Fresh off the U.S. debut of Senseonics’ Eversense E3 continuous glucose monitor system, the system's distributor Ascensia Diabetes Care has now completed its initial launch in Europe, too.
Ascensia got right to work after securing CE mark approval for the CGM in June. At the time, it plotted out a launch path that would begin in August and bring the diabetes monitoring system to people in Germany, Switzerland, Poland, Italy, Spain, Norway, Sweden, the Netherlands and Andorra; in a Monday announcement, the company confirmed that the E3 system is now available in all of those markets.
With the initial launch complete, diabetes patients in those countries will have access to a new long-term sensor option, with the E3 system boasting a six-month lifespan. That’s not the first long-lasting Senseonics CGM to make its way across the pond: In 2017, the New Jersey-based company scored a CE mark for the 180-day Eversense XL system.
The E3’s European rollout kicked off just a few months after the system went live in the U.S. It won FDA clearance in February—about a year later than originally expected, due to COVID-related delays at the regulatory agency—and began its domestic rollout in April.
Eversense’s E3 CGM comprises a fluorescence-based sensor that’s implanted in the upper arm for up to six months. A removable and rechargeable transmitter is placed over the sensor, from which it gathers glucose readings that can be sent wirelessly to a connected mobile app. The transmitter also emits on-body vibrations to alert wearers to any urgent changes in their blood sugar levels.
Users can reference the readings collected on the app to help treat their diabetes and track the amount of time spent in their ideal glucose ranges. Additionally, they can give up to five people remote access to the app’s data, allowing loved ones to help monitor their health in real time.
Beyond its lengthy lifespan, which allows users to limit their sensor insertion and removal procedures to just two per year, the E3 also promises to cut down on fingerstick testing. The system only requires fingersticks for calibrations, which occur twice per day for the first three weeks of use, then typically only once per day after that.
Clinical trial results published earlier this year showed that the E3 system’s glucose readings differ by as little as 8.5% on average from standard fingerstick measurements. That’s comparable to mean absolute relative difference, or MARD, ratings of other recently launched CGMs, which typically aim for an MARD below 10%.