Senseonics recently announced CE Mark approval in Europe for its Eversense 90-day implantable CGM sensor, body-worn transmitter (worn over the sensor with adhesive tape), and mobile app for viewing real-time glucose data. Eversense was first to launch in Sweden last June. Eversense is being positioned as the “world’s first long-term wear sensor.” Eversense uses a 90-day implanted sensor (a bit larger than a pill) that is placed in the upper arm in a 5-10 minute in-office procedure. A rechargeable transmitter device is worn on top of the skin, directly over the sensor, which powers the implant and sends the current glucose value and trend arrow to a smartphone. The transmitter is removable (users can take it off/put it back on without wasting a sensor), though it must be on in order to get glucose readings. Eversense requires two fingerstick calibrations per day, and its average error in trials relative to a lab measurement is ~11% (slightly worse than Dexcom’s G5 at ~9%, but slightly better than Medtronic’s Enlite at ~14%; Abbott’s FreeStyle Libre is also ~11%, though it does not require any fingerstick calibrations).
Both the smartphone and transmitter will alert the user of a high or low glucose. When the phone is out of range, the transmitter will provide an on-body vibration alert to indicate a high or low – a nice feature that distinguishes Eversense from other systems. Eversense is approved as an adjunct device to complement standard home glucose meters, meaning it is not approved for insulin dosing (like G5 or FreeStyle Libre in Europe). The company plans to submit the device for FDA approval by the end of 2016, meaning it could be approved sometime in late 2017 or early 2018. In addition to seeing a current glucose value every 5 minutes, the app is also intended to display where you are headed and how fast, so you can take steps to stay in control.