Dexcom starts selling its new over-the-counter glucose monitor in the U.S. | Hacker News Reader

Dexcom starts selling its new over-the-counter glucose monitor in the U.S.

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35 pointsbookofjoe72 comments

I hate that doctors are gatekeepers of so many things. Why should a small computer that measures blood sugar be gated behind a doctor in the first place?

The only reason I can think of is: supply is short and they need to be preserved for diabetics.

But if supply is not short, why should I need to go through a gatekeeper to measure my own biometrics?

Same with glasses. If I want to buy a pair of glasses with arbitrary optical properties, why shouldn't I be able to?

Seems like the medical world is sometimes a bit too paternalistic, probably to keep themselves cemented as middle men, like a car dealer preventing consumers from buying directly from source.

To be fair, certain things are dangerous and probably should be gated behind a doctor for safety reasons, but sometimes I think Rx fever gets a bit out of hand.

It's to protect people like you (and in fact many on HN) from themselves (and their incompetence). I don't expect you to understand, but self-diagnosing and self-medicating is not safe for you when you don't have the credentials.

Because doctors never misdiagnose or prescribe wrong medications...

I'd rather make my own choices, thank you very much.

"I don't expect you to understand, but self-diagnosing and self-medicating is not safe for you when you don't have the credentials."

This is extremely condescending and also very profitable for the medical industry. On the one hand we have a wild west market where hospitals, pharmaceuticals and doctors can see all data and charge whatever prices they feel like. For the patient it's a market where we aren't even allowed to collect data about ourselves, aren't allowed to import drugs that are approved and safe somewhere else and with many treatments we won't even get an price before it's done. But we have to pay. Talk about asymmetry!

Speaking of self diagnosing: I went to several doctors about my joint pain and chronic headaches. they all wanted to describe steroids, anti inflammatories and whatever. Turns out if I reduce sugar, I am totally fine. I came up with that after reading some literature and testing on myself. None of the doctors mentioned this for the hundreds of dollars in deductible and copay this cost me. Self diagnosis works. I know there are limits to this but many of us can read the medical literature as well as doctors and draw our own conclusions.

The person obviously has a strong conflict of interest, and stands to lose when people empower themselves. You will not convince them if they're not operating in good faith.

Speaking of joint pain, also consider:

1. Avoiding microplastics. Wash everything and filter your water, but not with a resin based filter that leaks more plastics than it removes. Avoid contact of food and drink with plastic.

2. Sometimes it's due to gut dysbiosis. In fact this goes hand in hand with the sugar theory. Antibiotics can often fix it, although the exact antibiotic needed can vary significantly.

A person is no more likely to suffer from "self-diagnosing" the implications of their blood sugar readings than they are from misunderstanding their weight or blood pressure measurements.

Given the massive scam industry promising health and fitness based on CGM readings, I'd say that already has happened. And Abbott and, now, Dexcom, are more than happy to capitalize on the kind of Son of Dunning or Daughter of Kruger who think, that BG readings are the new HRV. 99 bucks/month for no discernible benefit? Buying Dexcom shares now.

Contacts and eye glasses regulations are far looser in EU and they are doing fine. They don't need yearly rechecks for contact lens for example.

> If I want to buy a pair of glasses with arbitrary optical properties, why shouldn't I be able to?

Don't sites like Zenni Optical already offer this?

No, you need to upload a prescription.

That's blatant nonsense. In practice, you do need to have a prescription so you know exactly what to get, but you can type in the numbers without having to upload anything.

That's literally not true. Places will request your prescription and will not fulfill your order until the prescription is sent over.

Nope, not true at all. Go to eyebuydirect.com, enter any random prescription and buy those glasses. I've done this like 20 times, mostly because my prescriptions were from doctors outside United States.

It's an American company. AFAIK there is no regulation in the US that requires prescription from a doctor to get the glasses.

Yes me too! This is amazing for reading glasses -> computer glasses. Converting a normal distance -> reading means adding 1.15 to one column of numbers. But it was too strong for me, so I used eye buy direct to try a sweep from 100%, .66%, and .33% and each are great for different situations

.33 of 1.15 was amazing for computers, comfortable but I can still look at distance somewhat

This thread was a reminder that I needed some prescription sunglasses.

