Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

• Pregnant with viable fetus at 6 to less than 23 weeks gestation

• Maternal age 18-50 years old

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
University of California at San Diego
RECRUITING
San Diego
North Carolina
University of North Carolina - Chapel Hill
RECRUITING
Chapel Hill
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Prisma Health Greenville Memorial Hospital
RECRUITING
Greenville
Texas
University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Ashley Battarbee, MD, MSCR
anbattarbee@uabmc.edu
205-975-2361
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2029-07
Participants
Target number of participants: 564
Treatments
Experimental: Continuous Glucose Monitoring
Real-time continuous glucose monitoring
No_intervention: Self-Monitoring of Blood Glucose
Self-monitoring of blood glucose (standard of care)
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov

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