The World’s First Year-Long CGM Gets FDA Approval

Somewhere in America, pigs are flying. Blue moons are appearing in the sky. Cows are coming home. In other words…there’s big news in the diabetes world! The first-ever year-long CGM sensor just received FDA approval!

On September 17^th, the Eversense 365 was given the green light for people 18 years and older with type 1 or type 2 diabetes. Eversense 365 is the latest generation CGM from the Senseonics/Ascensia Diabetes Care partnership, and it comes about two years after their 180-day sensor was approved in 2022. This really is a landmark moment as all other CGM sensors have a wear time of 15 days at most.

What Is the Eversense 365 CGM?

The Eversense 365 is an implantable continuous glucose monitoring device worn under the skin that sends glucose readings to a smartphone every five minutes, 24/7. The system has three main components:

1. A Sensor: A tiny sensor is inserted under the skin of the upper arm and stays in place for one year.
2. A Transmitter: A water-resistant, removable and rechargeable transmitter is worn on top of the skin via a gentle silicon adhesive patch.
3. A Mobile app: The Eversense app (compatible with Apple and Android) receives data from the transmitter, displays glucose values and trend arrows, and also provides alerts and alarms.

Additional features of the Eversense 365 include on-body vibration alerts (in addition to audio alerts) which can be a great option for people who are hard of hearing or visually impaired…or sick of annoying loud alarms. The vibration pattern is different for high and low alerts so you can differentiate between the two. Vibration alerts are provided even if your phone is out of range (even if you are scuba diving down to 33 feet).

There is also a Share My Data feature which allows you to share your CGM data with your healthcare team, family, friends, etc.

Pros and Cons of the Eversense 365 CGM

As with any pump or CGM system, there are pros and cons.

Pros:

• Since the sensor only needs to be changed once a year, you’ll spend less time managing diabetes supply orders and swapping out sensors.
• The removable transmitter offers more freedom for certain activities (e.g., swimming, being intimate, or being intimate while swimming) but you will not get any readings when it’s not connected.
• There’s less environmental waste since you aren’t using new sensors, applicators, and transmitters every couple of weeks.
• Naked showers!
• A  sensor worn under the skin means it cannot be accidentally knocked off.

Cons:

• It requires an in-office procedure for sensor implantation and removal. Each procedure takes approximately 15 minutes and requires a local anesthetic.
• Fingerstick calibrations are required once a day for the first 13 days, and then only once a week from day 14 onward (and when symptoms do not match CGM information or when taking medications of the tetracycline class).
• It does not integrate yet with an insulin pump (but plans are in the works).
• You need to charge the transmitter once every 1-2 days for five minutes.

How Accurate is the Eversense 365?

The Eversense 365 has a MARD of 8.8 % for a one-year time period. MARD stands for Mean Absolute Relative Difference and is a percentage that measures the accuracy of continuous glucose monitors. A lower MARD indicates that the CGM is more accurate, and a CGM with a MARD of less than 10% means it has a very good accuracy performance. The fact that the MARD for the Eversense 365 is consistent over a year is important to note.

Does the Eversense 365 Integrate with Insulin Pumps?

Eversense 365 is cleared as an integrated CGM (iCGM) system, meaning it can integrate with compatible medical devices including insulin pumps. However, no official insulin pump partnerships have been announced yet.

Is the Eversense 365 Covered by Insurance and Medicare?

The Eversense 365 and the insertion and removal procedures will be covered by most commercial insurance and Medicare. There is also a patient assistance program called PASS (Payment Assistance and Simple Savings) which allows eligible participants to receive their sensors and transmitter for $199. See eversensecgm.com for details.

When Will the Eversense CGM Be Available?

The Eversense 365 is expected to launch in the U.S. early in the fourth quarter of 2024. Work is ongoing to transition coverage availability to facilitate immediate access to as many people as possible upon launch. To learn more about Eversense 365 and receive information on when the system will be available, visit www.eversensecgm.com.

In Summary

An implantable CGM sensor may not be the right fit for everyone, but the technological advancements that allow for a sensor to last for a year are pretty remarkable. By reducing the need for frequent sensor replacements, the Eversense 365 not only offers greater convenience, but also improves long-term adherence to CGM therapy. This extended wear time, combined with high accuracy and customizable features, could lead to better glycemic control and, consequently, fewer diabetes-related complications over time. While some challenges remain, this innovation marks an exciting step forward in the ongoing quest to empower people with better tools for controlling blood sugar and improving quality of life.

So…what would you do with all that time you could save not being on hold with insurance or swapping out sensors every 7-14 days?  Learn the tango? Read Don Quixote? Binge-watch all of Jeremy’s IG videos of his dog Benny? That will be up to you.

Dr. Edelman is on the Board of Directors of Senseonics. Ascensia is a 2024 sponsor of TCOYD.

Additional Resources:

My Review of the FDA-Approved Eversense E3 CGM

Watch Dr. E’s Eversense E3 CGM Insertion – We Filmed It LIVE!

Eversense E3 CGM Approved for Two Sensors per Year: Your “Happily Ever(sense) After”