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An ICU Study of Safety and Accuracy Using the GlucoClear CGM System
The primary purpose of this Study is evaluation of the safety and accuracy of the GlucoClear CGM System.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
December 1, 2014
Primary Completion Date
December 1, 2015
Completion Date
December 1, 2015
Last Updated
October 1, 2015
GlucoClear System
DEVICE
Lead Sponsor
Edwards Lifesciences
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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