CGM for Management of Type 2 Diabetes in Pregnancy
Recruiting · NCT06628453 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions
- Multiple gestation
- Major fetal anomaly or two or more minor fetal anomalies
- Planned delivery outside study consortium
- Participating in another conflicting interventional study
- Participation in this trial in a previous pregnancy
- Patient unable to consent
- Physician refusal for other reasons
Where it is running
7 locations listed across 7 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- University of California at San Diego - San Diego, California, United States
- University of North Carolina - Chapel Hill - Chapel Hill, North Carolina, United States
- Oregon Health and Science University - Portland, Oregon, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Prisma Health Greenville Memorial Hospital - Greenville, South Carolina, United States
- University of Texas Health Science Center at Houston - Houston, Texas, United States