FDA Approves World’s First Long-Term Implantable Continuous Glucose Monitoring System for Marketing in United States was announced by Senseonics, 21 June 2018.
Senseonics Holdings, Inc. (NYSE American: SENS) today announced the U.S. Food and Drug Administration has approved its Premarket Approval (PMA) application to market the company’s Eversense® Continuous Glucose Monitoring (CGM) System to people with diabetes in the United States. The system is the first and only CGM system to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months.
The Eversense System addresses many of the barriers to CGM use. The system consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. The sensor, which is inserted subcutaneously in the upper arm by a physician via a brief in-office procedure, lasts up to three months, thereby eliminating the need for patients to self-administer the weekly or biweekly sensor insertions required by traditional CGM systems.
The system’s smart transmitter is light, discreet, and comfortable to wear. Interpreting glucose data from the sensor and sending it to the system’s mobile application via Bluetooth, the smart transmitter provides on-body vibratory alerts for discretion and added safety, and is the only CGM transmitter that can be removed and recharged without discarding the sensor.
Although the device’s accuracy during the first 30 days of wear in the trial was questioned during the committee meeting, the overall accuracy of the device throughout the 90-day study was high, with a mean absolute relative difference of 8.5% (95% CI 8.0%-9.1%) from 15,753 unique readings. (MARD for Dexcom G5 is 9.0%, Dexcom G6 is also 9.0% but does not require fingerstick calibrations.) The device was also able to alert the user to 98% of hyperglycemic events and 96% of hypoglycemic events — however, 17% and 16% of these were false positives.
- FDA Approves World’s First Long-Term Implantable CGM
- Eversense Long-Term CGM System
- FDA OK’s 90-Day Implantable Continuous Glucose Monitor
BUT, Melissa Lee, a powerhouse in our Diabetes Online Community (and currently Director of PR for Bigfoot Biomedical), actually had a trial with the Eversense. Here are her comments with photos (kind of graphic but inquiring minds want to know!):