Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT

Not yet recruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2030

Conditions
Gestational Diabetes MellitusPregnancy, High Risk
Interventions
DEVICE

CGM device - Metformin group

Individuals randomized to metformin will be provided with a CGM device (Dexcom, Inc, San Diego, CA) to be worn for up to 10 days (minimum \>5 days) at two pregnancy (randomization to metformin or insulin, late third trimester \> 340/7 weeks) and three postpartum timepoints (immediately after delivery, \~6 weeks, and \~2 years).

DEVICE

CGM device - Insulin group

Individuals randomized to insulin will be provided with a CGM device (Dexcom, Inc, San Diego, CA) to be worn for up to 10 days (minimum \>5 days) at two pregnancy (randomization to metformin or insulin, late third trimester \> 340/7 weeks) and three postpartum timepoints (immediately after delivery, \~6 weeks, and \~2 years).

Trial Locations (4)

35487

University of Alabama, Tuscaloosa

43210

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus

45409

Premier Health - Miami Valley Hospital, Dayton

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

The George Washington University Biostatistics Center

OTHER

collaborator

DexCom, Inc.

INDUSTRY

lead

Ohio State University

OTHER