Nemaura Medical touted interim data today from the European clinical trial program evaluating its wireless, adhesive skin-patch for use as a non-invasive and needle-free glucose monitoring system.
The clinical trial program enrolled 75 patients, who continuously wore the 2nd-gen SugarBeat device for up to 14 hours per day over the course of seven days in a combination of home and clinical settings.
Interim results, based on 175 days of data, include no skin irritation or serious adverse events.
“The data generated thus far has indicated accuracy that is comparable to, and non-inferior to that previously achieved by the wired wrist worn predecessor SugarBeat device, which received a CE mark in 2016,” the company reported in prepared remarks.
The trial is slated to finish over the next ten weeks. Nemaura said it anticipates launching SugarBeat in the UK soon after the clinical trial is complete.
The England-based company also reported that it is planning studies in the U.S. to support FDA approval.