Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

FDA clears first over-the-counter continuous glucose monitor

fda.gov

Post reply on HN
Print view View original

211–220 of 439 posts

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

#211

Post by drdaeman »

gamepsys wrote: post #14

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

I don't get why things like CGMs require a prescription. It's just a kind of a wearable sensor. While typically only a diabetic person would need it, I fail to see any harm for any adult human if they get curious and want to stick one.

There are odd things like glasses or CPAP machine prescriptions - but at least I understand it's theoretically possible to cause some harm to oneself with those, if someone is really uneducated, reckless or stupid. With a CGM I just can't think of a sensible scenario. Except for the really stupid ones, but then a simple kitchen fork is a four times worse hazard.

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

#212

Post by lhl »

I’d highly recommend anyone considering trying one out to give it a pin. I’ve used a CGM multiple times besides being a great feedback mechanism, it also can give you really interesting insights. Here’s one interesting tidbit showing that having an ice cream cone in between an hour-long walk actually caused no postprandial glucose spike compared to an earlier “healthy” meal served with no activity (at a metabolic health conference) https://fediverse.randomfoo.net/notice/Aafczv5LO83OOwXrbU

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

#213

Post by user_7832 »

mlsu wrote: post #192
user_7832 wrote: post #171

Earlier quoted context omitted.

> The new Dexcom sensors are more accurate. Less drift and no calibration. As someone using a freestyle libre who's never calibrated, how often do you need to calibrate it? Reason for asking is that I'm likely to switch to the g6 if I go with the TSlim X2 for looping. TIA!

No calibration is required for Dex G6/G7. I think you can optionally calibrate the G6 but I never have nor have I ever had to. I am going to be biased: I both work on and use the t:slim X2. It is well worth it, especially if covered by your insurance. CIQ took me from ~70 to 85%, sometimes 90% time in range; my understanding is that it's the best closed loop algorithm out there currently. Regardless of which pump you…

Thanks! Hearing (I'm assuming) a fellow T1 using and working on a TSlim is quite a good recommendation haha.

It's good to hear that calibration isn't really required.

My "concern" (or rather, apprehension) with the TSlim/G6 setup (which fortunately should be fully covered by Dutch insurance) is that I'm aware I can do a DIY loop using the omnipod dash and with a libre/g6 (using a 3rd party app like diabox & nightscout if necessary). From what I've heard TSlim does seem to be the best "official"/FDA approved loop; however AndroidAPS looks very powerful and probably has much finer tunings possible.

However my diabetic nurse is strongly against the Dash/DIY setup, which is understandable (she isn't familiar with it and can't guide me, I'm also close to the 150u/3day limit, and it's my first time with a pump.)

For what it's worth an A1C of even 8 would unfortunately be an improvement where I am :') so I'd rather be sure of reaching say 7 rather than try aggressively for something like 6.3 (which I had achieved in a distant era...). I think I'll try the 1 year trial option if I can, the thought of locking in a 4 year period feels quite long.

If you're familiar with them, what are your opinions on diy loop setups? Do you have any other suggestions for someone in my situation? Thanks a lot!

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

#214

Post by cableshaft »

throwup238 wrote: post #141
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…

> Hunter gatherers would maybe eat some berries here (much smaller and less sweet than modern berries) and there. Archaic humans had access to plenty of wild fruit that were high in sugar and tubers that were high in complex carbs. They even had access to concentrated forms of sugar like sugarcane and honey. They obviously didn't have refined sugars in everything they eat like we do but that they had access to limite…

They also moved around more than most people do today. Most of us are stuck sitting pretty much all day in front of a computer.

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

#215

Post by haswell »

pastage wrote: post #59
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 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 gluc…

I'm more curious about the experience a non-diabetic person has. For one, the purpose of using the device is quite different, and not related to a life threatening situation. And because the focus isn't to manage this specific issue, the insights and potential utility seem like they'd be of an entirely different variety.

e.g. I know that the things I eat impact my blood sugar, but don't have the same kind of intimate awareness a diabetic person would have, nor would the changes in my levels have the same meaning/impact.

