The company expects to win CE Mark approval for its sugarBeat system in the coming months and also hopes to launch additional trials in the U.S. to support a regulatory bid with the FDA.
“This expansion is expected to enable Nemaura to meet anticipated demand arising from the planned sugarBeat launch in the UK, Europe, Middle East and Australia,” the company explained in prepared remarks.
Earlier this year, Nemaura touted positive data from the European clinical trial program for its sugarBeat glucose monitoring system. The summary results were taken from a 25-patient group in the three-stage trial, made up of 80% Type I diabetics and 20% Type II diabetics. Each patient continuously wore the sugarBeat device for 14 hours across seven consecutive days.
Researchers compared the participants’ blood glucose levels as measured by Nemaura’s sugarBeat device with glucose concentrations from a laboratory blood glucose analyzer.
The data showed an overall mean absolute relative difference, or MARD, of 13.8% over a broad range of glucose levels. The company noted that up to 70% of the data from the study paired between sugarBeat and the venous blood glucose concentration had an average MARD of 10.3%.
No serious or major device-related adverse events were reported during the trial, Nemaura reported.