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.
“These results are a significant milestone towards commercialization of sugarBeat. We anticipate our miniature wireless device format, which is directly adhered to the body using a non-irritant soft silicone gel, together with our improved sensor performance, will prove to be a formidable tool in helping persons with diabetes globally to better manage their blood sugar levels,” CEO Faz Chowdhury said in prepared remarks. “We also believe the non-invasive nature of sugarBeat will lend itself well to the rapidly growing consumer wellbeing market, for lifestyle glucose management by non-diabetic and pre-diabetic persons.”
Nemaura expects that its sugarBeat system will win CE Mark clearance and launch in the U.K. in the coming months. The company also plans to conduct clinical trials in the U.S. to support a regulatory submission to the FDA.
NMRD shares were trading at $5.58 apiece in mid-afternoon activity, up 6.3%.