OptiScanner Versus Standard Blood Glucose Monitoring
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Manual vs. Automated moNitoring Accuracy of GlucosE II (MANAGE II)|
- Glucose Prediction error [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
- Clarke Error Grid analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2012|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720381
|Erasme University Hospital|
|Principal Investigator:||Jean-Charles Preiser, MD, PhD||Erasme University Hospital|