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

Description

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.

Conditions

Gestational Diabetes Mellitus, Pregnancy, High Risk

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Gestational Diabetes Mellitus
Intervention / Treatment

-

Contacts and Locations

Tuscaloosa

University of Alabama, Tuscaloosa, Alabama, United States, 35487

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Newark

Christiana Care, Newark, Delaware, United States, 19718

Tampa

University of South Florida, Tampa, Florida, United States, 33620

Boston

Tufts University, Boston, Massachusetts, United States, 02111

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
  • * Age 18 years or older
  • * Gestational age at randomization between 20 0/7 - 31 6/7 weeks based on project gestational age.
  • * GDM diagnosis between 20 0/7 - 31 6/7 weeks based on project gestational age.
  • * Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record.
  • * Patient willingness and ability to attend 2-year follow-up visit.
  • * Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function.
  • * Major structural malformation of the fetus.
  • * Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
  • * Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
  • * Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5%
  • * Fasting hyperglycemia \>115 mg/dl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
  • * Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).
  • * Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
  • * Language barrier (appropriate translation resources unavailable at the site)
  • * Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University,

Kartik Venkatesh, MD, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University

Study Record Dates

2030-12