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RECRUITING
NCT06445946
PHASE4

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

Sponsor: Ohio State University

View on ClinicalTrials.gov

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

DRUG

Metformin

Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.

DRUG

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