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 (“MARD”) 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, (the proportion of the CGM system values that are within ±20% of relative difference of reference value at glucose levels >80 mg/dL and ±20 mg/dL of absolute difference at glucose level ≤ 80 mg/dL (referred to as % 20/20). 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. The Company is currently further evaluating the remaining cohorts and variables with a view to establishing the extent to which auto-calibration may be feasible, and to also determine the optimal sensor application method. The Company intends to publish findings of the study in forthcoming conferences, as well as to use the data to supplement product registration applications for an increased sensor wear period of up to 24 hours for a second-generation sensor as it progresses commercialization of the 14-hour wear sensor.
