Nemaura: Positive Interim Data from Glucose Monitor FDA Clinical Trial

Nemaura Medical Inc. (NMRD), a medical technology company developing sugarBEAT® as a non-invasive affordable and flexible Continuous Glucose Monitor (CGM) for use by persons with diabetes and pre-diabetics, today reported data from an interim analysis of 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.

The interim results consisted of 25 patients, split approximately equally between Type I and Type II diabetics¹. The study was conducted in a clinic setting, and blood samples were taken via a catheter every 15 minutes over a 12 hour period for 3 non-consecutive days, for a total of 75 patient days. Blood samples were measured using an Architect c8000 Laboratory Instrument.

9,371 data points were analysed in total, consisting of 4,630 and 4,741 paired data points analysed using 1-point and 2-point calibration respectively. The MARD (Mean Absolute Relative Deviation, @ 30%/30mg/dL) for the 1-point calibration was 12.19% (80% of all data), and for the 2-point calibration the MARD was 10.65% (88% of all data)). The results are in line with the company’s expectations, and compare favorably with competitor products.

SugarBEAT® is expected to launch in the UK in the coming months, and is expected to be marketed to all categories of diabetics, including Type 1, Type 2 and pre-diabetics. Continuous Glucose Monitoring (CGM) is estimated to have a global total addressable market worth $82Bn. The U.S. has the largest number of CGM users, where 2018 usage numbers are estimated at 630,000 insulin users, representing 2.6% of 24.6 million people who have been diagnosed with diabetes.²

Nemaura previously reported data from the home-use portion of the same study, whereby 121 matched pair points between the Blood Glucose Meter and sugarBEAT® were evaluated, which indicated 84.3% of the data points had an overall MARD  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 respectively¹).

Completion of U.S. study and FDA submission is anticipated in Q1 2019, alongside poster presentation at the Advanced Technologies & Treatment for Diabetes (ATTD) conference in Berlin in February 2019 for the full in-clinic portion, which is designed to record approximately 16,000 matched data points.

https://finance.yahoo.com/news/nemaura-reports-positive-interim-data-120000656.html