Significant economic burden Conservative because focus on near-term medical costs, omitting increased long-term risks Insulin Resistance

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1 What s New in Gestational Diabetes? Diane Reader RD, CDE International Diabetes Center Park Nicollet Health Services Minneapolis, MN GDM Statistics What s New? Proposed Changes to Diagnostic Criteria Treatment of Mild GDM Blood glucose monitoring and targets New Weight Gain Guidelines Therapies for Management of GDM Post-partum testing Diabetes Prevention Efforts The Incidence of GDM is Rising Incidence is increasing as population becomes more sedentary and obese Prevalence of GDM by Race/Ethnicity Northern California Kaiser Permanente Incidence of GDM reflects the increase in type Getahun et al. Trends in gestational diabetes. Am J Obstet Gynecol; Costs of GDM in US Pathophysiology of GDM Significant economic burden Conservative because focus on near-term medical costs, omitting increased long-term risks Insulin Resistance Increase cost per pregnancy Increase in National medical costs Women with GDM Newborn Additional $3,305 Additional $209 Additional $230 million Additional $40 million Relative Insulin Deficiency Chen, Y. Population Health Management, 2009 Gestational Diabetes: Caring for Yourself and Your Baby, IDC Publishing

2 Pederson Hypothesis Maternal hyperglycemia Fetal hyperglycemia Fetal hyperinsulinemia (ß-cell hypertrophy and hyperplasia) Excessive fetal growth -macrosomia/ large for gestational age -post-partum hypoglycemia -increase rate of c-section; difficult deliveries -maternal hypertension - other problems Problems with the Current Diagnostic Criteria for GDM 1. Lack of consensus, worldwide, on the methods and glucose values to diagnose GDM Makes it difficult to compare research findings 2. Two abnormal glucose values needed to make the diagnosis; what happens when only one number is abnormal? 3. Is it really GDM when a woman has high glucose in the first trimester; isn t it really undiagnosed type 2 diabetes? Test Two Methods to Diagnose GDM ADA/ACOG 100 gm OGT 2 or more UK/WHO 75 gm OGT 1 or more Fasting >95 mg/dl >126 mg/dl 1 hour >180 mg/dl 2 hour >155 mg/dl >140 mg/dl 3 hour >140 mg/dl Simmons, D. Diabetes Care, January 2010, pp Hyperglycemia Adverse Pregnancy Outcomes Trial- HAPO Overt diabetes clearly increases the risk of adverse pregnancy outcome. What level of glucose intolerance during pregnancy, short of diabetes, is associated with the risk of adverse outcome? Study designed to evaluate maternal hyperglycemia and its association with increased risks of adverse pregnancy outcomes Birth weight above 90 th percentile Cesarean delivery Clinically diagnosed neonatal hypoglycemia Cord serum C-peptide above the 90 th percentile Metzger. NEJM, May 8, 2008 pp Hyperglycemia Adverse Pregnancy Outcomes Trial- HAPO At weeks- 75 gram Oral Glucose Tolerance If FPG < 105 mg/dl or 2 hour < 200mg/dL data was blinded If above these numbers then monitored Over 23,000 women, at 15 centers over 7 years United States (CA, IL, OH, RI) Canada (Toronto) Barbados; UK and Northern Ireland; Netherlands Bangkok; Israel (2) Australia; Hong Kong; Singapore HAPO Trial Outcomes Strong continuous association of maternal glucose levels below those diagnostic of DM with increased birth weight, cord-blood C-peptide Metzger. NEJM, 2008 Metzger. NEJM, 2008

3 Frequency (%) Adjustment for Confounders: HAPO Trial Maternal glucose and perinatal outcome associations are independent of: Maternal age BMI Family history of diabetes Associations did not differ among centers Results can be used globally to develop outcome based criteria for classifying glucose metabolism in pregnancy HAPO trial, data analysis and publication of paper in NEJM May 8, 2008 International Assoc. of Diabetes and Pregnancy Study Groups (IADPSG) consensus panel IADPSG recommendations will be published in March 2010 Diabetes Care. Hope for worldwide acceptance How much is too much risk? Chose a reference group From Associations to Diagnostic Criteria Apply both statistical models and outcome frequencies Used an odds ratio of 1.75 Chose cutoff values Fasting 92 mg/dl 1 hour 180 mg/dl 2 hour 153 mg/dl Cord C-Peptide >90th Percentile Glucose Categories Fasting One Hour Two Hour IADPSG Proposed Recommendations for Diagnosis of GDM Current OGTT OGT 100 gram 75 gram Diagnostic criteria 2 values equal to or greater than: IADPSG Proposal 1 value equal to or greater than: Fasting 95 mg/dl 92 mg/dl ( 5.1 mmol) 1 hour 180 mg/dl 180 mg/dl (10.0 mmol) 2 hour 155 mg/dl 153 mg/dl (8.5 mmol) 3 hour 140 mg/dl IADPSG Recommendations on Diagnosis and Classification of Hyperglycemia in Pregnancy. Diabetes Care, March 2010 Frequency of GDM and LGA Problems with the Current Diagnostic Criteria for GDM Time Glucose Percent % Cumulative % LGA % with GDM Fasting 92 mg/dl 8.3% 19.5% 1-Hour 180 mg/dl 5.7% 14.0% 16.5% 2-Hour 153 mg/dl 2.1% 16.1% 16.2% Lack of consensus, worldwide, on the methods and glucose values to diagnose GDM Makes it difficult to compare research findings Two abnormal glucose values needed to make the diagnosis; what happens when only one number is abnormal? Is it really GDM when a woman has high glucose in the first trimester; isn t it really undiagnosed type 2 diabetes?

4 IADPSG Recommendation: First Trimester Test women at high risk as soon as possible Use any diagnostic criteria accepted to diagnose diabetes Fasting > 126 mg/dl A1C > 6.5% 75 OGT with 2 hour value >200 mg/dl Diagnose with overt diabetes and implement diabetes self-management ADA Clinical Recommendations in January 2010 IADPSG Recommendations on Diagnosis and Classification of Hyperglycemia in Pregnancy. Diabetes Care, March 2010 Crowther, NEJM, June 16, 2005 Australian Carbohydrate Intolerance Study Does treatment reduce risks of perinatal complications? Nutrition and SMBG 50% less macrosomia Less post-partum depression 1000 women at risk Routine Care Higher birth weights Perinatal deaths Treatment of Mild GDM Study question: Does treatment of mild GDM (fasting <95 on OGT) improve pregnancy outcomes? 958 women tested between wks with mild GDM Randomized to control group or nutrition intervention with self-monitoring and insulin therapy if needed Intervention group had: 50% reduction in risk for delivering newborns with excess body fat and shoulder dystocia Fewer c-sections Reduction in pre-eclampsia and hypertension Landon M. NEJM, October 1, 2009; pp Variable Compare Glucose Levels Using CGM Normal pregnancy (n=57) GDM- MNT (n= 26) Mean glucose mg/dl Fasting (mg/dl) GDM- Insulin (n=19) Pre-prandial (mg/dl) Post-prandial peak (mg/dl) Post-prandial peak (minutes) Mean nighttime glucose (mg/dl) Ben-Haroush A, et al. AJObGyn (2004)p 576 Yogev et al. AJObGyn (2004) p 949 Blood Glucose Targets in GDM Pregnancy ADA ACOG Fasting mg/dl <95 mg/dl 1 hour post <140 mg/dl <130 mg/dl 2 hour post meals <120 mg/dl <120 mg/dl Diabetes Care. Gestational Diabetes Position Statement pp88-90 ACOG Practice Bulletin. Obstet-Gynecol, Sept 2001:98: Pre-Pregnancy Body Wt Bad news: maternal pre-pregnancy overweight and obese at all-time high Good news? Rates have leveled off from U.S. women ages BMI % < > > > > Institute of Medicine, 2009 Over 50% of women conceive at BMI >25

