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Continuous Glucose Monitor Use in Pregnancy

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 1, 2026 → Dec 31, 2026
See other at-risk trials from University of Massachusetts, Worcester

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jul 1, 2026 to Dec 31, 2026v7
  2. Re-verified, no change to tracked fieldsv6
  3. Start date changed from estimate of Sep 1, 2024 to May 23, 2024v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 1, 2024 to Sep 1, 2024
    • Site details revised
    v4
  5. Start date: Jan 1, 2024 to Oct 1, 2024
    • Enrollment target: 162 to 180
    • Study description revised
    v3
  6. Primary completion date: Jul 1, 2025 to Jul 1, 2026
    • Start date: Jul 1, 2023 to Jan 1, 2024
    • Study completion date: Jul 1, 2025 to Jul 1, 2027
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.
Trial Details
NCT Number NCT05317585
Lead Sponsor University of Massachusetts, Worcester
Conditions
(from sponsor)		 Type 2 Diabetes Treated With Insulin, Pregnancy, High Risk
Related terms Diabetes Mellitus, Type 2
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov