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.

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NCT06628453

CGM for Management of Type 2 Diabetes in Pregnancy

Recruiting
NAAges 18–50InterventionalTreatment
University of Alabama at Birmingham
~564 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:CGM

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time in Range (TIR) at 34 weeks gestation
Measured over 33 to 35 weeks gestation
+1 more outcome measured
Type 2 Diabetes Mellitus (T2DM)
Pregnancy
7 sites across 7 states
Alabama1
California1
North Carolina1
Oregon1
Pennsylvania1
South Carolina1
Texas1
  • Ashley Battarbee, MD, MSCR · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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

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
  • 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.