Back to search results

Comparing Metformin and Insulin for Gestational Diabetes

This study, called DECIDE, is comparing two common treatments for gestational diabetes (diabetes that develops during pregnancy): metformin and insulin. Researchers want to see if metformin, taken as a pill, is as effective as insulin, which is given by injection, in preventing certain problems for babies, such as being born too large or having low blood sugar. They will also look at the child's weight at two years old. The study will involve about 1,572 pregnant individuals with gestational diabetes who need medication to manage their blood sugar. You might be able to join if you are 18 or older, are pregnant with one baby, and were diagnosed with gestational diabetes between 20 and almost 34 weeks of pregnancy. The study's current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to receive either metformin or insulin. It aims to enroll 1,572 individuals.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Children will be followed up to measure their body mass index (BMI) at 2 years of age. Neonatal outcomes are measured at birth or within the first week after birth, and death up to 30 days postnatal.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06445946

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Ohio State University
~1,572 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:MetforminInsulin

At a glance

Recruiting sites
19 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.
Measured over LGA at birth. Hypoglycemia <24 hours after birth. Hyperbilirubinemia within the first week after birth. Death between randomization to hospital discharge or 30 days postnatal.
+1 more outcome measured

Conditions

Gestational Diabetes Mellitus
Pregnancy, High Risk

Explore related trials

Gestational Diabetes

Where it's being run

24 sites across 15 states
Massachusetts3
Ohio3
Texas3
California2
North Carolina2
Pennsylvania2
Alabama1
Delaware1

Study leadership

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

Who to contact

Kartik Venkatesh, MD, PhD
[email protected]
614-293-2222
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.LGA at birth. Hypoglycemia <24 hours after birth. Hyperbilirubinemia within the first week after birth. Death between randomization to hospital discharge or 30 days postnatal.

    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 neonatal death can be due to any indication between randomization to hospital discharge or 30 days postnatal if still hospitalized (excluding voluntary pregnancy termination).

  • Child body mass index (BMI) at 2 years of age2 years of age.

    Child BMI measured in kg/m2 as a continuous measure standardized using U.S. CDC reference adjusted for child sex