This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.
DECIDE
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes (DECIDE)
Gestational diabetes
All genders
18+
Recruiting now
Overview
Principal Investigator: Erika Werner
Contact Us
Alysa St. Charles
Study details
Inclusion Criteria
- Singleton pregnancy
- Gestational diabetes diagnosed between 20 0/7 weeks and 31 6/7 weeks
- Requiring medication for glucose control
Exclusion Criteria
- Renal disease
- Gestational diabetes diagnosed between 20 0/7 weeks and 31 6/7 weeks
- Requiring medication for glucose control
Study Requirements
Participation is from randomization until 2 years after delivery. In pregnancy, there will be monthly visits with study coordinator. Once your baby is born we request you come back for a 6 week and 2 year follow up visits that will involve body measurements and an A1c.