Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT (NCT06490874) | Clinical Trial Compass
WithdrawnNot Applicable
Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT
Stopped: We will focus on parent study
United States0Started 2025-09
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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 wee…
What they're measuring
1
Time in range (TIR)
Timeframe: From medication randomization till late third trimester, up to 14 weeks