GDM: Insulin with or Without Metformin? (NCT06781775)
Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
🩺 Plain-English Summary (8th-Grade Level)
This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (2 items).
Location: University of Virginia — Charlottesville, Virginia
Age range: 18 Years to 50 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:
- 1\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Virginia — Charlottesville, Virginia
📞 Contact the Study Coordinator
Phone: (434) 409-3100
Email: ajr5y@uvahealth.org
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
- Preventing Obstetric Complications With Dietary Intervention — Milwaukee, Wisconsin
- DETERMINE: Detemir vs NPH — Los Angeles, California
- Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes — Birmingham, Alabama
- Immediate Postpartum Glucose Tolerance Testing — Long Beach, California
- Healthy Eating in Women at Risk of Gestational Diabetes — Québec, Quebec
- Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2) — Rochester, New York
Explore by condition: All Gestational Diabetes 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.