Gestational Diabetes During and After Pregnancy

25. Diabetes Control Programs and Policy

Lois Jovanovic 


Department of Research, Sansum Diabetes Research Institute, 2219 Bath Street, Santa Barbara, CA 93105, USA

Lois Jovanovic



Gestational diabetes mellitus (GDM) is a controversial subject. Medical organizations such as the American Diabetes Association, the American College of Obstetrics and Gynecology, and the World Health Organization have each published clinical guidelines for women with GDM. These guidelines overlap in some areas and have recommendations for screening, diagnosis, treatment, and postpartum screening. Many differences across published guidelines stem from the absence of gold standard GDM diagnostic criterion. Screening is a major area of controversy; medical agencies variously recommend selective or universal screening. A consensus diagnostic criterion needs to be established to avoid adverse pregnancy outcomes and alleviate the confusion associated with multiple diagnostic guidelines for GDM. In this chapter, different organizations’ published clinical guidelines for women with GDM are reviewed and compared.

25.1 Introduction

Gestational diabetes mellitus (GDM) is most accurately defined as “a transient abnormality of glucose tolerance during pregnancy.”1,2 This definition does not include type 2 diabetes that is diagnosed during pregnancy.2 In 1997 the American Diabetes Association (ADA) defined GDM as diabetes diagnosed during pregnancy.3 This definition lead to a broad range of screening, diagnostic, treatment, and postpartum screening plans. Medical organizations have developed their own courses of action to deal with GDM. While the broad points of management are generally agreed upon, controversy does exist.

The ADA, The American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO) are three of the primary medical organizations regarding GDM. In this chapter, we will focus on the overlap in these organizations’ GDM guidelines.

The ADA is a nonprofit health organization that supports diabetes research, provides information, and engages in advocacy. The mission of the ADA is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To fulfill this mission, the ADA funds research, publishes scientific findings, and provides information and other services to individuals with diabetes, and to their families, health professionals, and the public.4 ACOG supports measures to ensure healthy outcomes for mother and child. ACOG advocates a range of programs that support medical research and translates research into information that can be used to provide direct care for women. GDM is but one area of women’s health that ACOG focuses upon.5 WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the global health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.6 GDM is also but one of numerous medical conditions that WHO addresses.

25.1.1 Screening and Diagnosis

Screening for GDM is a highly controversial topic. Differences between medical organizations are also discussed in the two other chapters on screening and the one chapter on prevalence of GDM. Broadly speaking, North America and Europe use two different methods for GDM screening.7 A universal method for screening and diagnosis does not exist. Organizations such as the ADA and the WHO set their own clinical guidelines. Recent studies conducted by the United States Preventative Task Force (USPSTF) and the Canadian Task Force on Preventative Health Care both have agreed that there is insufficient evidence to recommend that all pregnant women undergo screening for GDM.7,8 The purpose of the USPSTF review was to determine if the benefits of screening for GDM outweighed the harms. The review found that screening combined with treatment for hyperglycemia could reduce macrosomia in newborns, but the panel concluded that better scientific evidence was needed to determine if universal screening reduces adverse health outcomes for mothers and their infants.7

The ADA recommends that women who are at very high risk for GDM should be screened at the first prenatal visit.9 Very high risk criteria are:

·               Severe obesity

·               Prior history of GDM or delivery of large-for-gestational-age (LGA) infant

·               Presence of glycosuria

·               Diagnosis of polycystic ovarian syndrome

·               Strong family history of type 2 diabetes

All women at 24–28 weeks gestation, including those that were not found to have diabetes early in pregnancy, should be screened unless they are considered low risk. Women must have all of the following criteria to be considered low risk:

·               Age less than 25 years

·               Weight normal before pregnancy

·               Member of an ethnic group with a low prevalence of diabetes i.e., non-Hispanic white women

·               No known diabetes in first-degree relatives

·               No history of abnormal glucose tolerance

·               No history of poor obstetrical outcome

As recommended by the ADA, GDM screening at this stage is performed using a two-step approach. The first step is a 50-g glucose challenge test (GCT). Plasma glucose is measured 1-h after the 50-g glucose load is given. A value of 140 mg/dL (7.8 mmol/L) and above identifies approximately 80% of women with GDM, and a value of 130 mg/dL (7.2 mmol/dL) and above identifies approximately 90% of women with GDM.9 If the threshold is exceeded, women are given a 100 or 75-g oral glucose tolerance test (OGTT) on a separate day. The threshold values recommended by the ADA for the 75 and 100-g OGTT at fasting, 1-h, and 2-h are exactly the same. The 25-g glucose difference between the 75- and 100-g glucose challenges is not addressed by the ADA. The OGTT is preformed in the morning following an 8-h overnight fast. Diagnosis of GDM requires at least two of the following plasma glucose levels:


