Eversense E3 Continuous Glucose Monitor Gains FDA Approval, Offers Extended Wear-Time
Editor’s Note: This is a breaking news story and will continue to be updated as more information becomes available.
On Friday, February 11, 2022, Senseonics announced the FDA approval of its Eversense E3 continuous glucose monitor (CGM), which patients can wear for six months. It is the world’s first and only continuous glucose monitor that accurately tracks patients’ glucose levels for this amount of time using a single sensor.
The CGM prioritizes accuracy and wear-time. It should be available to patients in the United States through Ascensia Diabetes Care (Senseonic’s global commercial partner) as soon as the second quarter of 2022.
The E3 is designed for patients 18 years of age and older. Though it is a continuous glucose monitor, patients should keep a blood glucose monitor on hand with the E3 (and other CGMs) for A blood sugar calibration first requires a finger prick for the user to test their blood. Once the blood glucose (BG) value appears on the meter, patients should enter the same number into the calibration functionality of their continuous glucose monitor (CGM) transmitter or app with the same number to improve the accuracy of their blood sugar readings.calibration purposes. The E3 will require only one calibration per day. Blood sugar calibration typically improves the accuracy of glucose level tracking with a continuous glucose monitor among patients with diabetes, especially when users feel differently than their levels are reading.
The E3 comes with a removable transmitter worn above the skin over the implanted sensor that is kept in place with a mild silicone-based adhesive, improving the discretion of the device. The E3 transmitter provides discreet on-body vibratory alerts and transmits data to a mobile app where patients can see real-time glucose levels, trends in their glucose levels over time, and view their displayed alerts.
In a PROMISE study (clinical trial), which was delayed one year because of COVID-19, the third generation sensor demonstrated a mean absolute relative difference (MARD) of 8.5 percent. MARD scores identify the accuracy of a CGM. As of 2020, MARD scores of 10 percent or lower are considered ideal for CGMs.
“Patients will appreciate the excellent accuracy of the system and the ability of the sensor to last 6 months. This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor,” said Satish Garg, M.D., Professor of Medicine and Director of the Adult Diabetes Program at the Barbara Davis Center of the University of Colorado, and the Principal Investigator of the PROMISE Study.
Eversense reports that after multiple clinical trials, their currently accessible CGMs helped patients with diabetes lower their A1Cs by an average of 0.5 percent in the first 90 days of wear-time. Patients could wear former versions of the Eversense continuous glucose monitors for three months, which was a feat in and of itself for the community (as most CGMs on the market today allow for 10 to 14-day wear). However, there are some barriers for patients with diabetes to gain access to the technology.
To wear the Eversense CGMs, patients must have the sensor implanted under their skin, which a select number of doctors across the U.S. are trained to do. Because it will only need to be replaced every six months (or currently, every three), a two-hour drive to the nearest clinician (for example) may be worth it for some patients. It all depends on patient preferences, needs, accessibility, and affordability. The best way to know if a provider is near you is to reach out to an Eversense rep.
Insurance coverage varies for Eversense products among users. Eversense reps can help patients determine the cost and how to bill to insurance if they are interested in pursuing the technology. Patient assistance programs and Care Credit may also help improve product affordability for some patients.
If you are interested in learning more about the E3, Eversense recommends signing up for product alerts here.