Sunday , November 19 2017
Home / Resources / Articles / New Implantable CGM Receives Approval

New Implantable CGM Receives Approval

Senseonics’ Eversense 90-day implantable CGM approved in Europe.

The first long-term implantable CGM (continuous glucose monitor) will be launched this month in Norway and Denmark. How does it compare to current CGMs?

Eversense will be the “world’s first long-term wear sensor.” Current CGMs in market include glucose sensors from Abbott (FreeStyle Libre-only available in Europe), Dexcom (G4, G5), and Medtronic (Enlite, Enlite 2), which require a new insertion every 7-14 days. The Eversense CGM uses a 90-day implanted sensor that is placed in the upper arm in a 5-10 minute in-office procedure. A rechargeable transmitter device is worn on top of the skin, directly over the sensor, which powers the implant and sends the current glucose value and trend arrow to a smartphone. The transmitter is removable (users can take it off/put it back on without wasting a sensor), though it must be on in order to get glucose readings.

Based on fluorescence technology embedded within a tiny sensor, the Eversense CGM System measures glucose from interstitial fluid below the skin surface.

The sensor wirelessly sends glucose data to the smart transmitter worn on the upper arm above where the sensor is implanted. In turn, the smart transmitter calculates the current glucose value along with the direction it’s headed, how fast, and whether glucose values are expected to exceed pre-set low and high targets. Data and alerts are simultaneously sent to the smartphone app that provides real-time tracking, intuitive displays to help identify patterns, and information to help stay in control.

No part of the sensor sticks through or shows through the skin surface. Encased in a biocompatible material, the sensor utilizes a unique fluorescent, glucose-indicating polymer. A light emitting diode embedded in the sensor excites the polymer, and the polymer then rapidly signals changes in glucose concentration via a change in light output. The measurement is then relayed to the smart transmitter. This entire measurement is designed to be done automatically, and without need for user intervention.

Eversense1Eversense requires two fingerstick calibrations per day, and its average error in trials relative to a lab measurement is ~11% (Dexcom’s G5 at ~9%, Medtronic’s Enlite at ~14%; Abbott’s FreeStyle Libre is ~11%, though it does not require any fingerstick calibrations).

Both the smartphone and transmitter will alert the user of a high or low glucose. When the phone is out of range, the transmitter will provide an on-body vibration alert toEversense2 indicate a high or low – a feature that distinguishes Eversense from other systems. Eversense is approved as an adjunct device to complement standard home glucose meters, meaning it is not approved for insulin dosing (like both the G5 or FreeStyle Libre are in Europe). The company plans to submit the device for FDA approval by the end of 2016, meaning it could approved in the U.S. some time in late 2017 or early 2018.

The system is intended to:

  • aid in the management of diabetes.
  • provide real-time glucose readings.
  • provide glucose trend information.
  • provide alarms for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).

If the Senseonics system is successful, it may help expand the CGM market in the U.S. and Europe, as a minority of people currently use this technology.

Practice Pearls:

  • Eversense requires two fingerstick calibrations per day, and its average error in trials relative to a lab measurement is ~11%.
  • The system is intended to be used as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
  • Senseonics is currently conducting a pivotal trial of the Eversense system, expected to complete in June 2016

 

Sensesonics.com