DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes (NCT06445946)
DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama — Tuscaloosa, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (24 Sites)
- University of Alabama — Tuscaloosa, Alabama
- Cedars Sinai Medical Center — Los Angeles, California
- University of California San Francisco — San Francisco, California
- Christiana Care — Newark, Delaware
- University of South Florida — Tampa, Florida
- Tufts University — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Washington University in St. Louis — St Louis, Missouri
- University of New Mexico — Albuquerque, New Mexico
- Columbia University Irving Medical Center — New York, New York
- University of North Caroline — Chapel Hill, North Carolina
- Wake Forest University — Winston-Salem, North Carolina
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio
- Premier Health - Miami Valley Hospital — Dayton, Ohio
- Kettering Health — Kettering, Ohio
- University of Pennsylvania — Philadelphia, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania
- Brown University — Providence, Rhode Island
- University of South Carolina Greenville — Greenville, South Carolina
- University of Texas Austin — Austin, Texas
- Austin Maternal Fetal Medicine — Austin, Texas
- University of Texas Health Science Center — Houston, Texas
- Eastern Virginia Medical School - Old Dominion University — Norfolk, Virginia
📞 Contact the Study Coordinator
Phone: (614) 293-2222
Email: kartik.venkatesh@osumc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Gestational Diabetes Mellitus
- A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus — Los Angeles, California
- Produce Rx in High Risk Pregnant Mothers at Harris Health — Houston, Texas
- Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial — Houston, Texas
Explore by condition: All Gestational Diabetes Mellitus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.