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FDA clears first over-the-counter continuous glucose monitor

fda.gov

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Re: FDA clears first over-the-counter continuous glucose monitor

#31

When your smartphone becomes a critical health device to support/treat a condition I wonder how that will impact case law around things like police confiscation.

What happens when an officer confiscates your glucose monitor today? I assume you die and they claim they did it for some valid reason or the other.

Or just withholding the insulin itself: https://www.thenation.com/article/society/diabetes-police/

Re: FDA clears first over-the-counter continuous glucose monitor

#32
I bought a Sibionics GS1 recently and am about to use it (SIBIONICS GS1 Sensor Continuous... https://www.amazon.de/dp/B0CPDHKGYK?ref=ppx_pop_mob_ap_share). Reading this thread I’m wondering if it is a safe / good product to use. Does anybody happen to have knowledge?

Re: FDA clears first over-the-counter continuous glucose monitor

#33

When your smartphone becomes a critical health device to support/treat a condition I wonder how that will impact case law around things like police confiscation.

What happens when an officer confiscates your glucose monitor today? I assume you die and they claim they did it for some valid reason or the other.

Yes, but you can't easily use your non-smartphone glucose monitor as a communications device to manage a bunch of drug dealers which can't be confiscated because your life depends on it. That changes once it's your smartphone.

Re: FDA clears first over-the-counter continuous glucose monitor

#34
post #23

Earlier quoted context omitted.

Technically you can buy them on Facebook marketplace, craigslist etc

Not really. It's against ToS in both cases, to sell used medical equipment.

Yet renting medical equipment is a flourishing business, at least in the U.S.

Re: FDA clears first over-the-counter continuous glucose monitor

#35

I like this trend of the FDA making more and more things OTC.

Don't be fooled by the reason though > The markup on OTC products is generally higher than on prescription medications. https://www.eposnow.com/us/resources/how-do-pharmacies-make-... .

For medical products though, it seems great. OTC hearing aids are a big win for society.

Re: FDA clears first over-the-counter continuous glucose monitor

#37
post #33

Earlier quoted context omitted.

What happens when an officer confiscates your glucose monitor today? I assume you die and they claim they did it for some valid reason or the other.

Yes, but you can't easily use your non-smartphone glucose monitor as a communications device to manage a bunch of drug dealers which can't be confiscated because your life depends on it. That changes once it's your smartphone.

See, my point is that they’ll do it already when it’s not even reasonable to do so. So when they take your phone away, which can be done so more credibly, why would you expect more protections?

Re: FDA clears first over-the-counter continuous glucose monitor

#38

I dove into CGMs a little bit about a year ago, mostly just for fun. Yes, I paid money to some online prescription mill for CGMs (Abbott Freestyle Libre 3, IIRC), and then put one in my arm (the applicator is a short syringe section that has the monitor tube threaded into it, so the tube stays in your arm and your skin under the monitor remains broken) for a couple weeks. Just to see how various foods would affect my…

I would love to see the results of that!

Re: FDA clears first over-the-counter continuous glucose monitor

#39

I like this trend of the FDA making more and more things OTC.

Don't be fooled by the reason though > The markup on OTC products is generally higher than on prescription medications. https://www.eposnow.com/us/resources/how-do-pharmacies-make-... .

I have an extremely hard time buying into the idea that that the reason for making glucose monitors available over the counter is simply to increase the profit margins of drug stores.

Re: FDA clears first over-the-counter continuous glucose monitor

#40
post #15
post #3

I'm T1D (insulin-dependent). I used a Dexcom for a couple years a while ago, back around the G3 through G5 era or so. I ended up stopping using it because my diabetes is very well managed, and I found it didn't make a huge difference to my management. With my insurance, each new sensor every week cost about $50, and would fail in various annoying ways: sometimes it would just stop working in the middle of the week, o…

Dexcom and Freestyle both have options (G7, FSL2) that have a much narrower form factor than the old sensors. They end up being far more reliable, because the sensor doesn't dislodge. The new Dexcom sensors are more accurate. Less drift and no calibration. Out of pocket cost is obviously your own situation but I think anyone with T1 should look at them. For me they are life changing, even moreso if you have a pump th…

Glad to hear they're improving, though the waste situation is bizarre. I will probably go back on one at some point, I didn't hate it, just didn't feel it was worth the cost/benefit ratio. It didn't impact my A1c, I've always been in the low 6s, and I've only had two lows that I would consider significant in my 25 years with the disease. Benefit just wasn't there for the hassle and price.
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