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CGM for Management of Type 2 Diabetes in Pregnancy

RecruitingNAAges 18 Years - 50 YearsFemaleUniversity of Alabama at Birmingham
NCT06628453 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, 3

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📋 Eligibility rules (as published)
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
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What it tests

  • CGM
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Where

7 sites
University of Alabama at Birmingham
Birmingham, United States
University of California at San Diego
San Diego, United States
University of North Carolina - Chapel Hill
Chapel Hill, United States
Oregon Health and Science University
Portland, United States
University of Pennsylvania
Philadelphia, United States
Prisma Health Greenville Memorial Hospital
Greenville, United States
University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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