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FDA clears first over-the-counter continuous glucose monitor

fda.gov

51–60 of 439 posts

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

#51

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…

At least for me the readings that it shows are not accurate (when verified with old style finger pricking glucose monitoring machine). These CGMs are good for knowing the general variability of glucose level in your blood based on your diet exercise etc; I don’t trust the absolute numbers from CGM like Freestyle Libre - haven’t used any other one though yet.

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

#52

Earlier quoted context omitted.

I haven't noticed this as a consumer in the context we're talking right now. I think that article is measuring the difference between OTC and pharmacy pricing after a drug is approved OTC. But it is not looking at prices pre- vs. post- OTC approval. Olopatadine eye drops are amazing for allergy season, and they used to be like $250-400/bottle just 5 years ago or so, even the generic version. Then they went OTC for li…

It turns out when you strip out as much of the billing bureaucracy as possible, that things become cheaper.

I think "captive market" probably contributes more than "billing bureaucracy" ... the billing is still the same issue after the generics have gotten OTC approval for doctor prescriptions filled by a pharmacist. It's still very common for doctors to prescribe, and pharmacists to fill OTC drugs, and the payments go through the same insurance company red tape as any other Rx.

And yet, the article from GP shows that the added cost of this insurance billing bureaucracy is still less than the added cost of consumer shelf-branding markups.

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

#53

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…

[deleted]

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

#54
post #43

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.

Type 1 diabetics have been managing their insulin for decades with occasional blood sugar testing - i.e. certainly not testing for every dose. They’d be fine to manage things for a period without a confiscated monitor.

There are people who connect insulin pumps to their CGM. There will be situations where people can't quickly switch to manual BG management after setting up an automated solution.

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

#55
post #21

I wish Theranos had worked on a more reasonable goal - like an implantable CGM. I had T2D, well controlled now, my A1C is below the diabetic diagnostic range. I used CGMs, and they taught me a lot about how my body reacted to food and exercise. But I sweat a lot and they would always fall off, halving the useful life of each monitor. I would probably still use them from time to time if they didn't sweat off; and if a…

I used to have this problem as well, so I talked it over at my endo office. They suggested that I order some specially shaped stickers to keep them on, but instead I just bought some Kinesiology Tape (hansaplast, but also exists store-brand). 10cm of that works perfectly, even for heavy contact sports combined with sweating (and many showers).

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

#56
I would recommend anyone to experiment with this. I did, and found out I was more glucose sensitive than I expected. This led me to get more broad labs done, with which I was able to find additional treatable issues that are likely the cause. If I hadn't done this, I would have found out via symptoms years later, after irreversible damage had already been done.

You are your only medical advocate, no one else is going to do it for you. The standard of care is shit, don't rely on it.

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

#57
I'm a T1 diabetic, and CGMs are a great tool for blood sugar management. Combined with a closed loop system, they are literally life changing.

I am glad to see an increase in access to live changing medical care for a disease that is mostly just bad luck.

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

#58

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…

At least for me the readings that it shows are not accurate (when verified with old style finger pricking glucose monitoring machine). These CGMs are good for knowing the general variability of glucose level in your blood based on your diet exercise etc; I don’t trust the absolute numbers from CGM like Freestyle Libre - haven’t used any other one though yet.

It would be interesting to see whether a group of 20-100 people could manually calibrate their readings by fitting their CGM readings to their fingerprick glucose readers. I wonder what the accuracy would be after a very basic personal curve fit.

I do this with a lot of consumer measurement devices. Both for thermometers and scales (food, human, and cheap 0.1mg scales). As well as thermostats, like the kitchen oven. I also do it for my multimeters. I validate my volumetric measuring cups/spoons by weighing water in them but I don’t correct them, just return if they’re way off.

It’s okay if the reading is off as long as I can correct it the same way every time and get a pretty accurate result.

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

#59
post #45

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…

Aside from the fun, how did it go? Find anything surprising or insightful in the process? It sounds like an experiment I’d like to do for the purpose of optimizing my daily habits and establishing a better mental model for how my eating habits impact me throughout the day. But I really dislike needles.

If you want to know more about it you can just read about how diabetics treat different foods. Short version; high GI is fast high blood sugar, lots fat and sugar can results long period of with high blood sugars.

It is a CGM more or less what you would expect, insulin is the only hormone that lowers blood sugar, then you have all the stress hormones that raise it like adrenalin, growth hormone and cortisol plus glucagon for long time storage of sugars in the body. So measuring blood sugar with a CGM gives you a value between 2.9-13.5 mmol/liter that is supposed to give you picture of a rather complex system. A CGM also needs perfect access to your free flowing blood which in it self is a difficult task.

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

#60
post #50
post #45

Earlier quoted context omitted.

Aside from the fun, how did it go? Find anything surprising or insightful in the process? It sounds like an experiment I’d like to do for the purpose of optimizing my daily habits and establishing a better mental model for how my eating habits impact me throughout the day. But I really dislike needles.

If the needle in the CGM bothers you, don't let it. It's a quick, painless jab with a tiny needle at the beginning and then the needle comes out. The part that stays in your body is just a flexible filament made of plastic. I did this experiment as well, and the main thing it did was completely stop me from snacking. My habits got better because I could see how my BG could never return to baseline if I allowed myself…

Where do you put the needle thing? Does it get in the way of everyday things?
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