OptiScan Biomedical Presents Study Results Demonstrating OptiScanner's Excellent Glucose Monitoring Accuracy in Critically Ill ICU Patients
BRUSSELS, March 21, 2012 /PRNewswire/ -- OptiScan Biomedical Corporation, a developer of innovative continuous glucose monitoring systems for use in intensive care units (ICU), announced positive clinical study data for the OptiScanner™, the company's first-of-its-kind automated, bedside glucose monitoring system. Study results demonstrated excellent clinical accuracy for the OptiScanner in monitoring the blood glucose levels of critically ill patients in severely ill ICU patients. Findings were presented at the 32nd International Symposium on Intensive Care and Emergency Medicine (ISICEM) being held this week in Brussels, Belgium.
Data presented from the MANAGE Study (Manual vs. Automated moNitoring Accuracy of GlucosE) included results from a total of 63 critically ill medical and surgical ICU patients. Using Clarke Error Grid (CEG) analysis, 94.2 percent of the OptiScanner patient test results appeared in the grid's A zone with the remaining 5.8 percent falling in the B zone. CEG is considered the gold standard for assessing the accuracy of glucose measurement devices, with the grid's zone A representing results that are the most clinically accurate and results in zone B considered clinically acceptable. CEG zones C, D and E are considered inaccurate and not suitable for guiding insulin dosing. CEG results for this study, which was conducted at the Academic Medical Center at the University of Amsterdam, were achieved using the Yellow Springs Instruments Blood Glucose Analyzer (YSI), a laboratory blood glucose instrument, as reference.
The patients' extreme severity of illness was indicated by a number of clinical measures including:High mortality rates (> 16 percent in the ICU and > 21 percent in hospital) Lengthy average stay in ICU (9.2 days average) and in hospital (24 days average) Need for significant therapies (nearly 92 percent required mechanical ventil