PLANNING COMMITTEE. FIRST HURRICANE SANDY BUT THE RECENT SEQUESTRATION A LOT OF THINGS THIS MONTH ARE GOING TO BE CANCELED, SPECTACULAR YOU'RE GOING TO BE ABLE TO CONTINUE ON WITH THIS CONFERENCE. GOT IT. THANK YOU SO MUCH. SO I WILL SAY THAT I DO HAVE ONE DISCLOSURE ANT BIAS. I RAN A DIABETES PRACTICE FOR A DECADE AT UCSF AND I WAS TAUGHT AS A RESIDENT THAT GESTATIONAL DIABETES IS A DIAGNOSIS LOOKING FOR A DISEASE BUT FOR TEN YEARS I TOOK CARE OF THESE WOMEN AND I HOPE THAT I ACTUALLY MADE SOME DIFFERENCE IN THEIR LIVES REALLY FOR THE PANEL TO DECIDE IF WE MAKE A DIFFERENCE WHEN WE TREAT WOMEN WITH GESTATIONAL DIABETES. THE OVERVIEW OF THE TALK AND THE CHALLENGE GIVEN TO ME TO DISCUSS ECONOMIC IMPLICATIONS OF A CHANGE. CHANGING FROM OUR TRADITIONAL WAY OF SCREENING FROM 50 TO 100-GRAM LOAD VERSUS SINGLE RECOMMENDED ISSG AND OTHERS SO I'LL DISCUSS ECONOMIC ANALYSES AND BROADLY HOW THEY'RE DONE. THEN SPEAK THE TO ECONOMIC ANALYSES JUST IN THIS QUESTION. THEN THINK ABOUT FUTURE DIRECTION AND NEEDS. I RECOGNIZE FOUR OUR FIVE MEMBERS OF THE PANEL PROBABLY ARE MORE EXPERT THAN I IN THIS AREA. DR. (INDISCERNIBLE), SO I RECOGNIZE EWE DON'T NEED MUCH EDUCATION IN THIS ARENA BUT OTHERS OF US DON'T QUITE UNDERSTAND AND ARE USING A TERM LIKE COST EFFECTIVENESS LOSELY. SO I WANT TO BE CLEAR ABOUT WHAT THESE TERMS MEAN. SO A COST ANALYSIS IS A SIMPLE ACCOUNTING OF HOW MUCH THINGS COST TO DO. IN HEALTHCARE, WE'RE NOT GOOD AT THIS. BECAUSE WE USE A LOT OF CHARGES, THEY'RE ONLY LOOSELY, AND SOMETIMES POORLY RELATED TO ACTUAL COST. SO THERE ACTUALLY ARE VERY FEW GOOD COST ANALYSES IN THIS FIELD OR MANY AREAS OF HEALTHCARE. I'LL POINT TO ONE OR TWO TODAY. SO WE'RE TRYING TO FIGURE OUT THE COST OF SOMETHING. COST BENEFIT ANALYSIS TAKES THE COST OF DOING SOMETHING PLUS COST OF THE HEALTHCARE RECEIVED ON THE OUTCOMES RELATED TO THOSE INTERVENTIONS, AND SUMS THEM UP AND SAYS THIS THING WOULD LEAD TO THIS KIND OF ECONOMIC IMPACT AS OPPOSED TO THIS THING. THAT IS A COST BENEFIT THIS IS WHAT YOU'RE DOING IF YOU WANT TO START A BUSINESS. IF I START A BUSINESS AND SPEND SOME MONEY, WILL I GET A RETURN ON DOING THOSE THINGS AND WHAT'S THAT SUM AND WHAT'S THE DIFFERENCIAL? WE DON'T USUALLY MAKE DECISIONS IN HEALTHCARE THAT WAY. I KNOW WE ALL EMBRACE THE TRIPLE AIM AND WE WANT TO BELIEVE BY DOING SOME STUFF WE'LL SAVE SOME MONEY. WE'LL TALK LATER, THAT'S VERY, VERY LITTLE OF HEALTHCARE. MOST HEALTHCARE COSTS MONEY. IF I'M GOING TO SPEND MONEY ON SOMETHING AM I GOING TO GET SOMETHING BACK I WANT FOR IT. SAY YOU'RE GOING TO NORDSTROM TO BUY SHOES. YOU DON'T USUALLY EXPECT MONEY BACK. YOU'RE GOING TO GET SOMETHING BACK, A PAIR OF SHOES. AND YOU DECIDE WHETHER IT'S COST EFFECTIVE. A COST UTILITY ANALYSIS SUBSET WHERE WE TRY TO COMPARE DIFFERENT AREAS OF HEALTHCARE WE WANT THE SAME UNIT IN THE DENOMINATOR, WE USE QUALITY ADJUSTED LIFE YEARS WHICH ARE FUZZY TO MEASURE TO SAY THE LEAST. BUT WE DO OUR BEST. SO COST ANALYSES, FIGURING THE COST OF SOMETHING AND WE WANT TO TRY COST GENERAL LANE NOT CHARGES. SO THINKING ABOUT GESTATIONAL DIABETES, THE COSTS INVOLVED, A NUMBER OF SPEAKERS MENTIONED THESE TODAY, THINGS LIKE COUNSELING SESSION. THEY SEE MAYBE A LITTLE MORE DOCTOR TIME, MORE NURSING TIME, HOPEFULLY TIME WITH NUTRITIONIST. THAT'S A DIFFERENT COST OF LABORATORY TESTS. DIFFERENT WE WHETHER YOU DO 50-GRAM TEST FIRST AND THEN YOU DO THE 100-GRAM SCREEN VERSUS A SINGLE TEST. IT'S DIFFERENT WHETHER YOU DO ONE HOUR TEST, FASTING ONE AND TWO. PARTICIPANTS TIMES SO THESE COSTS ARE NOT COUNTED BY INSURANCE COMPANIES OR THE HOSPITALS. BUT FROM A SOCIETAL PERSPECTIVE THESE THINGS MATTER TO OUR PATIENTS. WHETHER THEY HAVE TO GET UP FASTING AND COME AND GET FASTING BLOOD SUGAR, THAT'S A DIFFERENT COST, IT'S A CERTAIN TIME OF DAY YOU HAVE TO COME FOR IT, WHETHER YOU COME ONCE OR TWICE. IF YOU THE A SCREENING TEST YOU HAVE TO COME BACK. WHETHER YOU HAVE TO HANG FOR THROW HOURS OR COME ONCE, ALL THESE ARE DIFFERENT AMOUNTS OF TIME. MED MEDICAL THERAPY. ONCE WE DIAGNOSE SOMEBODY WE'RE GOING TO DO SOME STUFF. THAT'S THE INTERACTION WE HAVE AS DOCTORS, WE TALKED ABOUT THE PLUS KNIFE VISIT AND PLUS 2 VISITS, MORE DOCTOR TIME AND VISIT TIME BUT ALSO WHETHER WE USE AGENTS. THEY'RE RELATIVELY INEXPENSIVE BUT THEY HAVE COSTS. TRANSPORTATION, PATIENTS GOT TO GET TO AND FROM PLACES. THEN THERE'S DOWNSTREAM COSTS, THESE ARE HARD TO ESTIMATE BUT THESE ARE THINGS WE'RE MENTIONING IF YOU SAY GOSH, THERE'S IMPACT ON RATE OF SHOULDER DISTOTIA, WHAT'S THE COST, IF THERE'S FEWER CESAREAN DELIVERIES WHAT ARE THE COSTS OF THOSE THING? EVEN HARDER WHICH ERICA -- DR. WERNER PUT IN HER MODEL HOW DO WE FIGURE OUT WHAT THE IMPACT AND COSTS OF ON A WOMAN WHO GETS DIAGNOSED WITH GDN NOW AND SOMEHOW GIVES IMPACT TO HER PROBABILITY OF BEING MANAGED WITH TYPE 2 DIABETES DOWNSTREAM? DECISIONS LEVEL 1, 2, 3, LEVEL 1 FAMILY, LEVEL 2 PRACTICE LEVEL 3 SOCIETAL LEVEL, THAT SHOULD BE SOCIETAL COSTS. -- SOCIETAL COSTS. WE NEED TO BE AWARE OF PERSPECTIVES OF YOU ARE PARENTS. IF I SAY YOU NEED INSULIN IN MY STATE THAT'S NOT COVERED BY MEDICAID AND COSTS HUNDREDS OF DOLLARS A MONTH OUT OF POCKET. THEY'RE NOT GOING TO PAY THAT. SO WE HAVE TO FIGURE OUT, WE USE REGULAR INSULIN. CAN YOU IMAGINE REGULAR INSULIN. WHEN WAS THE LAST TIME YOU -- EARLY 1990? IT'S CRAZY. BUT WE HAVE TO DO THAT BECAUSE THEY CAN GET THAT MUCH CHEAPER. PAYER PERSPECTIVE, WHO IS PAYING FOR THINGS MATTERS BECAUSE THEY WILL CHOOSE NOT TO REIMBURSE. SO HERE IS AN EXAMPLE, REMEMBER THE COSTS WE TALK ABOUT COUNSELING SESSIONS, WHO WOULD BEAR THOSE COSTS? FOR COUNSELING SESSIONS THE INSURANCE COSTS BEAR SOME COSTS MAYBE ALL, PROBABLY NOT MAYBE ALL. THE INDIVIDUALINGS BEAR SOME COSTS. SO THEY HAVE COTO COME AND SIT AND BE TALKED TO. THAT'S TIME OUT OF THEIR DAY. A AS A SOCIETY WE ENCOMPASS ALL THE COSTS. AS A SOCIETY WE SHOULD BE ABLE TO PICK UP ALL THEst COST. TRANSPORTATION, INSURANCE COMPANY DOESN'T PAY FOR THAT BUT THE INDIVIDUALS PAY FOR THEIR EXTRA TRIP IN THEIR CAR OR WHATEVER IT MIGHT BE. SO THERE HAS BEEN AN RCT COST MINIMIZATION BY DR. MELTSER PUBLISHED A FEW YEARS AGO IN THE BRITISH JOURNAL. IN THIS STUDY THEY DEMONSTRATED THE LOWEST -- GREATEST COSTS WERE GROUP 3, THE SINGLE 75-GRAM LOAD, WITH A COUPLE OF HOURS. THAT WAS THE MOST EXPENSIVE. THIS WAS JUST TO MAKE THE DIAGNOSIS. THEY DIDN'T TRY TO FIGURE DOWNSTREAM THINGS BUT THEY DID A NICE JOB MEASURING COSTS IN THE STUDY. SO SEEMS HIKE IT WILL COST MORE MONEY IF WE WANT TO CHANGE. GROUP 2, NOBODY HAS GROUP 2, THAT WAS LEAST EXPENSIVE, AT LEAST IN THIS COUNTRY, 50 AND 75. AND THIS WAS THE MILLION DOLLAR ONE. SO MARGINALLY MORE EXPENSIVE TO DO GROUP 3 WHAT WE'RE TALKING ABOUT. COST BENEFIT ANALYSIS, THE COSTS NOT JUST DOING THE THING BUT ALSO WHAT YOU'RE GOING TO GET FROM IT, COST, DOWNSTREAM COSTS. THERE'S SEVERAL COST EFFECTIVENESS ANALYSES THAT HAVE COSTS OF THE SEQUENTIAL TEST AND SINGLE TEST. AND DR. NICHOLSON STUDY IN SINGLE LOAD TEST THAT WAS THE WHO CRITERIA SO IT WAS ANT IDPSG, SO NOT PERFECT BUT YOU GET THE SENSE. IT WILL BE A LITTLE MORE EXPENSIVE. IN DR. WERNER STUDY ALSO MORE EXPENSIVE AND IN OUR STUDY ALSO MORE EXPENSIVE SO IT WILL COST MORE MONEY THAT SEEMS REASONABLE. THAT ISN'T ALWAYS THE CASE, IF YOU'RE GIVING VACCINATIONS YOU GIVE MONEY BACK. RIGHT? BUT TREATING GESTATIONAL DIABETES IT DOES APPEAR IT WILL COST MONEY. SO IS IT WORTH IT? THAT GETS COST EFFECTIVENESS OR UTILITY ANALYSIS. THIS IS REALLY MATTER. WHEN YOU'RE MAKING POLICY DECISIONS, IT MATTERS. SHOULD WE SPEND THE MONEY, WILL WE GET RETURN ON OUR INVESTMENT. SO I DRIVE THIS VEHICLE, THIS IS A MINI VAN FOR THOSE NOT ACQUAINTED. I HAVE A LOT OF CHILDREN SO I HAVE TO FIT THEM IN MY MINI VAN. I'M HAPPY WITH THIS CAR, WE PAID ABOUT $35,000 FOR IT. GOOD FRIEND WHO DRIVES THIS