The SugarBEAT CGM is a flexible, disposable patch that’s connected to a rechargeable transmitter and Bluetooth-enabled smartphone app, designed to deliver glucose readings at five-minute intervals throughout the day. The company says the device allows users to spend more time in range by offering an ambulatory glucose profile chart.
The CE Mark approval covers predictive alerts from the device that give visual indications of rising and falling glucose levels above minimum and maximum thresholds. Audible alerts and physical vibrations can be sent to the user’s smartphone through a Bluetooth connection, Nemaura said.
“We are very pleased to report CE Mark approval in Europe for SugarBEAT, which is the world’s first non-invasive, needle-free, continuous glucose monitor,” CEO Faz Chowdhury said in a press release. “Importantly, as a daily disposable adhesive skin-patch that sits on the surface of the skin, SugarBEAT is painless and versatile in terms of wear time. Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets.
“The inclusion of our new predictive alert capabilities will also have particular appeal to Type I diabetics who are at higher risk of hypoglycemia or very low glucose levels. Insulin users can adjunctively use SugarBEAT when calibrated with a finger-stick glucose reading,” Chowdhury said.
Nemaura said it plans to launch SugarBEAT in the U.K. in the next quarter, aiming at the wearable health technology market, and is seeking partnerships with smartphone and wearables makers. The company also said it’s on track to submit an application to the FDA for approval by the middle of the year .
In clinical studies, SugarBEAT had a mean absolute relative difference of 11.92% using finger-stick calibration, according to Nemaura. The study was split between 75 Type 1 and Type 2 diabetics over a 225 day period. There were more than 12,000 paired data points with blood samples taken by catheter every 15 minutes over a 12-hour period for three nonconsecutive days, the company said.