Nemaura Medical completes 100 patient study for sugarBEAT 24-hour wear

Nemaura Medical announced it has recently completed a 100-patient study across 4 cohorts of 25 diabetic patients for sugarBEAT(R) and provided interim results. The Company has previously received CE approval in Europe, and SFDA approval for its sugarBEAT glucose sensor for a wear period of 14 hours. The study was conducted in the Middle East on 100 adult patients aged 18 to 75 comprising 20 persons with Type 1 diabetes and 80 persons with Type 2 diabetes, with an approximately equal split between male and female. The Company reports interim data from a first cohort comprising 25 patients, on a single day sensor wear. Over a 12-hour period using a retrospectively applied algorithm, the results indicated an overall mean absolute relative difference of 9.8% with 86% of the paired points within 20/20 of the reference value based on 1,037 paired points and two calibrations. A further calibration indicated an overall MARD of 12.8% over a 24-hour sensor wear period based on 1,379 paired points, and 76% of the paired points within 20/20 of the reference blood serum glucose value. The results indicate that a 24-hour sensor wear period using a single sensor is possible, which is expected to allow users to monitor their glucose fluctuations overnight.