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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

#201

Post by coldpie »

thecosas wrote: post #184
coldpie wrote: post #87

Earlier quoted context omitted.

Eh, maybe, but the bulk of the applicator is just empty plastic molded to fit an adult's hand. I have to believe they could figure something less wasteful out (reusable applicator?) if they wanted or needed to. Regardless, it was just another downside for me weighed against the relatively few upsides that made me quit using it. It felt terrible to chuck all that in the trash, especially when I'd have to do it two day…

T1D currently using G6 / Omnipod Dash / open source Loop app. The worst is every 90 days when I get a new G6 transmitter. It comes in a box the size of Two video tapes stacked on top of each other. I've tried reaching out to my mail-order pharmacy about it since I know there are smaller versions of it (or used to be), but nothing yet. From what I've seen, the packaging for Dexcom G7 and it's applicator seems much sma…

Hahaha, the huge syringe thing? That was pretty wild! The spring ones felt like putting a needle to a balloon though, always made me tense when I was putting one on.

Yeah the Dexcom stuff always felt like they were going for super-premium Packaging Experience. But after the first couple weeks that wears thin, and now you've got all this crap to throw away. Like, guys, my pen needles come in a dense little cardboard box and it's totally fine. Chill out with the packaging.

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

#202

Post by thecosas »

Just noticed this line in the press release from Dexcom [1]:

  Stelo will be available for purchase **online** without a prescription starting summer 2024.
I wonder if that means that this will be direct-to-consumer in addition to retail channels (CVS, RiteAid, Amazon, etc).

[1] https://investors.dexcom.com/news/news-details/2024/Stelo-by...

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

#204

Post by CadmiumYellow »

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…

Not to mention humans 150 years ago who ate plenty of bread and still didn't have the problems we have with obesity and diabetes. Or even 50 years ago...

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

#205

Post by colordrops »

jseliger wrote: post #148
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…

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.

Is 80 high? That seems totally fine.

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

#206

Post by RobotToaster »

Johnny555 wrote: post #28
RobotToaster wrote: post #2

So the ones already all over amazon aren't supposed to be there?

I don't see any non-prescription CGM's on Amazon, are you using Amazon USA? I searched for "CGM" and "Continuous Glucose Monitor", and only found test-strip devices and CGM devices on Amazon Pharmacy available with prescription. What search string are you using? Can you post one?

I was using the UK site, that probably explains it.

Usually we lag behind the USA on approvals so just assumed if it wasn't OTC there it won't be OTC here.

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

#207

Post by T1DTech »

csours wrote: 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…

Eversense is implantable, but you have to have a healthcare provider insert it and remove it. So mini surgery every six months. I'll pass.

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

#208

Post by mlsu »

autoexec wrote: post #167
mlsu wrote: post #161

Earlier quoted context omitted.

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…

I'm bet they probably do collect e.g. your phone's operating system and use that to figure out which market segment you belong to. But as far as I know Dexcom doesn't have any agreements with anyone to sell their user's data; If they have ads in the dex app I've never seen one. I would be extremely surprised if that were the case.

>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

What they're talking about here isn't necessarily what you expect. It's that, if you e.g. encounter a bug in the product that they need to disclose to the FDA, you cannot withhold information from them that would prevent them from doing that. Or, if they need to know what kind of diabetes you have so that they can charge your insurance for the correct prescription, you can't say "you're not allowed to share that." (doesn't really apply here, but that's kind of what's meant in that clause). You can see: treatment, payment, or operations. The scope of each of those is kept as small as possible, and they do have audits from time to time ensuring that it is.

I assure you that CGM readings, trends, averages, reports, etc. ALL of that stuff is absolutely, positively considered PHI and considered extremely privileged. The only time anyone, even in the company, can see that data is if they are a customer support agent helping a specific customer, or if they are on the data science team looking at broad trends to help e.g. calibrate the product.

>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)."

It's because they have extra requirements around storage, retention, etc of that PHI data. It's very likely that they can't send you a report because all parties have much stricter access controls on that data so it can't be aggregated and put in a report without filing a mountain of paperwork.

I assure you, these companies do not fuck around with patient data. They don't even do things that give off the appearance of fucking around with patient data, because they know that if the HHS thinks that they are that's millions of dollars in audit costs.

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

#209

Post by illegalsmile »

jseliger wrote: post #148
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…

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.

Desserts can definitely send your levels quite high but I don't think I'd qualify some biryani and naan with a reading of 80 as unhealthy. You probably ate a healthy portion and left it at that. Is 80 not well within the normal range?

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

#210

Post by crimsontech »

Aurornis wrote: post #105
Aaronstotle wrote: post #79

Earlier quoted context omitted.

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?

> Where is the harm in getting data on how your own body deals with glucose? We have a relatively good indicator of long-term glucose levels: HbA1c blood testing. It's included in a lot of physicals now because it's relatively cheap. It's not 100% sensitive to every possible condition, but it's quite good as a screening mechanism for the general population. CGMs will often give an "estimated HbA1c" value based on sta…

At the age of 45 I had never had an HbA1c test. I found out I had T2 diabetes from getting a CGM as part of a health study I applied for, and seeing my blood glucose was at 22mmol (it should be under 10). I ordered a finger prick test kit from Amazon assuming the GCM was faulty but it wasn’t. After this I went to the doctors who confirmed with an HbA1c and put me on Metformin.

It certainly should be part of routine checkups in my opinion, but I had never had more than blood pressure check and a weigh in from my doctor.

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