The alerts will provide a visual indication when glucose levels fall or rise above minimum and maximum thresholds. If glucose levels fall to dangerously low levels, the company said it will automatically trigger “additional audible alerts.” It will also make a Bluetooth-enabled mobile phone connected to sugarBEAT vibrate to warn a diabetes patient.
SugarBEAT, which has been honed and perfected over seven years is expected to receive CE approval in the UK soon. It will launch first in the UK and then the rest of Europe and Qatar.
The Loughborough, England-based medical technology company said it is making the enhancements to sugarBEAT with a sign-off from the British Standards Institute, which is reviewing the supporting verification and documentation.
“Adding the alerts and alarms, based on predictive algorithms, as part of the current CE review process avoids the need for a subsequent CE application thus shortening the time that it would have otherwise taken to integrate these key features in the device,” said Nemaura Medical CEO Faz Chowdhury. “Even with these additions, we remain on track for CE Mark approval followed by our commercial launch later this year.”
A predecessor sugarBEAT device from Nemaura, which was based on a wired wrist-watch form factor, received CE Mark approval in 2016.
The global addressable market for continuous glucose monitoring devices is estimated at $82 billion annually, and over $1.3 billion in the UK alone. Globally, there are more than 400 million diabetics and 1 billion prediabetics, according to PiperJaffray Co data.
“While the non-invasive nature of SugarBEAT opens up the Continuous Glucose Monitoring (CGM) market to Type 2 diabetics and pre-diabetics, the inclusion of these alerts will particularly appeal to Type 1 diabetics who are at higher risk of hypoglycemia, or very low glucose levels,” said Chowdhury.
Nemaura stock was recently trading flat at about $1.06 in morning trade.
Since sugarBEAT doesn’t require needles or insertion, it is likely to disrupt the continuous glucose monitor (CGM) device market. It will challenge entrenched players like DexCom Inc (NASDAQ:DXCM), which markets the Dexcom G6 and Abbott Laboratories (NYSE:ABT) Libre System.
SugarBEAT consists of a daily disposable adhesive skin-patch connected to a rechargeable transmitter, with an app displaying glucose readings at five-minute intervals for periods up to 24 hours. The innovation of sugarBEAT lies in its groundbreaking skin-patch technology, which allows for better glucose management.
Contact Uttara Choudhury at [email protected]