5 Excess Adiposity at Conception May increase risk for: GDM Macrosomia C-section HTN Pre-eclampsia May increase risk of post-partum weight retention Why new guidelines? Rising obesity rates in women of childbearing age 50% of women gain more than the IOM weight gain guidelines; 30% gain within guideline Strong evidence linking gestational weight gain to pregnancy outcomes Changes with new guidelines: Use WHO BMI categories Narrow the range of wt gain for Obese to 11-20# Institute of Medicine 2009 Weight gain guidelines based on prepregnant weight Category BMI Total Gain in Pounds Total Gain in Kilograms Underweight < Normal Overweight Obese > Medical Nutrition Therapy for GDM In general, Medical Nutrition Therapy for GDM is: carbohydrate controlled meal plan promotes adequate nutrition appropriate weight gain achieves normoglycemia absence of ketones. * Individualized carbohydrate counting meal plan Rasmussen KM. Weight gain during pregnancy. The National Academy Press; 2009 *American Dietetic Assoc. Nutrition Practice Guidelines, 1997, 2002, 2008 Carbohydrates: How Much? 175 grams/ day for pregnancy (DRI 02) 130 gm non-pregnant plus 33 gm/day for fetal brain Eleven carbohydrate choices x 15gm = 175 grams Carbohydrate intake affects postprandial glucose levels; which are associated with increased incidence of poor outcomes Control total amount of carb consumed to <45 % Distribute carbohydrate across the day- small feedings My Food Plan for GDM Sample distribution of carbohydrate 1 Choice = 15 grams carbohydrate Breakfast limit of 2 (30 grm) Noon meal 3 4 (45-60 grm) Evening meal 3 4 (45-60 grm) 3-4 Snacks 1 2 (15-30 grm) Dietary Reference Intake, 2002

6 Glucose (mg/dl) Less Carbohydrate for Breakfast Higher hormone levels in AM Test one hour after eating; target glucose <130 mg/dl Avoid highly processed foods, like cereals at breakfast Carbohydrates: What type? Carbohydrate intake affects postprandial glucose levels; which are associated with increased incidence of poor outcomes Select low glycemic index carbohydrates Avoid sweetened beverages: soda pop, juices, sweet tea Impact of Glycemic Index The rise in blood glucose that occurs over the next 2 hrs after eating a food containing 50 grams of carbohydrate Potato Dextrose Corn Rice Bread Time (min.) Crapo. Diabetes 26 (12):1180, mg/dl difference Strengths Encourages use of unprocessed, whole, high fiber foods May explain post-meal glucose variability May help fine-tune glucose control Fernandes et al. JADA 2005:105,557 The Glycemic Index Fiber Fat Fructose Brand-Miller, J et al. Am J Clin Nutr 2002:765 Challenges Person to person variability Not easily accessible Impacted by food preparation, ripeness and country of origin Methodology not standardized Does not address portion control Refined Processed white Low GI High GI Assessment Using Food Record Is the patient counting carbohydrates correctly? Is the meal/snack within the food plan? Are the food choices healthy? What is glucose level after eating within target? Less than 130 mg/dl Glycemic Index Can a low-glycemic index diet reduce the need for insulin in GDM? Individualize food plan with min. 175 gr carb; 6 sm meals; SMBG Randomized to Low GI or High fiber/low sugar GI Insulin needed: Low GI diet 29%; high fiber/low sugar 59% 9 insulin Low GI Diet n = no insulin 63 GDM 19 insulin High fiber/low sugar n =32 13 no insulin Diabetes Care June insulin 9 no insulin

