Nemaura Medical, a medical device company developing the sugarBEAT CGM System as a minimally invasive, wireless continuous glucose monitoring system, announced that it has conducted a further interim analysis of clinical data from its ongoing 540 patient day clinical program of Type I and Type II diabetic Patients, and have determined a reduction in MARD from 18% to less than 11.8%.
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.