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CGM device - Metformin for Gestational Diabetes (DECIDE CGM Trial)

N/A
Waitlist Available
Led By Kartik Venkatesh, MD, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years postpartum
Awards & highlights
No Placebo-Only Group

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).

Eligible Conditions
  • Gestational Diabetes
  • Pregnancies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time in range (TIR)
Secondary study objectives
Cholesterol
Coefficient of variation (CV)
Hyperbilirubinemia
+18 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: CGM device - MetforminExperimental Treatment1 Intervention
Individuals 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). The CGM device will be used in blinded mode for both participants and providers (i.e., neither will be able to see glucose values).
Group II: CGM device - InsulinExperimental Treatment1 Intervention
Individuals 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). The CGM device will be used in blinded mode for both participants and providers (i.e., neither will be able to see glucose values).

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
864 Previous Clinical Trials
654,140 Total Patients Enrolled
The George Washington University Biostatistics CenterOTHER
26 Previous Clinical Trials
111,032 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
143 Previous Clinical Trials
35,096 Total Patients Enrolled
~200 spots leftby Dec 2029