OptiScanner Versus Standard Blood Glucose Monitoring
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The study is to demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in critically ill patients when compared to a reference YSI 2300 STAT Plus and the Gem 3000, the reference standard for Erasme University Hospital.
Percent (%) predicted error is the percent (%) error result of the OptiScanner on central venous blood from the superior cava versus the YSI and the GEM using arterial blood.
Secondary Outcome Measures :
Clarke Error Grid analysis [ Time Frame: 1 year ]
The Clarke Error Grid analysis shows the percentage of paired values falling within each zone between the glucose results of the OptiScanner on central venous versus the YSI and the GEM using arterial blood.
Biospecimen Retention: Samples Without DNA
One additional blood sample (4 ml)will be collected once a day, separated into Draw an additional ~ 4.0 mL from the subject into a syringe once per every 24 hour period. The study site will indicate where and at what time the sample was taken. This sample is placed into a sodium heparin tube, labeled with the subject number and sampling time and centrifuged on a refrigerated centrifuge. The gained plasma will be frozen at minus 70 degrees Celsius or less and may be used for potential analysis by the Sponsor, should an analysis of outliers indicate the potential presence of an interferent.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Critically ill patients admitted to the intensive care unit (ICU) of Erasme University Hospital in Brussels, Belgium.
Signed Informed consent.
Age ≥ 18 years.
Admitted to the ICU of Erasme University Hospital.
Expected ICU stay of ≥ 3 days at the time of enrollment (as judged by the Principle Investigator).
APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
Existing central venous catheter + arterial catheter.
No participation in any other investigational interventional study while enrolled in this study.
Hyperglycemia (BG > 150 mg/dl) at the time of admission.