Gestational diabetes mellitus (GDM). Comparative evaluation of two treatment regimens, diet versus insulin and diet.

Two-hundred and two pregnant women with impaired glucose tolerance were randomized to treatment with diet or diet and insulin by stratified selection. Self-monitoring of blood glucose was performed six times a day, 3 days/wk. Dietary treatment was considered inappropriate if fasting and postprandial blood glucose values exceeded 7 and 9 mmol/L, respectively, in which case insulin therapy was instituted. Insulin doses were adjusted according to blood glucose values, aiming at fasting and postprandial values below 5 and 6.5 mmol/L, respectively. There were no perinatal deaths. The two treatment regimens disclosed no differences regarding achieved degree of maternal blood glucose control, hemoglobin A1c at delivery, obstetric or neonatal complications, infant's size at birth including skin-fold thickness, or C-peptide concentration in cord serum. Routine treatment of pregnant women with mild carbohydrate intolerance with insulin seems unnecessary. However, 15 patients (14%) in the diet group needed insulin to achieve acceptable blood glucose control, underlining the importance of monitoring blood glucose to detect those who are at risk of developing overt diabetes.

RCT Entities:   Population Interventions Outcomes