Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U.
The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive days in both home and clinical settings.
Interim data revealed no instances of skin irritation or major adverse events, according to Nemaura. The study also showed that the device’s accuracy is comparable to its wrist-worn predecessor sugarBeat device. That product won CE Mark clearance last year.
Nemaura reported that it will release its full clinical report next month alongside the device’s CE Mark submission.
The company’s sugarBeat monitor includes a disposable skin-patch connected to a rechargeable transmitter and a mobile app to display glucose readings in five minute intervals.
Nemaura plans to conduct additional studies to support FDA approval in the U.S. and also hopes to study the device in critical care settings, the company reported.