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Recruiting Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT06445946

Public ClinicalTrials.gov record NCT06445946. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 10:24 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06445946
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Ohio State University
Other
Enrollment
1,572 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2024
Primary completion
Nov 30, 2029
Completion
Nov 30, 2030
Last update posted
Jun 24, 2026

2024 – 2030

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
21
Facility City State ZIP Site status
University of Alabama Tuscaloosa Alabama 35487 Recruiting
Cedars Sinai Medical Center Los Angeles California 90048 Recruiting
University of California San Francisco San Francisco California 94143 Recruiting
Christiana Care Newark Delaware 19718 Withdrawn
University of South Florida Tampa Florida 33620 Recruiting
Tufts University Boston Massachusetts 02111 Recruiting
Massachusetts General Hospital Boston Massachusetts 02114 Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 Terminated
Washington University in St. Louis St Louis Missouri 63130 Recruiting
University of New Mexico Albuquerque New Mexico 87131 Recruiting
Columbia University Irving Medical Center New York New York 10032 Recruiting
University of North Caroline Chapel Hill North Carolina 27599 Withdrawn
Wake Forest University Winston-Salem North Carolina 27106 Recruiting
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine Columbus Ohio 43210 Recruiting
Premier Health - Miami Valley Hospital Dayton Ohio 45409 Recruiting
Kettering Health Kettering Ohio 45429 Not yet recruiting
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting
University of Pittsburgh Pittsburgh Pennsylvania 15213 Recruiting
Brown University Providence Rhode Island 02912 Recruiting
University of South Carolina Greenville Greenville South Carolina 29605 Recruiting
University of Texas Austin Austin Texas 78705 Recruiting
Austin Maternal Fetal Medicine Austin Texas 78758 Not yet recruiting
University of Texas Health Science Center Houston Texas 77030 Recruiting
Eastern Virginia Medical School - Old Dominion University Norfolk Virginia 23501 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06445946, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 24, 2026 · Synced Sep 11, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06445946 live on ClinicalTrials.gov.

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