GlucoClear ICU Study

Edwards Lifesciences

Status: Withdrawn

Conditions: Intensive Care Unit Blood Glucose Monitoring

Treatments: Device: GlucoClear System

Study type: Observational

Funder types: Industry

Identifiers

NCT02238041

2014-02

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

GlucoClear System

Treatment:

Device: GlucoClear System