AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes

RecruitingPhase 4Ages 18 Years - anyFemaleOhio State University
💬

In plain words

What the trial is, and whether it could suit you

This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin. This study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 or older * Gestational age at randomization between 20 0/7 - 33 6/7 weeks based on project gestational age. * GDM diagnosis less than or equal to 33 6/7 weeks based on project gestational age. * Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) 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. 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. * For individuals with GDM diagnosed \<20 0/7 weeks, documented A1c ≥\>6.5% within prior 6 months. * Pregestational diabetes documented in the medical record 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 (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.
💊

What it tests

  • Metformin
  • Insulin
📍

Where

26 sites
University of Alabama
Tuscaloosa, United States
Cedars Sinai Medical Center
Los Angeles, United States
University of California San Francisco
San Francisco, United States
Yale School of Medicine
New Haven, United States
Christiana Care
Newark, United States
University of South Florida
Tampa, United States
Tufts University
Boston, United States
Massachusetts General Hospital
Boston, United States

…and 18 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy