RecruitingNot ApplicableNCT06628453

CGM for Management of Type 2 Diabetes in Pregnancy

Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy


Sponsor

University of Alabama at Birmingham

Enrollment

564 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether using a continuous glucose monitor (CGM) — a small wearable sensor that tracks blood sugar levels in real time — improves pregnancy outcomes in women with type 2 diabetes. CGM provides more detailed glucose data compared to traditional finger-prick testing. **You may be eligible if...** - You are pregnant (between 6 and 23 weeks along) and between 18 and 50 years old - You have type 2 diabetes with a hemoglobin A1c of 6.5% or higher, treated with insulin or oral medications - You are carrying a single (not multiple) viable baby **You may NOT be eligible if...** - You have a skin condition or allergy to medical adhesives that makes wearing a CGM sensor difficult - You are pregnant with twins or more - Your baby has a major structural abnormality - You are enrolled in another conflicting study - You plan to deliver at a hospital outside the study network Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECGM

Real-time continuous glucose monitoring


Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT06628453


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