CGM for Management of Type 2 Diabetes in Pregnancy
This study is looking at whether using a continuous glucose monitor (CGM) is better than checking blood sugar with fingersticks (self-monitoring of blood glucose) for pregnant women with type 2 diabetes. We want to see if CGM helps improve the health of both the mother and the baby. You might be able to join if you are a woman between 18 and 50 years old, have type 2 diabetes treated with insulin or pills, and are between 6 and almost 23 weeks pregnant with a healthy baby. The study will measure how well blood sugar is controlled at 34 weeks of pregnancy and look at any health problems for the baby after birth. This study is currently recruiting 564 participants.
- Study design
- This is an open-label, randomized study comparing continuous glucose monitoring (CGM) to self-monitoring of blood glucose (SMBG) in 564 pregnant women with type 2 diabetes.
- What's involved
- You would be randomly assigned to either use a Dexcom G7 CGM, replacing the sensor every 10 days, or perform SMBG at least four times daily. You will also have blood tests (HbA1c and maternal serum) at enrollment and at 24 weeks, 34 weeks, and delivery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The health of the baby will be assessed from birth until hospital discharge, and up to 12 months of life.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CGM for Management of Type 2 Diabetes in Pregnancy
At a glance
Conditions
Where it's being run
7 sites across 7 statesStudy leadership
- Ashley Battarbee, MD, MSCR · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Time in Range (TIR) at 34 weeks gestation33 to 35 weeks gestation
Percentage of time spent within target range (63-140mg/dL) on Continuous Glucose Monitoring at 34 weeks gestation
- Composite Neonatal MorbidityFrom the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life
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.