CAR. THIS IS A NICE CAR BUT THIS CAR COSTS MORE THAN MY CAR. IT COSTS I THINK NOT COST BENEFICIAL. IT'S LIKE $105,000 VERSUS $35,000, THERE'S NOT COST BENEFICIAL. BECAUSE WE DONE GET ANYTHING BACK, IT JUST COSTS MONEY. BUT THERE ARE 25,000 VEHICLES SOLD EVERY DAY IN THE UNITED STATES, ARE ALL THESE PEOPLE CRAZY? MAYBE. BUT I WOULD SUGGEST TO THOSE INDIVIDUALS IT'S COST EFFECTIVE. THEY'RE GETTING RETURN WORTH THE MONEY THEY'RE SPENDING IS THAT'S WHAT COST EFFECTIVE AND EWE UNTIL I ANALYSES ARE ABOUT. WHEY TO THEM? RESOURCE ALLOCATIONS IS A REALITY, WE'RE NOT GIVING MONEY BACK FOR EVERYTHING WE PUT IN, WE'LL GET STUFF AND WE HAVE TO FIGURE OUT WHAT STUFF WE'RE GOING TO GET. THE DOLLARS WE SPENT ON ONE INTERVENTION COULD BE SPENT ELSEWHERE. WELCOME PUT ON MORE CONFERENCES LIKE THESE IF WE DECIDE NOT TO EXPAND. PROBABLY A FEW HUNDRED MILLION DOLLARS. WE CAN FUND MORE RESEARCH. WOULDN'T THAT BE NICE? WE DON'T LIKE TO SPEND MONEY ON THINGS THAT BARELY OR WERE NOT EVEN CERTAIN THEY WORK. WE LIKE TO USE HEALTHCARE DOLLARS TO DO THE MOST GOOD. THE COST EFFECTIVENESS OR UTILITY MEASURE OF EFFICIENCY, ALLOCATION, AS A CARD CARRYING ECONOMIST, I CARE LESS ABOUT MONEY THAN EFFICIENT ALLOCATION OF RESOURCES WHAT IS THE ADDED HEALTH BENEFITS FOR EACH IDAL DOLLAR, INCREMENTAL COMPARISON OUR FRAMEWORK IS THIS. COST THIS WAY AN EFFECTIVENESS THIS WAY. YOU CARE ABOUT THIS REALM WHERE THINGS COST MORE AND YOU GET MORE STUFF. IF IT COSTS LESS, IF IT COSTS MORE AND GIVES YOU WORST STUFF WHY WOULD YOU DO IT, RIGHT? IF YOU COST MORE AN IT GIVES YOU MORE STUFF, COSTS LESS GIVES YOU MORE STUFF THAT'S TRIPLE AIM. COST SAVING, BETTER CALL, BETTER OUTCOMES DO ALL THAT STUFF. DO AS MUCH OF THAT AS YOU CAN. NOT THAT INTERESTING FROM A COST EFFECTIVENESS P STANDPOINT. I'LL GIVE YOU $100 TO TAKE THIS PORSCH OFF MY HANDS. YOU TAKE A DOZEN OF THEM, RIGHT? IS THE MONEY I SPEND WORTH THE EXTRA STUFF I'M GOINGy. SO INCREMENTAL COMPARISON, CHANGE IN COSTS OVER THE CHANGE IN OUTCOMES. SO WE'RE THINKING WHETHER OR NOT WE SHOULD EXPAND DIAGNOSIS. WHETHER WE SHOULD DO -- LOWER THE THRESHOLDS. DR. COUSTAN FRAMED IT ELEGANTLY, IT'S ANT SHOULD WE TREAT WITH ONE ELEVATED VALUE. WE HAVE BEEN IN THE SPACE WITH SLIGHTLY LOWER VALUES. THAT'S ONLY A MILD LOWER. IT DOES SEEM COST EFFECTIVE TO TREAT WOMEN WITH MILD GESTATIONAL DIABETES BROADLY. THIS IS A STUDY WE PUBLISHED A COUPLE OF YEARS AGO, $20,000 FOR QUALITY ADJUSTED LIFE YEAR, A BASIC THRESHOLD WHEN UTILIZES IN THE U.S. IS AROUND 100,000 FOR QUALITY. TO BE FAIR IN THE UK WHICH DOES STUDIES BEAR THAN WE DO, BECAUSE THEY USE THEM FOR POLICY, THEY USE 20,000 FOR QUALITY. CONSIDERED MARGEALLY OR ALMOST NOT COST EFFECTIVE AND THEY CHOOSE NOT TO TREAT THESE PATIENTS. MILD GDM THIS IS A WERNER STUDY MENTIONED A NUMBER OF TIMES, MARCH I BELIEVE MARCH 2012. AND THEY CONSIDER CONSIDERED THE LONG TERM OUTCOMES. IN DOING SO, LET ME POINT OUT THE DIFFERENCE BETWEEN AVERAGE COST EFFECTIVENESS AND INCREMENTAL COST EFFECTIVENESS. SO ARM 2, THAT'S WHAT WE'RE DOING CURRENTLY, 50 AND 100-GRAMS, ARM 3 WAS 75-GRAM (INDISCERNIBLE) SO THE AVERAGE COST SEEMS INCREDIBLY COST EFFECTIVE. WE SHOULD DO IT ALL, BUT THAT DOESN'T MAKE SENSE. WE ALREADY GET THIS BUT H WE CARE ABOUT IS THE DIFFERENCE, THE INCREMENTAL COST EFFECTIVENESS. THE INCREMENTAL COST EFFECTIVENESS IS ALSO AROUND $20,000 QUALITY STUDY. BUT AS POINTED OUT, THAT'S INCLUDING APPROXIMATE ASSUMPTION THERE'S MATERNAL BENEFITS BENEFITS FROM BEING DIAGNOSED DOWNSTREAM GESTATIONAL DIABETES. WHEN THEY EXCLUDED THOSE YOU GET TO INCREMENTAL COST EFFECTIVENESS OF $565,000 FOR QUALITY. TO BE FAIR, THAT'S NOT COMPARED BETWEEN STRATEGY 3 AND STRATEGY 2, THAT'S STRATEGY 3 DOING NOTHING THAT'S NO SCREENING WHATSOEVER. SO WHAT THAT WOULD SUGGEST, I DON'T KNOW IF THE PANEL WILL BE THIS RADICAL BUT THAT SUGGESTS FROM AN ECONOMIC STANDPOINT THAT IF YOU DON'T BELIEVE ANY DOWNSTREAM BENEFITS YOU SHOULDN'T SCREEN ANYONE. AS DR. COUSTAN POINTED OUT THAT HIGH RISK POPULATION 85 TO 95 PERCENT SO IT'S A LITTLE CONFUSING. IN A MODEL WE BUILT, LOOKING AT EXACT QUESTION, THE NEW IDPSG GUIDELINES WE FOUND IT NOW 61,000. SO REMEMBER OUR MILD GROUP WAS 20,000 FOR QUALITY, IF WE CARVE OUT NEW PATIENTS IT WOULD BE 61,000 FOR QUALITY. IF YOU USE 100,000 THAT'S COST EFFECTIVE, 50,000 THAT'S MARGINAL. WHETHER IT'S WORTH THOSE ADDITIONAL DOLLARS. WE DID NOT ASSUME DOWNSTREAM BANG FOR YOUR BUCK. IF YOU BELIEVE -- AND YES IT'S TRUE YOU'LL GET 40% OF THESE WOMEN SCREENED AND GOT DIAGNOSED WITH TYPE 2 DIABETES, BUT SOME WILL. SOME WILL GET SOME BENEFIT. BUT IT'S HARD TO QUANTITATE. I APPRECIATE, I THINK IT WAS THE VERY OPTIMISTIC VIEW I ECHO AS WELL. WE HAVE NOT DONE A GOOD JOB TO THIS POINT. THERE'S NO REASON TO THINK WITH INCREASING ELECTRONIC MEDICAL RECORDS, INCREASING INTEGRATION OF HEALTH SYSTEMS WE MIGHT BE ABLE TO FIGURE THIS OUT. PROVIDE CARE TO WOMEN AFTER PREGNANCY. THAT'S WHAT THE ACA IS SUPPOSED TO HELP US DO. SO NO REASON TO THINK THAT ISN'T POSSIBLE IN THE FUTURE. BUT IT IS ON OPTIMISTIC. SO SHOULD WE TREAT ALL THESE WOMEN, MARGINALLY COST EFFECTIVE. WHY WOULD THE RATE OF POPULATION TRIPLE IN TERMS OF GESTATIONAL DIABETES? THAT DOESN'T MAKE SENSE. IS THAT POSSIBLE? MAYBE IT'S SOME RAPID EVOLUTION, MAYBE THAT'S WHAT'S GOING ON, I WOULD SUGGEST NO, IT'S NOT BUT ACTUALLY WHAT WE HAVE SEEN IN OUR COUNTRY IN A RAPID PERIOD OF TIME, ONLY 20 YEARS IS GONE TO RATES LIKE THIS TO RATES LIKE THIS IN TERMS OF OBESITY, AND HERE REFLECTED IN DIABETES AND OBVIOUSLY DIABETES JUST FOLLOWS GESTATIONAL DIABETES BY A DECADE OR 15 YEARS. SO IT IT IS NOT CRAZY WE TREAT MORE WOMEN TODAY THAN PREVIOUSLY. SO I WAS ASKED BY CAROLYN, SHE SAID I WANT TO FIGURE OUT WHAT THIS IS GOING TO MEAN, I THINK BILL WILL DEAL WITH THE REALITY OF THE IMPLICATIONS. WHO -- WE HAVE TO DOUBLE THE SIZEL nrX– OF DIABETES CLINICS, WHO WILL SEE THESE PATIENTS, OBGYN, AND WHO WILL BE ABLE TO DO IT. SO I EMAILED COLLEAGUES UP AND DOWN THE COUNTRY TO FIND PLACES THEY WERE ACTUALLY MOVING. I FOUND A FEW DOING THIS. ALREADY DOING THIS IN BOSTON ONE PROGRAM. THEY'RE DOING THIS AT STANFORD AND UP AND DOWN THE STREETS THEY HAVE BEEN RECOMMENDING THIS. BUT IT WAS ACTUALLY UNABLE THE FINE ANYBODY TO GIVE DATA. SO LUCKILY AT OREGON SCIENCE UNIVERSITY ABOUT 12, 15 MONTHS AGO WE CONVENE AD PANEL TO THINK WHETHER WE SHOULD MOVE FORWARD BECAUSE THEY SAID NO, DON'T DO IT, WAIT FOR THE DATE. THERE IS A TRIAL, THE A CHOICE TRIAL DID STUDY WOMEN LOWER RISK AND HAD BENEFIT. IN MY STATE YOU CAN'T MEET WITH NUTRITIONIST UNLESS YOU HAVE A DIAGNOSIS OF GESTATIONAL DIABETES. CALIFORNIA EVERYBODY WITH MEDICAID GETS A KNEW TRYSTIST. IN OREGON YOU ONLY SEE IF YOU GET A DIAGNOSIS OF GESTATIONAL DIABETES. I THOUGHT IT'S REALLY USEFUL FOR PREM WOMEN TO SEE KNEW TRYSTISTS SO I THINK ETHICALLY I'M OKAY WITH OVERMEDICALLIZING, NOT TO DO STUFF TO THEM, BUT TO GET THEM TO MEET EXPERTS THAT HAVE EXPERTISE THAT I DO NOT HAVE, NUTRITIONISTS. SO WE DECIDED TO MOVE FORWARD. THIS IS WHAT WE ACCOMPLISHED SO FAR. THIS IS THE VERY MINIMAL DATA BUT IN THE FIRST SICK MONTHS OF 2012, JANUARY TO JUNE, WE HAD 968 WOMEN SCREENED IN THE OLD SCHOOL L WAY, 50 THEN 100, AND 5 DIAGNOSED WITH (INAUDIBLE) AND 5.6% RATE. IN THE SECOND HAFT OF YEAR THOUSAND SCREENED, 11.7% SO ABOUT A DOUBLING. I KNOW IT'S BEEN TALLED ABOUT MAYBE A TRIPLING. OUR RATES ARE RELATIVELY LOW COMPARED TO SOUTHERN CALIFORNIA, TO BE FAIR OUR POPULATION IS RELATIVELY HOMOGENOUS AND SKEWS CAUCASIAN, BMI IS SMALLER EN. STILL HIGHER THAN MISSISSIPPI 20 YEARS AGO BUT FOR THE COUNTRY IT'S SMALLER. IF YOU TRANSLATE TO THE U.S. THAT END UP COSTING $120 MILLION. THAT IS A LOW BENEFIT. COST ANALYSIS JUST THE COST, THE COSTS DO APPEAR GREATER BUT COST EFFECTIVENESS ANALYSIS WE WANT TO EXAMINE WHETHER WE GET GAIN FROM OUR INVESTMENT. THINK ABOUT CONSUMERISM, YOU GET SOMETHING FOR WHAT YOU SPEND. FROM TWO STUDIES APPEARS COST EFFECTIVE BUT YOU HAVE TO MAKE CERTAIN ASSUMPTIONS ABOUT IMPACT ON CESAREAN DELIVERY DOWNSTREAM. YOU HAVE TO MAKE ASSUMPTIONS, THEY SHOULD BE EXAMINED CLOSELY. FUTURE DIRECTION IS IMPORTANT. I APPRECIATE AS AN ECONOMIST BEING INVITEED TO THIS MEETING BECAUSE COSTS MATTER. I APPRECIATE BEING AIM 3A MOST PEOPLE'S GRANTS. WE'RE ALSO GOING TO LOOK AT COSTS. WE'RE HAPPY TO DO THAT. WE THINK COSTS MATTER. COSTS ARE GOING TO MATTER MORE AND MORE. WE NEED TO THINK AND MADE DECISIONS ON WHAT THINGS COST SO FUTURE DIRECTIONS, LOOK AT THOSE OUTCOME BUS WE NEED REAL OUTCOMES AN PREFERENCES WHAT WOMEN WANT IN THEIR UTILITIES. THANK YOU VERY MUCH. [APPLAUSE] >> THANKS, AARON. THE FINAL SPEAKER THIS AFTERNOON IS BILL BARTH, CHIEF MATERNAL FETAL MEDICINE AT THE MGH AND ASSOCIATE PROFESSOR OBSTETRICS GYNECOLOGY HARVARD MEDICAL SCHOOL. BILL. >> FOR THE OPPORTUNITY TO SPEAK OUTSIDE OF MY AREA OF EXPERTISE AFTER A DAY OF PEOPLE THAT SPENT DISTINGUISHED CAREERS IN THE FIELD I WOULD LIKE TO THANK CATHY, I FEEL A LITTLE BIT LIKE SOMEONE FROM OUTSIDE THE FAITH ASKED TO TRAVEL TO ROME AND CRITIQUE THE LORD'S PRAYER IN FRONT OF VATICAN. I AM A CLINICIAN, I THINK I GOT HERE BECAUSE I RECENTLY COMPLETED TOUR AS CHAIR OF THE COMMITTEE ON OB PRACTICE FOR ACOG, WAS THERE WHEN THE EMAIL BOXES STARTED FILLING UP AFTER THE IAD IPSG ISSUED RECOMMENDATIONS. I HAD TO TALK TO MEDIA, CLINICIANS, PRETTY SURE THAT'S WHAT GOT ME HERE SO FROM A PRACTICE IMPLICATIONS, PERSPECTIVE, I WOULD LIKE TO GO OVER SOME OF THE DAY TO DAY PRAGMATIC AND LOGISTICAL ISSUES OF SCREENING, TALK ABOUT IMPACT ON PRE-NATAL CARE AND IMPACT ON INTERVENTIONS LIKE SRI FOR INDUCTION AND CAESAREAN. MUCH YOU WILL HAVE HEARD TODAY. IN THE U.S. THE MOST COMMON IS THE 50-GRAM SCREEN, GENERALLY APPLIED UNIVERSEALLY, IT IMPORTANTLY CAN BE PERFORMED IN CONJUNCTION WITH PRE-NATAL VISIT FAING IS NOT REQUIRED. WHICH ENABLES THE TEST TO BE DONE IN MORNING CLINICS OR AFTERNOON CLINICS. SO FOLK WHOSE REFER AFTERNOON CLINICS CAN DO IT DONE. DEPENDING ON CUT OFF CHOSEN, 14 TO 25 REST e% REQUIRE GLUCOSE CHALLENGE TEST, THEY HAVE TO FAST FOR THREE DAY'S SPECIAL DIET FOR THREE DAYS TO MAKE SHOWER THEY GET ENOUGH CAR BUOY BOW HYDRATES THEN FAST OVERNIGHT AND THEY HAVE TO ARRIVE IN THE MORNING. AS CLINICIAN I MUST ADMIT THERE IS APPEAL TO THE SIMPLICITY OF A ONE STEP TEST. AS CLINIC ADMINISTRATOR THAT SOUNDS NICE BUT PATIENTS MUST ARRIVE AT SOME POINT IN THE MORNING FASTING. THOSE VISITS HAVE TO BE IN THE MORNING. THEY HAVE TO STAY TWO HOURS. AND SCREENING IN THE AFTERNOON MAY NOT BE AS EFFECTIVE OR SENSITIVE. WE HEARD THE 50-GRAM TEST PERFORMS VARIABLY OVER THE COURSE OF THE DAY. THIS IS DATA FROM N HAYNES 3 SHOWING A NON-PREGNANT POPULATION THAT PREVALENCE OF DIABETES DIAGNOSED WITH FASTING IS BASICALLY CUT IN HAUF BY THE AFTERNOON, PROBABLY DUE TO CHANGES IN CORTISOL. SO TIMING OF THE DAY HOW WE DEPLOY IN REGULAR OB CLINICS POTENTIALLY MAKES A DIFFERENCE. THERE'S NOT MUCH LABORATORY WORKLOAD, WHAT IS OUT THERE THOUGH IS NICE, FROM THE UNITED ARAB EMIRATES AS REFERRED TO EARLIER BUT THIS IS A CAP CERTIFIED LAB UNDER JOHNS HOPKINS, THEY LOOKED AT WHAT WAS REQUIRED TO TAKE CARE OF 1100 PATIENTS OVER THE COURSE OF THE YEAR AT THEIR HOSPITAL. THEY USED TIME BASED ACTIVITY ACCOUNTING WITH A WORKLOAD UNIT WHICH MEANT A MINUTE OF HANDS-ON TIME. OUR CURRENT PRACTICE WAS 28,000 COMPARES TO NEW ONE STEP WHICH WAS 18,000 BUT THAT DID NOT INCLUDE INCREASE IN THE PREVALENCE AND DID NOT INCLUDE THE NEEDTOR POSTPARTUM SCREENING. SO HAD THEY INCLUDED THE POSTPARTUM SCREENING I WOULD HAVE FOUGHT THIS NUMBER MORE CONFIDENTLY. SOMEBODY MENTIONED EARLIER FASTING BELOW A CERTAIN LOW LEVEL OR ABOVE A CERTAIN HIGH LEVEL, DON'T GIVE THE 75-GRAM AND YOU CAN DECREASE YOUR WORKLOAD. BUT BIGGEST PRACTICE IMPLICATIONS COME FROM CHANGE IN PREVALENCE THAT WE HAVE HEARD ABOUT PREPARING FOR THE TALK ONE COLLEAGUE REMINDED ME WHILE THERE IS GREAT DIFFERENCES, HETEROGENEITY AROUND THE COUNTRY, WITH WHAT PREVALENCE WOULD BE WITH NEW CRITERIA, MANY ARE CENTERED IN AREAS THAT ARE HAVE HIGHER RATES OF OBESITY, ETHNIC RACIAL MICS THAT REFLECT UNDERSERVED POPULATION. SO WHEN WE TALK ABOUT THESE NEW GUIDELINES THEY ARE GOING TO IMPACT POTENTIALLY UNDERSERVED AREAS MORE THAN AREAS THAT ARE PERHAPS A BIT MORE AFFLUENT. SO TO REALLY SUMMARIZE A LOT OF WHAT YOU HAVE HEARD ABOUT PRE-NATAL VISITS, I THINK IT'S HELPFUL TO WALK THROUGH WHAT IS BASICALLY ENGENDERED BY DIAGNOSIS OF GESTATIONAL DIABETES, ESPECIALLY NON-CLINICS IN THE ROOM. IF WE TAKE PATIENTS WHO HAVE NO GDM, EVERYBODY SHOULD HAVE NUTRITIONAL COUNSELING WITH DIETITIAN, THEY'RE GOING TO REQUIRE BLOOD GLUCOSE MONITORING BY THE PERSON IN THE CLINIC BUT LIKE IN OUR PRACTICE, WITH A NURSE OR DIABETES EDGE KAYTOR. EVERYBODY WILL HAVE ANTI-NATAL VISITS BUT THOSE WITH GESTATIONAL DIABETES REQUIRES ADDITIONAL ANTI-NATAL VISITS. DEPENDING ON DEGREE OF CONTROL SOUGHT, ANYWHERE FROM 25 TO 40% WILL ENUP ON MEDICATION, INSULIN VERSUS ORAL AGENTS AND WILL REQUIRE TEACHING FOR THAT. PATIENTS WILL REQUIRE ANTI-NATAL FETAL TESTING. ANTI-NATAL FETAL TESTENING PATIENTS WHO REQUIRE MEDICAL THERAPY COMMON PRACTICE IS TO INSTITUTE ANTI-PARTUM FETAL TESTING. SO THEY'RE GOING TO TO HAVE ANTI-PARTUM TESTING. SO HOW DO WE TAKE THE EXTRA WORK, THESE EXTRA EPISODES ENGENDERED BY DIAGNOSIS I HAVE GDM AND TRY TO FIGURE OUT WHAT WOULD BE THE IMPACT OF THE NEW CRITERIA, TO THE EXTENT THE TWO CLINICAL TRIALS WE HAVE HEARD ABOUT TODAY ARE SIMILAR ENOUGH THAT GROUP THAT WOULD BE DIAGNOSED WITH THE NEW RYE TIERIA, NOT CURRENTLY DIAGNOSED WITH TWO STEP SCREENING THE TRIAL STEPS CAN INFORM THEM. THIS IS THE CROWDER STUDY IN HERE, THREE MORE VISITS WITH THE CLINICIAN. ONE FOR ONE BECAUSE THEY'RE GOING TO GET DIETARY COUNSELING AND ALL GOING TO GET DIABETIC EDUCATION. TOTAL OF FIVE MORE VISITS. FROM DR. LANDON'S TRIAL THE NICHD TRIAL, TWO MORE PRE-NATAL CARE VISITS. JUST BACK OF THE ENVELOPE VERY CRUDE, VERY ROUGH, ASSUMING 4 MILLION BIRTHS PER YEAR, THIS WOULD BE A HALF MILLION OR MORE PATIENT EDUCATION VISITS REALLY PROBABLY CLOSE TO A MILLION IF YOU DO THE TWO VISITS THAT DIABETIC EDUCATION AND DIETARY VISITS. PRE-NATAL VISITS, BETWEEN 5 AN 7 CONSERVATIVELY A MILLION MORE, PROBABLY MORE LIKE 2 MILLION MORE. ANTI-NATAL TESTING VISITS, DEPENDING WHAT ANTI-NATAL TESTING PROGRAM IS STARTED: THIS COULD BE ANYWHERE FROM WEEKLY UNTIL DELIVERY OR MORE COMMONLY TWICE WEEKLY UNTIL DELIVERY. THIS IS EXTREMELY CONSERVATIVE AND CAN GET TO 2, 3 MILLION MORE BY CHANGING THE CRITERIA. MORE IMPORTANTLY ARE THE ISSUES AROUND TIME OF LABOR AND DELIVERY AFFECTED BY CHANGING THE PREVALENCE THIS MUCH. AGAIN, WE CAN TURN TO THE TWO CLINICAL TRIALS. IT'S BEEN MENTIONED MULTIPLE TIMES TODAY THAT IN THE CROUDER TRIAL THERE WAS 30 TO 40% INCREASE IN UTILIZATION OF INDUCTION OF LABOR AND NO DIFFERENCE THE IN THE CAESAREAN RATE. NICHD TRIAL NO DIFFERENCE IN THE UTILIZATION OF INDUCTION OF LABOR. BUT ABOUT A 20% REDUCTION IN THE USE OF CESAREAN DELIVERY. WHY MIGHT THAT NOT REALLY ANSWER THE QUESTION? NEITHER STUDY WAS BLIND LIKE WE WANT THEM TO BE TO ANSWER THE QUESTION ABOUT THIS ADDITIONAL GROUP THAT WOULD BE DIAGNOSED. TO BE SPECIFIC, IN THE CROUTHER STUDY EVERYBODY HAD GLUCOSE INTOLERANCE PREGNANCY AND TWO HOUR BETWEEN 140 AND 188. IN THE TREATMENT GROUP EVERYBODY HAD GLUCOSE TOLERANCE PREGNANCY AN CONTROL GROUP DID NOT HAVE GESTATIONAL DIABETES BUT THEY KNEW ABOUT THIS. ADMIRABLY IN BOTH OF THESE STUDIES THERE WERE ATTEMPTS TO TRY TO BLIND IT AS BEST THEY COULD AND THE WAY THEY DID IT HERE WAS TO INCLUDE ONE IN FIVE PATIENT WHOSE HAD A COMPLETELY NORMAL 75-GRAM TEST. IN MARK'S TRIAL, ALL PATIENTS HAD A 50 GRAM BETWEEN 135 AND 