NCT04397965

Cascade Continuous Glucose Monitor (CGM) 15-Day US Performance Assessment

Cascade CGM 15-Day US Performance Assessment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: WaveForm Technologies Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess a 15-day wear period of the Cascade Continuous Glucose Monitoring (CGM) System

Detailed description

To assess a 15-day wear period for the Cascade CGM. The study wear period includes four in-clinic days in which frequent blood draws and Yellow Springs Instrument (YSI) glucose measurements will be performed. Participants will be blinded to CGM glucose values during the study. A retrospective performance assessment will be conducted following the study.

Conditions

• Continuous Glucose Monitoring

Interventions

Type	Name	Description
DEVICE	Cascade Continuous Glucose Monitor	Continuous Glucose Monitoring

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-04-01
• Completion: 2021-05-01
• First posted: 2020-05-21
• Last updated: 2020-10-12

Regulatory

• FDA-regulated device study