Nemaura Medical (NMRD) SugarBEAT Study Show Positive Results in European Clinical Program
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Nemaura Medical Inc. (NASDAQ: NMRD), a medical technology company developing the wireless sugarBEAT® non-invasive glucose monitoring system for adjunctive use by persons with diabetes today announced positive summary data for its sugarBEAT® European clinical trial program.
The summary results were taken from a 25 patient cohort of the previously reported European three-stage 75 patient Clinical study, consisting of 80% Type 1 and 20% Type 2 Diabetics. The study was designed as a single centre open-label, single arm, within-subject comparison of sugarBEAT®, with blood samples drawn from a venous catheter at corresponding time points, with glucose concentration measured using a Laboratory blood glucose analyser, ARCHITECT C8000. Each patient continuously wore sugarBEAT® for 14 hours on seven consecutive days. Three of the seven days were in-clinic where venous blood samples were taken at 15 minute intervals over a continuous 12 hour period.
Results indicate an overall MARD (Mean Absolute Relative Difference) of 13.76% over a broad dynamic glucose concentration range. However, up to 70% of the data from the study paired between sugarBEAT® and the venous blood glucose concentration achieved an average MARD of 10.28%, denoting even greater accuracy. A MARD of 10% is deemed to be sufficient for making therapeutic decisions. No serious or major device related adverse events were noted.
CEO, Dr Faz Chowdhury commented, “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. 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.”
SugarBEAT® consists of a disposable skin-patch connected to a rechargeable transmitter, with a mobile app displaying glucose readings at regular five minute intervals. Unlike the Dexcom or Abbott Libre devices, sugarBEAT® is non-invasive and does not require the insertion of a needle-like sensor into the skin.
SugarBEAT® is expected to launch in the UK, followed by other territories upon achieving CE approval, which is anticipated in the coming months. Additional clinical studies are planned for sugarBEAT® for FDA approval in the US, and for use of sugarBEAT® in critical care settings.
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