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: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (12 items).
Location: University of Alabama — Tuscaloosa, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function.
- Major structural malformation of the fetus.
- Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
- Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
- For individuals with GDM diagnosed \<20 0/7 weeks, documented A1c ≥\>6.5% within prior 6 months.
- Pregestational diabetes documented in the medical record or prior A1c\>= 6.5%
- Fasting hyperglycemia \>115 mg/dl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
- Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).
- Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
- Language barrier (appropriate translation resources unavailable at the site)
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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.
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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.