There was an option to upload my prescription, so they could auto-detect the values from it. But there's a button just below that for "manually enter". I never saw any other prompts, on the way to checking out.

Maybe in the US. You can just order glasses globally (friends use HK, I'm in Europe) and nobody gives a damn about any prescription.

I have used Zenni and several other online stores, and all of them will require you to upload a current doctor ordered prescription (one that has not expired). You cannot just take the numbers you already know and order a pair for yourself on any of these sites, as far as I know.

If you look closely, there is an option to enter your prescription numbers manually.

Glasses do not require a prescription - you can enter arbitrary values. Contacts on the other hand, require a prescription within the last year and is verified with your optometrist.

The situation is actually much worse. If you go to an optician to get a prescription for eyeglasses, assuming you pay via your insurance, if the optician believes that you will not be ordering glasses from the optician, the optician intentionally and vindictively gives you an erroneous prescription that is off by 0.5 in one eye, leading to a lack of focus when seeing at a distance. It took me many years to catch on to this scam because I had to distinguish it from the prospect of Zenni shipping out bad glasses which they didn't.

This is malpractice, so if you have evidence of this you should consider reporting them. Certainly I've never had this issue with my opticians, but have certainly had plenty of bad Zenni glasses.

Are you so certain after hearing a first hand account?

When you say "bad glasses", distinguishing the two is exactly something to worry about. I found that the problem disappeared when I started paying hard cash for a prescription, although it still varies by the practitioner.

Fwiw, it would be very hard for the government to correctly investigate and accurately prove in court, since it will require a statistical proof over many patients that get tested at both good and bad places.

> If you go to an optician to get a prescription for eyeglasses, assuming you pay via your insurance, if the optician believes that you will not be ordering glasses from the optician, the optician intentionally and vindictively gives you an erroneous prescription that is off by 0.5 in one eye

You state this like it is standard practice, like all opticians do this. What evidence do you have?

> But if supply is not short, why should I need to go through a gatekeeper to measure my own biometrics?

> Seems like the medical world is sometimes a bit too paternalistic

The charitable explanation is this: why would you want to measure those specific biometrics in the first place? Normies normally don't do stuff like that. Do you suspect you may have some medical issue that those biometrics would help you diagnose? Did someone tell you that, or did you read about it on-line? If the answer to those last questions is "yes", then the system really wants you to visit an actual doctor before you go out on your own and hurt yourself (and/or get scammed while also hurting yourself). It's not that they're worried a glucose monitor - or any other measurement tool - will kill you; it's just that it's hard enough to get people to visit the doctor over literally anything, from inconveniences to immediate life threatening dangers, so the system takes every opportunity to nudge you to cross paths with it.

> Normies normally don't do stuff like that.

Maybe this attitude needs to stop. Get people more engaged with their health while collecting data so they can show up to their doctor with more information.

We don’t shut down the sale of car parts because Normies don’t normally do their own car repairs. Even if only a small But passionate group takes control of their health data collection, why stop them?

I totally agree with everything you said, but just to further the point...

> We don’t shut down the sale of car parts because Normies don’t normally do their own car repairs.

We actually have done this, across industries. And now we have a "right to repair" movement because people realized their freedoms were curtailed.

It's important that we don't disrupt people's ability to learn about their own body. Some things are a health risk, and we want to prevent scams, but we shouldn't lock people out behind expensive and bureaucratic gate keepers.

> We actually have done this, across industries. And now we have a "right to repair" movement because people realized their freedoms were curtailed.

The difference is that for tests requiring doctor requisitions that is the government locking down access, whereas right to repair is laws preventing companies from locking down access (to increase their profits)

You’re absolutely right that most people don’t need to measure this data. That said, most people didn’t need to measure step count or heart rate or sleep and we’ve found utility in that.

Realistically, the medical community is extremely gate-keeper oriented. The doctor shortage is entirely fabricated by organizations run by doctors. Some barrier to providing medical care is good, of course.

Realistically, we don’t have a lot of data on the blood glucose levels of healthy people. The explosion of Fitbit’s and Oura rings and similar products gave us an explosion in data on basic vitals of millions of people during sleep. This can inform a ton of research, even if the quality of data is not as high as in a clinical setting. The difference between collecting 40 hours a week of data on 5 people vs 40k hours on 5k people (or more!) is huge in a research setting.

