OptiScan Biomedical has announced the positive clinical study results of its OptiScanner, an automated, bedside glucose monitoring system, for use in hospital intensive care units (ICU).
The manual vs. automated monitoring accuracy of glucose (MANAGE) study included a total of 63 critically ill medical and surgical ICU patients, in order to investigate the glucose monitoring accuracy of the OptiScanner.
The MANAGE study showed that using Clarke Error Grid (CEG) analysis, 94.2% of the OptiScanner patient test results appeared in the grid's A zone with the remaining 5.8% falling in to the B zone.
CEG is the standard for assessing the accuracy of glucose measurement devices, with the grid's zone A representing results that are clinically accurate, with zone B as clinically acceptable, while CEG zones C, D and E are considered inaccurate and not suitable for guiding insulin dosing.
OptiScanner displays glucose level trend data updated every 15 minutes to help manage a patient's glucose levels within an optimum target range, providing accurate, automated monitoring of glucose levels measured in just plasma
OptiScan Biomedical chairman and chief executive officer Peter Rule said the clinical study results, combined with the breadth of additional supportive clinical data, showed the paradigm-shifting potential of the OptiScanner technology.
In September 2011, the OptiScanner received CE mark approval for use in the European Union.
The company is currently working to expand the capability of the OptiScanner platform technology by detecting additional analytes within the same blood sample, thereby providing additional information about the condition of a critically ill patient.