Actively Recruiting
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Led by Ohio State University · Updated on 2026-01-07
1572
Participants Needed
21
Research Sites
330 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant with a single baby (twin reduction to singleton before 14 weeks is allowed)
- Age 18 years or older
- Gestational age between 20 0/7 and 33 6/7 weeks at randomization
- Diagnosed with gestational diabetes mellitus (GDM) at or before 33 6/7 weeks
- Requires medication for glucose control with at least 30% elevated glucose values prior to randomization
- Willing and able to attend follow-up visits for 2 years after delivery
You will not qualify if you...
- Kidney disease with serum creatinine greater than 1.3 mg/dL
- Major structural malformation of the fetus
- Known fetal aneuploidy from invasive testing or positive cell-free DNA screening
- Contraindications to metformin or insulin such as history of lactic acidosis, severe nausea/vomiting, allergy, or anaphylaxis
- GDM diagnosed before 20 weeks with A1c equal or greater than 6.5% in past 6 months
- Pregestational diabetes or prior A1c equal or greater than 6.5%
- Fasting blood sugar over 115 mg/dL for at least half of fasting tests in past week
- Enrolled in another trial affecting the same study outcomes
- Prenatal care or delivery planned where electronic medical records are not accessible to researchers
- Language barriers without available translation resources
- Participation in this trial during a previous pregnancy
AI-Screening
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Trial Site Locations
Total: 21 locations
1
University of Alabama
Tuscaloosa, Alabama, United States, 35487
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
5
Tufts University
Boston, Massachusetts, United States, 02111
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Not Yet Recruiting
9
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
10
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
11
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
Actively Recruiting
12
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Premier Health - Miami Valley Hospital
Dayton, Ohio, United States, 45409
Actively Recruiting
14
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
15
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
16
Brown University
Providence, Rhode Island, United States, 02912
Actively Recruiting
17
University of South Carolina Greenville
Greenville, South Carolina, United States, 29605
Actively Recruiting
18
University of Texas Austin
Austin, Texas, United States, 78705
Actively Recruiting
19
Austin Maternal Fetal Medicine
Austin, Texas, United States, 78758
Not Yet Recruiting
20
University of Texas Health Science Center
Houston, Texas, United States, 77030
Actively Recruiting
21
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, United States, 23501
Actively Recruiting
Research Team
K
Kartik Venkatesh, MD, PhD
CONTACT
A
Anna Bartholomew, MPH, BS, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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