CGM for Management of Type 2 Diabetes in Pregnancy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Alabama at Birmingham

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CGM

Treatment groups

564 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator