Nemaura Publishes Positive Data from SugarBEAT FDA Clinical Trial

Nemaura Medical (NASDAQ:NMRD), a medical technology company developing sugarBEAT® as a non-invasive, affordable and flexible Continuous Glucose Monitor (CGM) for use by people with diabetes and pre-diabetics, today published clinical data from its recently completed study intended to support a De Novo submission to the U.S Food & Drug Administration (“FDA”) for approval of its sugarBEAT® product.

As quoted in the press release:

The global addressable market for CGM is estimated at $82B per annum, with the U.S. the largest single market estimated at $13B. CGM adoption amongst people with diabetes is minimal and growing rapidly, with the U.S. having an estimated 2.6% (630,000 users) of all diagnosed diabetics using CGM in 2018, representing annualized growth of 117%.(1)

The results from the recently completed clinical study consisted of 75 patients, split approximately equally between Type I and Type II diabetics. Blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 225 patient days, and measured using an Architect c8000 Laboratory Instrument.(2)

Over 12,000 paired data points were analysed using 1-point and 2-point calibration respectively, using a predictive algorithm. MARD +/-20% or +/- 20mg/dL (76% of paired data) was 8.02% for the single finger prick calibration and 7.96% (78.7% of all data) for the 2-point calibration.

Click here to read the full press release.