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DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

Study acronym: DECIDE
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints: details revised at 1 of 2 entries Show 5 more changesShow less
    • Study sites: 24 to 26
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 14 of 26 entries
    • Publications: details revised at 4 of 4 entries
    • Study description expanded, about 5 words
  2. Trial sites expanded: 21 → 24 locationsv9
  3. Study sites: 19 to 21v8
  4. Eligibility criteria revised
    • Site contacts updated at 1 of 19 sites
    v7
  5. Study sites: 20 to 19v6
Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria expanded, about 10 words
    • Study sites revised (20)
    v5
  2. Site details revised at 1 of 20 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2024 to Aug 1, 2024
    • Site details revised at 20 of 20 sites
    v3
  4. Site contacts updated at 1 of 20 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ohio State University
253 trials monitored
See 12 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
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.
Trial Details
NCT Number NCT06445946
Lead Sponsor Ohio State University
Collaborators: Patient-Centered Outcomes Research Institute, The George Washington University Biostatistics Center
Conditions
(from sponsor)		 Gestational Diabetes Mellitus, Pregnancy, High Risk
Related terms Diabetes Mellitus, Diabetes, Gestational, Insulin Resistance
Enrollment 1,572 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov