Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Nasim Sobhani, MD (ucsf)
Headshot of Nasim Sobhani
Nasim Sobhani

Description

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

Details

Keywords

Gestational Diabetes Mellitus, Pregnancy, High Risk, Insulin, Pregnancy, Glycemic control, Metformin, Gestational diabetes, Diabetes, Adverse pregnancy outcomes, Diabetes Mellitus

Eligibility

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • University of New Mexico accepting new patients
    Albuquerque New Mexico 87131 United States

Lead Scientist at University of California Health

  • Nasim Sobhani, MD (ucsf)
    Dr. Nasim Sobhani is a perinatologist, an obstetrician who specializes in care during high-risk pregnancies. She provides comprehensive care for women with preexisting conditions that can affect pregnancy and for women with pregnancy-specific health conditions. She also cares for developing fetuses when genetic or structural conditions have been diagnosed in utero.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ohio State University
ID
NCT06445946
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 1572 study participants
Last Updated