Following FDA clearance for its long-lasting Eversense E3 CGM System (continuous glucose monitoring) earlier this year, Senseonics‘ Ascensia Diabetes Care division announced CE Mark approval for the platform. Alfred Poor first wrote about FDA approval for the earlier Eversense 90-day product in 2018. With the CE Mark announcement, diabetics in both the U.S. and European Union countries will be able to use the latest Eversense CGM. The Eversense E3 sensor lasts up to 6 months.

There are three components in the Eversense E3 system: a sensor implant, a smart transmitter, and a mobile app. Health care professionals insert the sensor in the patient’s upper arm where it monitors blood glucose level for up to 6 months. The removable and rechargeable transmitter is worn on the arm over the sensor. It sends data via Bluetooth from the sensor to an associated mobile device. The mobile app displays readings every 5 minutes. The transmitter also uses vibration alerts to inform the wearer to take action if their glucose levels get out of range.

Patients still need to use a manual blood glucose meter to initialize and calibrate the E3 system. Compared to other CGM systems, according to Ascensia, the Eversense E3 System has a 6-month sensor life; it requires just two sensor changes per year. The transmitter is removable and uses a silicon-based adhesive for reduced irritation.

Advances in self-managed care technology for people with diabetes are significant especially because of the prevalence of the disease. According to the latest CDC National Diabetes Statistics Report, 37.3 million people — or 11.3% of the U.S. population — have diabetes. An additional 38.0% of U.S. adults and 48.8% of people 65 or older are prediabetic. Not all forms of diabetes can be prevented, but CGM systems can reduce the lifelong management burden for people who must track their glucose levels.