Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Diabetes

First implantable glucose monitor approved by FDA

The first continuous glucose monitoring system with a fully implantable sensor has been approved by the US Food and Drug Administration (FDA).

The agency endorsed the Eversense Continuous Glucose Monitoring (CGM) system for use in people aged 18 years and older with diabetes. It is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose. The sensor can be worn for up to 90 days.

The Eversense CGM system uses a small sensor that is implanted just under the skin during an outpatient procedure. It is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to an app on a phone or tablet, which alerts users if glucose levels are too high or too low.

To inform its decision, the FDA evaluated clinical study data from 125 adults with diabetes and reviewed the device’s effectiveness by comparing readings from the Eversense CGM system to those obtained by a laboratory-based glucose analyser.

FDA commissioner Scott Gottlieb said: “These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205052

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.