FDA clears first over-the-counter continuous glucose monitor • Hacker News Board

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

#161

Post by mlsu » Wed, Mar 06, 2024, 9:10 PM UTC

autoexec wrote: post #145

It'd be pretty interesting to see that kind of data, but it looks like this product violates my policy on not buying hardware that requires a cell phone app to use, and my policy on keeping as much of my medical information as far away from my mobile device as possible. I'm not sure exactly who the app itself sells/leaks the data being collected to, but even having that kind of data on the device would make me uncomf…

They sell the data to nobody. It's considered PHI so covered by HIPAA. Dexcom has to trace custody of the data from the sensor to app to wherever it goes, so it is encrypted the whole way.

Nobody has access unless the patient wants them to.

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

#162

Post by crimsontech » Wed, Mar 06, 2024, 9:14 PM UTC

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 did it for fun about a year ago and found out I had T2 diabetes.

I was shocked but obviously glad I found out. I use them from time to time just to see how I’m doing and how different foods (and amounts of them) impact me.

I found I can control it through diet alone and exercising when there is a spike by using a GCM for the constant feedback.

They are very expensive here though (UK) and my doctor won’t prescribe me one because metformin is cheaper, so it’s not something I can use all the time.

I hate needles, this really isn’t like a needle though, it’s a small filament which sits just under your skin, you can’t feel it, I thought it hadn’t gone in until I saw the reading appear on my phone.

Some things I found out besides what foods and amounts give me big spikes are that I have a blood glucose spike in the morning just before I wake up, and that if I eat a small enough portion of white rice, ice cream, bread, whatever I can reduce the spike quickly by going for a walk. If I had a lot though, a walk isn’t going to help.

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

#163

Post by thfuran » Wed, Mar 06, 2024, 9:15 PM UTC

mattl wrote: post #116

thfuran wrote: post #6

Earlier quoted context omitted.

I just searched for one and found >Important information Legal Disclaimer : Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition. At the very bottom of the description. That seems like complete BS that shouldn't hold up, but I don't know.

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.

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

#164

Post by thecosas » Wed, Mar 06, 2024, 9:15 PM UTC

T1D here who has been using Dexcom G6 for many years now. Interesting to see the differences between Stelo and G7 which are built on the same platform.

Curious if anything is driving the increase in wear time other than battery life savings from reporting back fewer readings.

  CGM:                   G7 / Stelo
  Wear time:             10 / 15 days
  Time between readings:  5 / 15 minutes

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

#165

Post by huytersd » Wed, Mar 06, 2024, 9:17 PM UTC

dansitu wrote: post #160

If you find this field interesting, Know Labs is working on a non-invasive continuous glucose monitor using RF spectroscopy: https://www.knowlabs.co

Non invasive would be a golden goose. I don’t think I want to have something sticking into my skin for weeks on end.

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

#166

Post by mangoman » Wed, Mar 06, 2024, 9:17 PM UTC

I recently had an unusual health event that resulted in me passing out. My wife, who is a physician, thought it might be hypoglycemia, since i'm at high risk for diabetes. She found a super friendly endocrinologist who put me on a CGM for two weeks. I never hit the hypoglycemia range during those two weeks, so it didn't really explain what my issue... but honestly the data was SUPER interesting. Just observing the various spikes made me make healthier choices, or noticing when I was feeling extra tired and seeing if that correlated to not having eaten for little while, or eating something sugary before.

It's sort of like tracking your steps when you first get a smart watch. It may not have been the reason you got the device, but seeing the data, people are encouraged to act on it, even if you don't have an acute issue. since I didn't have a prescription, I couldn't get one here (didn't want to go through some sketch online site). I tried to get one from my family in India, but the prices were really high and they couldn't get the fancier one that tracks straight to your phone, so I didn't get one.

I think this could be a god send for preventing pre-diabetic people who would take preventative steps if it weren't such a pain in the ass to measure consistently.

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

#167

Post by autoexec » Wed, Mar 06, 2024, 9:19 PM UTC

mlsu wrote: post #161

autoexec wrote: post #145

It'd be pretty interesting to see that kind of data, but it looks like this product violates my policy on not buying hardware that requires a cell phone app to use, and my policy on keeping as much of my medical information as far away from my mobile device as possible. I'm not sure exactly who the app itself sells/leaks the data being collected to, but even having that kind of data on the device would make me uncomf…

They sell the data to nobody. It's considered PHI so covered by HIPAA. Dexcom has to trace custody of the data from the sensor to app to wherever it goes, so it is encrypted the whole way. Nobody has access unless the patient wants them to.

Their own privacy policy says they share data for marketing purposes. I don't think they'd do that without any compensation and their app includes personalized ads.

HIPAA only covers "protected health information" and not all of the data collected by their products.

They also state: "You can ask us not to use or share certain protected health information for treatment, payment, or our operations. We are not required to agree to your request"

Once a year you can also request that they send you a report on who they shared your data with and why without paying them for it, but it will not include anything involving "treatment, payment, and health care operations, and certain other disclosures (such as any you asked us to make)."

see https://www.dexcom.com/notice-of-privacy-practices

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

#168

Post by zxienin » Wed, Mar 06, 2024, 9:20 PM UTC

I use Abbott Freestyle Libre 3 and it has been deeply insightful about my progress with T2D. An increase in fasting glucose over 2-3 days tells me I need course correction (more movement, choice of food). I also noticed consistent correlation between bad sleep days and raised glucose levels over the day. Made me internalize how important sleep is.

I believe, next major uptick will come from CGM in wearables like Apple/Samsung watches [1][2]. I hope, even non diabetic folks use it to improve their health.

[1] https://www.macrumors.com/2023/09/14/apple-watch-blood-gluco... [2] https://www.macrumors.com/2024/01/23/samsung-racing-to-beat-...

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

#169

Post by pcorsaro » Wed, Mar 06, 2024, 9:21 PM UTC

TaylorAlexander wrote: post #74

smt88 wrote: post #50

Earlier quoted context omitted.

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…

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.

I'm not the OP, but I had a CGM several times through Levels. I can tell you that the major spikes (glucose over 200 after sitting between 80-90) really made me feel like shit. The 2 times I can remember it getting that high were when I had too much sushi, and a huge bowl with white rice from Chipotle. Brown rice never seemed to spike me nearly as bad, especially if paired with something high in fiber like black/brown beans. From a long term health perspective, I have no idea if it's a problem or not. I didn't like how bigger spikes felt, so there's probably something to it being bad for you long term. Obviously the more often you spike as a "healthy" person, the less sensitive your body is to insulin. Staying even on my glucose levels is always where I felt the best.

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

#170

Post by mlsu » Wed, Mar 06, 2024, 9:22 PM UTC

coldpie wrote: post #40

mlsu wrote: post #15

Earlier quoted context omitted.

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.

That is impressive control, especially with no CGM!