200. THE TREATMENT GROUP ALL THEAL ALL HAD MILE GDM AND THE CONTROL GROUP FOLKS TAKEN CARE OF THEM NEW THEY MIGHT HAVE GDM. A NUMBER OF PATIENTS WERE INCLUDED AND FOLLOWED BY PROTOCOL WHO HAD COMPLETELY NORMAL GLUCOSE TOLERANCE TESTS BUT UNTIL AT ONE OF THOSE CENTERS YOU KNEW PATIENT WOULD HAVE WHY IS THAT IMPORTANT? THIS IS A PHOTO FROM THE LABOR DELIVERY BOARD SIGN OUT AT MY HOSPITAL AT 7 IN THE EVENING. THIS HAPPENS TWICE A DAY. THESE ARE CLINICS AROUND THE ROOM, FACULTY, FELLOW, FACULTY, RESIDENCE, THESE ARE THE CHARTS. EVERY PATIENT HAS GONE THROUGH IN DETAIL INCLUDING ANTI-NATAL HISTORY. FROM SITTING THROUGH THESE FOR YEARS SAYING SOMEBODY HAS GESTATIONAL DIABETES IS ONE THING, WE CAN'T GET THROUGH BOARD SIGN OUT WITH SOMEBODY SAYING WELL, THE PATIENT HAD A POSITIVE 50-GRAM TEST, BUT HAS A NEGATIVE THREE OUR GTT. IT INFLUENCES DECISION MAKING. BECAUSE EVERYBODY KNOWS WEIGHT FOR WEIGHT, THE DIAGNOSIS OF DIABETES, INCREASE IT IS THE LIKELIHOOD OF FEARED INTERPARTUM COMPLICATIONS, THAT'S SHOULDER DISTOTIA. THIS IS A VISCERAL FEAR WHEN TRYING TO DECIDE AM I GOING TO PUT A VACUUM ON OR FORCEPS ON, THAT UNAVOIDABLY INFLUENCES HUMAN DECISION MAKING. THE STUDY IS REFERRED TO TODAY. THIS IS THE NAYLOR STUDY. TO CLARIFY FOR THE PANEL MEMBERS, IN THE NAYLOR Sjky THESE PATIENTS WHO HAVE POSITIVE 50-GRAM DIAGNOSED BY NDDG CRITERIA, CLINICIANS KNEW THAT THEY HAD GESTATIONAL DIABETES. THESE PATIENTS HAD A POSITIVE 50-GRAM AND DIDN'T HAVE BY THIS CRITERIA BUT DID BY THE CARPENTER AND COUSTAN CRITERIA. CLINICS DIDN'T KNOW THESE PATIENTS HAD GDM. KNOWING AND TREATING FOR GDM REDUCED THE LIKELIHOOD OF INFANT OVER 4,000-GRAMS SUBSTANTIALLY. REDUCED LIKELIHOOD OF 45-GRAMS SUBSTANTIALLY BUT DID NOT IMPACT THE CAESAREAN RATE. IN FACT IT WAS A LITTLE HIGHER AND ADJUSTED ANALYSES THE FACTOR OF DIAGNOSE KNOWS IS, KNOWING THAT WAS FACTOR OF TWO. THE DIAGNOSIS OF GDM SHIFTS OBSTETRICAL PRACTICE STYLE, A HYPOTHESIS MOTIVATED BY EVIDENCE THAT OPERATOR DISCRETION IS AN IMPORTANT REVERSIBLE DETERMINANT OF CESAREAN DELIVERY. TO SUMMARIZE, WHAT QUESTION SAY ABOUT PRACTICE IMPLICATIONS OF ADDITIONAL 11%? WHAT HAPPENS TO THEM? I THINK UNTIL WE INCLUDE POSTPARTUM SCREENING AND PREVALENCE, IMPACT ON LABORATORY WORKLOAD IS UNKNOWN. EDUCATION VISITS NECESSARILY GO UP PRE-NATAL VISITS GO UP, ANTI-NATAL FETAL TESTING VISITS GO UP DRAMATICALLY. INDUCTION OF LABOR IS NOT CLEAR, I AGREE WITH MARK'S STATEMENTS THAT UNTIL WE HAVE TRULY BLINDED STUDIES, WE DON'T KNOW WHAT THE IMPACT WOULD BE ON THE CAESAREAN RATE OF ADOPTING THE NEW CRITERIA. IN CONCLUSION, UNLESS ACCOMPANYD BY SIGNIFICANT CHANGES IN THE WAY WE CARE FOR PATIENTS, THE DRAMATICKEN CREASE IN PREVALENCE ASSOCIATED WITH NEW CRITERIA HAS THE POTENTIAL FOR MAJOR IMPLICATIONS IN PRACTICE. SPECIFICALLY INCREASES IN CLINIC VISITS, ANTI-PARTUM FETAL TESTING AND INDUCTION OF LABOR AND CESAREAN DELIVERY. BUT TO BE FAIR, IF THE IMPROVEMENTS IN NEWBORN OUTCOMES SEEN IN THE TREATMENT TRIALS WITH LESSER DEGREES OF DIABETES, IF THOSE ARE ACCOMPLISHED WITH MORE SELECTED USE OF INTERVENTION SUCH AS TESTING INDUCTION OF LABOR AND CESAREAN DELIVERY THE INCREASE AND PREVALENCE ADOPTING NEW CRITERIA MAKES MORE SENSE, WITH ONLY WAY TO INFORM WITH RANDOMIZED CLINICAL TRIALS, MATERNAL AND NEWBORN OUTCOMES WHERE THE PATIENTS ARE IDENTIFYED TO PEOPLE TAKING CARE OF THEM WITH GDM OR NONE BY THE DIAGNOSTIC APPROACHES. [APPLAUSE] >> COULD WE HAVE THE LAST SPEAKERS COME UP TO THE PODIUM. QUESTIONS, GEORGE. >> THANK YOU TO THE SPEAKERS TO YOUR EXCELLENT PRESENTATIONS. I HAVE TO QUESTIONS FOR DR. CAUGHEY AND ONE TO DR. BARTH THEY'RE RELATED TO EACH OTHER. CERTAINLY PATIENT EXPERIENCE IS IMPORTANT. WE'RE GOING TO HEAR MORE ABOUT THAT TOMORROW. I WOULD LIKE TO KNOW MORE ABOUT HOW YOU MEASURE UTILITY TO DO THE QUALITY ADJUSTMENT FOR YOUR LIFE YEARS. AND IF YOU CAN TELL US A BUILT MORE ABOUT THAT. THE SECOND QUESTION IS WHAT PROBABILITY IN YOUR MODEL DROVE THE MODEL? IT -- AND I ASK THAT SPECIFICALLY IN THE CONTEXT OF DR. BARTH'S LAST SLIDE SAYING RANDOMIZED TRIAL WOULD HELP FIGURE THIS OUT BUT I'M A LITTLE BIT CURIOUS WHETHER OR NOT ANY DIFFERENCES WE MIGHT SEE IN A TRIAL, PLAUSIBLE TO SEE, WHETHER OR NOT THEY ULTIMATELY ARE POWERFUL ENOUGH OR DRIVING THE MODEL FOR US TO ULTIMATELY COME UP WITH DIFFERENT DECISION MAKING. >> THANK YOU, GEORGE, FOR YOUR EXCELLENT QUESTION. I EXPECTED NOTHING LESS FROM YOU. SUBTLE QUESTIONS. >> WHAT GEORGE IS ASKING SPECIFICALLY IS UTILITY FOR BOTH MODELS BY DR. ONO AS WELL AS DR. WERNER. THE UTILITIES FOR FOR BIG OUTCOMES. HAVING A CESAREAN DELIVERY, THOSE OUTCOMES, AND NOT FOR HAVING A POSITIVE DIAGNOSIS OF SOMETHING. OAR HAVING A BAD OUTCOME AND WONDERING IF I HAD A FALSE NEGATIVE. WE DON'T HAVE UTILITIES FOR THOSE THINKING SUCH AS MYRRH I DIDN'T MEAN WITH DOWN SYNDROME SCREENING ABOUT WE DIDN'T TRY TO USE -- BECAUSE IT'S A DIFFERENT TEST SO WE DON'T HAVE UTILITY FOR THAT. THAT'S AN IMPORTANT CONSIDERATION WHEN THINKING ABOUT EXPANDING A DIAGNOSIS BY 10% THAT'S A REASONABLE CONSIDERATION. BUT GOES BOTH WAYS. HAVING A BAD OUTCOME AND FALSE NEGATIVE AS WELL. IN TERMS OF PROBABILITY THAT DROVE THE MODEL; WE DIDN'T FIND HUGE CHANGES SO ASSAYS WERE ROBUST FOR SINGLE UNIVARIANT ANALYSES, AND THE OVERALL MONTE CARLO WAS ROBUST. HOWEVER, WE MADE ASSUMPTIONS ABOUT THE EFFECT FROM MARK AND ACHOICE TRIAL AND THOSE EFFECT SIZES MATTER. SO THAT'S WHEN BILL SUGGESTS WE KIND OF -- WE SHOULD USE MORE ICT DATA I SUPPORT WHAT HE HAS O THE SAY, WE NEED TO KNOW EFFECT SIZES AND HOW THEY WILL IMPACT THE OUTCOMES. THIS ENYOU CONSIDER THEM IN TOE TOE, WE CREATED A VARIABLE WHERE WE DECREASE THE BENEFIT ACROSS ALL SPECTRA TOGETHER, THEN YOU OF COURSE EVENTUALLY BECOMES NOT COST EFFECTIVE EDGING CLOSE TO ZERO EFFECT. >> I'M NOT SURE EXACTLY -- THE LAST PART OF YOUR QUESTION, IF I COULD REPHRASE IT, IS IT WORTH DOING A RANDOMIZED CONTROL TRIAL, IS THAT WHAT YOU'RE GETTING AT? >> LET ME ASK WHY I SAID THAT. AARON IS SAYING IF EFFECT SIZE YOU'RE GOING TO SEE IF THAT DRIVES THE MODEL THE QUESTION IS WHO WERE ANY RANDOMIZE TRIAL YOU DESIGN COULD BE POWERED ENOUGH TO SHOW DIFFERENCES IN EFFECT SIZES SUCH THAT AT THE END OF THE DAY, IF YOU DID -- WERE ABLE TO PROVE DIFFERENCES WHETHER THEY WOULD BE IMPLEMENTABLE AS A POLICY. >> I THINK EFFECTS FROM THE NICHD TRIAL WERE BIG ENOUGH TO GET MY ATTENTION AS CLINICIAN. 20% REDUCTION IN CESAREAN DELIVERIES GETS MY ATTENTION TODAY. REDUCTION IN MACROSOMEIA GETS MY ATEXT. BUT TO THE EXTENT -- ATTENTION.e1 BUT THE EXTENT THOSE ARE CONSTRUCTED IN THE TRIAL WITH VERY CLEAR GUIDANCE WHAT THE DO WITH THE INFORMATION IN THE PATIENT IN THE TRIAL WITH A GIVEN BIRTH WEIGHT OR GIVEN ESTIMATED FETAL WEIGHT, GIVEN DIAGNOSIS OF GESTATIONAL DIABETES OR NOT, YEAH. WE HAVE TO DO THE MATH TO SEE HOW BIG THE TRIAL WOULD BE NEEDED. I'M NOT A CLINICAL TRIAL ECONOMIST. >> THIS IS FOR DR. CAUGHEY, BACK TO MODELS YOU WERE DESCRIBING. YOU SHOWED TWO MODELS ONE BY WARNER ONE BY YOUR GROUP, COST EFFECTIVENESS OF 20K, 60K AND 5060K. THIS 60K WHICH CAME FROM YOURS, HOW DOES THAT COMPARE THE TWO WERNAR MODELS, DID IT HAVE THE LONG TERM BAKED IN OR NOT? THEN I HAVE A FOLLOW-UP DEPENDING ON YOUR ANSWER. >> E WE DIDN'T HAVE THE LONG TERM DOWN STREAM IMPACT ON WOMAN'S RISK OF DEVELOPING OR BEING TREAT RECORD DIAGNOSED EARLY WITH TYPE 2 DIABETES THAT LONG DOWNSTREAM EFFECT. DR. WARNER HAD SO WHY ARE WE DIFFERENT? >> THAT'S MY QUESTION. 