DECIDE Study Comparing Oral Metformin and Injectable Insulin for Treating Gestational Diabetes in Pregnant Women

What this Trial Is About

Researchers are conducting a comparative effectiveness trial involving 1,572 pregnant individuals diagnosed with gestational diabetes mellitus GDM who require medication to control their blood sugar. The trial aims to find out if oral metformin is not worse than injectable insulin in reducing negative pregnancy outcomes. It also evaluates the safety for both mothers and their children, as well as patient-reported experiences including barriers and facilitators of using metformin compared to insulin. Participants and their children will be followed up to two years after delivery. Participants will be randomly assigned to one of two treatment groups oral metformin or injectable insulin. Metformin may be given as immediate- or extended-release tablets, with doses increased up to a daily maximum of 2,500 mg, and insulin may be added if blood sugar control is inadequate. Insulin treatment follows clinical dosing standards with up to four daily injections of basal and prandial types, including rapid-, intermediate-, and long-acting formulations. Participants remain on metformin even if insulin is added. The trial will track outcomes from pregnancy through delivery and up to two years postpartum. During the study, participants will have regular assessments for maternal and child health, including monitoring blood sugar control, pregnancy complications, delivery outcomes, and child growth measurements at two years old. Patient questionnaires about treatment satisfaction and acceptability will be collected at six weeks and two years postpartum. The main outcomes measured are a composite of adverse neonatal events and child body mass index at two years. The study also includes long-term follow-up to evaluate maternal and child safety and health effects related to the treatments.

DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes