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DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
Sponsor: Ohio State University
Summary
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.
Official title: DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1572
Start Date
2024-08-01
Completion Date
2030-12
Last Updated
2026-01-07
Healthy Volunteers
No
Interventions
Metformin
Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.
Insulin
Individuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.
Locations (21)
University of Alabama
Tuscaloosa, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
University of South Florida
Tampa, Florida, United States
Tufts University
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Washington University in St. Louis
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
Columbia University Irving Medical Center
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States
Premier Health - Miami Valley Hospital
Dayton, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
University of South Carolina Greenville
Greenville, South Carolina, United States
University of Texas Austin
Austin, Texas, United States
Austin Maternal Fetal Medicine
Austin, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
Eastern Virginia Medical School - Old Dominion University
Norfolk, Virginia, United States