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Nemaura Medical reports the European clinical trial program consisted of a total of 525 patient days, comprising 75 patients continuously wearing sugarBEAT® for up to 14 hours per day over 7 consecutive days in a combination of home and clinic settings. Interim results based on all 525 patient days have detected no instances of skin irritation or major adverse events resulting from the device. Interim accuracy results, taken from a cohort of 175 patient days, have indicated MARD as low as 10% over a large dynamic range, with average MARD comparable to accuracy previously achieved by the wired wrist-worn predecessor SugarBEAT® device, which received a CE mark in 2016.
A summary of the full clinical report is due to be published next month alongside CE submission.
SugarBEAT® consists of a disposable skin-patch connected to a rechargeable transmitter, with a mobile app displaying glucose readings at regular five minute intervals.
Further clinical studies are planned including those for FDA approval in the US, and to investigate the use of sugarBEAT® in critical care settings.