The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects. Accuracy Hypothesis: The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow Springs, OH). Safety Hypothesis: The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated automated blood glucose levels for critically ill subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
230
treatment of blood glucose per standard of care
Tufts Medical Center
Boston, Massachusetts, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGProvidence Heart and Vascular Institute
Portland, Oregon, United States
RECRUITINGPrimary Accuracy Endpoint
The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.
Time frame: Accurancy up to 72 hours of monitoring per subject
Secondary Accuracy Endpoint
The "population CV" will be computed as the standard deviation of the difference between the glucose level reported by the OptiScanner and the glucose level reported by the YSI Analyzer divided by the mean of the YSI Analyzer values. Repeated measures analyses will be used to account for possible correlation of measurements within patients. The population CV therefore gives an estimate of the extent of the effect of outliers on the accuracy estimation. If the "population CV" is less than 13%, the outcome of the secondary accuracy analysis will be considered a success.
Time frame: Accuracy up to 72 hours of subject monitoring
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hermann Memorial Hospital
Houston, Texas, United States
RECRUITING