Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06445946 · ClinicalTrials.gov registry record · Phase 4
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
A Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 1,572
- Enrollment target
- 20
- Study locations
NCT06445946: Recruiting Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, sponsored by Ohio State University.
NCT06445946 is a Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 1,572 participants, above the 239-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (558% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06445946, a Phase 4 study of Pregnancy, High Risk and Gestational Diabetes Mellitus, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 1,572 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
LGA will be defined as a birthweight ≥90th%tile for gestational age based on a US birth certificate reference adjusted for parity and/or fetal sex. Neonatal hypoglycemia will be defined as a blood glucose \<35 mg/dL or treatment \<24 hours after birth with either IV, PO, or gel glucose therapy. Neonatal hyperbilirubinemia will be defined as treated with phototherapy or exchange transfusion in the first postnatal week and either treatment in the first postnatal week or kernicterus. Fetal or neona
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Insulin
Study Locations (20)
Massachusetts
- Tufts University - Boston
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Texas
- University of Texas Austin - Austin
- Austin Maternal Fetal Medicine - Austin
- University of Texas Health Science Center - Houston
California
- Cedars Sinai Medical Center - Los Angeles
- University of California San Francisco - San Francisco
Ohio
- The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine - Columbus
- Premier Health - Miami Valley Hospital - Dayton
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
Alabama
- University of Alabama - Tuscaloosa
Florida
- University of South Florida - Tampa
Missouri
- Washington University in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,572 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2030-12 |
| Phase | Phase 4 |
What NCT06445946 shows while recruiting
NCT06445946 is an interventional study that assigns participants to a tested intervention. Its 1,572 participants enrollment target places it among the larger protocols in the corpus, above the 239-participant average among 20 other Pregnancy, High Risk trials with a reported enrollment target (558% higher).
The record links to 2 conditions, with Pregnancy, High Risk appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT06445946 names 20 study sites across 13 states, led by Massachusetts, Texas, California.
Frequently Asked Questions
What is clinical trial NCT06445946 about?
NCT06445946 is a clinical study titled "DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes". 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 ins...
What is the current status of trial NCT06445946?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 1,572 participants. The study started on 2024-08-01. Estimated completion is 2030-12.
What conditions does trial NCT06445946 study?
This clinical trial studies the following conditions: Pregnancy, High Risk, Gestational Diabetes Mellitus.
What interventions are being tested in trial NCT06445946?
The interventions under investigation include: Metformin (DRUG), Insulin (DRUG).
Who is sponsoring clinical trial NCT06445946?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06445946 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy, High Risk
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06445946's enrollment target sits among peer trials
1,572 1st of 20 higher than 20 of 20 other Pregnancy, High Risk trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy, High Risk trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
RECRUITING · Phase 4
-
Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)
RECRUITING · Phase 4
-
Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus
COMPLETED · Phase 4
-
Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)
COMPLETED · Phase 4
-
Continuous Glucose Monitor Use in Pregnancy
RECRUITING · NA
-
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06034080 · 1,566 participants · NA
Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections
- NCT05483855 · 1,580 participants
Telehealth-delivered HealthcaRe to ImproVe Care
- NCT06881069 · 1,560 participants · NA
Reach Through Equitable Implementation in Utah
- NCT05552222 · 1,590 participants · Phase 3
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI