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FDA clears first over-the-counter continuous glucose monitor

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

#261

Post by philsnow »

haswell wrote: post #45
philsnow wrote: post #30

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.

I almost completely forgot about the monitor itself, and only paid attention to the numbers on my phone. It's that unobtrusive (at least the Libre 3 one that I used).

I let the needle (actually: annulus? see sibling comment) get into my head because I was curious and looked at it. It looks a lot scarier than it is, kind of like using contact lenses for the first time: before you've used them, you get into your own head about it, but once you've done it a couple times it's just rote and easy.

I had started the first one a day before I started a few weeks of (6-days-on, 1-day-off) keto. Keto guides will say that you should have edit: One more thing, I used this time to play around with various sugar substitutes and see how they affected my blood glucose. Allulose came out as the winner (if money is no object) based on not having any noticeable off-taste or aftertaste and on measuring gram-for-gram the same as sugar (well sort of, it's only like 80% as sweet as sugar, so you get the same mechanical effects of sugar if you weigh it gram-for-gram and your baked goods or whatever come out not quite as sweet, which is perfect for me. Creaming butter with liquid stevia extract or something just plain doesn't work.

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

#262

Post by jablongo »

pie420 wrote: post #104
TaylorAlexander wrote: post #74

Earlier quoted context omitted.

My understanding is that for healthy individuals, spiking blood glucose levels is not a problem. Did you get in to any of the research on that? Glucose is a problem for diabetics because they can’t regulate it, but healthy people can. At least this is loosely what I have heard, somewhat third hand. Any information is appreciated.

Not a doctor, but from what I have seen, there is a healthy amount of spiking from eating normal foods, but our modern diets are so sugar and carb heavy that the glucose spikes are way outside the range that our bodies evolved to handle. Hunter gatherers would maybe eat some berries here (much smaller and less sweet than modern berries) and there. The modern human eating pizza, tons of bread, ice cream, soda, etc. cr…

It's not really that the pancreas itself can't handle it (though this may be true also). What happens is that having high blood glucose, even if it's not continuously high, is just bad for you by virtue of the high concentration of glucose in your blood. Having high blood glucose leads to the creation of "Advanced Glycation Endproducts" (AGEs) which bind to certain receptors (RAGEs). The AGE-RAGE interaction is linked to downstream diabetes side effects like atherosclerosis.

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

#264

Post by innolitics »

bsder wrote: post #49
coldpie wrote: 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…

> Each sensor also used a ludicrous amount of plastic for its applicator, like a tennis-ball-sized hunk of hard plastic, that you just chucked in the trash, every week. Erm, let's be a little defensible here. These sensors have to be stored in sterile packaging--that means thick enough to be a barrier. That means it also has to hold the sensor in such a way that a palette can be gamma irradiated. It also needs to be…

I work in the medical device space (mostly software as a medical device). I attended the AAMI Nexus conference two weeks ago and attended a talk about making devices more eco friendly. The tension between safety and sterilization and packaging was definitely brought up. It’s a hard balance to make. One example I thought was interesting was that the NIH did a study to see if it was necessary to swab people’s skin and use gloves before a shot. It turned out it wasn’t and it didn’t make a difference, so they stopped requiring the providers to swab people’s skin or wear gloves, thus saving an immense amount of waste when taken over all vaccine shots.

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

#265

Post by squirrel6 »

I have been doing CGM for 7 months now and the learning has been invaluable. My metrics were never in the danger zone but I feel like I’ve learned so much about how many different factors play into insulin resistance and have managed to build much healthier habits over time.

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

#266

Post by philsnow »

smt88 wrote: post #50
haswell wrote: 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…

> A lot of "keto" and "diabetic-friendly" products are terrible for most people's BG and were for mine.

Absolutely, there are a lot of companies trying to cash in on this new-ish market, and they'll do anything to their products to get the net carbs down to 0-2g "per serving" -- scare quotes around that because this is a particular annoyance of food labeling in the States: food labels declare the amount of various nutrients per "serving", but 1) they get to choose the serving size [0] and 2) they get to round numbers, so if they just pick the serving size such that it's 1.499g of carbs per serving, they get to put that it's "1g", and so on.

It makes it impossible to compare food labels between different items even among the same manufacturer (and even the same SKU but different/later packaging, because they don't have to issue a new SKU when they change the food label). If instead they were required to show amounts in g per kg (or ml per l for liquids, or whatever), they could be compared more easily.

[0] The FDA provides "Reference Amounts Customarily Consumed" and asks manufacturers to refer to them when deciding their serving sizes, but (from [1]):

> FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations [...]

so really they can pick almost anything they like

> [...] unless specific regulatory or statutory requirements are cited.

unless the food is medicinal in some way, I guess?

[1] https://www.fda.gov/media/102587/download

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

#267

Post by philsnow »

jablongo wrote: post #262
pie420 wrote: post #104

Earlier quoted context omitted.

Not a doctor, but from what I have seen, there is a healthy amount of spiking from eating normal foods, but our modern diets are so sugar and carb heavy that the glucose spikes are way outside the range that our bodies evolved to handle. Hunter gatherers would maybe eat some berries here (much smaller and less sweet than modern berries) and there. The modern human eating pizza, tons of bread, ice cream, soda, etc. cr…

It's not really that the pancreas itself can't handle it (though this may be true also). What happens is that having high blood glucose, even if it's not continuously high, is just bad for you by virtue of the high concentration of glucose in your blood. Having high blood glucose leads to the creation of "Advanced Glycation Endproducts" (AGEs) which bind to certain receptors (RAGEs). The AGE-RAGE interaction is linke…

There's also research that indicates that cancer thrives in high-glucose environment, and that starving cancers of glucose reduces their size over time.

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

#268

Post by 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.

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

#269

Post by TylerE »

patsplat wrote: post #268

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 o…

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.

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

#270

Post by [deleted] »

philsnow wrote: post #261
haswell wrote: 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.

I almost completely forgot about the monitor itself, and only paid attention to the numbers on my phone. It's that unobtrusive (at least the Libre 3 one that I used). I let the needle (actually: annulus? see sibling comment) get into my head because I was curious and looked at it. It looks a lot scarier than it is, kind of like using contact lenses for the first time: before you've used them, you get into your own he…

[deleted]
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