Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT

Withdrawn before enrolling

Conditions studied: Gestational Diabetes Mellitus, Pregnancy, High Risk

In brief

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).

Key facts

Study ID: NCT06490874
Run by: Ohio State University
People needed: 0
Starts: 2025-09-01
Expected to finish: 2030-12-01
Last updated by the study team: 2025-10-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Alabama — Tuscaloosa, Alabama, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine — Columbus, Ohio, United States
Premier Health - Miami Valley Hospital — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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