NCT06445946 · Ohio State University
DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
(DECIDE)
What this study is about
This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomly assigned controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomly assigned to taken by mouth metformin versus injectable insulin.
View original scientific 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.
Interventions
DRUG
Metformin
Individuals randomized to this arm will receive oral metformin tablets for their Gestational diabetes mellitus treatment.
DRUG
Insulin
Individuals randomized to this arm will receive injectable insulin for their Gestational diabetes mellitus treatment.
Primary outcome measures
A neonatal composite adverse outcome of large-for-gestational-age (LGA) birthweight, hypoglycemia, hyperbilirubinemia, and/or death.
Time frame: 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 age
Time frame: 2 years of age.
Child BMI measured in kg/m2 as a continuous measure standardized using U.S. CDC reference adjusted for child sex
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 - 32 6/7 weeks based on project gestational age.
- GDM diagnosis less than or equal to 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) 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, i
Where
- Tuscaloosa, Alabama
- Los Angeles, California
- San Francisco, California
- Newark, Delaware
- Tampa, Florida
- Boston, Massachusetts
- St Louis, Missouri
- Albuquerque, New Mexico
- New York, New York
- Chapel Hill, North Carolina
- Winston-Salem, North Carolina
- Columbus, Ohio
And 9 more locations — see the full list below.
Collaborators
Patient-Centered Outcomes Research Institute, The George Washington University Biostatistics Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations