Last June, the FDA approved its first continuous glucose monitoring system to feature a fully implantable sensor. Good for up to 90 days, Senseonics’ Eversense CGM comes paired with a mobile app that can notify adults with diabetes if their blood sugar levels go too high or dip too low.
The system relies on a small device, about the size of a grain of rice, placed just under the skin in an outpatient procedure. It’s coated with a fluorescent chemical that glows when exposed to varying levels of glucose in the bloodstream. A sensor patch monitors those light levels and uploads its measurements every five minutes to the user’s smartphone and can vibrate itself to alert the user when their glucose levels are out of range.
When it was approved, the FDA described the device as a “more seamless digital system” that vividly illustrates the potential for mobile platforms to help patients effectively manage chronic diseases.
Senseonics debuted the system in the U.S. in August, touting a three-month life span that outstrips the one to two weeks offered by other CGM platforms. However, that expiration feels quick compared with the 180 days Senseonics' Eversense XL system offers. That product claimed a CE mark in September 2017 to deliver that longer-lasting version of its implant.
Last year, the company also submitted a premarket supplement application to the FDA to support an automated insulin dosing claim on its label and began a U.S. clinical study of its 180-day sensor.
In 2016, the Maryland-based company first inked a small European distribution deal with Roche—a deal the companies reupped for two more years in February and expanded to cover 17 additional countries, including Brazil, Russia, India and China.
The Big Pharma—which previously helped Senseonics raise $41 million to commercialize its device—will remain Eversense’s exclusive distributor in Europe, the Middle East and Africa, outside of Scandinavia and Israel, as it adds markets in the Asia-Pacific and Latin American regions.
A comparison of the Eversense system and other continuous glucose monitors, including Dexcom’s G5 and Abbott’s Freestyle Libre Pro, found Sensonics' implant coming out slightly ahead. In daily use over a period of six weeks, 23 participants with Type 1 diabetes wore all three devices at once, for a study published by the American Diabetes Association.
While researchers found that the three were less accurate in real-world situations compared with clinical trial results, Eversense edged out its competition with a relative difference of 14.8% compared with a test-strip-based glucose reader, versus the G5’s 16.3% and the Libre Pro’s 18.0%.