Actively Recruiting
CGM for Management of Type 2 Diabetes in Pregnancy
Led by University of Alabama at Birmingham · Updated on 2025-06-15
564
Participants Needed
7
Research Sites
220 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CGM for Management of Type 2 Diabetes in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Unable or unwilling to wear continuous glucose monitor due to intolerance to medical adhesives or skin conditions
- Multiple gestation pregnancy
- Major fetal anomaly or two or more minor fetal anomalies
- Planned delivery outside the study consortium
- Participating in another conflicting interventional study
- Participation in this trial in a previous pregnancy
- Unable to provide consent
- Physician refusal for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University of California at San Diego
San Diego, California, United States, 92121
Actively Recruiting
3
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
Oregon Health and Science University
Portland, Oregon, United States, 97213
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
7
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ashley Battarbee, MD, MSCR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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