Nemaura Medical (NMRD) Reports Positive Interim Data from Home-Use Portion of SugarBEAT Study
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Nemaura Medical Inc. (NASDAQ: NMRD) today announced it has initiated the first of a number of planned studies in support of a submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product, and further announced positive interim results from the home-use portion of this initial study. The interim results evaluated data from 25 patients, split approximately equally between Type I and Type II diabetics, each wearing sugarBEAT whilst 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 approximately equal intervals, over periods up to 14 hours. Readings were measured using the Abbott Freestyle Optimum neo Blood glucose meter (BGM). The results analysed 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*). It is the first time the company has published data from a home use study, which replicates all the challenges of real-world usage, and the data compares favorably to existing CGMs. The initial U.S. study is expected to enroll a total of 75 patients wearing the device over a 7-day period, including 3 days in a clinical setting (525 total patient days; 225 total in-clinic days). Initial U.S. study completion and FDA submission is anticipated in Q1 2019, alongside poster presentation at ATTD in Berlin in February 2019 for the in-clinic portion, which is designed to record approximately 16,000 matched data points. SugarBEAT® is expected to launch in the UK, followed by other territories upon achieving CE approval, which is anticipated in the coming months. *Further detailed summary of the results are available on the publications page of the company’s website.
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