Recently the Agency for Healthcare Research and Quality (AHRQ) debuted two new treatment guides to help pregnant women and their physicians make the most informed choices about the treatment of gestational diabetes.
Wanda K. Nicholson, MD, MPH, FACOG, an associate professor in the Department of Gynecology & Obstetrics for Johns Hopkins School of Medicine, led the team that reviewed current research and data. The resulting guidelines were developed by The Eisenberg Center in collaboration with AHRQ based on the evidence-based report published by Nicholson and her colleagues at Johns Hopkins. This latest report is part of AHRQ's larger Effective Health Care Program.
Gestational diabetes occurs in approximately 7 percent of pregnancies in the United States. Although many women diagnosed with gestational diabetes are able to control blood sugar with diet and exercise during pregnancy, for those who cannot, there are serious risks of complications for both the mother and baby.
"Traditionally in pregnancy with gestational diabetes, the primary medical management was with insulin," said Nicholson. "Recently, there has been some use of oral diabetes medicines — primarily glyburide and metformin."
She continued, "Insulin has been used for a long period of time. It has been shown in gestational diabetes to be effective without adverse effects on the developing infant or newborn." However, Nicholson noted, "There's always been some concerns about compliance because it involves a needle stick."
From the review, her team hoped to ascertain whether the oral medications were equally as safe and effective for treating gestational diabetes as insulin. The ongoing hypothesis, which has yet to be confirmed, is that the ease of the oral medicine options might increase compliance.
After a review of the published literature, the bottom line, Nicholson said, is "All three — insulin, glyburide and metformin — are each effective for lowering blood sugar in women with gestational diabetes, and based on the available evidence, all appear to be safe."
All of the Effective Health Care reports include a "level of confidence scale" — low (1), medium (2), or high (3). A rating of one would indicate a low confidence level because very few studies exist, or the existing studies are flawed. A three shows consistent results from good quality studies. The medium ranking of two indicates findings supported by good studies but recognizes additional research might change the published conclusions. The gestational diabetes guide issued a rating of two on the confidence scale to the clinical bottom line findings.
Nicholson concurred with the medium ranking and said she believes larger studies need to be conducted among women with gestational diabetes to look at direct, head-to-head comparisons between insulin and oral medications in terms of blood glucose control and safety. "I think there needs to be an adherence and compliance measure, as well." She added there are a limited number of studies on the use of oral medications in pregnant women at this point.
However, she continued, the current evidence review opens up new lines of treatment options. "It does give the physician more tools to use in their potential management of the patient."
Nicholson added that gestational diabetes casts a shadow long after the birth of a child. "Any pregnant woman who develops gestational diabetes is at higher risk to develop type 2 diabetes. That needs to be another important 'take home' message and a conversation between the patient and her provider."
She said the American College of Obstetricians and Gynecologists has issued a committee opinion, separate from this new AHRQ guide, that calls for fasting blood sugar or the oral glucose tolerance test to be given at the six-week postpartum appointment. Nicholson added that because the onset of type 2 diabetes might happen years after a woman gives birth, there also needs to be further research and policy considerations to ensure the presence of gestational diabetes is clearly noted in a patient's history. Only about 5 percent of women with gestational diabetes develop type 2 diabetes within six months of delivery. However, nearly 60 percent are diagnosed with type 2 within 10 years of giving birth.
The Eisenberg Center publishes guides for providers, consumers and policy makers with clear, actionable language, as part of an ongoing effort to conduct comparative analyses of treatment protocols and measure effectiveness of outcomes. Information for the guides is taken from reports produced by AHRQ scientific and research networks including Evidence-Based Practice Centers (EPCs), Centers for Education and Research on Therapeutics (CERTs) and Developing Evidence to Inform Decisions about Effectiveness (DEcIDE).