NCT05492890

Continuous Glucose Monitoring for Women With Diabetes Mellitus in the Intrapartum and Postpartum Inpatient Care

The Use of Continuous Glucose Monitors in the Intrapartum and Postpartum Inpatient Care of Women With Diabetes Mellitus: A Randomized Noninferiority

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: —

Summary

Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.

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: 2022-08-09
• Last updated: 2022-08-09

Regulatory

• FDA-regulated device study