NOT_YET_RECRUITING
Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT
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
🗓️ Study Start (Actual) September 2024
🗓️ Primary Completion (Estimated) December 2029
✅ Study Completion (Estimated) December 2030
👥 Enrollment (Estimated) 300
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Tuscaloosa, Alabama, United States
📍 Boston, Massachusetts, United States
📍 Albuquerque, New Mexico, United States
📍 Chapel Hill, North Carolina, United States
📍 Columbus, Ohio, United States
📍 Dayton, Ohio, United States

📋 Eligibility Criteria

Description

    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 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 June 2024
  • First Submitted that Met QC Criteria 1 July 2024
  • First Posted 8 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 July 2024
  • Last Update Posted 8 July 2024
  • Last Verified July 2024