CGM for Management of Type 2 Diabetes in Pregnancy
Sponsored by University of Alabama at Birmingham
About this study
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
We will conduct a multicenter, open-label randomized controlled trial of pregnant individuals with T2DM to test the effectiveness of CGM at improving maternal and neonatal outcomes, compared to SMBG. All pregnant women who have T2DM will be screened for eligibility. If a patient is eligible, the study will be explained to them and if they consent to participate, they will be randomized centrally in a 1:1 ratio to CGM or SMBG. Participants randomized to CGM will receive a Dexcom G7 CGM and be instructed how to apply it, access the CGM data, and how to interpret and respond to trend arrows and alerts. Participants will replace the CGM device with a new sensor every 10 days for the entire pregnancy. Participants randomized to SMBG will be instructed to perform SMBG at least 4 times daily (fa…
Where this study is enrolling (7)
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University of Alabama at Birmingham
Birmingham, Alabama
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University of California at San Diego
San Diego, California
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University of North Carolina - Chapel Hill
Chapel Hill, North Carolina
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Oregon Health and Science University
Portland, Oregon
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University of Pennsylvania
Philadelphia, Pennsylvania
Show all 7 locations
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Prisma Health Greenville Memorial Hospital
Greenville, South Carolina
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University of Texas Health Science Center at Houston
Houston, Texas
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.