OptiScanner Versus Standard Blood Glucose Monitoring
Completed
- Conditions
- Hyperglycemia
- Registration Number
- NCT01720381
- Lead Sponsor
- OptiScan Biomedical Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
- 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.
Exclusion Criteria
- Pregnancy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glucose Prediction error 1 year 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
Name Time Method Clarke Error Grid analysis 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.
Trial Locations
- Locations (1)
Erasme University Hospital
🇧🇪Brussels, Belgium