I used to work doing ML to measure and improve athletic performance, and to measure and detect physiological strain and risks during physical exercise. Our limitation was always access to enough data to not overfit. Compared to data corpus’s using in “generative AI” or image recognition models, or any other number models that are now standard in industry, we’re still in the Stone Age.

So much gatekeeping is upheld by regulations, which are in turn written by the professional organizations these medical practitioners belong to. It is a silent violation of our liberties but also a silent driver of costs. Glasses are a great example. CPAP machines are another, forcing people to take expensive sleep studies that cost thousands (before insurance) all to get machines that are freely available in many other countries.

This device in particular basically maintains and obscures view of an open wound on your body, and must keep it protected at all times to limit the chance of a bad infection. I can certainly see why it took awhile to build up the trust that their supply chain can create such a device safely.

Plus, the whole host of problems that occur when there's too much or too little insulin in your body. Comas and death in both directions! For better or worse, having certification and a professional watching after it is not the worst thing for a newbie on a dexcom monitor.

Acute low blood glucose (<10 mg/dL) is much, much worse. Acute high blood glucose (say 500 mg/dL) is really miserable and takes variable days to years to be fatal. There is an LD50 for glucose but it's difficult to reach without other problems.

> I can certainly see why it took awhile to build up the trust that their supply chain can create such a device safely.

We've had the devices for almost 20yrs, just not available over-the-counter.

> the whole host of problems that occur when there's too much or too little insulin in your body

Which healthy bodies regulate. This device does NOT administer insulin, and it's not a tool for insulin administration in any way. This tool is only approved for use for people who do NOT have insulin prescriptions. This is a tool for healthy people to monitor their levels.

Exactly. The medical profession is based on a ubiquitous form of elitism protected by knowledge hoarding (expensive journals and inaccessible language) and approvals (regulatory, appointments, and prescriptions) for routine, on-going condition maintenance. While there are laudable ostensible and obvious reasons for having clinicians periodically overseeing aspects, you don't need a clinician for a paper cut or every single purchase of lifelong maintenance supplies and equipment necessary or optional.

I guess the thing is that in countries where there is universal healthcare, gating is necessary to contain costs for patients who don't have a medical need. In countries without universal healthcare, the downside of prescription->OTC is shifting costs onto the patients where insurance may not cover them.

I'm wearing one now, bought it when it came out, because I love fitness trackers and the "Quantified Self" idea. Not convinced it's really going to change much, probably won't repurchase. That said, it is great to see costs and accessibility drop to the point that over-the-counter purchases are feasible (~100USD/mo).

It's pretty cool, completely painless to implant (didn't even realize it went in), but made my arm surprisingly sore for a few day. I don't think the science of interpreting glucose levels is clear and deterministic enough to find actionable insight from the data unless you're generally concerned about being pre-diabetic. Seeing a glucose spike isn't bad, and not seeing a spike isn't bad. If you're not diabetic or pre-diabetic, your body will adjust and maintain homeostasis, so the data isn't particularly actionable. Oh and the packaging has a TON of waste. Each sensor comes with a single-use applicator which a prescription user would re-use for months.

PS - I’d love to see better and more accessible monitors or testers for things that your body can’t self regulate as easily, like cholesterol levels.

Do you worry that such data (not actionable or easy to interpret) is actually a net negative? The nocebo effect [1] is very real in my experience. I now leave it to a doctor to tell me the important side-effects of medication and forbid myself from Googling it further for example.

[1] https://en.wikipedia.org/wiki/Nocebo

Not at all (it's a fair question). I think the idea of deferring exclusively to a doctor is wrong (for me at least). People wear fitness trackers to count their steps without damaging their exercise goals, and I view other medical testing similarly.

First, I'm not "undergoing treatment" so I don't think my negative perceptions would cause anything to have a worse efficacy (which is my understanding of "nocebo").

Second, I think that measurement is ok (great even) as long as you have correct expectations. Doctors will often say that you shouldn't get tests unless undergoing a differential diagnosis from a doctor, because tests all have ranges, and slightly off results can freak out patients who are otherwise healthy. Frankly, I assume it's actually a cost/effort thing. I disagree because (1) you have to wait until something is wrong before getting a test and (2) its would good to have a baseline level of <thing> for when something goes wrong to avoid red-herrings.

