Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial
University of Virginia
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.
Description
This research study is being conducted to better treat patients who develop gestational diabetes which is diabetes that is diagnosed and present only during the course of pregnancy. Normally patients that develop gestational diabetes are treated with either metformin or insulin. Some need treatment with both. Both are considered safe in pregnancy and both are considered as standard treatments by national guidelines. Many patients ask to start with metformin because it is easy to take and does not require an injection. Sometimes, patients' blood sugars are not controlled enough on metformin so…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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 kidn…
Interventions
- DrugMetformin + Insulin
Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stay on metformin and add insulin.
- DrugInsulin
Pregnant women who have have gestational diabetes and have uncontrolled blood sugar with metformin alone will stop on metformin and add insulin.
Location
- University of VirginiaCharlottesville, Virginia