NCT05491954

Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

The Use of Continuous Glucose Monitors Among Women With Various Degrees of Glucose Intolerance: An Observational Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.

Conditions

• Diabetes, Gestational

Interventions

Type	Name	Description
DEVICE	Dexcom G6	Continuous glucose monitoring

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2022-08-08
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study