Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Study acronym: iGDM
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Oct 1, 2026 → Dec 31, 2026
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Record History

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  1. Primary completion pushed from Oct 1, 2026 to Dec 31, 2026 Show 5 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 5 of 17 entries
    • Study description revised
    • Site contacts updated at 1 of 5 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Apr 1, 2026 to Oct 1, 2026
    • Study completion date: Apr 8, 2026 to Dec 31, 2026
    • Site contacts updated at 1 of 5 sites
    v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 1 to 5v6
  5. Eligibility criteria revised
    • Secondary endpoints: 16 to 17
    • Collaborators: 4 to 5
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Start date changed from estimate of Jan 31, 2022 to Mar 1, 2022v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 15, 2021 to Jan 31, 2022
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • 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.
Indiana University
313 trials monitored
See 44 trials at risk
Diabetes
5,101 trials monitored
See 233 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.
Trial Details
NCT Number NCT05124808
Lead Sponsor Indiana University
Collaborators: University of Pittsburgh, University of Alabama at Birmingham, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)		 Gestational Diabetes, Pregnancy, High Risk, Overweight and Obesity
Related terms Diabetes, Gestational, Obesity, Overweight
Enrollment 828 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov