Nemaura Finishes 100-Patient Study for sugarBEAT 24-Hour Wear

Nemaura Medical, a company developing and commercializing non-invasive wearable sensors and tools for personal diabetes management and metabolic health, has completed a 100-patient study across four cohorts of 25 diabetic patients for its sugarBEAT device. The company also released interim results.
 
The company’s sugarBEAT non-invasive and flexible continuous glucose monitor (CGM) has CE mark and SFDA (Saudi Food and Drug Authority) approval for a 14-hour wear period. The study was designed to evaluate increasing wear period up to 24 hours, the possibility of auto-calibration, and different methods to apply the device to the skin.
 
The new sensors were engineered to reduce the steps involved in sensor application to the skin, to a “peel and place” method.
 
sugarBEAT’s study was conducted in the Middle East on 100 patients ages 18-75, comprising 20 people with Type 1 diabetes and 80 people with Type 2 diabetes. The company said there was about an equal split between male and female subjects.
 
Nemaura reported interim data from the first cohort of 25 patients on single-day sensor wear. Results showed an overall mean absolute 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 (proportion of the CGM system values 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 demonstrated 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 company said this data indicates 24-hour sensor wear with a single sensor is possible, so users can potentially monitor glucose fluctuations overnight. Nemaura is still evaluating remaining cohorts and variables to establish the extent to which auto-calibration might be feasible and to determine optimal sensor placement methods.
 
The company said it plans to use data from this study 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.