DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Key facts
- Who runs it
- Ohio State University
- Where
- Albuquerque, Austin, Boston, Chapel Hill, Columbus, Dayton, Greenville, Houston, Kettering, Los Angeles, Milwaukee, New Haven, New York, Newark, Norfolk, Philadelphia, Pittsburgh, Providence, San Francisco, St Louis, Tampa, Tuscaloosa, and Winston-Salem, United StatesSee the 26 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 1,572 people, planned
- Started
- 1 Aug 2024
- Expected to end
- Dec 2030
- Type of study
- Interventional, 2 groups
- Treatments tested
- Metformin
- Insulin
- Record updated
- 7 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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%
- Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included
- Renal disease (serum creatinine >1.3 mg/dL) due to the potential impact of metformin on renal function
- 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)
- Major structural malformation of the fetus
- Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening
- 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)
Where in United States
- University of New MexicoAlbuquerque, United StatesContact: Vivek Katukuri, MDTaking people
- Austin Maternal Fetal MedicineAustin, United StatesContact: Mollie McDonnold, MDTaking people
- University of Texas AustinAustin, United StatesContact: Lorie Harper, MDTaking people
- Massachusetts General HospitalBoston, United StatesContact: Lydia Shook, MDTaking people
- Tufts UniversityBoston, United StatesContact: Erika Werner, MDTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesContact: Kartik Venkatesh, MD, PhDNo longer taking part
- University of North CarolineChapel Hill, United StatesContact: Kartik Venkatesh, MD, PhDNo longer taking part
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineColumbus, United StatesContact: Kartik Venkatesh, MD, PhDTaking people
- Premier Health - Miami Valley HospitalDayton, United StatesContact: Samantha Wiegand, MDTaking people
- University of South Carolina GreenvilleGreenville, United StatesContact: Kacey Eichelberger, MDTaking people
- University of Texas Health Science CenterHouston, United StatesContact: Hector Mendez-Figueroa, MDTaking people
- Kettering HealthKettering, United StatesContact: Hind Moussa, MDNot yet recruiting
- Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Tania Esakoff, MDTaking people
- Medical College of WisconsinMilwaukee, United StatesContact: Anna Palatnik, MDTaking people
- Yale School of MedicineNew Haven, United StatesContact: Tulin Ozcan, MDTaking people
- Columbia University Irving Medical CenterNew York, United StatesContact: Noelia Zork, MDTaking people
- Christiana CareNewark, United StatesContact: Kartik Venkatesh, MD, PhDNo longer taking part
- Eastern Virginia Medical School - Old Dominion UniversityNorfolk, United StatesContact: Malgorzata Mlynarczyk, MDTaking people
- University of PennsylvaniaPhiladelphia, United StatesContact: Celeste Durnwald, MDTaking people
- University of PittsburghPittsburgh, United StatesContact: Maisa Feghali, MDTaking people
- Brown UniversityProvidence, United StatesContact: Martha Kole-White, MDTaking people
- University of California San FranciscoSan Francisco, United StatesContact: Nasim Sobhani, MDTaking people
- Washington University in St. LouisSt Louis, United StatesContact: Megan Lawlor, MDTaking people
- University of South FloridaTampa, United StatesContact: Anjali Kaimal Kaimal, MDTaking people
- University of AlabamaTuscaloosa, United StatesContact: Ashley Battarbee, MDTaking people
- Wake Forest UniversityWinston-Salem, United StatesContact: David Stamilio, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- MetforminTreatment being tested
Metformin as either immediate- or extended-release formulations can be utilized, and titrated to a maximum daily dose of 2,500 mg. Participants receiving metformin will have insulin added only if they have not achieved euglycemia for at least 30% of glucose values after generally receiving the maximum daily dose of metformin of 2,500 mg, or in select situations in the setting of participant intolerance due to mild gastrointestinal symptoms. Participants will be asked to continue taking metformin after treatment supplementation with insulin.
- InsulinTreatment being tested
Insulin will be initiated utilizing clinical standards using trimester-specific weight-based dosing criteria, including both basal and prandial insulins for up to a total of 4 daily injections. Consistent with clinical practice, some people may be managed with a single dose of intermediate- or long-acting insulin at night to treat isolated fasting hyperglycemia, while others may require additional treatment of postprandial hyperglycemia with shorter-acting insulin. The sites' insulin formularies include rapid- (Novolog and Humalog), intermediate- (Humulin N, Novolin N, and NPH), and long-acting insulins (Detemir and Lantus).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes
- Publications
- Record updated
- 7 October 2026