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Gestational Diabetes and Pharmacotherapy (GAP)

Study acronym: GAP
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Mar 31, 2026 → Jun 15, 2026
See other at-risk trials from Medical College of Wisconsin

Record History

  1. Primary completion pushed from Mar 31, 2026 to Jun 15, 2026v14
  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv13 Show 1 more changeShow less
    • Site details revised
  3. 2 versions Re-verified since Jan 2, 2025, no change to tracked fieldsv11-v12
  4. Primary completion date: Oct 1, 2026 to Mar 31, 2026 Completion date: Oct 31, 2026 to Oct 1, 2026v10 Show 1 more changeShow less
    • Completion date: Oct 31, 2026 to Oct 1, 2026
  5. Primary completion date: Feb 1, 2026 to Oct 1, 2026 Completion date: Mar 31, 2026 to Oct 31, 2026v9 Show 1 more changeShow less
    • Completion date: Mar 31, 2026 to Oct 31, 2026
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: May 1, 2021 to May 4, 2021v8
  2. Re-verified, no change to tracked fieldsv7
  3. Study description expanded, about 49 words Collaborators expanded, about 12 wordsv6 Show 1 more changeShow less
    • Collaborators expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study description revisedv5 See this version in full on ClinicalTrials.gov ↗
  5. Primary completion date: Jun 1, 2024 to Feb 1, 2026 Enrollment target: 284 to 416 · Completion date: Jun 1, 2025 to Mar 31, 2026v4 Show 2 more changesShow less
    • Enrollment target: 284 to 416
    • Completion date: Jun 1, 2025 to Mar 31, 2026
  6. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jun 1, 2021 to Jun 1, 2024 · Start date changed from estimate of Sep 1, 2020 to May 1, 2021 · Completion date: Jun 1, 2028 to Jun 1, 2025 · 5 morev3 Show 8 more changesShow less
    • Primary completion date: Jun 1, 2021 to Jun 1, 2024
    • Start date changed from estimate of Sep 1, 2020 to May 1, 2021
    • Completion date: Jun 1, 2028 to Jun 1, 2025
    • Interventions: Glyburide (Drug), Insulin (Drug), Metformin (Drug) to Insulin (Drug)
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 1 to 2
    • Site details revised
    • Study title shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  7. Start date: Aug 1, 2018 to Sep 1, 2020v2
  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.
The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.
Trial Details
NCT Number NCT03527537
Lead Sponsor Medical College of Wisconsin
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Gestational Diabetes
Enrollment 416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov