GlucoClearTM System ICU Study

The primary purpose of this Study is evaluation of the safety and performance of the GlucoClear System (System).

The primary safety objective will be assessed by:

• Evaluation of any serious adverse device effects upon Sensor insertion through Sensor removal and a follow-up assessment one week (7 ± 3 days) after Sensor removal.

The primary performance objective will be evaluated using the following criteria:

15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs within ± 15 mg/dL of Comparator values ≤ 75 mg/dL and within ±20% of Comparator values > 75 mg/dL).

Study Overview

• Status: Completed
• Conditions: Accurate Blood Glucose Monitoring in Critical Care Setting

Detailed Description

Design: Non-randomized, non-treatment, prospective, open label Study.

After providing written informed consent, subjects meeting Inclusion/Exclusion Criteria will be connected to the System for a maximum of 72 hours.

For the purposes of this clinical Study, the System will not display real-time glucose values, glucose trend graphs, or glucose alarms to either the Study Subjects or the Study Site Personnel. There will be no treatment of any Subject based on the output of the System. Diabetes management decisions throughout this Study (if applicable) will be conducted according to hospital procedures.

• 1 set of laboratory measurements will be drawn per Subject for baseline.

• A maximum of 82 blood samples will be drawn per Subject during the 72 hour monitoring session including.

  • Up to 75 blood samples drawn for comparative glucose measurement on laboratory analyzers. Blood samples will be taken from the sampling catheter in the peripheral vein in the contralateral extremity (relative to placement of the System) with no more than 25 samples taken within one day (00:00 to 23:59) for glucose measurement on laboratory analyzers (e.g., Yellow Springs Instrument glucose analyzer (YSI), Radiometer blood analyzer);
  • Up to three (3) sets of laboratory measurements; and
  • Up to 4 other blood samples, as needed. One week (7 + 3 days) after Sensor removal, subjects will be contacted for a follow-up assessment and document any subsequent adverse events.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Medical University Graz
• Belgium
  • Aalst, Belgium, 9300
    • Onze-Lieve-Vrouwziekenhuis

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 ICU stay of at least 24 hours.

Description

Inclusion Criteria:

• ≥ 18 years
• ICU ≥ 24 hours
• Signed consent

Exclusion Criteria:

• Transplant patient
• Brain injury/surgery patient
• End stage medical conditions or diseases
• Restricted venous access
• History of HIT
• Contraindication for anti-coagulation or bleeding disorder
• Positive pregnancy test
• In other drug, device, or biologic study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
GlucoClear System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
15/20% Performance	15/20% Performance: Blood glucose measurements from the System must meet the ISO 15197 15/20% accuracy criteria (at least 95% of the matched pairs 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
12/12.5% Performance	12/12.5% Performance: Propor-tion of matched pairs meeting within ± 12 mg/dL for Compara-tor values ≤ 100 mg/dL and within ± 12.5% for Comparator values > 100 mg/dL.	During 72 hours of anticipated Sensor dwell time

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Collaborators: MedPass International; 95 bis boulevard Pereire; 75017 Paris - France
• Investigators: Principal Investigator: Luc Foubert, MD, PhD, Onze-Lieve-Vrouwziekenhuis

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Estimate): March 24, 2014
• Last Update Submitted That Met QC Criteria: March 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Glucose Monitoring
• Other Study ID Numbers: 2012-05 (Other Identifier: AP HM)