Savvy HOT News: FDA Approves World’s First Long-Term Implantable CGM

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.

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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!):

I’m pleased that the first implantable CGM sensor has been approved by ADA and I can verify that it’s accurate. I also thought it was a wholly terrible user experience and I can’t imagine for the life of me who would prefer/buy/use it.

While I understand that there are elements that changed from trial version to commercial version – like the size of huge transmitter box has been reduced a little and it’s now waterproof – many of the elements remain the same.

The transmitter must be charged and retaped on daily. It still requires an office visit and a scalpel to insert – my arm has a noticeable scar two years later. It still, I think, has strict calibration windows and can restart into a blinded mode if you don’t calibrate (not sure about commercial version). My arm was bruised and bloodied for weeks after insertion.

One of my chief complaints was that, because the transmitter is read via a coating that responds to light (or some such), I would get errors when I was outside that the sensor was receiving too much ambient light. Just walking to my car.

I know someone who was in the Canadian trial who had TWO sensors crap out on them and had to go in to get them removed during the trial. It’s an office visit.

I believe that the benefit of an implantable should be that it’s set it and forget it AND that it’s exceptionally discrete. This is neither.

There you go … YMMV (or as they say, Your Mileage May Vary … all user experiences may vary!) THANK YOU, Melissa!