60 AND 20 YOU COULD SAY IT'S JUST LIKE A FEW DIFFERENT BUT 60 AND MORE THAN 560. >> HER 560 PER QUALITY IS DOING IDDSG SCREENING VERSUS DOING NO SCREENING AT ALL. IT DOESN'T -- DOWN INCREMENTAL COMPARISON BETWEEN THE SECONDARY THING. WE COMPARE I IDPSG TOWARDS CURRENT STANDARD. >> WHAT I WOULD SAY IS 560, THAT SHOULD BE WORSE BECAUSE YOU'RE COMPARING YOU HAVE TAKEN OUT YOU HAVE SUCKED UP SOME OF THE COST EFFECT I'VE -- EFFECTIVENESS SO YOU EXPECT T IT TO BE HIGHER. WHAT DO YOU THINK I GUESS MY QUESTIONS IS ARE THE DIFFERENCES IN YOUR MODELS THAT ARE -- >> I THINK IT'S A GREAT QUESTION BUT WE OBVIOUSLY HER PAPER CAME OUT ABOUT TWO MONTHS AFTER WE PRESENTED OURS AND WE SUBMIT OUR MANUSCRIPT. THAT'S HAPPENED TO EVERYBODY, RIGHT? SO WE LOOKED CAREFULLY. THERE ARE SMALL ASUMS THAT ARE BUT THE BIG DRIVER IS THAT ALL OF OUR WOMEN WERE -- ARE GETTING SOME SCREEN AT BASELINE. THAT HAS COSTS IN IT. IN THE MELTSER STUDY THOSE COSTS OF SCREEN AND TRAVEL, LIKE 500 TO $1,000. SO ALL THE ARE GETTING A SCREEN. IN HER NOSE SCREENING ARM THOSE COSTS AREN'T THERE. AT $1,000 A POP WITH THE MODEST EFFECTS YOU GET FROM TREATING THESE PATIENTS, END UP BEING NOT COST EFFECTIVE. IN HER MODEL, AGAIN, I CAN'T POKE IT A EVERY LITTLE -- ADS COMPARED TO NOTHING. FROM THAT MODEL IT WOULD SUGGEST WE SHOULDN'T BE SCREENING FOR GESTATIONAL DIABETES WHATSOEVER. >> I WOULD LIKE TO THANK THE SPEAKERS FOR A VERY INFORMATIVE SET OF PRESENTATIONS. MY QUESTION RELATES TO THE ECONOMIC ANALYSES. SO RELATING TO THE SENSITIVITY ANALYSES, FOLLOWING UP ON WHICH KEY PARAMETERS THAT AFFECTED ROBUSTNESS AS A RESULT? AND WHO ARE MONTE CARLO ANALYSIS CONDUCTED ARE THERE RESULTS AVAILABLE THAT WOULD RELATE TO A QUASI CONFIDENCE INTERVAL FOR COST EFFECTIVENESS RATIO AND FOLLOWING FROM THAT POTENTIALLY MODEL UNCERTAINTY SO COULD YOU COMMENT ON HOW THOSE SHOULD DRIVE ATHAT WILLSIS AND BIGGEST GAPS INFORMATION ARE. >> THANK YOU FOR THIS WONKY QUESTION, I APPRECIATE IT. I APPRECIATE IT. GREAT QUESTION. IN TERMS OF MONTE CARLO STIMULATION IT IS TRUE THE SUBSEQUENT MODEL DID NOT -- WAS NOT COST EFFECTIVE GREATER THAN 95% OF THE TIME. THE ACCEPTABILITY CURVE AT $100,000 WAS NOT 95%, I BELIEVE IT WAS LIKE 65 PERCENT SO THAT SUGGESTS THAT IF YOU ARE -- HOLD THE MODEL TO THE CRITERIA THAT'S KIND OF P LESS THAN .05, IT WOULDN'T BE CONSIDERED COST EFFECTIVE AT LEVEL 100,000 QUALITY. 95% OF THE TIME OR GREATER. I CAN'T SPEAK FOR DR. WERNER OBJECTION MODEL BECAUSE I DONE RUN IT, I KNOW HER BUT -- I CAN TELL YOU IN OUR PRIOR MODEL WHICH IS LOOKING AT ALL GDN PATIENTS IT WOULD HAVE REACHED THAT SIGNIFICANCE. SO THEREABOUTS. MY RESPONSE THE GEORGE GETS TO NO SINGLE INPUT WAS A DRIVER WHEN YOU CONSIDER THE RANGE WHICH IS COMMON. THAT'S WHY WE THINK MULTI-VARIABLE SENSITIVITY ANAL SITS AND COST EFFECT ACTIVENESS IS SO IMPORTANT MONTY THE CAR LOW TWO WAYS. ONE A LOT OF SINGLE AREAS DON'T RUN IT SO I APOLOGIZE, OTHER THAN OVER EFFECT SIZE, VARIED OVERALL EFFECT SIZE, THAT MATTERS. FROM A CHOICE AND MFMU IT APPEARS COST EFFECTIVE. IF YOU DON'T GET THE BENEFITS, 50% LESS, IT'S NO LONGER COST EFFECTIVE. >> THERE SEEMS TO BE ONGOING QUESTIONS ABOUT WHAT ADMISSION TO THE NEONATAL NURSERY MEANS IN CHOICE. I WOULD LIKE TO READ TWO EMAILS THAT I JUST GOT. JEFFREY SAYS BABY WERE ADMITTED TO THE NURSERY AND IF THEY STAYED MORE THAN FOUR HOURS THAT'S AN ADMISSION SO IT DOES NOT MEAN ALL WERE ADMITTED TO -- CAROLYN SAYS (INAUDIBLE). MAJORITY WERE OBSERVATION OF TRANSITIONAL NURSERY SIGNIFICANTLY MORE INTERVENTION GROUP THAN ROUTINE CARE AND SHE SAYS WE INTERPRET THIS LABELING EFFECT AND NURSERY FOR OBSERVATION MORE LIKELY WHEN NO INFANT OF MOTHER (INAUDIBLE). SO WHEN PRACTITIONER KNOWS THAT THE PATIENT HAS THE DIAGNOSIS. DID THAT HELP? I WOULD LIKE TO ASK A QUESTION. THIS IS TO AARON. I FEEL LIKE I'M BEATING A DEAD HORSE. BUT SOUND LIKE MOST ANALYSIS COST EFFECTIVE ANALYSES HAVE BEEN IADPSG AS A PACKAGE. 75-GRAMS, ONE TIME POINT. IT'S 92, 180, 153. HAS ANYPLACE DONE SENSITIVITY ANALYSIS FOR PUT ANOTHER DATA THAT LOOKED AT DIFFERENT NUMBERS OF TIME POINTS AND CUT POINTS PER TIME. SEEMED TO BE A REALLY IMPORTANT QUESTION. WHEN DECIDING HOW TO SCREEN. >> THANK YOU, I THINK THAT'S A THOUGHTFUL QUESTION. SO WANDA NICHOLSON HAS A MODEL WHERE SHE LOOKED AT USING WHO CRITERIA, THE 140 AND ABOVE. THERE'S THAT MODEL. THAT'S IN A SINCE CRUDER THAN WHAT YOU'RE TALKING ABOUT WHAT ABOUT 155, REALLY GETTING READY -- UNFORTUNATELY WHAT WE DON'T HAVE IS ALL WE HAVE IS THE DATA FROM -- HOPPO, WE CAN DO IT BY GROUP SO WE HAVE GOT A MODEL THAT'S HOPO GROUP 5 AND WE HAVE A MODEL FOR HOPO GROUP 4. NOW IT'S LIKE $97,000 FOR QUALITY. TO GET BACK TO LISA'S QUESTION IT'S COST EFFECTIVE LIKE 36% OF THE TIME. AND HOPA GROUP 4 IS NOT COST EFFECTIVE. >> HOW ABOUT GROUP 6? THE DIRECTION I'M ALWAYS PUSHING. >> SO IT WOULD BE COST EFFECTIVE BUT IN OUR MODEL. >> MIC LUCAS. >> THANKS, -- MIKE LUCAS. >> THANKS, PETER. WHAT I WANT TO COMMENT ABOUT THE HEPO TRIAL, I THINK IT WAS A TRIAL DR. COUSTAN BECAUSE THERE WAS AN UNSTATED HYPOTHESIS THAT WAS TESTED AND CAME UP NEGATIVE, THAT IT'S SAFE NOT TO DO GLUCOSE TOLERANCE TESTING IN WOMEN WITH FASTING # 05 OR LESS, THE ANSWER WAS, IT IS. THE OTHER THING WE ADDRESSED THIS AFTERNOON, I'LL FEEL LIKE I'M IN AN ALTERNATE UNIVERSE AT HOME, THE CRITERIA, AS IT CHANGED IN A CLINIC ENVIRONMENT, FROM THE NDDG CRITERIA TO THE CARPENTER AND COUSTAN CRITERIA, THE RESIDENCE HAVE GOTTEN LESS MINDFUL, LESS ATTENTIVE, MORE FOCUSED ON GLYCEMIA, AND MUCH LESS EFFECTIVE AND MORE DANGEROUS THAN WHEY THAT DO. I HAVE SEEN HYPOGLYCEMIA, UNDERREPORTED, NOT REPORTED AND I HAVE SEEN CASES OF WOMEN FALLING OUT, AND SEEDING, AS -- SEIZING AND IT BEING HANDED OUT IN VERY DANGEROUS WAYS. AND THEY'RE ALSO BEING PARADOXICAL RESULTS. OF TREATMENT. THAT IS THAT WITHOUT ATTENTION CONTINUOUSLY TO EFFECTS OF FLY SEEMIA ON APPETITE -- GLYCEMIA ON APPETITE AND WEIGHT GAIN, INCREASED NUMBER OF LGA BABIES BECAUSE THE WOMEN IS NOW EATING FIVE TIMES A DAY, BECAUSE INCREASED TREATMENT HAS RESULTED IN DECREASED POST PRANGIALS BUT SHE'S EATING EVERY THREE HOURS. I DON'T KNOW, HAS ANYBODY ELSE HAVING PROBLEMS LIKE THIS? I FEEL LIKE IF WE WHEN TO THE DPSG CRITERIA, THAT MY RESIDENTS WOULD QUIT AND GOO TO A SURGICAL SUBSPECIALTY. >> IN THE BACK. >> DIANE GREETER. DIETITIAN AN DIABETES EDUCATOR. I WOULD LIKE THE COMMENT, FIRST FIRST OF ALL IT'S GREAT EVERYBODY IS SUPPORTIVE OF NUTRITION COUNSELING. A NUMBER OF PEOPLE HAVE SAID, WOMEN PREGNANT ARE OPEN AND RECEPTIVE TO MAKING CHANGES. SO IT IS A GREAT TIME TO GET THEIR ATTENTION. BUT I WANT TO SHARE IN OUR PRACTICE, WE DO GROUP EDUCATION, I DON'T KNOW IF THAT HAS COME UP IN THESE MODELS BUT AS YOU TALK ABOUT INCREASING VISITS, AND SERVICES BUT SUCCESS ANY HAVE DONE ANY TWO TO SIX PEOPLE IN A GROUP, NURSE AND DIETITIAN, HAVE BEEN EFFECTIVE. SO I WANT TO SAY THAT. AND ALSO JUST ALSO OFFER IN OUR PRACTICE IT'S NOT INCREASE IN VISITS BECAUSE ONE WEEK FOLLOW-UP IS WITH THE NURSE AND DIETITIAN SO THAT TAKES AWAY A VISIT FROM THE PRACTITIONER. AGAIN AS A DIETITIAN I'LL SAY DIETITIANS ARE PROBABLY VERY GOOD AT UNDERSTANDING WHEN NUTRITION THERAPY HAS MAXED OUT AND YOU NEED TO ACTUALLY ADD MEDICATION. AGAIN, I HAVE BEEN GREAT HERE. THANK YOU. >> I THINK I TRIED TO BE CAREFUL TO SAY AS CURRENTLY PRACTICED IN THE UNITED STATES, BUT CLEARLY THERE ARE NOVEL PRE-NATAL CARE GROUP VISITS, MEDICAL HOME KIND OF CONCEPT. BUT NOT A LOT OF PUBLISHED DATA FUELING THAT YET SO I TRY TO STICK WITH WHAT WE'RE DOING. >> I WILL ECHO BILL, BECAUSE WE CHANGED IT, AND OUR DIABETES CLINIC IS FLOODED. THE PRACTICAL NATURE WE HAVE BEEN ABLE TO MAINTAIN THE SAME NUMBER OF DOCTORS SO IT DOESN'T COST MORE SALARY TIME, DOCTORS GOING THROUGH THE ROOF, PATIENTS, IT'S CLOTTED SO PATIENTS ARE -- AND WE'RE HAVING NURSING TIME SO A MIDWIFE HERE SALLY IS GOING TO DEVELOP, EXPERT IN GROUP PRE-NATAL CARE WILL DEVELOP THE MODEL YOU'RE TALKING ABOUT. THERE'S PLACES AROUND THE COUNTRY THAT HAVE DONE THAT AS WELL. HOPEFULLY THOSE ARE WAYS TO REDUCE COSTS TO PROVIDE EXCELLENCE IN CARE. ISSUE OF ADDING FASTING BEEN PROBLEMATIC? >> YES. >> I GUESS THIS IS MORE FOR PRACTICING