Eversense CGM Approved by FDA

The FDA has approved Senseonics’ Eversense continuous glucose monitoring (CGM) system. It’s the first implantable CGM in the United States.

Eversense CGM System

The system includes a pill-sized sensor implanted in the upper arm for 90 days, an on-body transmitter, and a smartphone app for viewing data. Eversense’s 90-day wear removes the need for frequent sensor insertions required by other CGMs, which currently last for 7-14 days.

The FDA has approved Eversense for users 18 years and older, and the first insertions are expected this July. Eversense is very accurate, but it does require two fingerstick calibrations per day. It is not approved for insulin dosing though.

Some of the positive reports from Eversense users in Europe are the following:

  • The insertion and removal procedure is quick.
  • The Eversense transmitter is worn right above the sensor and uses a gentle adhesive.
  •  The transmitter can be easily removed and put back on, leaving the implanted sensor in place.

Eversense CGM Features

This is the first CGM to provide on-body vibration alerts. If you were to experiences any highs and lows, the transmitter would vibrate to notify the user, even if the phone is out of range.

Eversense is extremely accurate, especially since it minimizes the number of day 1’s, which is the early period right after a sensor is inserted when it is the least accurate.  Acetaminophen does not interfere with the sensor.

The system is compatible with Android and Apple devices. Glucose readings are sent to the smartphone app every five minutes from the on-body transmitter. There is not a separate receiver for Eversense, the smartphone app is the only way to view your data.

Pricing for the system is expected to be similar to other CGMs in the US. According to Senseonics, there will be some insurance coverage within 2018.

The approval came after a unanimously positive March FDA advisory panel, where health professionals, patient advocates, and study participants strongly argued for approval.