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, the company said.

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.

“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate…The next generation Eversense E3 System delivers on both,” said PROMISE study principal investigator Satish Garg, MD, professor of medicine and director of the adult diabetes program at the Barbara Davis Center, University of Colorado, Aurora, in a company press release.

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.

The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. Eversense readings may be used for treatment decisions, but users still must perform fingerstick glucose checks for calibration.

The regulatory review for the Eversense E3 was delayed for a year due to the COVID-19 pandemic. It will be distributed in the United States through a partnership with Ascensia Diabetes Care beginning in the second quarter of 2022, according to a Senseonics’ statement.

In addition, “The company expects the majority of its expenses for 2022 to be for research and development for ongoing feasibility and pivotal clinical trials for additional products in its product pipeline, including the start of its 365-day pivotal trial.”

Healthcare providers who want to offer the Eversense CGM System to their patients can sign up here or call 844-SENSE4U (844-736-7348).

Patients interested in getting started on Eversense can sign up here and will be among the first to know when Eversense E3 is commercially available.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter: @MiriamETucker.

For more diabetes and endocrinology news, follow us on Twitter and Facebook.

Note: This article have been indexed to our site. We do not claim legitimacy, ownership or copyright of any of the content above. To see the article at original source Click Here

Related Posts
Ramalan Zodiak Hari Ini 4 Februari: Gemini Pikirkan Sebelum Bicara, Cancer Jangan Takut Mengambil Risiko thumbnail

Ramalan Zodiak Hari Ini 4 Februari: Gemini Pikirkan Sebelum Bicara, Cancer Jangan Takut Mengambil Risiko

BAGAIMANA peruntungan zodiakmu hari ini? Melansir horoscopefriends, berikut ramalan zodiak hari ini untuk Gemini dan Cancer. GEMINI Kamu cenderung tidak bergerak dan berpikiran sempit dalam pandanganmu, dan ini membawa kamu ke dalam konflik dengan orang-orang di sekitar kamu yang memiliki pendapat yang berbeda. Namun, planet-planet akan membantumu menemukan solusi mendesak untuk masalahmu. Dengarkan pendapat orang…
Read More
FDA finds Salmonella in Darwin’s pet food again; company still refuses to recall product thumbnail

FDA finds Salmonella in Darwin’s pet food again; company still refuses to recall product

For recall information and photos of pet food packaging, use the links in this story. The Food and Drug Administration is updating its previously issued advisory concerning Darwin’s Natural Pet Products after finding Salmonella in yet another sample of the company’s raw pet food. The latest Salmonella finding concerns the following product: Darwin’s Natural Pet Products Natural Selections Antibiotic & Grain-Free Chicken
Read More
Can Dogs Detect Breast Cancer? thumbnail

Can Dogs Detect Breast Cancer?

Claire Guest remembers the day her Fox Red Labrador retriever, Daisy, started to act strangely. Rather than jump out of the car with Guest’s other dogs at a park, Daisy nosed Guest’s breast insistently.That night, Guest checked the area Daisy had nuzzled. She felt a lump and scheduled a doctor’s appointment. The lump turned out to…
Read More
'Superdonor' Samples Don't Increase FMT Success in UC thumbnail

‘Superdonor’ Samples Don’t Increase FMT Success in UC

The success of fecal microbiota transplantation (FMT) in people with active ulcerative colitis (UC) was not improved by using highly standardized and controlled "superdonor" samples versus control samples, according to results reported at the 17th congress of the European Crohn's and Colitis Organisation. Indeed, a similar percentage (10% and 13.9%, respectively; P = .72­) of…
Read More
Index Of News
Consider making some contribution to keep us going. We are donation based team who works to bring the best content to the readers. Every donation matters.
Donate Now

Subscription Form

Liking our Index Of News so far? Would you like to subscribe to receive news updates daily?

Total
0
Share