FDA Okays 6-Month Implanted Eversense CGM for Diabetes!!
The US Food and Drug Administration has approved a new second-generation version of the implanted continuous glucose monitoring (CGM) system Eversense (Senseonics) that lasts for 6 months. The Eversense E3 CGM system doubles the wear time from 3 months with the previous Eversense device approved in the United States in 2018. As before, the new system is approved for adults with diabetes aged 18 years and older. This means that it will be the longest lasting CGM system available in the United States, with essentially two sensor insertion and removal procedures per year. Please share your comments on this.
@anurup Data from the pivotal PROMISE trial of the 6-month version were presented at the American Diabetes Association Scientific Sessions in 2021, as reported by Medscape Medical News. An older 6-month wear time version (Eversense XL) has been available in Europe since 2017. The new second-generation 6-month system is currently under regulatory review there. The PROMISE trial included 181 participants with diabetes, about two thirds with type 1 and one third with type 2 diabetes, at eight clinical research sites. The Eversense E3 consists of a fluorescence-based sensor, a transmitter, and a smartphone app that displays glucose values, trends, and alerts. The sensor is inserted subcutaneously into the upper arm by a certified healthcare professional in a brief office procedure. The transmitter is placed on the skin on top of the sensor. Glucose data are sent to the app automatically every 5 minutes.