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DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
NCT06445946 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Insulin
Study Locations (20)
Massachusetts
- Tufts University — Boston
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
Texas
- University of Texas Austin — Austin
- Austin Maternal Fetal Medicine — Austin
- University of Texas Health Science Center — Houston
California
- Cedars Sinai Medical Center — Los Angeles
- University of California San Francisco — San Francisco
Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus
- Premier Health - Miami Valley Hospital — Dayton
Pennsylvania
- University of Pennsylvania — Philadelphia
- University of Pittsburgh — Pittsburgh
Alabama
- University of Alabama — Tuscaloosa
Florida
- University of South Florida — Tampa
Missouri
- Washington University in St. Louis — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,572 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2030-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06445946
The ClinicalTrials.gov registry entry for NCT06445946 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,572 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 640 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 2 interventions — of which Metformin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06445946 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Massachusetts, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06445946 about?
NCT06445946 is a clinical study titled "DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes". 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 ins...
What is the current status of trial NCT06445946?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,572 participants. The study started on 2024-08-01. Estimated completion is 2030-12.
What conditions does trial NCT06445946 study?
This clinical trial studies the following conditions: Pregnancy, High Risk, Gestational Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06445946?
The interventions under investigation include: Metformin (DRUG), Insulin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06445946?
This trial is sponsored by Ohio State University, which has 640 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06445946 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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