180-Day Implantable CGM, Eversense E3, Approved by the FDA
The Eversense E3 continuous glucose monitor (CGM) has been approved by the FDA and it has received a CE Mark approval in Europe for people with diabetes aged 18 and older. The 180-day implantable sensor will be available later in 2022.
The long-awaited FDA approval of Sensonics 180-day implantable continuous glucose monitor (CGM) – The Eversense E3 – is finally here. The new CGM is approved for people with diabetes who are 18 years old or older. In addition, in June 2022, the system also received a CE Mark approval in Europe.
Senseonics is the medical technology company that created the implantable Eversense CGMs. In the fall of 2020, Senseonics partnered with Ascencia Diabetes Care (the maker of the Contour blood glucose meters), allowing Ascencia to handle the marketing and distribution of the Eversense products.
“All of us at Senseonics and Ascensia Diabetes Care are most excited about extending sensor life – actually doubling it,” said Dr. Tim Goodnow, the president and CEO of Senseonics. “And we’re extremely proud of the sensor accuracy during the entire six-month period.”
In the PROMISE study, researchers analyzed the safety and accuracy of the Eversense E3 in 181 adults age 18 and up. Overall, results showed that the Eversense E3 was safe and accurate for up to 180 days. The accuracy of the Eversense E3 was also better than any currently available CGM on the market – though it does require daily fingerstick calibrations to make it accurate.
What is the Eversense E3?
The Eversense E3 is an implantable CGM that can be used for 180 days before replacement. The components of the CGM include:
Implantable sensor. The sensor is inserted under the skin of the upper arm (and removed) every six months by a trained healthcare provider.
Rechargeable smart transmitter. The transmitter sends glucose data via a bluetooth connection to a mobile device app. It is the only CGM that provides on-the-body vibrating alerts for highs and lows. It can be taken off and replaced each day using a gentle adhesive patch.
Mobile app. Available on both iOS and Android devices, the app shows the user their glucose data and trends every five minutes and allows them to receive alerts for highs and lows. It is the same app that is used with the 90-day sensor, but it has been updated to reflect the longer sensor life and reduced calibration needs.
Unique Eversense E3 features
The Eversense E3 will have several new features that make it a significant upgrade over the currently available Eversense 90-day sensor.
The 180-day sensor now only requires two insertions and removals a year, lowering the number of clinic visits required and providing greater convenience – doubling the wear time of the 90-day option.
The sensor requires two calibrations per day for the first 21 days of wear. After day 21, one fingerstick calibration is required each day (an improvement over the 90-day sensor which requires two calibrations per day for the entire 90 days).
Like the Freestyle Libre and Dexcom G6, it can be used to make decisions about treatment and insulin dosing. “With the long-term convenience of an implantable sensor, there is no weekly or bi-weekly hassle of changing your sensor, you can’t dislodge a sensor, [and] you reduce the number of supplies you need to carry or order,” said Goodnow.
When will the Eversense E3 become available?
The Eversense E3 will be released in the coming months and will require a prescription. For those interested in getting started on Eversense, Senseonics suggests that you sign up here to be alerted when the CGM is available.
For those in Europe, following the recent CE Mark approval, Ascencia has said that the system will become available in Germany, Italy, Spain (including Andorra), the Netherlands, Poland, Switzerland, Norway and Sweden in the second half of 2022.
How much will the Eversense E3 cost?
Though Senseonics has not shared the exact out-of-pocket cost of the Eversense E3, it is believed that the new model will have the same per day cost as the 90-day sensor.
Most insurance companies cover the cost of the insertion and removal procedures and the device itself. If you have Medicare and require insulin to treat your diabetes, your insurance should also cover the associated costs. You can find more information on the cost of this CGM here.
In addition, because Ascencia is in charge of the marketing and distribution of the Eversense products, it offers a Patient Assistant Program (PAP) to help cover the cost for those without adequate insurance coverage. The current PAP can save users up to $1,200 a year and Ascencia has indicated that they plan to update the PAP now that the Eversense E3 is gearing up to launch. To learn more, you can contact Ascencia here.
The bottom line
“The goal is to get insulin-using type 1 and type 2 diabetes patients using CGM, relying on Time in Range, and reducing their risk of short- and long-term diabetes complications,” said Goodnow. “Having options concerning how systems are inserted, how long they last, how they measure glucose, how the transmitter is held in place and how it elicits alerts, adhesives, and accuracy is important.”
Though far fewer people currently use an Eversense CGM when compared to leading brands like the Freestyle Libre and the Dexcom G6, the Eversense E3 adds an additional option into the landscape – one that is markedly different from other models.
While it does require minor procedures and fingerstick calibrations throughout its duration, the convenience of a CGM that only has to be replaced once every six months could be an attractive alternative to those devices that must be replaced every 10 to 14 days, and a major improvement over the previous Eversense model by doubling the sensor life.
To learn more about the Eversense E3, its features, and its availability, click here.