LISBON -- International guidelines on screening for gestational diabetes that will likely raise the prevalence of the condition have sparked questions over appropriate diagnostic tools and cost efficacy, researchers said here.
During a press briefing at the European Association for the Study of Diabetes meeting here, some researchers said that recommendations from the International Association of Diabetes and Pregnancy Study Groups released in 2010 are cost-effective.
But others are concerned that the two-step screening process, which could raise the prevalence from about 7% of pregnant women to 16% or more, may be too costly and too demanding.
Ob/Gyns and diabetologists have long recognized a need for more consensus on diagnosis and screening for gestational diabetes, but not all medical associations, including the American Congress of Obstetricians and Gynecologists, have accepted the international guidelines.
The 2010 guideline recommends an initial oral glucose tolerance test (OGTT) at the first prenatal visit, and a follow-up at 24 to 28 weeks' gestation if diabetes is not diagnosed initially.
Disease is diagnosed if the 75-g OGTT readings at 0, 1, and 2 hours exceed 5.1 mmol/L (126 mg/dL), 10.0 mmol/L (180 mg/dL), or 8.5 mmol/L (153 mg/dL), respectively.
Sue Kirkman, MD, senior vice president of medical affairs and community information at the American Diabetes Association, said her organization adopted the recommendations into its standards of care last January.
But some researchers have argued that this type of testing is too demanding -- and much more costly -- for pregnant women, especially when a fasting plasma glucose (FPG) test is simpler and may be more accurate, thus reducing the potential problem of overdiagnosis.
In fact, the World Health Organization (WHO) and recommends using FPG levels to diagnose gestational diabetes, which is diagnosed at an FPG of 4.4 mmol/L or higher.
And ACOG said it has declined to adopt the guidelines because of concerns with a lack of randomized controlled trials for the diagnostic criteria.
But Peter Damm, MD, of the University of Copenhagen in Denmark, who was on the international guideline writing committee, said during a press briefing that the group's conclusions were based on the best evidence available -- the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study.
Robert Fraser, MD, of the University of Sheffield in England, added that several subsequent studies also have vouched for the benefits of screening and treating the condition.
Those include the 2005 ACHOIS study and the 2009 Maternal-Fetal Medicine Units Network Trial, which both found that treatment reduces perinatal complications such as increased rates of cesarean section, increased fetal size, neonatal hypoglycemia, and shoulder dystocia, he said.
As well, a meta-analysis of both studies showed a reduction in preeclampsia, birth weight, and the proportion of large-for-gestational-age infants, though there were no effects on C-section rates or neonatal hypoglycemia, Fraser said.
And a cost-efficacy study published in Diabetologia, based on two treatment trials, found screening with FPG and OGTT in which risk was found to be 1% to 4.2% was "most likely" cost-effective and risk higher than 4.2% was cost-effective for universal glucose tolerance testing, he added.
Treatment typically involves diet and lifestyle modification, with a move to insulin if the diabetes is not controlled, Fraser said. Oral diabetes medications, particularly sulfonylureas or metformin, also have been supported by short-term studies.
Disclosures
Damm and Fraser reported no conflicts of interest.