Put another way, and setting aside the issue of oversimplifying a complex system (so is measuring RHR, HRV, blood oxygen, etc.), the benefit of CGM for a diabetic person is obvious. The benefit of CGM for a curious person less so.

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

#217

Post by Retric »

meindnoch wrote: post #173
jseliger wrote: post #148

Earlier quoted context omitted.

Before I got cancer, I had one through Levels, and it was informative. Dessert is much worse than I'd thought. Rice, too, including brown rice. I remember eating some biryani and a small bit of naan at an Indian restaurant and thinking that I'd been pretty healthy, only to see a spike of like 80.

Momentary high blood sugar is perfectly fine after eating carbohydrate-rich meals.

This was down voted, but it's all about the time scale. A major pathway of transporting energy from your food to your cells is via glucose in your blood and your cells then use or store it for later. Insulin production reduces the spike, but that response isn't instantaneous.

So on a second by second basis numbers that would be concerning across an hour are fine. Similarly your average over an hour post meal can be much higher than a healthy average across a day.

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

#218

Post by mattl »

thfuran wrote: post #163
mattl wrote: post #116

Earlier quoted context omitted.

That's on virtually every supplement website it seems.

Sure, but a blood glucose monitor isn't a dietary supplement. I think it's a bit dodgy that that kind of disclaimer means anything for a dietary supplement in the first place, but it certainly shouldn't apply to a medical device.

Probably just placeholder text I'm sure.

Look at all the legalese at the bottom of https://www.freestyle.abbott/us-en/home.html

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

#219

Post by user_7832 »

graeme wrote: post #197
user_7832 wrote: post #181

Earlier quoted context omitted.

> If having more information leads to worse outcomes, that's fundamentally a problem with how you're responding to the information, not with having the information. Not necessarily. Rohin Francis (Medlife crisis) has I think a video on overtesting, but for example, if you have a new technology that tests and suspects a tumor, which results in CT scans for patients, if millions of users use this tech there's a likely…

That's still the response though. You can simply say "Well, we expect an error rate of X with this new test, so in the absence of other risks factors we predict the actual odds of the condition are Y". Then you can decide whether a test makes sense or doesn't make sense, given the tradeoffs of radiation and cost vs. the risks of harm. In the real world, information absolutely can lead to harm, but it's still all in t…

I get your point, however I think there are a few confounding things. For a lot of people, if you get a positive result from a test that a doctor brushes off that's not going to go well. I'm very much in favor of more testing personally, there are almost certainly folks who're on SSRIs who'd benefit more from Vit D/Mg supplementation for example.

Another thing I seem to remember in his video was that a tumor is not necessarily dangerous. Out of a hundred (say) tumors in a person's life, only maybe 5 are risky. But I'm paraphrasing this badly.

Edit: https://www.youtube.com/watch?v=7kQk9-KLPfU is one of the videos, however I think he's talked about this more (likely on instagram or another video too).

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

#220

Post by metabagel »

I put something like this on my cat, because the vet thought she may be pre-diabetic, but stress response can also cause blood sugar to spike, so we needed to see what her blood sugar was like multiple times per day.

The device worked for 5 days until she had managed to dislodge it enough so it wouldn't get a reading. The skin glue lasted another 5 days before the device fell off. Since then, she has had a "crop circle" behind her shoulder where her fur was shaved away, and which is ever so slowly filling in.

Her readings were fine, so we are feeding her low carbohydrate food, because the vet thinks she may become diabetic in the future.

Unfortunately, I had to place the reader device almost directly on the sensor, which was a pain, because my cat likes to hide under the bed. So, I had to squirt her with water to get her out, which was undesirable, but didn't seem to affect the readings.

The device was the Freestyle Libre 2.

https://www.freestyle.abbott/us-en/products/freestyle-libre-...

Post reply on HN