Needle-Free Continuous Glucose Monitor Receives European Approval

Nemaura Medical’s needleless Continuous Glucose Monitor (CGM) has recently received European approval for use by diabetic patients. This innovative CGM, named sugarBEAT, is a low-profile device that pairs with a smartphone app to display glucose readings every five minutes. Receiving the CE-mark this past week, this wearable device offers a convenient alternative to the traditional finger pricking method used to monitor blood glucose.

The disposable sugarBEAT patch functions by passing an electric current across the user’s skin to draw trace quantities of glucose out of the interstitial fluid and into the device. This mild current is not felt by the user, and the process is completely pain-free. Each sugarBEAT patch requires a 30-60 minute warm up before glucose readings can be taken and provides readings for 24 hours. The company notes that this disposable patch design allows for a lighter adhesive to be used, maximizing comfort.

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A rechargeable transmitter within the device then measures the level of glucose drawn and reports this data to a companion app via Bluetooth. This secure transmission takes place every five minutes, providing the user with prompt readings for up to 24 hours.

cgmOnce these readings arrive to the app, an algorithm converts this data into meaningful glucose values. The app also records data regarding lifestyle factors, medications, diet, exercise, and mood to provide a comprehensive review of how glucose levels are affected. The app displays an Ambulatory Glucose Profile (AGP) that can be securely shared with the patient’s physician through the cloud. Nemaura also offers a stand-alone device for patients who do not have a smartphone, smartwatch, or tablet.

The global CGM market is estimated at $82 billion per year, with the US being the largest individual market at $13 billion. CGM use is increasing at a rapid pace, displaying a 2018 annualized growth of 117 percent in the US. Nemaura is eager to enter this market, with plans to launch sugarBEAT in the UK and Germany in the next few months and to attain US approval this year as well.

“We look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets,” said Nemaura Medical CEO Dr. Faz Chowdhury. “In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth.”

The ball is rolling for US approval, with sugarBEAT recently completing clinical trials for FDA De-Novo 510(k) Submission. The study consisted of 75 patients over 225 patient days, split roughly in half between Type I and II diabetes. Every 15 minutes, blood samples were taken via catheter and analyzed over a 12-hour period for 3 days (nonconsecutive).

The clinical research created over 12,000 paired data points using a predictive algorithm, and overall the researchers found that sugarBEAT displayed acceptable performance with no adverse outcomes. Nemaura feels that De-Novo 510(k) is the best approval pathway for their technology and expects this route to facilitate the regulatory approval process.