NCT04605497

Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus

A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Continuous glucose monitoring (CGM)	Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission \& discharge + additional 10 days during postpartum period
DIAGNOSTIC_TEST	Self-Capillary Blood Glucose Monitoring (SCBG)	Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear

Timeline

• Start date: 2021-02-11
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-10-28
• Last updated: 2024-05-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study