OBSTETRICIAN, ECONOMIST CAN CERTAINLY ADD TO THIS AS WELL. AND THIS GOES WITH WHAT YOU WERE JUST SAYING, WE HAVE MADE THE ASSUMPTION THAT IF WE COME UP WITH SOME CRITERIA THAT WILL DOUBLE THE NUMBER OF PEOPLE THAT WE HAVE WITH DIAGNOSIS WE'RE GOING TO DOUBLE COST AND DOUBLE WORK. WONDERING HOW REALISTIC THAT IS. TODAY REALISTICALLY, WITH THE CRITERIA YOU'RE USING, DO YOU SPEND AS MUCH TIME AND MONEY ON A WOMAN WITH MILD GDM WHOSE DIABETES IS EASILY CONTROLLED WITH DIET AND EXERCISE AND DOESN'T GAIN WEIGHT ON A WOMAN AT THE OTHER END OF THE OF THE SPECTRUM DIFFICULT TO CONTROL WITH INCREASING DOSES OF INSULIN AND DEVELOPS COMPLICATIONS? SHOULD WE BE LOOKING AT SOMETHING LESS THAN 50%? >> PROVIDE THE ESTIMATES I TRY THE TURN TOWARDS WHAT HAPPENED IN THE TRIALS TO FUEL THE NUMBER OF ENCOUNTERS BUT AS PRACTICING CLINICIAN DO I MANAGE THE EASILY CONTROLLED DIABETIC WITH FEWER VISITS THAN I DO THE DIFFICULT COMPLIANT PATIENT WITH OUT OF CONTROL? SURE, THAT LATTER PATIENT TAKES OUR -- MORE OF MY TIME. I'M MORE INCLINED FOR ANTI-NATAL FETAL TESTING, PROBABLY MORE ULTRASOUND. GOING TO SCHEDULE MORE CLINIC VISIT. THAT'S MY GUT AS A CLINICIAN. YES, I DO PRACTICE DIFFERENTLY DEPENDING ON HOW TO DO IT. >> THE NEW PATIENT WILL BE THE OTHER END. FOR THE MOST PART. >> GREAT QUESTION. I THINK THE ASSUMPTION AS BOTH HEALTH ECONOMIST BUT ALSO CARD CARRYING MEMBER OF OBGYN, I DO BOTH. SO I WILL SAY THAT THE ASSUMPTION IS THESE ADDITIONAL PATIENTS WE DIAGNOSE ARE MILDER THAN THE ONES ALREADY DIAGNOSED BUT I THINK DR. COUSTAN POINTED OUT WE'RE TALKING ABOUT A TWO POSITIVE VALUE TEST. SO YOU'RE NOT JUST ADDING THE MOST MILD PATIENTS OUR PRACTICE IN SAN FRANCISCO WHEN WE STARTED GIVING THE PATIENTS THE ONE ELEVATED VALUE, MAYBE ABOUT FIVE YEARS AGO, JUST A METER FOR A WEEK, JUST TO MAKE SURE TO GET STABILITY, WE FOUND THAT ABILITY A THIRD OF THE PATIENTS ENDED UP ON INSULIN. WE DON'T USE -- IT CAUSES DANGEROUS THINGS THE GENTLEMAN WAS TALKING ABOUT. IT'S A DANGEROUS MEDICATION, I CAN'T IMAGINE ANYBODY TO USE IT SO WE USE INSULIN AND OUR PATIENTS WERE HAPPY AND THEY DIDN'T BECOME HYPOGLYCEMIC. >> OTHER SIDE. >> MICHELLE (INAUDIBLE) FROM UCSD. I SAW EARLIER I THINK WE ALL SAW EARLIER THE GRAPH THAT SHOWED HOW LIFESTYLE MADE THE MOST IMPACT. GIVEN THAT, IS IT IT SHORTSIGHTED TO LOOK ONLY AT THE SHORT TERM EFFECTS OF WHAT'S WE'RE DOING WHEN WE DON'T HAVE THE DATA OR LONG TERM? WHEN I QUOTE PEOPLE, THIS IS YOUR INSTANT ANSWER YOUR CHANCE OF HAVING DIABETES IN FIVE YEARS PREGNANCY, I'M USING THE CARPENTER COUSTAN AND TALKING ABOUT PEOPLE WHO DID NOT HAVE THIS PROACTIVE COUPLING SO IMPORTANT ABOUT LIFESTYLE, DIET, EXERCISE AND MAINTAINING YOUR IDEAL BMI AND I THINK IF YOU LOCKET A THAT, IT'S VERY SHORTSIGHTED TO LOOK AT FINANCIAL IMPACT OF THE SHORT TERM. THAT'S AN EDITORIAL COMMENT. >> I WOULD AGREE, PROBLEM IS WE DON'T HAVE GOOD DATA. >> OTHER SIDE. >> (INDISCERNIBLE) FROM YALE. I JUST -- COUPLE OF THINGS THAT I WANTED TO MENTION, ONE WAS THAT IN THE 50-GRAM SCREEN, 175-GRAM TEST WE LOOKED AT COST, OVER HALF OF OUR POPULATION WERE PICKED ONE 50-GRAM SCREEN GREATER THAN 10.3 WHICH MEANT THEY DIDN'T COME BACK TO GLUCOSE TOLERANCE TEST SO WE SAVED MONEY THERE. WHICH ONE BE IF THE SCREEN WAS DEVELOPMENT WHETHER OR NOT THIS SAME CRITERIA WOULD BE MET IF CONCURRENTLY I CAN'T SHARE. THE OTHER THING I WOULD LIKE THE MENTION, BECAUSE IN CANADA WE SEEM TO HAVE THIS IMPAIRED GLUCOSE TOLERANCE LABEL, WE GIVE TO SOME PEOPLE WHEN ONE ABNORMAL VALUE IS THERE, THOSE PEOPLE GENERALLY GO TO SEE THE DIETITIAN, MAY OR MAY NOT HAVE SOME FURTHER GLUCOSE TESTING TO MAKE SURE SUGARS ARE STILL SAYING FINE, IF THEY PASS THAT THEY GO ON TO BE FOLLOWED NORMALLY. IF THEY DON'T, WE MEET THEM. AND I HAVE A FEELING SOMETHING LIKE THIS IS WHAT EVENTUALLY WILL HAVE TO HAPPEN IF WE GET BIGGER NUMBERS. THAT'S UP FOR COMMENT. >> HI. I'M SALLY HERSH, A NURSE MIDWIFE OREGON HEALTH UNIVERSITY WITH DR. CAUGHEY. OUR PRACTICE IS A SEPARATE -- CITY TRICKS PRACTICE THERE. THE PATIENTS ARE AFFECTD BY ADOPTING THE NEW CRITERIA BY THE IADPSG. INTERESTINGLY I WANTED TO COMMENT ABOUT OUR EXPERIENCE WITH CLINICIANS IMPLEMENTING THIS RYE TIERIA, I WOULD SAY OUR POPULATION HAS FAIRED WELL OF WOMEN LOOKING FOR GROUP CARE AN LOW INTERVENTION. WE WERE GONE FROM PEOPLE WHO WERE SOBBING, SCREAMED AT US FOR 15 MINUTES ON PHONE WHEN WE TOLD THEM THEY MISSED BY ONE POINT AND WE HAVE HAD EFFECT OF ELECTRONIC MEDICAL RECORD WHICH WOMEN RECEIVE RESULTS THROUGH THE ELECTRONIC MEDICAL RECORDS. THEY SEE WHAT THRESHOLDS WE'RE USING. AND HOW MUCH THEY MISSED IT BY. IN ADDITION, THEY'RE FAIRLY EDUCATED. IT'S NOT VERY EDUCATED, IF NOT HEALTHCARE PROFESSIONALS SO THEY GET THE FACT THAT THIS IS A NEW SCREENING CRITERIA WE'RE USING. AND THEY ARE UNHAPPY ABOUT IT. WE HAVE HAD WOMEN GOING TO OTHER HOSPITALS ACROSS THE CITY TO GET THE OLD CRITERIA, THE ONE HOUR GLUCOSE FOLLOWED BY THREE HOUR SO WIDE GAMUT OF EXPERIENCE WITH PATIENTS. AND I'M IN THE PROCESS OF COLLECTING DATA FROM JULY 1st UNTIL LAST WEEK, FEBRUARY 28th TO LOOK AT WHAT IT IS MEANT TO OUR PATIENT POPULATION, INTERESTED IN SHARING THAT WITH YOU. >> THANK YOU FOR SHARING THAT REAL LIFEG CRITERIA. ADDITIONAL FUNDS I AM FROM AND AM HOPING PART OF THE RECOMMENDATIONS OF THE CONSENSUS PANELS WILL COME OUT WITH WILL IDENTIFY AREAS IN CALIFORNIA CERTAINLY CENTRAL CALIFORNIA. IN THE BURDEN ACROSS THIS COUNTRY, AND I THINK AS WE GO FORWARD, IT'S EASY NOW AT 7% TO SAY GOSH, WE'RE DOING A GREAT JOB. WE REALLY ARE NOT. I AM THERE, YOU MAKE RECOMMENDATIONS FOR WHAT THIS WE MAY NEED, YOU'RE PILLING THEM OUT FAST BECAUSE AS YOU KNOW THE AREAS WHERE WE HAVE THE BIGGEST BURDENS UNFORTUNATELY ARE AREAS WITH THE LEAST RESOURS TO COPE. MUCH GOES STATE OF CALIFORNIA. WE OTHER STRUGGLING, WE JUST BEEN OUT OF BANKRUPTCY SO NOW THEY SAY WE'RE MOVING TO DIAGNOSTIC CRITERIA IN THE ABSENCE OF MOVING FORE. LET'S DO THIS. IT IS DISCONCERTING, AREAS, WHERE WILL IT COME FROM FOR RESOURCE POOR AREAS LIKE THIS? >> I DON'T KNOW. I'M PROBABLY NOT THE BEST -- I WAS AN AIR FORCE OBSTETRICIAN FOR 20 SOME ODD YEARS AND WE JUST ASKED TO PERFORM SINCERE VERY DIFFICULT QUESTION, AS I SHOWED WITH THE U.S. MAP, THE CENTERS WITH THE HIGHER PREVALENCE ARE CLEARLY THE UNDERSERVED WITH DIFFERENT RACIAL AND ETHNIC MIX, DIFFERENT RATES OF OBESITY. THE RESOURCE IMPLICATIONS WILL BE HARDER FELT IN THOSE CENTERS. >> I CERTAINLY DON'T HAVE ANSWERS OTHER THAN ONE OF THE IDEAS BEHIND HEALTHCARE REFORM IS ORDINARY CARE ORGANIZATIONS, RIGHT? THE IDEA THAT YOU COMBINE SOME VERTICAL FASHION, PAYER REIMBURSEMENT, HOSPITAL REIMBURSEMENT AND MEDICAID OR WILL LCAL MEDICAID ORGANIZATIONS SHOULD START THINKING ABOUT LONG TERM COSTS. THE THING IS IF YOU PREVENT SOMEONE FROM GOING ON TO DEVELOP TYPE 2 DIABETES THE, IT DOES LOWER LONG TERM COSTS. DO WE KNOW THE BENEFITS HOW MUCH, NO. O IT'S A MATTER OF SALESMANSHIP ON OUR SIDE TO CONVINCE POLICY MAKERS IF YOU PAID FOR THESE WOMEN NOW IN PREGNANCY, YOU WILL SAVE DOLLARS AN YOU HAVE TO BUILD A MODEL FOR PERFORMING, SELL THEM ON THE CONCEPT. AND GET THEM TO FUND. THERE'S NO ADDITIONAL RESOURCES. WE HAVE LOST DIGITAL RESOURCE AT THIS POINT SO IT'S HARD TO GET THE PEOPLE TAKEN CARE OF. >> (INDISCERNIBLE) WASHINGTON D. C. CXFC I HAVE A QUESTION ABOUT ASSUMPTIONS OF LONG TERM BENEFIT MATERNAL POSTPARTUM BENEFIT IN TERMS OF MAKING A DIAGNOSIS WITH EXPANDED CRITERIA. THE ASSUMPTION SEEMS TO BE WE'LL ONLY FIND WOMEN BASED UPON APPLYING CRITERIA 24 TO 28 WEEKS AND THEN INTERVENING OVER THE YEARS POST PARTUM INTERVENTION OR THROUGH TIGHTER CARDIOVASCULAR RISK FACTOR CONTROL. HOW MANY OF THOSE WOMEN WE WOULDN'T HAVE MADE A DIAGNOSIS AT 24 TO 28 WEEKS WOULD WE EVER HAVE TRIPPED OVER AND MADE A DIAGNOSIS BY THE TIME THEY LEAF HOSPITAL AFTER DELIVERY? THOSE WOMEN WOULDN'T HAVE INCREMENTAL BENEFIT LATER UNLESS YOU REALLY BELIEVED THOSE WEEKS OF TITER CONTROL IMPACT CARDIOVASCULAR HEALTH EIGHT YEARS LATER. >> GREAT QUESTION. AND I WILL SAY IN MY STATE, I KNOW THIS IS TRUE FOR CALIFORNIA, HALF THE WOMEN HAVE MEDICAID WHICH MEANS THEY HAVE NO HEALTHCARE. OR ACCESS TO HEALTHCARE. WHEN THEY ART PREGNANT. SO YOU CAN MAKE THE ASSUMPTION NONE WOULD BE TRIPPED OVER UNLESS THEY SHOWED UP IN SOME MILD (INDISCERNIBLE) TO BE FAIR. THE OTHER HALF OF THE‡J„ WOMEN, YOU'RE RIGHT. THEY HAVE INSURANCE. WE ASSUME THEY GET ANNUAL VISITS, THEY CROSS AN AGE THRESHOLD AND THEY GET KOREANED. BUT THEY WOULD GET, I REFER TO DON'S DATA BUT IT WAS DON'S THAT SHOWED THE NICE CURVE, MAYBE IT'S PAT CATALANO. WHERE IT GOES UP THE WHOLE POINT OF IS YOU GOT THIS OPPORTUNITY TO DIAGNOSE PATIENT EARLIER. AS MENTIONED BY NUTRITIONIST EARLIER PREGNANCY IS A TIME WHEN WOMEN WILL ACTUALLY CHANGE THEIR BEHAVIOR. SO I KNOW IF YOU'RE AN INTERNIST, SOMETHING ON THE ORDER OF FIVE PERCENT OF PATIENTS IN A YEAR IF YOU WORK HARD TO QUIT SMOKING. SO SOMETHING LIKE 50% WILL QUIT SMOKING. THEY MIGHT RESID VISE BUT WILL QUIT SMOKING. IN MY KYE BETTIC POPULATION, I'LL DEFER TO OTHERS TO TACK CARE OF EM WITH WOMEN WITH DIABETES. WHEN WE EXPLAIN THE DIET TO THEM THEY COME BACK IN A WEEK, 80% OR MORE ARE FOLLOWING THE DIABETES DIET. IF YOU DID THAT IN A REGULAR POPULATION, IT WOULD BE 5, 10% SO I DO THINK THERE'S A TEACHABLE MOMENT AND I THINK (INAUDIBLE) AL CAL POLYTALK IT IS TEACHABLE YEAR, WE DON'T HAVE REAL DATA BUT I DO THINK THAT VARIOUS POTENTIAL BENEFIT. >> SO MOVING ON WITH THAT THEORETIC BENEFIT ASIDE. PORNING TO THE QUESTION AT HAND, AND PERHAPS SUGGESTED WHAT DAVID PET'S QUESTION TO BILL BARTH YOUR DELIVERY VOLUME IN OREGON IS HALF WHAT MY DELIVERY VOLUME IS. YOUR ABILITY TO DOUBLE AND TAKE CARE OF THE FREQUENCY OF GESTATIONAL DIABETES IS DIFFERENT TASK AT HAND THAN IT WOULD BE IN MY DELIVERY SERVICE, YOU ARE BURSTING AT THE SEEMS SO DAVID'S QUESTION TO BILL, MAYBE CARE FOR THE MODEL OF GDM, IF YOU WILL, MIGHT BE A LITTLE BIT DIFFERENT. I THINK IT'S CRYSTAL CLEAR THAT IF WE'RE GOING TO INCREASE FREQUENCY OF GDM WE HAVE TO COME UP WITH A DIFFERENT NEW CARE MODEL FOR MILD GDM THAN ONE WE OTHER EMPLOYING. NO DOUBT ABOUT THAT. YOUR THOUGHTS. >> AGAIN, I THINK AS A CLINIC, CLINICS IN THE FIELD DEFAULT TO PROTOCOLS. THAT CLEAR SIMPLE GUIDANCE AN PROTOCOLS FORGIVEN DIAGNOSIS IS MUCH MORE DEPLOYABLE THAN A NUANCED SET OF GUIDELINES FOR THIS GDM PATIENT, FOR THIS GDM PATIENT AND I WORRY THAT EXPANDING THE DIAGNOSIS OR INCREASING THE PREVALENCE AS AN EFFECTIVE EXPANDING THE DIAGNOSIS WITHOUT SOME CHANGE WHAT WE DO WITH THOSE PATIENTS. THAT'S WHY I SAID IN THE SECOND TO LAST SLIDE, IF WE CAN CHANGE WHAT WE DO, WITH GESTATIONAL DIABETES THAT HASN'T BEEN TREATED, PERHAPS A WHOLE DIFFERENT QUESTION. RIGHT NOW WE DONE HAVE A PAIRED NUANCED CARED FOR DIABETES CARE CENTER MODEL AROUND THE COUNTRY. (OFF MIC) >> WHERE I PACK IT IS NOW I'M A PERINATOLOGIST, I COUNCIL FOR OBGYN, MIDWIVES AND WE PRACTICE ON A FEW OF THEM AND MANY OF THEM REFER PART OF THE CARE TO MEDICAL ENDOCRINOLOGIST TO A SECOND SET OF GUIDANCE AND GUIDELINES AND CONTROL GOALS AND IT'S NOT UNIFORM. >> MY NAME IS NEAL MURPHY, I'M A GENERAL OBGYN WITH THE INDIAN HEALTH SERVICE IN THE TRENCHES. WE SWITCHED TO THE NEW CRITERIA BACK IN AUGUST OF 2010 SOON AFTER THE CONSENSUS CONFERENCE AND WE ACTUALLY HAVEN'T SUNK THE SHIP. MOST ARE THE NEW THE ONES NEWLY DIAGNOSED WITH THE NEW SYSTEM ARE MILD. THEY DON'T NEED ANTI-NATAL TESTING, ANY AMOUNT OF ANTI-NATAL TESTING. WE HAVE MID LEVEL PRACTITIONERS, THEY HAVE PRACTICERS AND IT WORKED WELL, WE HAVE A GUIDELINE AND AND THEY FOLLOW THAT SO WE DON'T HAVE A GREAT DEAL OF PROBLEM WITH THE TESTING BUT THE ONE THING WE HAVE HAD, THIS I HATE TO BRING THIS UP, EACH TIME WE HAVE A SHOULDER DISTOTIA IT COSTS ABOUT 750,000 TO $850,000, IT'S QUITE EXPENSIVE. IT'S HARD TO BRING UP BUT IT'S A MEDICAL THING. I WAS WONDERING HOW IN YOUR MCANALYSIS HOW YOU DID THAT. >> GREAT QUESTION. WE DIDN'T INCORPORATE THE MALPRACTICE COSTS THERE ARE RESOURCES USED UP IN A LAWSUIT BUT IF IT COSTS YOU A MILLION DOLLARS THAT MILLION DOLLAR GOES TO THE ATTORNEY AND TO THE PATIENT. SO IT'S A COST SHIFT. THERE ARE SOME REAL COSTS, THERE'S A TRIAL. BUT COSTS ARE RELATIVELY MINUTE MALL IN A LAWSUIT TO SOCIETY. BIG TO YOU AN ME. AND BIG ON THE OTHER END TO THE LAWYER. SO WE DIDN'T INCORPORATE THOSE COSTS. >> MORE THAN JUST THE VISCERAL THING DR. BARTH MENTIONED, THEY WEREN'T EVEN THINGS LIKE MALPRACTICE OR SOME NEGLIGENCE, IT WAS JUST THE COST OF HAVING (INDISCERNIBLE) AND JUST HAVING THAT DIAGNOSIS ALONE SO JUST TO FOLLOW-UP ON WHAT DR. PETITT SAID MOST HAVE BEEN -- MOST HAVE BEEN THE MILD DIABETESES AND WE HAVEN'T HAD TO DO A GREAT DEAL OF TESTING BUT I WOULD SUPPORT DR. BASIS IDEA TO HAVE SOME PERHAPS MAYBE GUIDELINE THAT LET FAMILY PHYSICIAN OR NURSE PRACTITIONERS TAKE CARE OF THE MILD GESTATIONAL DIABETICS WITH ALL DUE RESPECT, AFTER THE FIRST COUPLE L OF WEEKS, MOST CAN GO TO MUCH LESS TESTING AND DON'T NEED ANTI-NATAL TESTING SO I BRING IT P UP AS THOUSAND. >> DO YOU KNOW WHAT HAPPENED TO YOUR -- AS A THOUGHT. >> DO YOU KNOW WHAT HAPPENED TO PREVALENCE? >> IT WEPT UP BY ONE AND A HALF TO TWO TIMES. I ENCOURAGE THE ALASKA NATIVE POPULATION. IT DIDN'T TRIPLE. >> THANK YOU. YES. >> HI. I'M SUSAN LANDY FROM RICHMOND, VIRGINIA. I TRAINED UNDER (INDISCERNIBLE) AN DR. DODDSON DURING RESIDENCY AND I'M HERE TO TELL YOU THE THREE HOUR TEST STINKS. FROM A PERSONAL STANDPOINT NOT THAT I DISAGREE WITH THE CONCEPT. I FIRMLY BELIEVE PREGNANT WOMEN CAN EFFECT ONLY THREE THINGS DURING THE COURSE OF THEIR PREGNANCY. HOW OFTEN THEY GET THE DOCTOR, WHAT GOES IN THEIR MOUTH AND WHETHER OR NOT THEY TAKE PRE-NATAL VIE MINUTES. HAVING SAID THAT, GIVEN THAT THEY ARE COMING TO THE DOCTOR AND AND THAT IS ONE THING THEY CAN EFFECT WHY IS IT NOT IMPLICIT THE DOCTORS ARE HELPING THE PATIENTS WITH NUTRITION FROM VERY EARLY ON IN THE PREGNANCY? I FIRMLY BELIEVE AND I DO THIS WITH ALL OF MY PATIENTS, I TAKE A BASIC DIET HISTORY USUALLY AFTER THEY'RE DONE THROWING UP IN THE FIRST TRIMESTER BUT A BASIC HISTORY AND FIGURE WHERE THEY ARE DEFICIENT AND TAYLOR THEIR DAILY INTAKE TOWARD ACHIEVING GOALS TO NOT NECESSARILY CREATE GLYCEMIA BUT STABILIZE BLOOD SUGAR LEVELS AND STABILIZE INSULIN LEVELS AND PROTONE CAN BLUNT THE INSULIN RESPONSE AND THE HYPERGLYCEMIA THAT GOES WITH THAT. HAVING SAID THAT, I FIRMLY APPRECIATE THAT I AM NOT THE BE ALL END ALL WHEN IT COMES TO KNOWLEDGE ABOUT NUTRITION AND PREGNANCY, I RELY ON REGISTERED DIETITIANS TO DO THAT. BUT ONE THING THAT I THOUGHT WAS VERY, VERY INTERESTING WAS EVERYBODY IS TALKING INCREASED PREVALENCE AND HOW WE CAN ACCOMPLISH GETTING THESE PATIENTS IN TO CARE. I'M GOING TO CREDIT DR. COUSTAN WITH THE FELLOWSHIP PROGRAM, WE HAD A DIABETES CLASS WE TAUGHT DURING FELLOWSHIP. IT IS THE PREDECESSOR TO CENTERING PREGNANCY. BUT CORRECT ME IF I'M WRONG, THEY'RE INTERNISTS HERE, IS THERE NOT A MODEL OF DIABETES CARE FOR THE INTERNAL MEDICINE PATIENT CALLED CENTERING DIABETES. WHY CAN'T WE LEARN FROM THAT? >> I AM A NEONAY TOLL GIST FROM BETHESDA AND I AM DAUNTEDLY BITHIS GROUP OF OBSTETRICIANS. IN REALM OF NEONATAL CARE THE OUTCOMES ARE REALLY MINOR. THAT BIG BABIES DON'T CAUSE US PROBLEMS, THEY CAUSE YOU PROBLEMS, SHOULDER DISTOTIA DO NOT CAUSE US PROBLEMS, WE DEAL WITH THE DIAGNOSIS OF A (INAUDIBLE) PALSY, NOT A SHOULDER DISTOCIA. FOR US DIABETES REALLY DOESN'T WHEN WE HERE HIGH RISK DELIVERY, IT'S NOT HIGH RISK FOR US. >> THANK YOU. >> I HAD A QUICK FOLLOW-UP QUESTION FOR DR. BARTH, THIS HAS TO DO WITH COLLABORATIVE MODELS (INDISCERNIBLE) DO CARE FOR DIABETIC WHOSE ARE DIET CONTROLLED. A FEW MORE THOUGHTS ABOUT THAT AS POTENTIAL PRACTICE