Dive Brief:

• A noninvasive continuous glucose monitor that can be worn on the arm has gained CE mark approval for sale in the European Union.
• Called SugarBeat, the disposable adhesive patch system can be worn on non-continuous days, making it suitable for Type II diabetes patients who typically check their blood sugar levels periodically, as well as pre-diabetics, manufacturer Nemaura Medical said.
• The Loughborough, England-based company plans to launch the device next quarter in the United Kingdom and Germany. In the United States, Nemaura said it is on track to submit an application for FDA approval in mid-2019.

Dive Insight:

The market for continuous glucose monitors that provide real-time continuous blood sugar readings is getting more crowded as technologies advance and gain wider acceptance. Earlier this month, former Johnson & Johnson unit LifeScan announced plans to launch a CGM system beginning next year in collaboration with Sanvita Medical, a subsidiary of Nova Biomedical.

Among the leading device makers in the sector, Abbott is looking to introduce its FreeStyle Libre 2 CGM in the next few quarters, while Dexcom is targeting late 2020 for the launch of its next-generation integrated G7 CGM. Medtronic plans a fiscal 2020 rollout of its latest CGM, the MiniMed 780G hybrid closed loop system with Bluetooth connectivity and improved algorithms. Relative newcomer Senseonics, which gained approval for its 90-day continuous glucose monitoring system last year, is also vying for market share.

Continuous glucose monitoring devices reduce or eliminate the need for routine finger stick testing, depending on the device. Patients benefit from knowing where their blood glucose levels are trending during the day and night.

Nemaura said it daily disposable system offers users an advantage in deciding when and for how long to wear the patch. The company also signaled it intends to compete on price, saying it plans to offer the lowest-priced CGM in the industry.

The needle-free skin patch connects to a rechargeable transmitter. The device generates a glucose profile chart to help patients achieve more time with their readings in target range. The Bluetooth-enabled SugarBEAT smartphone app displays glucose readings every five minutes while the patch is worn. Alerts indicate when glucose levels are falling or rising above minimum and maximum thresholds.

"We look forward to aggressively entering both the multi-billion-dollar diabetic (insulin and non-insulin dependent) and pre-diabetic markets," Nemaura CEO Faz Chowdhury said in a statement. Nemaura is also targeting the market for wearable health technology, Chowdhury said.

The company studied the device in 75 Type I and Type II patients over 225 days. Blood samples were taken with a catheter every 15 minutes over a 12-hour period for three non-consecutive days. The results showed a mean absolute relative difference of 11.92% using a single point fingerstick calibration, the company said. No device-related adverse events were reported.

SugarBeat’s IP portfolio contains more than 30 issued and pending patents, Nemaura said. Fred Schaesdau, former general manager of Dexcom Germany, is advising Nemaura on its European launch, the company noted.

The company plans to present information on the SugarBeat device at the European Association for the Study of Diabetes Barcelona Congress in September.