Nemaura Medical has started the first of several planned studies in support of submission to US Food & Drug Administration (FDA) for approval of its sugarBEAT® as a non-invasive glucose trending device for use by persons with diabetes and pre-diabetics.
sugarBEAT consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five minute intervals.
It can also be used by insulin using diabetic patients as an adjunctive glucose monitoring device when calibrated by a finger stick reading.
The company also announced positive interim results from the home-use portion of this initial study.
The interim results evaluated data from 25 patients, split about equally between Type I and Type II diabetics, each wearing sugarBEAT while going about their daily home/work routine for 1 or 2 non-consecutive days, for a total of 36 patient days.
Each patient recorded up to 5 finger prick readings per day, at about equal intervals, over periods up to 14 hours. Readings were measured using the Abbott Freestyle Optimum neo Blood glucose meter (BGM).
Analysis of the results showed 121 matched pair points between the BGM and sugarBEAT and indicated 84.3% of the data points had an overall MARD (Mean absolute relative deviation) of 10.63%, and an overall nominal MARD of 16.3%, compared with 14.8%, 16.3% and 18% for Eversense, Dexcom G5 and Abbott Libre Pro respectively.
Nemaura claims that the data from home use study, which replicates all the challenges of real world usage and the data compares favourably to existing CGMs.
Initially the US study is expected to enroll a total of 75 patients wearing the device for a 7 day period, including 3 days in clinical setting (525 total patient days and 225 total in-clinic days). The initial US study completion and FDA submission is expected to take place in the first quarter of this year.
Nemaura is also planning to launch sugarBEAT in the UK, followed by other territories, after it receives CE approval, which is expected in the coming months.