MODEL IF IN FACT THE INFLUX WOULD BE MILD DIABETIC. AND BACK TO EARLIER POINT ABOUT WHAT INTERVENTIONS WE WOULD DO AFTER PREGNANCY FOR THE MOTHER WHO IS DIAGNOSEDDED WITH GESTATIONAL DIABETES, YOUR THOUGHTS HOW ANY PRACTICE -- WHAT PRACTICE MODELS MIGHT ALSO BE USEFUL IN THAT PARTICULAR CIRCUMSTANCE. YOU ALL ANTICIPATEDDED ANY AT YOUR INSTITUTION? >> ON THE SECOND ONE, NO, BUT THERE ARE FOLKS IN HOSPITALS A STONE'S THROW AWAY FOCUSING ON THE POST PARTUM CARE OF THE PATIENT IDENTIFIED WITH GESTATIONAL DIABETES. I DON'T RUN IN THAT CIRCLE. TO THE FIRST ONE I HOPE I DIP IMPLY -- DIDN'T IMPLY ANYBODY WITH GESTATIONAL DIABETES HAS TO SEE A PHYSICIAN. I AM MEDICAL DIRECTOR RIGHT NOW FOR OUR PRACTICE AT MASS GENERAL AND DIAGNOSIS OF GESTATIONAL DIABETES DOES DOES NOT REQUIRE TRANSFER TO PHYSICIAN OR APPOINTMENT WITH THE PHYSICIAN. OUR OWN GROUP JUST DECIDED THAT WANTS MEDICATIONS REQUIRED AT LEAST VISIT SHOULD TAKE PLACE BUT THAT'S OUR OWN UNIQUE LOCAL CIRCUMSTANCE. I THINK THERE ARE A LOT OF DIFFERENT CARE MODELS, I DON'T THINK IT'S COMPLICATED. I DON'T THINK ANYBODY IN THE ROOM THINKS IT'S COMPLICATED TO HAVE OBSTETRICIAN OR PERIPERINATOLOGIST. >> I'M AT THE PODIUM. MIDWIFE BUT I THOUGHT I WOULD CLARIFY ABOUT THE GROUP PRE-NATAL CARE MODEL. THE PREVIOUS SPEAKER ASKEDDED GROUP MEDICAL VISITS IN THE PRIMARY CARE POPULATION. THERE WAS A LOT OF DATA OUT THERE ON THAT LOOKING AT HYPERTENSION AND DIABETES. IN THE NON-PREGNANT POPULATION. IN THE PREGNANT POPULATION THERE IS AN ALMOST 20 YEAR HISTORY WITH THE HEALTHCARE INSTITUTE OF CENTER PREGNANCY WHICH IS GROUP PRE-NATAL CARE. RIGHT NOW THERE'S A COUPLE OF PRACTICES ACROSS THE COUNTRY LOOKING AT DEVELOPING PROGRAMS FOR GROUP PRE-NATAL CARE FOR GESTATIONAL DIABETICS, THE ONE THAT DR. CAUGHEY AND I ARE LOOKING AT IS FOR THE PERINATAL CLAY IN THIS CASE DIABETES CLINIC AT OUR INSTITUTION FOR TYPE 2 DIABETES FOR WOMEN WITH TYPE 2 DIABETES. ONE INTRIGUING POSSIBILITY RELATED TO LONG TERM HEALTH EFFECTS WOULD BE TO DOVE TAIL CENTERING PREGNANCY WITH CENTERING PARENTING WHICH IS 12 MONTHS FOLLOWING THE DELIVERY OF THE BABY. THE WOMAN GOES WITH HER BABY AN CONTINUES TO KEEP MEETING WITH THE SAME GROUP ONE HOW ARE WOMEN DOING WITH WEIGHT LOSS, TWO HOW ARE BABIES DOING OVER TIME RELATED CARE NUTRITION, EXERCISE, THINGS LIKE THAT. >> I HEARD SEVERAL TIMESED TO MEMBERS AT THE TABLE I THEY DO THEIR GLUCOSE CHALLENGES PATIENTS BUT THEY DON'T HAVE THEM FROM FASTING. THE LAB SLIP COMES BACK AND ELEVATED HOW DO YOU DIFFERENTIATE A FALSE POSITIVE TO REAL POSITIVE? IF THEY'RE NOT FASTING YOU DON'T HAVE AN ELEVATED VALUE. >> I NEVER THOUGHT OF IT. LET ME MAKE SURE I UNDERSTAND YOUR QUESTION. IF THEY HAVE AN ELEVATED 50-GRAM -- >> IT HAS A ROLL AND ORANGE JUICE AND YOU GIVE THEM LOAD OF GLUCOSE. ODDS OF THEIR HAVING ELEVATED VALUE IS PRETTY GOOD. >> I RELY ON THE PUBLISHED WORK WHERE THE STUDY SCREENING TESTS WERE DEPLOYED IS WHAT WE'RE RELYING ON. BUT YOU'RE RIGHT, IT COULD BE >> (INDISCERNIBLE) CALIFORNIA, JUST A CLARIFICATION FROM THE PANEL AGAIN. THE COMMENT FROM THE INDIANA HEALTH SERVICES IS REALLY HELPFUL BECAUSE THAT'S A PRACTICAL ONGOING GROUP. AND I WONDER IF DEPENDING ON NUMBERS THEY'RE GETTING IF THEY HAVEN'T SEEN THE DR. TMATIC INCREASE -- DRAMATIC INCREASE BECAUSE THEY'RE DEALING WITH A HIGH RISK POPULATION ALMOST MAXIMALLY IDENTIFIED BY THE OLD CRITERIA SUCH THAT MOST STRINGENT NUMBERS IS REALLY NOT MODEL DISTRIBUTION WHERE YOU EITHER HAVE OR YOU DON'T AND THE TEST WAS PICKING UP EVERYTHING THEY HAD. MAYBE DOESN'T MAKE THAT MUCH OF A DIFFERENCE TO THEM. BUT THOSE ARE THINGS THAT WE WILL SEE AS WE ROLL OUT THE IF WE DO THE NEW CRITERIA TO SEE HOW THAT APPLIES IN DIFFERENT POPULATIONS BUT IF I CAN GET CLARIFICATION, WHAT I SEEM TO BE HEARING IS WE'RE GOING TO LABEL MORE WOMEN WITH THE DIAGNOSIS OF DIABETES, BUT WE DON'T THINK WE NEED TO DO MORE ANTI-NATAL TESTING, WE DON'T THINK THEY'RE GOING TO NEED MORE PHYSICIAN VISITS, WE DON'T THINK OF THE OBSTETRICIANS IN THE COMMUNITY IS NOT AN MFM TO PUT THEIR NAME ON THE CHARGE, THIS DIABETIC HAS AN AFFECT WHEN YOU HAVE THIS PRE-NATAL FETAL L DEMISE FOR WHATEVER REASON, SOMEBODY IS GOING TO LOOK ON THE CHART AND SAY HEY, YOU HAD A DIAGNOSIS OF GESTATIONAL DIABETES, YOUR FALL BECAUSE YOU DIDN'T REFER THIS. IN SOME WORLD THAT MIGHT BE THE CASE. BUT IN THE TRENCHES ON A DAY TO DAY EXISTENCE, IT WILL BE NAIVE TO THINK THAT WOULD HAPPEN. IN SOME AREAS THEY PREFER YOU DIDN'T KNOW, THIS HAPPENED AND IT WAS GOD'S FAULT AS OPPOSED TO GOSH, SHE HAS A DIAGNOSIS OF GESTATIONAL DIABETES AND YOU DIDN'T -- YOU LEFT OUT WITH NURSE PRACTITIONER ONLY OR YOU LEFT HER, DIDN'T DO ANYTHING -- AM I GETTING THE SENSE, DR. BARTH THAT WE'RE SAYING WE WILL HAVE THE DIAGNOSIS BUT THEY SHOULD STAY NURSE PRACTITIONER Q. I DONE I THINK WHAT YOU HEARD WHAT I SHOWEDED IN THE SLIDES IS MY GUT FEEL AS CLINICIAN WOULD BE TO INCREASE RATES BASED ON WHAT'S BEEN PUBLISHED. INCREASE ENCOUNTERS WHAT WE WERE HEARING IS SOME INTERESTING THOUGHTS FROM THE AUDIENCE THAT MAYBE IT'S NOT THAT EXTREME BECAUSE THERE ARE OTHER CARE MODELS, MAYBE THE PATIENTS ARE NOT RESOURCE DRIVING SEVERE GESTATIONAL DIE BETICS THAT DRIVE THOSE NUMBERS, MAYBE MILDER AND COULD BE TAKEN CARE OF LESS. BUT DIET CONTROLLED GESTATIONAL DIABETIC, I DON'T THINK THAT HAS TO BE AN MFM REFERRAL. I THINK THAT'S WITHIN THE SCOPE OF THE MID WIVES THAT I PRACTICE WITH. >> I DON'T KNOW THAT WE HAVE THE DATA YET BASED ON WHAT WE HAVE SO FAR. I THINK IT'S WHAT WE FEEL BUT I DON'T KNOW THAT (INAUDIBLE). >> REMEMBER, WE'RE CONCENTRATING MORE ON DIAGNOSIS THAN WE ARE TREATMENT. SO REMEMBER THAT AS WE CONTINUE OUR DISCUSSION. >> FOLLOWING UP IN RELATION TO THAT, WHAT I WAS SAYING EARLIER H WE SEE IN SAN FRANCISCO IS THAT AS DR. COUNTY POINTED OUT, A PATIENT CANNOT SEE THE TIETITION WITHOUT A DIAGNOSIS. -- DIETITIAN WITHOUT A DIAGNOSIS. IN ORDER FOR THE PRACTICE TO BE REIMBURSED FOR ANY DIETARY COUNSELING, THE DOCK DOCTOR HAS TO SEE THE PATIENT FIRST, WHETHER THE PATIENT IS SENT FOR NUTRITIONAL COUNSELING BECAUSE THE REFERRING PHYSICIAN THINKS IS PATIENT IS GAINING TOO MUCH WEIGHT OR ACTUALLY NEEDS 648.3, TBM YOU DONE HAVE TO SEE THE PATIENT ONCE AND FOR MANY PATIENTS I DO BECAUSE I HAVE A FAIRLY EDUCATE POPULATION. BUT THAT IS HUGE INCREASE ON PRACTICE AND MANY INSURANCES WILL NOT ALLOW A PATIENT TO SEE A DIETITIAN OR IT'S NOT EVEN THAT'S NOT ALLOWED THE PATIENT WILL -- THE PRACTICE WON'T BE REIMBURSED BECAUSE THEY DIDN'T SEND THE PATIENT TO SEE THE DIE -- DOCTOR FIRST, OR THE PATIENT WILL BE STUCK WITH A LARGE BILL BECAUSE SHE DOESN'T HAVE BENEFITS FOR DIETARY SERVICES. IN THE REAL WORLD PRIVATE PRACTICE MANY PATIENTS PAY THEIR DOG WALKER MORE THAN DOCTOR AND ARE NOT WILLING TO PAY FOR DIETARY SERVICES SO YOU HAVE A VICIOUS CIRCLE OF REALITY, THERE NEEDS TO BE MORE -- NEEDS TO BE IN A STATEMENT DIETARY SERVICES NEED TO BE MUCH MORE READILY AVAILABLE. AND A COVERED BENEFIT OR PROCLAIMED TO BE SOMETHING LIKE THAT BECAUSE YOU CAN'T REALLY GET AROUND THIS PROBLEM WITHOUT HAVING THAT. AND IN MANY CITIES, GENERALISTS WILL ADVOCATE ALL RESPONSIBILITY FOR THE DIETARY FOR THE GDM DIAGNOSIS. IN OTHER WORDS THEY WILL DO THE RUE TONE CARE BUT THEY WANT THE MFM TO MANAGE DIABETES. THEY'RE NOT GOING TO DO IT LIKE THE OTHER WOMAN WAS SAYING IN HER PRACTICE WHERE SHE CAN DO THAT, THAT'S NOT WHAT'S GOING TO HAPPEN IN MANY PRACTICES. >> OKAY. I WANT TO EXTEND A SPECIAL THANKS TO ALL OF OUR SPEAKERS TODAY AND FOR THE AUDIENCE PARTICIPATION, WE HAVE HAD A GREAT DAY. [APPLAUSE] >> THE PANEL IS BURSTING WITH INFORMATION AND WE WILL NOW GO TO THE DRAWING BOARD AND TRY TO COME UP WITH SOME -- AN EARLY RENDITION OF OUR CONSENSUS. IN THE MEANTIME EVERYBODY HAVE A GOOD EVENING, WE'LL RECONVENE AT 8:25 IN THE MORNING. THANK YOU.