The GlySure monitor, sensor, introducer and calibration pod have been developed to fully functional prototypes for human clinical testing.
GlySure’s earlier trials in human serum, plasma and whole blood confirmed that its sensor can measure glucose levels across the entire human physiological range with an extremely high degree of accuracy and repeatability. This was validated through in vivo models.
Glysure is continuing with a series of human use trials in the ICU first begun in late 2010. A snapshot of the latest results are contained within the PDF (below). The graphs compare Glysure’s continuous glucose management system with results from intermittent blood glucose measurement on a YSI analyser . Over two years of human use trials in the challenging environment of the ICU have confirmed the sensor’s performance and the ability of Glysure to provide a new dimension in Intensive Insulin Therapy (IIT). Experience to date is that the Glysure system is capable of monitoring for the entire length of stay of a patient in the ICU. The results of the human use trials are currently being prepared for peer reviewed publications and for presentation at major intensive care meetings in the USA and Europe. These developments are part of the ongoing programme which will lead to formal submissions to the regulatory bodies in the USA and EMEA.
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