NCT02238041

GlucoClear ICU Study

An ICU Study of Safety and Accuracy Using the GlucoClear CGM System

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.

Detailed description

Design: Non-randomized, non-treatment, prospective, open label Study. The GlucoClear System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study subjects or the Study site clinical personnel. There will be no treatment of any subject based on the output of the System. After providing written informed consent, subjects meeting inclusion/exclusion criteria will be monitored by the System for a maximum of 72 hours. Up to 51 1 mL blood samples will be drawn from each subject for comparative glucose measurements on blood glucose analyzers over the 72 hour period. After the GlucoClear Sensor removal, subjects will be contacted for a follow-up assessment 14 days later, and any subsequent adverse events will be documented.

Conditions

• Intensive Care Unit Blood Glucose Monitoring

Interventions

Type	Name	Description
DEVICE	GlucoClear System

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-09-12
• Last updated: 2015-10-01