GlucoClear ICU Study

Withdrawn

• Conditions: Intensive Care Unit Blood Glucose Monitoring
• Interventions: Device: GlucoClear System

• Registration Number: NCT02238041
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Study Timeline

• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Study Start: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GlucoClear System	GlucoClear System	-

Primary Outcome Measures

Name	Time	Method
15/20% Accuracy	During 72 hours of anticipated Sensor dwell time.	15/20% Accuracy: The proportion of GlucoClear glucose measurements within ± 15 mg/dL of Comparator values \< 75 mg/dL and within ± 20% of Comparator values ≥ 75 mg/dL)

Secondary Outcome Measures

Name	Time	Method
12/15% Trend Accuracy	During 72 hours of anticipated Sensor dwell time.	12/15% Trend Accuracy: The proportion of GlucoClear glu-cose measurements within ± 12 mg/dL of the interpolated value between two sequential Com-parator values if that interpolat-ed comparator value is \< 80 mg/dL and within ± 15% of in-terpolated Comparator values ≥ 80 mg/dL).