RECRUITING

CGM for Management of Type 2 Diabetes in Pregnancy

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

The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis

Official Title

Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy

Quick Facts

Study Start:2025-04-08
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06628453

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. * Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater
  2. * Pregnant with viable fetus at 6 to less than 23 weeks gestation
  3. * Maternal age 18-50 years old
  1. * Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions
  2. * Multiple gestation
  3. * Major fetal anomaly or two or more minor fetal anomalies
  4. * Planned delivery outside study consortium
  5. * Participating in another conflicting interventional study
  6. * Participation in this trial in a previous pregnancy
  7. * Patient unable to consent
  8. * Physician refusal for other reasons

Contacts and Locations

Study Contact

Ashley Battarbee, MD, MSCR
CONTACT
205-975-2361
anbattarbee@uabmc.edu

Principal Investigator

Ashley Battarbee, MD, MSCR
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
University of California at San Diego
San Diego, California, 92121
United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Oregon Health and Science University
Portland, Oregon, 97213
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Ashley Battarbee, MD, MSCR, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2025-04-08
Study Completion Date2029-07

Study Record Updates

Study Start Date2025-04-08
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Diabetes
  • Pregnancy
  • CGM

Additional Relevant MeSH Terms

  • Type 2 Diabetes Mellitus (T2DM)
  • Pregnancy