Comparing insulin treatment with or without metformin for gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of continuing metformin alongside insulin therapy in pregnant women diagnosed with gestational diabetes who require insulin for blood sugar control. Participants will be randomly assigned to either continue metformin or discontinue it when insulin is introduced. The study aims to determine if maintaining metformin can lower insulin dosage requirements and enhance both maternal and neonatal health outcomes. This research addresses a gap in current knowledge regarding the optimal management of gestational diabetes when both medications are needed.

Why it matters

Who can join: the full rules

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

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   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

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Study coordinator: Amanda R Urban, MS
• Email: ajr5y@uvahealth.org
• Phone: 4344093100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Mobile-based obstetric monitoring for hypertension and diabetes during pregnancy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.