OptiScan Biomedical Presents Study Results Demonstrating OptiScanner’s Excellent Glucose Monitoring Accuracy in Critically Ill ICU Patients
All Measurement Readings Demonstrate Sufficient Accuracy to Guide Clinical Treatment Decisions; Results Achieved in Most Severely Ill Patients —
BRUSSELS, March 21, 2012 – 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 ventilation and more than 78 percent required vaso-active drugs)
Marcus J. Schultz, M.D., Ph.D., the study’s principal investigator, presented the results. He concluded that the accuracy of the OptiScanner was “excellent” in this “very sick ICU population.” He also presented that even the use of accurate lab analyzers up to ten times per day resulted in dysglycemia (either hypoglycemia or hyperglycemia) in approximately 50 percent of the ICU patients studied, noting that this second finding was “surprising.”
This is the fourth clinical study to evaluate the glucose monitoring accuracy of the OptiScanner and the first to do so with the final configuration of the OptiScanner in critically ill ICU patients. These results are consistent with and reinforce findings from OptiScan’s previous studies of the prior generations of the OptiScanner in other ICU patient populations. A significant portion of the research that comprised these previous OptiScanner clinical studies was carried out by James Krinsley, M.D. and his team at Stamford Hospital at the Columbia University College of Physicians and Surgeons.
“These latest clinical study results, combined with the breadth of additional supportive clinical data we have collected on the OptiScanner, show the robustness and paradigm-shifting potential of this technology,” said Peter Rule, chairman and chief executive officer of OptiScan Biomedical.
The OptiScanner received CE Mark certification for use in the European Union in September 2011 and the company plans to launch the product in Europe in the next few months.
About the OptiScanner
The OptiScanner is a first-of-its-kind automated, bedside glucose monitoring system that provides physicians with information to manage patient glucose levels in the ICU. Through automated monitoring of a patient’s glucose values in plasma (as opposed to whole blood), the OptiScanner has alarms to alert clinicians to the existence of hyperglycemia (values that are too high) and hypoglycemia (values that are too low). It is estimated that between 60-80% of all ICU patients suffer from elevated glucose values, requiring insulin delivery and frequent glucose monitoring.