Senseonics Eversense, an implantable CGM

Senseonics Eversense is a continuous glucose monitoring system (CGM) with a sensor which is implanted under the skin. It measures glucose in the interstitial fluid for up to six months. The system consists of the implantable sensor, an external transmitter, and a smartphone app.

Senseonics CGM system: an implantable sensor with an external transmitter
Senseonics CGM system:
an implantable sensor with an external transmitter

The sensor continuously measures glucose levels and sends the results to a smartphone app. One implant works for at least 90 days. In a clinical study, around half of the implants lasted to 180 days.

Users will need to wear a transmitter above their skin. It is attached via a replaceable adhesive or an armband. The transmitter receives data from the sensor via NFC, and sends data to the smartphone via Bluetooth LE. When glucose levels are out-of-range, the transmitter sends discreet on-body alarms using vibration.

Sensor insertion
Sensor insertion

Since the sensor needs to be implanted, it can take a couple of weeks for the wound to heal. The sensor size is approximately 3 mm by 16 mm (or 0.12 by 0.63 inches). Apparently, the system needs to be calibrated twice a day.

For data export, Senseonics partnered with DiaSend to manage glucose data in the cloud. Glooko+DiaSend platform will offer an API for enterprise customers.

Accuracy

Senseonics’ Eversense CGM has shown exceptional results in a clinical study: 8.8% MARD (Mean Absolute Relative Difference), better than any CGM on the market. PRECISE II clinical study enrolled 90 adults with diabetes over 90 days of continuous glucose sensor wear. The study collected over 16,000 comparative data points with over 2 million glucose readings.

A previous study has shown a larger CGM error: 11.4% MARD. This study was smaller, with only 24 adults. The result of 11.4% put Eversense between Dexcom G4 and Dexcom G5 in terms of accuracy.

Availability

USA:

  • In October 2016, Senseonics submitted Eversense for a review by the US FDA. It can take months to get a premarket approval.

Europe:

  • Senseonics’ Eversense CGM has received a CE mark in Europe in May 2016.
  • Eversense has already been launched in Sweden and Norway in partnership with Rubin Medical.
  • The next countries are Germany, Italy, and the Netherlands: Senseonics announced a partnership with Roche Diabetes Care for exclusive distribution of Eversense in these countries. Senseonics and Roche are working on health insurance reimbursement.
  • In September 2016, Eversense has been launched in Germany in partnership with Roche.

Company details

The company Senseonics Holdinds, Inc. is based in Maryland, USA. Eversense is their first commercial product. The company’s focus is on design, development and commercialization of glucose monitoring systems. Senseonics’ stocks are traded on the New York Stock Exchange. The company holds 37 U.S. patents, 202 patents issued in other countries, with 111 patents pending worldwide.

References

Grace Carlson et al. Safety Analysis of a 90-Day Implantable CGM System in the PRECISE Study. 10/23/2015. Available online.

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