·               Fasting: above 95 mg/dL (5.3 mmol/L)

·               1-h: above 180 mg/dL (10.0 mmol/L)

·               2-h: above 155 mg/dL (8.6 mmol/L)

·               3-h: above 140 mg/dL (7.8 mmol/L)


·               Fasting: above 95 mg/dL (5.3 mmol/L)

·               1-h: above 180 mg/dL (10.0 mmol/L)

·               2-h: above 155 mg/dL (8.6 mmol/L)

Studies have identified problems associated with the above guidelines. One study showed that only 20% of women who exceeded the threshold value on the GCT also exceeded the threshold value on the OGTT.10 Therefore, the specificity of the text is extremely low. Another study tested the reliability of the GCT.11 It showed that 30% of women with GDM had ambiguous GCT results on repetitive testing.

The National Diabetes Data Group (NDDG) and the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus recommend OGTT cut-off values that are higher, and therefore less stringent, than those of the ADA.12 They recommend the following cut-off values:

·               Fasting: glucose 105 mg/dL (5.8 mmol/L)

·               1-h: 190 mg/dL (10.6 mmol/L)

·               2-h: 165 mg/dL (9.2 mmol/L)

·               3-h: 145 mg/dL (8.1 mmol/L)3

Threshold OGTT values from the NDDG and the ADA are both considered acceptable by ACOG.13 ACOG also states that women who are considered low risk by ADA guidelines need not undergo screening, however they do recognize that universal screening is the most sensitive and practical approach.13

WHO uses a different screening approach. Its approach, adopted in many countries outside of North America, uses identical diagnostic criteria for pregnant and nonpregnant women. WHO uses a 2-h 75-g OGTT. GDM is diagnosed if the fasting glucose is 126 mg/dL (7.0 mmol/L) and above, or if the 2-h glucose is 140 mg/dL (11.1 mmol/L) and above.14

The Hyperglycemia and Adverse Pregnancy Outcomes Study Cooperative Research Group (HAPO) conducted a prospective cohort study of 23,325 women.15 Women and clinicians blinded to test results were tested at 24–32 weeks gestation for glucose tolerance using the 75-g OGTT. Four primary adverse pregnancy outcomes were examined: birth weight above the 90th percentile for gestational age, primary cesarean delivery, clinically diagnosed neonatal hypoglycemia, and cord-blood serum C-peptide level above the 90th percentile. Six secondary outcomes were examined: delivery before 37 weeks of gestation, shoulder dystocia or birth injury, need for intensive neonatal care, hyperbilirubinemia, and preeclampsia. Women were unblinded if their OGTT results were extremely elevated, so study results focus on women with relatively mild gestational hyperglycemia. Ten of 12 analyses of primary outcomes and 12 of 15 analyses of secondary outcomes showed significant positive correlation with increased plasma glucose levels. Analyses of the primary outcomes showed the strongest correlations between increasing maternal glucose levels at fasting, 1-h, and 2-h, and two primary adverse outcomes: birth weight above the 90th percentile and cord-blood serum C-peptide level above the 90th percentile.15 Of note, Schrader and colleagues also showed significant correlation in women with a fasting plasma glucose above 90 mg/dL and increased delivery rates of macrosomic infants.16

Therefore, the investigators of both studies concluded that significant associations between adverse outcomes and higher levels of maternal glucose existed within what is currently considered a nondiabetic range, and lower gestational glycemic cut-offs needed to be defined.

The ADA did not address screening and diagnosis of GDM during the Fifth International Workshop-Conference on Gestational Diabetes but does plan on addressing the issue at the Sixth Workshop-Conference.17 Until a gold standard diagnostic criterion is reached, controversy will continue to surround the issue of screening and diagnosis of GDM.

