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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CGM
DeviceReal-time continuous glucose monitoring
Treatment groups
564 Participants
are divided into 2 treatment groupsGroup A: Continuous Glucose MonitoringExperimental treatment 1 intervention
Group B: Self-Monitoring of Blood GlucoseNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time in Range (TIR) at 34 weeks gestation
Percentage of time spent within target range (63-140mg/dL) on Continuous Glucose Monitoring at 34 weeks gestation
Time frame
33 to 35 weeks gestation2
Composite Neonatal Morbidity
Composite morbidity of the neonate including one or more of preterm birth (delivery less than 37 weeks for any indication), birth trauma (shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to resolve), hypoglycemia (requiring treatment with dextrose gel or IV within 24 hours of birth), hyperbilirubinemia (requiring phototherapy within 72 hours of birth), large-for-gestational-age infant (birthweight greater than the 90th percentile for gestational age), and miscarriage, stillbirth or neonatal death prior to hospital discharge.
Time frame
From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of lifeSecondary outcomes
1
Preterm birth
Delivery less than 37 weeks gestation
Time frame
Delivery2
Birth trauma
Shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to relieve
Time frame
Delivery3
Neonatal hypoglycemia
Low neonatal glucose requiring treatment with dextrose gel or IV within 24 hours of life
Time frame
Delivery to 24 hours of life4
Hyperbilirubinemia
Elevated bilirubin requiring phototherapy within 72 hours of life
Time frame
Delivery to 72 hours of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov