GDM: Insulin with or Without Metformin?
Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
University of Virginia
130 participants
Dec 12, 2024
INTERVENTIONAL
Conditions
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 Criteria7
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
- Ability to take oral medication and be willing to adhere to the metformin regimen
- Willing to take insulin if needed
- Willing to take blood sugars 4 times per day
- \-
Exclusion Criteria1
- \) 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
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Interventions
Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.
Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06781775