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RECRUITINGINTERVENTIONAL

CGM for Management of Type 2 Diabetes in Pregnancy

Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

CGM

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