OptiScan Biomedical has received the European CE Mark for its OptiScanner automatic bedside glucose monitoring system. It is a system designed for semi-continuous monitoring of glucose levels in ICU patients, to maintain tight glycemic control. Both hyperglycemia and hypoglycemia are common problems in the ICU. Current practice however, of using a handheld or point-of-care glucose meter or sending blood off to the lab to monitor glucose levels at regular intervals, is too time-consuming and labor-intensive to provide tight glycemic control.
The OptiScanner is attached to the patients’ existing IV lines and catheters, from which the device automatically draws a 0.12 mL sample every fifteen minutes. The blood is converted to plasma in a micro-centrifuge and then read by a near-infrared spectrometer. Measurement of glucose in plasma provides more accurate glucose readings than when using whole blood, like is done in most handheld devices. Measurement is reagent-free, meaning no daily calibration is necessary, and the OptiScanner can detect glucose levels of up to 1000 mg/dl as compared to handheld meter devices that typically have a limit of 300 mg/dl. It is equipped with a touch screen that provides trend data.
This device is quite revolutionary in the monitoring rate it allows for, however the question will still be if tight monitoring and control will translate into any real patient benefit. Results of previous studies have been inconsistent, however the high frequency of monitoring of the OptiScanner does allow for early detection and prevention of hypoglycemia that has often been associated with tighter glycemic control. Marketing of the OptiScanner will start during the first quarter of 2012 and OptiScan is in discussions with the FDA regarding the approval of the OptiScanner in the U.S.
Product page: OptiScanner…