RECRUITING

GDM: Insulin with or Without Metformin?

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial

Quick Facts

Study Start:2024-12-12
Study Completion:2027-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06781775

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment
  4. 4. Ability to take oral medication and be willing to adhere to the metformin regimen
  5. 5. Willing to take insulin if needed
  6. 6. Willing to take blood sugars 4 times per day
  1. * 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

Contacts and Locations

Study Contact

Amanda R Urban, MS
CONTACT
4344093100
ajr5y@uvahealth.org

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12
Study Completion Date2027-05-01

Study Record Updates

Study Start Date2024-12-12
Study Completion Date2027-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Gestational Diabetes