GlucoClear ICU Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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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

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Intensive Care Unit Blood Glucose Monitoring

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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GlucoClear System

Intervention Type DEVICE

Interventions

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GlucoClear System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years Surgical ICU or surgical ICU plus intermediate care unit stay ≥ 24 hours Signed consent

Exclusion Criteria

Transplant patient End stage medical conditions or diseases Restricted venous access History of HIT or heparin allergy Contraindication for anti-coagulation Positive pregnancy test In another study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No