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

Inclusion Criteria3

  • 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 Criteria8

  • 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

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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