Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT
Public ClinicalTrials.gov record NCT06490874. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Continuous Glucose Monitoring Among Individuals With Gestational Diabetes Treated With Metformin Versus Insulin: Protocol for a Nested Prospective Cohort in the DECIDE RCT (DECIDE CGM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a nested multicenter prospective cohort conducted concurrently and in conjunction with the DECIDE two-arm, pragmatic non-inferiority comparative effectiveness Randomized Controlled Trial (RCT) (NCT06445946) of metformin versus insulin among individuals with Gestational diabetes mellitus (GDM) requiring pharmacotherapy for glycemic control. Continuous Glucose Monitoring (CGM)-derived glycemic metric in pregnancy and postpartum will be compared between individuals randomized to metformin versus insulin. In addition, the association between CGM metrics and adverse pregnancy outcomes will be examined. Finally, whether CGM metrics can accurately identify diabetes postpartum compared with an oral glucose tolerance test and hemoglobin A1c will be determined. A total of 300 (150 metformin, 150 insulin) pregnant individuals will be recruited with GDM who require pharmacotherapy to use a blinded CGM device (Dexcom, Inc, San Diego, CA) at two pregnancy (medication randomization, late third trimester) and three postpartum timepoints (delivery, \~6 weeks, and \~2 years).
Study identification
- NCT ID
- NCT06490874
- Recruitment status
- Withdrawn
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2025
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2030
- Last update posted
- Oct 27, 2025
2025 – 2030
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Tuscaloosa | Alabama | 35487 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | — |
| Premier Health - Miami Valley Hospital | Dayton | Ohio | 45409 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Gestational Diabetes Mellitus trials
Other public records listing Gestational Diabetes Mellitus. Sorted by last update posted; newest first. Not a recommendation.
- NCT06445946: DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes Recruiting
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- NCT02610179: Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06490874, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 27, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06490874 live on ClinicalTrials.gov.