25.1.2 Monitoring, Management, Treatment, and Postpartum Screening

Organizations that have published guidelines on GDM also recommend different approaches to monitoring, management, treatment, and postpartum screening. As with diagnostic criteria for the identification of GDM, discrepancies exist between organizations regarding management guidelines. Many of these discrepancies stem from the lack of a consensus diagnostic criterion for GDM. Monitoring

The ADA recommends a basic plan for monitoring GDM.9 The plan includes maternal metabolic surveillance to determine if blood glucose levels are high enough to cause risks to the fetus. Metabolic surveillance consists of glucose self-monitoring by the gravida, with periodic checks by the health care provider. The ADA does not recommend a daily monitoring schedule but does acknowledge that postprandial measurements are more important than preprandial measurements. Maternal glucose levels should not be monitored from the urine. The ADA also advises closer maternal and fetal surveillance in pregnant women with a fasting glucose of 95 mg/dL (5.3 mmol/L) and above, or pregnancies that are post dates. This surveillance should consist of additional monitoring and possibly ultrasonography, to determine if asymmetric abnormal fetal growth is present, especially in the early third trimester.9Asymmetric abnormal fetal growth is defined as abdominal circumference greater than head circumference.18 Medical Nutritional Therapy

Medical nutritional therapy (MNT) should be given to all women with GDM. The ADA advises registered dietitians to deliver MNT, consistent with its guidelines.9 Nonobese women with GDM should consume enough energy to allow for normal weight gain during pregnancy. The ADA recommends food choices be made to accomplish three main goals: appropriate weight gain, normoglycemia, and absence of urine ketones.19 Women who are diagnosed with GDM should be placed on individualized diets that result in normal blood glucose levels. Quantity, type, and frequency of carbohydrate intake depends directly on individual responses of blood glucose levels. Glucose level consistency is very important because the fetus is constantly drawing blood from the mother. Women are encouraged to keep daily records of foods consumed and subsequent blood glucose levels. Change in carbohydrate intake and insulin dosage can be made based on these records. Obese women with a body mass index (BMI) over 30 kg/m2 are encouraged to reduce caloric intake by 30%. This caloric reduction can improve blood glucose control and avoid ketonuria.19 ACOG states that better evidence is needed to recommend for or against caloric restriction in obese women. If caloric restriction is used for obese women, ACOG recommends that it should not be restricted by more than 33%.13

In the Australian Carbohydrate Intolerance in Pregnancy (ACHOIS) trial, Crowther and colleagues examined whether treatment of GDM with dietary advice, blood glucose monitoring, and insulin therapy vs. routine care reduced the risk of perinatal complications.20 Participants were randomly assigned to receive GDM treatment or routine care. Primary outcomes were infant death, shoulder dystocia, bone fracture, nerve palsy, admission to the neonatal nursery, jaundice requiring phototherapy, induction of labor, cesarean birth, and maternal anxiety, depression, and health status. Infants of the 490 women who received GDM treatment were found to have significantly lower perinatal complications than the 510 infants whose mothers received routine care. The relative risk was 1 vs. 4%, respectively, after adjustment for maternal age, race or ethnic group, and parity.20

Major and colleagues demonstrated the effect of carbohydrate restriction on perinatal outcomes in women with diet-controlled GDM.21 Women were nonrandomly assigned to two groups: low dietary carbohydrate group vs. high dietary carbohydrate group. Women in the low carbohydrate group less frequently required the addition of insulin to control glucose, and also had fewer LGA infants and cesarean deliveries for cephalopelvic disproportion and macrosomia.21 Jovanovic and colleagues examined women who were placed on insulin because they could not maintain fasting blood glucose values below 90 mg/dL and 1-h postprandial glucose levels below 120 mg/dL with diet modification alone. These women had significantly lower infant birth weights.22

ADA guidelines advise women with GDM to set the following glycemic thresholds:

·               Fasting whole blood glucose of 95 mg/dL (5.3 mmol/L) and below

·               1-h postprandial whole blood glucose of 140 mg/dL (7.8 mmol/L) and below

·               2-h postprandial whole blood glucose of 120 mg/dL (6.7 mmol/L) and below9

ACOG recommends similar glycemic goals, except for a slightly different postprandial threshold at 1-h of 130–140 mg/dL (7.2–7.8 mmol/L). Of note, these thresholds are higher than those found in HAPO and by Jovanovic and colleagues to be associated with fetal outcomes.22 Insulin Therapy

Insulin therapy is recommended by the ADA when MNT does not maintain threshold blood glucose levels.9 Basal and prandial insulin injections provide the best results. Neutral Protamine Hagedorn insulin or NPH is recommended for basal insulin injections and should be injected 2–4 times daily. At the first prenatal visit or before pregnancy, women who are taking one daily dose of insulin should switch to multiple NPH injections daily. Another possible option for basal insulin is by continuous subcutaneous insulin infusion (CSII) of rapid-acting insulin. Prandial insulin amount should be determined by premeal blood glucose, anticipated activity, and carbohydrate intake. Lispro and aspart are the only two rapid-acting insulin analogs recommended for CSII and prandial insulin usage. Women using CSII need to know how to operate their insulin delivery devices and must frequently check blood glucose levels.9

Langer and colleagues examined whether insulin treatment significantly reduced adverse perinatal outcomes in women with GDM.23 Key factors in LGA infants were found to be fasting plasma glucose and treatment modality. Four hundred and seventy-one women were randomized to either insulin treatment or dietary therapy only, to optimize glycemic control. In women with a fasting glucose <95 mg/dL (5.3 mmol/L), insulin treatment resulted in 3.5% LGA neonates vs. 5.3% LGA neonates in dietary therapy. In women with a fasting glucose of 95–105 mg/dL (5.3–5.8 mmol/L), insulin treatment resulted in 10.3% LGA neonates vs. 28.6% LGA neonates in dietary therapy. Obese women with a fasting glucose of 95–105 mg/dL (5.3–5.8 mmol/L) who received dietary therapy only had a fourfold increase in LGA neonates compared with the insulin treated group. The study concluded that women with a fasting glucose >95 mg/dL (5.3 mmol/L) should be given insulin treatment to optimize blood glucose levels.23 Physical Activity

Moderate physical exercise programs are encouraged by the ADA for women with GDM.9 These programs have been shown to lower maternal blood glucose levels.9 Exercise guidelines for women with GDM are based on three randomized studies. Bung and colleagues compared women with GDM in an exercise treatment group vs. an insulin treatment group. Both groups had similar prevalence of macrosomia and mean glucose values during pregnancy.24Another randomized study of women with GDM determined that diet combined with exercise vs. diet alone significantly reduced fasting plasma glucose and blood glucose levels 1-h after a 50-g GCT.25 The third study did not find significant benefits in maternal blood glucose control but did find a significant benefit on cardiorespiratory fitness.26 It also showed exercise programs are safe in women with GDM.26 All three studies were limited by small patient populations.

ACOG recommends that women who are pregnant and do not have any contraindications exercise 30 min per day.27 The exercise should be moderate-intensity aerobic physical activity. Blood glucose levels need to be monitored closely around times of exercise and women must be hydrated adequately for individual exercise programs. GDM patients who use insulin should adjust insulin requirements and carbohydrate intake according to blood glucose measurements with exercise. Supine position and activities in which loss of balance could cause fetal trauma are highly discouraged during exercise.27 Women should stop exercising and seek medical attention when any of the following occur: vaginal bleeding, faintness, decreased fetal activity, or low back pain.28 Oral Hypoglycemic Agents

The use of oral glucose-lowering agents has not been approved by the United States Food and Drug Administration during pregnancy, and neither the ADA nor ACOG recommend the use of these agents for GDM.9,13 Clinical trials are needed to establish their safety. Glyburide is an oral glucose-lowering agent that one study found to be effective.29 Langer and colleagues assigned 404 women with GDM into two groups: an insulin treatment group and a glyburide treatment group. The primary outcome was optimal glycemic control, with secondary outcomes including a wide range of maternal and neonatal complications. The study found that there were no significant differences in primary outcomes and only one secondary outcome that was significantly different. Additionally, glyburide was not found in the cord serum of any infant in the glyburide treatment group. Although this study did show promising data, the sample size of the clinical trial was not large enough to conclude that glyburide was safe and effective during pregnancy.30 Trends toward poorer outcomes such as neonatal hypoglycemia, higher birth weights, macrosomia, lung complications, and hyperbilirubinemia were not significant in the trial, but might potentially be observed in larger trials.30 At the time ACOG published its practice bulletin, this was the only randomized trial on glyburide and therefore the bulletin did not recommend it.13 The ADA also did not recommend glyburide use at the Fifth International Workshop, awaiting further data of its efficacy.17 A 2008 USPSTF review of three glyburide and insulin randomized trials and four observational studies also found insufficient evidence to support its use.31 Many physicians ignore these organizations’ recommendations and prescribe glyburide because it is much easier to use, as compared with insulin.32 Metformin is currently not recommended by the ADA or ACOG until further clinical trials are conducted13,17; the Metformin in Gestational Diabetes, or MiG trial, is discussed in further detail in the accompanying chapter on pharmacological management during a GDM pregnancy. Antepartum Assessment and Delivery

ACOG recommends beginning antepartum fetal assessment at 32 weeks gestation for women who have poor glycemic control, require insulin therapy, or have other perinatal risk factors such as hypertension.13 The type of antepartum test should be determined by local practice. ACOG states that evidence of antepartum testing regimens in women with controlled blood glucose levels, who do not use insulin, and who do not have any other perinatal risk factors, are insufficient.13 The ACOG Practice Bulletin states that women who have good glycemic control and do not have any maternal or fetal complications should not have routine delivery before 40 weeks of gestation.13 In their 2008 review, the USPSTF found insufficient evidence to recommend elective cesarean delivery or timing of induction.31 One randomized study of insulin-requiring women compared induced labor at 38 weeks gestation to expectant management of delivery.33 Significant differences in rates of shoulder dystocia and cesarean delivery were not found between the two groups. The study did find that there was an increase in the prevalence of LGA infants in the expectant delivery group. The rates were 23% for the expectant delivery group and 10% for the induced labor group. ACOG recommends discussion with the patient about possible cesarean delivery if the estimated fetal weight is ≥4,500 g. At 4,000–4,500 g other factors need to be considered in the mode of delivery. These factors include: patient’s past delivery history, clinical pelvimetry, and progress during the pregnancy.13 Amniocentesis is recommended if delivery is planned before 39 weeks gestation, in order to confirm pulmonary maturity.13

25.1.3 Postpartum Screening

A consensus on the follow-up test of choice and frequency does not exist for women with prior GDM. The ADA recommends screening women with GDM 6–12 weeks postpartum.34 The diagnosis criterion that the ADA recommends for women with prior GDM is the same criteria used to diagnosis all adults with diabetes in a nonpregnant state.12 These consist of a fasting glucose of 126 mg/dL (7.0 mmol/L), and if a 2-h OGTT is performed, a 2-h glucose of 200 mg/dL (11.1 mmol/L). However, ADA states that a fasting test is preferred, due to ease of administration and reduced cost. ACOG guidelines were revised in 2009 to approximate those of the ADA, although previous guidelines13 stated little data existed that established the benefit of screening; this discrepancy is discussed further in the accompanying chapter on Postpartum Diabetes Risk.

Women with prior GDM should be educated as to their risk for developing diabetes and the best ways to prevent its onset.9 Exercise and diet modifications to maintain normal body weight are highly encouraged for all women. These women should not use medications that increase insulin resistance.9 Women who plan to have more children should be taught the importance of maintaining glycemic control both between and throughout pregnancies to avoid the adverse effects of hyperglycemia. The ADA recommends combination estrogen-progestogen pills as contraception if no contraindications exist.9 The lowest dose of hormones should be used to achieve the desired effect.17 When combined with breastfeeding, progestin-only pills have been shown to increase the risk of developing type 2 diabetes in women with prior GDM,35 and therefore are not the agent of first choice in high-risk women. Intrauterine devices are also considered a safe and effective contraceptive method36; family planning methods are discussed further in the accompanying chapter on contraceptive options.

25.1.4 Recommendations

Our recommendations for women with GDM are the following:

·               Universal screening at 24–28 weeks gestation for all women.

·               Carbohydrate restricted diet.

·               MNT and moderate exercise programs as the initial approach to treatment.

·               Self blood glucose monitoring to evaluate effectiveness of treatment.

·               Insulin therapy when MNT and moderate exercise cannot maintain glycemic control.

·               No oral-hypoglycemic agents.

·               Postpartum screening for all women with previous GDM.

Clearly, a single gold standard GDM diagnostic criterion needs to be agreed upon and implemented. We are optimistic that the dissemination of the HAPO results will lead to such a consensus. After the definition of GDM is established, assessment of postpartum risk can occur, and guidelines for postpartum screening can be formulated. In the meantime, further work on the safety of glyburide during pregnancy should be done to examine the effects of medication on neonatal outcomes, particularly anoxia and birth trauma. Ongoing studies of metformin should answer some of the questions regarding the use of metformin for GDM.



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