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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

#91

Post by alright2565 »

reaperman wrote: post #58
itpragmatik wrote: post #51

Earlier quoted context omitted.

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.…

Calibrating my scales and thermometers would be nice. What procedure do you use for it? is it documented online anywhere?

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

#92

Post by anonfornoreason »

epistasis wrote: post #62
anonfornoreason wrote: post #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…

Agreed, this is one of the better things I have done to take control of my own health! It was very very surprising which foods, and quantities of foods, caused huge spikes. However, this stuff is difficult to interpret. What should be the goal number for managing glucose spikes? What's good, what's bad? Ultimately there's a lot of judgement calls, just as there is with any health or fitness goal. I learned a lot from…

+1 +1 +1 to Peter Attia, huge amounts of great content. My philosophy is that if there's any single topic where I should be spending five hours a month researching, it's personal health.

As far as spikes are concerned, I convinced my wife and my dad to both try out the same CGM. Neither of them really ever had any spikes of significance (maybe up to 130's), even when eating cake, etc. Obviously it varies from person to person, but the fact I would spike easily above 140 with boring foods (steel cut oats with no sweetener as an example) said to me something was wrong. My daily averages hovering around 100 to 105 were not in the pre-diabetes level but were close to it, even when eating minimal carbs and being extremely fit with a natural healthy diet. Also most of what you read out there with CGMs is related to people who actually have diabetes.

Finally, there's no one really to talk to about this stuff. You can eclipse your doctor's knowledge on the topic with about 5-10 hours of research. You can go get a broad set of labs and be right at the edge of the reference range on something (which is, depending on the lab, just a range of the general population, not a healthy range) and your doctor will shrug it off. The system is setup so that as long as you are in a sort of average, even with that average being pretty bad (half of the country is fat and pre-diabetic), the standard of care is to ignore it until you fall off the end. The line between hypochondria and being on top of your health is pretty thin, and most doctors will consider you a hypochondriac if you research and come ready to talk about the topic with any level of knowledge.

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

#93

Post by coldcode »

chx wrote: post #66

I got the dexcom g6 three years ago via a simple online order in Canada. Is Canada more lax? What's the difference?

In the U.S., until this one, you needed a prescription to buy one. Many countries allow them to be purchased without.

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

#94

Post by pastage »

justinclift wrote: post #69
hammock wrote: post #27

Earlier quoted context omitted.

CGMs use bluetooth

Bluetooth has a terrible reputation around reliability. :(

In the loop community (CGM+insuling pump) you usually have a list of phones that work well with Bluetooth. Yes that changes when the phones get new powersaving settings and driver updates, usually it works well on good phones.

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

#95

Post by eitally »

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…

fwiw, my wife uses Freestyle Libre 3 and the with-insurance cost every two weeks is about $40. Whenever she's had one fail (which seems to be about 1:10), Abbott has replaced it free of charge and sent a pre-paid label so she can return the failed device for QA review.

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

#96

Post by rockooooo »

Aaronstotle wrote: post #79
anonfornoreason wrote: post #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…

This is why it made me upset to see this Doctor on TikTok telling people unless you have Diabetes, you don't need a glucose monitor and making fun of people who had one. Where is the harm in getting data on how your own body deals with glucose?

There are downsides to over-medicating, even if your personal budget for health is ~unlimited. Nobody wants to be a false positive.

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

#97

Post by coldcode »

moralestapia wrote: post #68

Great news. Reading through their website and just found out they're disposable(!). Anyone knows if there's a reason for this? I don't want to think is just a money grab. Perhaps the patch wears off?

All CGMs only work for a period of time, like a couple of weeks or so. Then you get a new one. To keep the size reasonable it can't be too big.

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

#98

Post by Aurornis »

anonfornoreason wrote: post #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…

Read up on what's normal, though.

I tried a CGM twice. I triggered the hypoglycemia (blood sugar too low) alarm multiple times, but felt completely fine.

After some research I discovered it's actually not uncommon for healthy people to have occasional dips below the preset hypoglycemia threshold, but as long as you're not having symptoms then there's no cause for concern.

I also talked to a doctor who complained that she had multiple patients showing up with concerns about their glucose numbers for various reasons after trialing CGMs, but they had similar spurious and unimportant problems (brief excursions out of range, etc.).

So if you're going to experiment, at least familiarize yourself with what's truly problematic. It's easy to misinterpret the data if you don't know what it means.

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

#99

Post by anonfornoreason »

pastor_bob wrote: post #81
anonfornoreason wrote: post #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…

What are 'treatable' causes other than food intake?

One example is an iron overload disorder. Excess iron accumulates in various organs including your pancreas, liver, and pituitary gland. Catch it early and you can avoid liver cirrhosis, busted pituitary function, poor pancreatic function, heart issues, dementia, etc. Wait too long and you are on the transplant list.

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

#100

Post by mapkkk »

moralestapia wrote: post #68

Great news. Reading through their website and just found out they're disposable(!). Anyone knows if there's a reason for this? I don't want to think is just a money grab. Perhaps the patch wears off?

The patch does wear off but the main reason is because there's a finite amount of enzyme (glucose oxidase) on the filament that does the actual glucose measurement on the sensor. So over time the enzyme is "spent". That, and of course it's lucrative. There are clever ways people have come up with (particularly from low income regions) where you can trick these sensors or the apps to reset and apparently you can get way longer lifespans like that (for the dexcom you also have to file down the bluetooth transceiver so that you can get at the battery within) at the risk of no longer being able to trust the readings.

There's one company that's experimenting with an implantable CGM that will supposedly have a 6 month lifespan, with a bluetooth powered patch that you apply on the skin overlying the implant.

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