Senseonics gets approval for implantable 365 day CGM

Libre Life reports on news that Senseonics has received FDA approval for world-first implantable 365 day CGM. Read our overview of the features in this article.

Eversense 365: The World’s First One-Year CGM is here!

If you’re already using a CGM, you know how much it can simplify life with diabetes. But let’s be real—having to change sensors every 10-14 days can be a hassle. That’s why the latest news from Senseonics could prove to be a game-changer for all of us living with diabetes.

The FDA has just cleared the Eversense® 365, the world’s first implantable one-year CGM.

What makes Eversense 365 different?

Imagine only having to insert a new CGM sensor once a year. Yes, that's right—no more frequent sensor changes! With the Eversense 365, you get a fully implantable sensor that lasts for a full year. For those of us used to swapping out sensors every couple of weeks, this could be a breakthrough.

According to Tim Goodnow, President and CEO of Senseonics, “Eversense 365 was designed for real life.” Potentially meaning we can focus more on living and less on managing the medtech that helps us manage our levels.

Features overview

• Longest-lasting CGM: One insertion every 365 days! Instead of constantly juggling new sensors, you’ll only have to deal with one "Day 1" per year, compared to every 10-14 days with typical CGMs.

• Fewer interruptions: With a full year of sensor life, you don’t have to worry about sensor failures or gaps in data. No more dealing with those frustrating errors or missed readings when a short-term sensor decides to act up.

• No more wasted sensors: Since the sensor is implanted under your skin, it can’t be knocked off or accidentally dislodged. No more scrambling to replace lost or damaged sensors, which also saves on costs.

• Accuracy: Eversense 365 promises exceptional accuracy for a full year. And with fewer false alerts (goodbye, compression lows during sleep!), you can trust the data you’re getting.

• Comfort: It uses a gentle silicone-based adhesive for the transmitter that can be replaced daily, significantly reducing the risk of skin irritation that can happen with longer-term adhesives.

• Freedom and flexibility: Eversense is the only CGM with a removable transmitter. You can take it off when you want—whether you’re showering, swimming, or simply taking a break—without having to worry about wasting a sensor or waiting through a warm-up period when you reattach it.

• Discreet alerts: On-body vibration alerts mean you’ll be notified even when your phone is out of reach or on silent. It’s a discreet way to stay on top of your glucose levels without constantly checking your app.

How Eversense 365 can make life easier

Let’s face it—living with diabetes can be overwhelming. The constant monitoring, calculations, and decisions around food, exercise, and insulin doses add up to a full-time job. The goal of CGM technology has always been to reduce that burden, and the Eversense 365 takes this to the next level. With just one sensor insertion per year, a removable transmitter, and consistent accuracy, this system is about giving wearers back time and peace of mind.

Brian Hansen, President of CGM at Ascensia Diabetes Care, explains:

“Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs.”

A new era?

What’s even more exciting is that the Eversense 365 has been cleared as an integrated CGM (iCGM) system, meaning it can work with other devices, like insulin pumps, in an automated insulin delivery (AID) system. This opens up more possibilities for simplifying diabetes management even further, and there are already discussions underway with various pump manufacturers to make this integration a reality.

When will it be available?

Ascensia (partner of Senseonics) is planning to roll out Eversense 365 in the US early in the fourth quarter of 2024. They’re also working to ensure that insurance coverage will be available from day one so that as many people as possible can access this next-gen CGM system. Those interested can already register their interest on the Senseonics website.

It's not yet known if this will become an option for CGM on the NHS in the UK.

Costs & insurance

Details of pricing for Eversense 365 have not yet been released. It’s not known if  the Eversense 365 will align with the same per day cost as the 180-day sensor - estimated to be approximately $2,900, inclusive of the sensor, transmitter and procedure.

Many insurance companies and Medicare, cover the cost of Eversense insertion and removal procedures, as well as that of the device. 

Ascensia have confirmed that a new Payment Assistance and Simple Savings (PASS) Program is to be launched and eligible individuals will pay as little as $199 out of pocket for 1 year of continuous glucose monitoring.

Final thoughts

For those of us who have experienced the ups and downs of using short-term CGMs, the Eversense 365 represents a major leap forward. With a full year of sensor life, more accuracy, and greater flexibility, it’s a system designed to fit seamlessly into everyday life—letting you focus more on what matters and less on sensor replacements and data interruptions.

If you’ve been dreaming of a CGM that’s more dependable, less disruptive, and packed with features that make managing diabetes easier, Eversense 365 might just be the solution we’ve been waiting for. Keep an eye out for the U.S. launch later this year—this is going to be a game-changer!

Reference

Sensonics: https://www.senseonics.com/investor-relations/news-releases/2024/09-17-2024-120118174

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