7 Adding Glyburide or Insulin Therapy When optimal glucose levels have not been maintained and/or the rate of fetal growth is excessive, pharmacologic therapy in conjunction with nutrition therapy is indicated 2 or more glucose values of target within a week, without explanation OR unable to consume adequate calories/nutrients and maintain glucose control Use of insulin, glyburide improves glycemic control and reduces incidence of poor neonatal outcomes Use of Glyburide in Pregnancy Eight studies reported that glyburide therapy is effective in maintaining glycemic control in conjunction with nutrition therapy, especially in women with less severe disease. 2000: Langer study showed safety and efficacy of glyburide Use of Glyburide for Treatment of GDM: San Antonio Experience If unable to achieve glucose targets within 2 weeks on MNT, started on glyburide 2.5 mg AM and dose adjusted upwards 84% had success with Glyburide Conway. J of Maternal-Fetal and Neonatal Medicine, 2004 Lower OGT values Initiated later gestation 75% successful on mg/day Metformin Pregnancy category B Does cross placenta Pilot study No increase in neonatal morbidity or macrosomia Preconception Type 2- glucose control, fertility, decreased miscarriage risk PCOS- fertility and decrease in miscarriage risk Discontinued after conception Not recommended for nursing mothers Awaiting long term outcome data Metformin in GDM Metformin versus Insulin for the Treatment of Gestational Diabetes 751 women with GDM randomly assigned to metformin (with supplemental insulin if needed) or insulin Metformin group: 92.6% continued until delivery, 46.3% received supplemental insulin Primary and secondary outcomes were statistically similar Women preferred metformin to insulin No studies to compare metformin and glyburide Regular Mealtime Insulin in Pregnancy Pregnancy category B Used for twice daily injection regimens to cover snacks Longer duration of action may lead to more hypoglycemia Lispro (Humalog) and Aspart (Novolog) Pregnancy category B Lower incidence of hypoglycemia May cover post meals more appropriately; improved BG control Discontinue between meal snacks or add to cover snacking Rowan J. MiG Trial, NEJM, May 2008 Jovanovic L. Diabetes Care 1999 Sep 22 (9)

8 Cases per 100 person years Background Insulin in Pregnancy NPH Pregnancy category B Used in twice daily injections Can cover meals and snacks well Increased risk of hypoglycemia as compared to analogues Glargine (Lantus) Pregnancy category C Has been used now for many years Limited basal insulin choices may lead to more use Levemir (Detemir) Pregnancy category C Predictors of Diabetes in Women with Previous GDM 302 followed post GDM OGT at 9 months, 2, 5, 8 and 11 yrs. 8 year risk of postpartum diabetes = 52.7% Increase risk with: Women who required insulin Women with BMI >30 Women with more than 2 prior pregnancies Auto-antibodies to GAD (glutamic acid decarboxylase) autoimmunity test Lobner K. DIABETES, March 2006 Meta Analysis: Type 2 after GDM Relative risk 7.43 higher than non-gdm Diabetes Prevention Program-DPP 3234 people at high risk for developing DM IGT and BMI >24 kg/m2 Lifestyle intervention had 58% lower incidence Metformin had 31% lower incidence CLOSE Women with hx of GDM: Lifestyle or Metformin equal effectiveness at 31% lower incidence DPP With GDM 0 Lifestyle Metformin Placebo Bellamy; The Lancet, May 09 Diabetes Prevention Program Research Group. Diabetes Care Ratner R. Prevention of diabetes in women with hx of GDM. J Clin Endocrinology Metab. Dec P Prevention or Delay of Type 2 Patients with IGT, IFG or A1C % Referred to effective ongoing support program for wt loss of 5-10% and increase in activity to 150 min/week Follow up counseling appears to be important for success National Diabetes Education Program NDEP translates the latest science and spreads the word that diabetes is serious, common, and costly, yet controllable and, for type 2, preventable. Standards of Medical Care. Diabetes Care Supplement 1, Jan. 2010

9 Resources Fifth International Conference-Workshop on Gestational Diabetes, Diabetes Care supplement, July 2007 International Diabetes Center Publishing My Food Plan for GDM; Gestational Diabetes Gestational Diabetes BASICS- guide and curriculum Nutrition Practice Guidelines for Gestational Diabetes; American Dietetic Association, 2002, ACOG Technical Bulletin 30 September 2001; Gestational Diabetes American Diabetes Association: Clinical Recommendations 2004 AADE Desk Reference, Chapter 12 Gestational Diabetes American Dietetic Association, GDM. Thomas and Gutierrez

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