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

Sponsored by Ohio State University

About this study

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.

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycemic control decreases the risk of adverse pregnancy outcomes for the pregnant individual with GDM and the infant exposed in utero (1). One in four individuals with GDM will require pharmacotherapy to achieve glycemic control. Insulin has been the mainstay of pharmacotherapy. Metformin is an alternative option increasingly used in clinical practice (2). Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterized, adequately powered, and diverse U.S. population remain lacking (3). Because metformin crosses the placenta, long-term safety data, in particular the risk of childhood obesity, from exposed children are also…

Where this study is enrolling (21)

Show all 21 locations

  • Massachusetts General Hospital

    Boston, Massachusetts

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  • Washington University in St. Louis

    St Louis, Missouri

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  • University of New Mexico

    Albuquerque, New Mexico

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  • Columbia University Irving Medical Center

    New York, New York

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  • Wake Forest University

    Winston-Salem, North Carolina

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  • Kettering Health

    Kettering, Ohio

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  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

    Columbus, Ohio

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  • Premier Health - Miami Valley Hospital

    Dayton, Ohio

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  • University of Pennsylvania

    Philadelphia, Pennsylvania

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  • University of Pittsburgh

    Pittsburgh, Pennsylvania

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  • Brown University

    Providence, Rhode Island

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  • University of South Carolina Greenville

    Greenville, South Carolina

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  • University of Texas Austin

    Austin, Texas

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  • University of Texas Health Science Center

    Houston, Texas

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  • Austin Maternal Fetal Medicine

    Austin, Texas

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  • Eastern Virginia Medical School - Old Dominion University

    Norfolk, Virginia

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Who can participate

Inclusion 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 - 33 6/7 weeks based on project gestational age.
  • ✓GDM diagnosis less than or equal to 33 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) 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.

Exclusion criteria

  • ✕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.
  • ✕For individuals with GDM diagnosed \<20 0/7 weeks, documented A1c ≥\>6.5% within prior 6 months.
  • ✕Pregestational diabetes documented in the medical record 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.

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Trial data sourced from ClinicalTrials.gov.