BridgeMD
Compares treatment options for Gestational Diabetes Mellitus
Official title DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes
ClinicalTrials.gov ID: NCT06445946
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gestational diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- 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...
- For individuals with GDM diagnosed \ 6.5% within prior 6 months.
- Pregestational diabetes documented in the medical record or prior A1c\>= 6.5%
See the full 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 - 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.
- 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 \ 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 assigned by chance, may be included.
The study team makes the final eligibility decision.
Where it's taking place
- Tuscaloosa, Alabama, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Newark, Delaware, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Dayton, Ohio, United States
- Kettering, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Greenville, South Carolina, United States
- Austin, Texas, United States
- Houston, Texas, United States
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tuscaloosa, Alabama, United States; Los Angeles, California, United States; San Francisco, California, United States; Newark, Delaware, United States; Tampa, Florida, United States; Boston, Massachusetts, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.