UK-based technology company Nemaura Medical has secured the European CE-Mark for the SugarBEAT continuous glucose monitor (CGM).
The marketing authorisation covers predictive alerts that provide visual indication in case glucose levels are falling or rising above minimum and maximum thresholds.
For use by diabetics and pre-diabetics, SugarBEAT comes with a non-invasive, needle-free, disposable and adhesive skin-patch connected to a rechargeable transmitter. It provides an ambulatory glucose profile (AGP) chart to help users spend more time in range (TIR).
Audible alerts or physical vibration of the mobile phone connected to SugarBEAT can also be enabled, alerting the user when glucose levels are estimated to decrease to dangerously low levels.
Nemaura Medical CEO Dr Faz Chowdhury said: “Given these benefits, we look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets.
“In addition, we plan to target the wearable health tech market for health-conscious consumers, which is experiencing explosive growth.”
Initially, the company intends to target the type II diabetes market, which makes up 95% of diabetics. This group commonly depend on periodic A1c readings every three to six months in order to manage their glucose levels.
A1c measurements are obtained from a lab blood test and offer a single value indicating the average glucose level over the past 60-90 days.
Meanwhile, CGM offers a time in range’ (TIR) metric, which measures the time per day when glucose is kept within the normal range.
The SugarBEAT smartphone app provides glucose readings every five minutes for the duration of wear. The CGM is expected to cut the number of daily finger prick tests.
Nemaura intends to launch the device in the UK and Germany in the coming months. The company is also planning to seek US regulatory approval this year.