Status:
WITHDRAWN
Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
The George Washington University Biostatistics Center
DexCom, Inc.
Conditions:
Gestational Diabetes Mellitus
Pregnancy, High Risk
Eligibility:
FEMALE
18+ years
Brief Summary
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)...
Detailed Description
Gestational diabetes mellitus (GDM) is the most frequent metabolic complication of pregnancy, and affects nearly 1 in 10 pregnant individuals in the U.S. annually. GDM increases the risks of both adve...
Eligibility Criteria
Inclusion
- Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
- Age \>18 years
- Gestational age at randomization between 200/7 - 316/7 weeks based on project gestational age.
- GDM diagnosis between 200/7 - 316/7 weeks based on project gestational age.
- Requires medication for glucose control defined as ≥30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record.
- Patient willingness and ability to attend 2-year follow-up visit.
- Patient willingness to wear and return a blinded CGM device. It is possible that some enrolled individuals may choose to use a separate CGM device for glucose monitoring as part of clinical care.
Exclusion
- Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function.
- Major structural malformation of the fetus.
- Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
- Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
- Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5%
- Fasting hyperglycemia \>115 mg/dl for ≥50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
- Enrolled in a trial that influences primary study outcomes of the parent DECIDE trial (composite neonatal outcome at delivery or childhood body mass index at 2 years).
- Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
- Language barrier (appropriate translation resources unavailable at the site).
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
- In addition, individuals who report a prior allergy or sensitivity to CGM will also be excluded.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2030
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06490874
Start Date
September 1 2025
End Date
December 1 2030
Last Update
October 28 2025
Active Locations (4)
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1
University of Alabama
Tuscaloosa, Alabama, United States, 35487
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
4
Premier Health - Miami Valley Hospital
Dayton, Ohio, United States, 45409