[patsplat]

I just heard about a related device from a family member who is an endocrinologist.

https://www.fda.gov/news-events/press-announcements/fda-clea...

First off, he had discomfort with the study methodology. Didn't go into details, but was surprised that the FDA was less conservative than himself in this case.

Secondly, it has been common in his practice for someone to have an unusual event. Someone does something out of the ordinary, they have an unusual circumstances, they don't adjust their treatment, and something goes wrong.

His question was -- does the device have a reset button? Is there a way to restart the management and learning? The answer is no -- the device will learn! But there's no way for the patient or the physician to adjust the treatment. So his answer is -- he would never recommend this device, not the way it's currently setup. It's opaque and there's no means for a person to influence the device's learning.

[TylerE]

This is just monitoring, not a pump. There is no learning or tuning or dosing. If it’s anything like the Freestyle I wore for a while there’s a self calibration process that takes a couple hours, but that’s per-sensor, and those get changed out every two weeks.

[patsplat]

You are correct, I think he was talking about a different device:

https://www.fda.gov/news-events/press-announcements/fda-clea...

[xattt]

> But there's no way for the patient or the physician to adjust the treatment.

This does not parse. This device is for patients that are managed with oral meds and not insulin. Yes, sulfonylureas carry some risk of hypoglycemia, but not as much as insulin proper and its fast- and slow-acting friends.

If someone is on a pump, they sure as heck will be using prescribed equipment.