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Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT

NCT06490874 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-10-28

No results posted yet for this study

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) (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).

Conditions

  • Gestational Diabetes Mellitus
  • Pregnancy, 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).

Sponsors & Collaborators

  • The George Washington University Biostatistics Center

    collaborator OTHER

  • DexCom, Inc.

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Kartik Venkatesh, MD, PhD · Ohio State University

  • Donna Gregory, RNC, BSN · Ohio State University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06490874 on ClinicalTrials.gov