CGM for Management of Type 2 Diabetes in Pregnancy

Description

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

Conditions

Type 2 Diabetes Mellitus (T2DM), Pregnancy

Study Overview

Study Details

Study overview

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

Continuous Glucose Monitoring for Management of Type 2 Diabetes in Pregnancy

CGM for Management of Type 2 Diabetes in Pregnancy

Condition
Type 2 Diabetes Mellitus (T2DM)
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

San Diego

University of California at San Diego, San Diego, California, United States, 92121

Chapel Hill

University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States, 27599

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97213

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Greenville

Prisma Health Greenville Memorial Hospital, Greenville, South Carolina, United States, 29605

Houston

University of Texas Health Science Center at Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Ashley Battarbee, MD, MSCR, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2029-07