GlucoClear ICU Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Intensive Care Unit Blood Glucose Monitoring
• Intervention / Treatment: Device: GlucoClear 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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with an anticipated surgical lCU or surgical lCU plus intermediate care unit stay of at least 24 hours.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GlucoClear System	Device: GlucoClear System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15/20% Accuracy	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)	During 72 hours of anticipated Sensor dwell time.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12/15% Trend Accuracy	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).	During 72 hours of anticipated Sensor dwell time.

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Estimate): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Intensive care unit; Glucose monitoring
• Other Study ID Numbers: 2014-02