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

Launched by OHIO STATE UNIVERSITY · Jun 4, 2024

Keywords

ClinConnect Summary

The DECIDE trial is studying the effectiveness of two treatments for gestational diabetes, a condition that affects some pregnant women and can lead to complications. Specifically, it compares metformin, an oral medication, with insulin, which is given by injection. The goal is to find out if metformin is just as effective as insulin in preventing problems during pregnancy and if both treatments are safe for mothers and their babies. The trial will involve 1,572 pregnant women who need medication to control their blood sugar levels, and they will be followed for up to two years after giving birth.

To be eligible for this study, participants must be at least 18 years old, pregnant with a single baby, and diagnosed with gestational diabetes between 20 to 31 weeks of pregnancy. They should also require medication for high blood sugar levels. Those interested will attend regular appointments to monitor their health and that of their baby, providing valuable information that could help improve treatment options for future mothers with gestational diabetes.

Gender

FEMALE

Eligibility criteria

• 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, 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.