GDM: Insulin with or Without Metformin?
NCT06781775
Summary
This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.
Eligibility
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment 4. Ability to take oral medication and be willing to adhere to the metformin regimen 5. Willing to take insulin if needed 6. Willing to take blood sugars 4 times per day \- Exclusion Criteria: * 1\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy
Conditions2
Locations1 site
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NCT06781775