MARD is the Mean Absolute Relative Difference between finger-stick measurements and CGM sensor glucose values. A lower MARD indicates higher accuracy.
Nemaura previously reported an interim evaluation that indicated the primary endpoint of accuracy and secondary endpoint of safety had been met.
The current evaluation was taken from a further 76 patient day study, consisting of 19 patients wearing the device on four separate days, for 12 hours per day.
The CGM data was compared with blood finger prick analysis using the Hemocu BGM device, up to 3 times per hour. Despite the enhanced results the skin safety profile was maintained without any complaints of adverse skin irritation.
The sugarBEAT device displays real time glucose readings on the device and on a mobile phone app via blue tooth. Nemaura have patents that allow the device to self-calibrate using an internal standard concept, eliminating the need for routine daily finger prick calibrations.
The company plans to submit for CE approval of the device by the end of 2015 and launch in Europe and other select territories by mid 2016 via strategic partnerships and licensees. Nemaura is also currently preparing to file a pre-submission application to the FDA to consolidate their US clinical roadmap and product approval process.
Nemaura is developing the sugarBEAT System as a non-invasive, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring.
