Add Eversense 365 a new BG source

[CAPTCG]

Add Eversense 365 a new BG source

[Chaspirateur]

Hi,

The Eversense 365 should be considered a trusted BG source in AAPS:

• FDA clearance (Sept 2024) as an iCGM, explicitly allowed to communicate with Automated Insulin Delivery (AID) systems.
  FDA document K241335

• Commercial launch (Oct 2024, US) after FDA approval.
  MedicalDeviceNetwork, Yahoo Finance

• Technical specs: implantable sensor for up to 1 year, only 1 calibration per week after the initial phase.
  Eversense official site, Mercy press release

• European CE Mark: Submission completed in Q1 2025, launch expected in second half of 2025. Distribution planned in Germany, Italy, Spain (incl. Andorra), Poland, Switzerland, and Sweden.
  Senseonics press release, GlobeNewswire, DrugDeliveryBusiness, Clival News

Thanks!

[Philoul]

@Chaspirateur Thank's for this first status.

Currently AAPS only receive "eversens" as type of sensor, so we don't know which sensor is connected (365, 180, XL, other)

My understanding (discord discission) is this issue can be extended to also include Eversense 180.

In my mind (@MilosKozak could confirm), it's important to have not only 365 and 180 status concerning approval by health authorities but also the status of previous "unapproved sensors" XL and others.

When manufacturing of these unapproved sensor has been stopped? When usage has been stopped all around the world?

• can we still have today at least one user somewhere with an old unapproved sensor running and providing BG values, yes or no ?

This could probably helps a lot...

• if yes Eversens app should provide exact sensor (180, 365, XL...).
• if no, maybe be Eversens is enought to be sure it can only be 180 or 365 so approved sensors for closed loop usage in several countries 🤔

[Chaspirateur]

@Philoul

Here’s the current status of Eversense sensors:

Old/unapproved sensors (XL, 90d):

• Eversense XL (180d): CE-marked 2017, distributed via Roche until early 2021, replaced by E3 (SEC, Diatribe, Senseonics)

• Eversense 90d: CE-marked 2016, discontinued 2021 (SEC)

Lifespan ≤180 days → no XL or 90d sensors could still be active today

Approved sensors:

• E3 (180d): FDA cleared Feb 2022, CE June 2022 (Senseonics, Senseonics)

• 365 (1y): FDA cleared Sept 2024, US launch Oct 2024, EU CE submission Q1 2025, launch H2 2025 (Senseonics, Senseonics)

Conclusion:

• Any sensor showing as “Eversens” is either E3 or 365 (both approved: FDA and CE-marked).

• There are no active, unapproved sensors in use today.

[Philoul]

@Chaspirateur Thank's for your answers

@MilosKozak do you think it's ok to make "Eversense" sensors trustable for SMB Allways ?

[HighRye]

@MilosKozak Hello hello, how can I help move this forward?

[CAPTCG]

@HighRye I have a temporary work around. Not a real solution, but I am able to use Eversense 365 fully with no SMB restriction w/Master 3.3.2.1. Esel is needed. Not real total intergration into AAPS like Dexcom. That would be nice. I hope you can help.