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      11-23-2021, 08:27 PM   #36
vreihen16
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Originally Posted by vreihen16 View Post
FWIW, the Freestyle Libre 2 (CGM!) was recently approved for sale in the USA. The iPhone app has apparently not been approved yet by the FDA, or I'd have that on my arm right now to see how it works.....
Following up on this, the FDA finally approved the Freestyle Libre 2 (FL2) iPhone app for use in the USA back in late August. I've been using the FL2 for a few days now, and thought that I should provide some feedback.

Most importantly is that because it is classified as a CGM, the FL2 sensors are 100% free on my health insurance plan! I was self-funding the original 10-day and 14-day first-generation sensors, so this alone is enough to make me use them more.

The FL2 sensors are the same size as the first-gen ones, and my third-party donut bandages fit the new sensors the same as the old ones.

The biggest gotcha coming from the FL to the FL2 is the phone app use. On the original FL, you could scan a newly-installed sensor with the meter, and also link it to the phone if you scanned it within a few minutes of linking the meter. With the FL2, it is one or the other for a newly-installed sensor...but not both. When I was seeing an endocrinologist, his staff only wanted to see a meter and not the phone. I would scan with the meter for the doctor, and scan with the phone for myself. That isn't an option with the FL2.

Under the covers, I suspect that the FL2 sensors use NFC like the originals but also have Bluetooth/BLE radios in them. The new FL2 iPhone app asked for security permission to use Bluetooth when I installed it. If you read the reviews in the App Store, there are a lot of complaints about sensor range for receiving CGM alerts. Reading between the lines, it looks like the consensus there is that the FL2 meter seems to have much better Bluetooth range. I can tell you that my phone was about 6' away from my pillow through one sheetrock wall, and lost contact with my sensor twice while I slept last night. It seems like you have to manually scan the sensor via NFC to re-establish the Bluetooth CGM link and download the missed/stored data.

Speaking of alarms, that is also a popular gripe in the App Store reviews. The app uses the iOS emergency notification bypass to send high/low/signal loss alerts. This means that do not disturb and the slider mute/vibrate switch on the iPhone are not honored, so it could be fun if you are in a meeting/conference/theater where it makes you the doofus who has the ringing/beeping phone. They appear to have added optional toggles to honor/bypass the silent modes for each alert in the current app release. I left them all bypassing for now, since having a CGM that cannot alert seems silly. Just pointing this out because it was the reason why I knew my phone lost contact with the sensor twice last night. It sounded the alert on both my phone and Apple Watch, waking me up twice.

Just like with the original first-gen stuff, you apparently still need to buy the FL2 meter even if you never intend to take it out of the box. I vaguely recall reading that part of the FDA approval process was having a strip meter integrated into the unit, for use as a backup or when the sensor was reading implausibly. The first-gen meter and app used to both request finger sticks on occasion. The new FL2 app hasn't asked me yet in the few days of use so far. I haven't even broken the seal on my FL2 meter's box yet, but am considering at least putting a charge into the batteries just in case.

The iPhone app needs to be left running (minimized) 24/7 in order to use the CGM function. If you try to close the app, it will throw an emergency alert that doing so is a bad idea. I did notice that the app started dogging out and taking 10+ seconds to perform a manual scan after a day of continuous running, and suspect that it has a memory or task leak bug of some sort. If I see it happening regularly, I'll make it a habit to close/restart the app a few times per day to clear things up.

If anyone has questions, feel free to ask. In the mean time, we can all wait for the FL3 to get FDA approval for the USA, which has a much smaller sensor than the original FL and FL2.....
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