If you have a mole or lump, a doctor would not recommend you undergoing surgery, or even get an invasive biopsy unless it's really scary looking at start. Many/Most are benign. BUT a doctor generally would suggest you watch it regularly in case it changes. Clearly monitoring benign-looking things is good, because it can become less benign or it can be a symptom of something dangerous.

Concretely, I'm a very healthy and active individual, but also a vegetarian. Vegetarian diets can easily be vitamin deficient, so I get tested. Doctors generally don't want to test me because I "clearly look healthy and don't have symptoms of deficiency". But I was absolutely deficient for years, and while I felt fine, supplementing for my deficiency showed me I could feel better than before.

Thanks for the response. I do think there is a big difference between routine checks of a mole and daily quantifying of a biometric signal that is of questionable use outside elite sports or specific illnesses. My point about nocebos is that people can take data, knowledge of potential side-effects for example, and cause themselves ill effects by worrying about them. I can easily imagine some of my friends checking their perfectly healthy but noisy glucose levels and worrying that there is something wrong. I guess it's about mindset (mostly curiosity?) for self-quantifiers.

Oh yes, continuous glucose monitoring is totally overkill for most people. I just wanted to try it out because it’s a hobby. But yearly blood work or similar should be fine for anyone who wants it IMO. Well, anything that is measuring-only I think should be available to anyone who wants it TBH.

I think you need to go in with the right perspective, and I think the setting of doctors only offering tests when there is something wrong sets the tone that they catch dangerous things. Imagine if blood testing were available at gyms (not a suggestion, just an example) - the data would be viewed very differently. Imagine if doctors’ offices had treadmills, you’d view exercise very differently too.

If your X metric is a bit outside of a normal range, it doesn’t mean you’re going to die or you can’t handle some biological function (generally). It means it may be more strenuous for your body, or you’re predisposed to issues when something else goes wrong, or your body is simply a bit outside “normal”. It’s like someone who is really tall - being tall is “not normal” but it’s generally recognized as not deadly, despite the reality that certain health issues are correlated with abnormal height.

I have heard that these glucose monitors are very inaccurate compared to blood tests - like as much as 25% off when measuring levels after meals. What has been your experience?

I don't have diabetes, so I'm not regularly comparing it to alternatives, so I can't comment on my personal accuracy against clinic measurements. Which is obviously a nice privilege to ignore for "hobby" usage.

A huge portion of glucose management (even for diabetics) is the actual trend of the data vs the actual blood glucose levels. These CGMs capture trends correctly, even if the absolute value is off. A prescription variant would have periodic calibrations as an option. If you eat a meal that spikes blood glucose level, the CGM probably won't smooth out a peak, so you'd still see the magnitude of the effect. The other thing to consider is that when read from the arm or a "fleshy" bit, a change in glucose level is about 20min delayed from blood levels.

The healthy range for a non-diabetic is ~70-140 mg/dL, and your body regularly can swing up more than +50mg/dL after a meal. This is a pretty big range and swing, and being 15% off (in either direction) is not particularly problematic. Your bodily response to the same meal can vary more than 25%. One test I did do is consume "glucose tablets" (which are basically candy), they're products meant to spike your blood sugar (for diabetics who get "low"), and all you can predict is that my levels go "up fast". Again, all that matters is the trend, especially if your body can self-regulate.

The FDA does study how accurate these products are, and they conform to certain expectations. That said, you're not wrong that it can be 25% off sometimes. According to a study (linked below), ~99% of the time, the device is within 30% of clinical test levels, and about 90% of the time, the device is within 15%.

https://pubmed.ncbi.nlm.nih.gov/35157505/

> PS - I’d love to see better and more accessible monitors or testers for things that your body can’t self regulate as easily, like cholesterol levels.

Not sure if this overlaps with your interest, but you can now self-order tests from mainstream labs. e.g. [1].

Personally I think this cuts into the attractiveness of single-purpose devices. You can order a whole bunch of tests with one blood draw, and selectively only repurchase those that need monitoring over time. You're also likely getting higher-quality data in both the average and worst cases.

[1] https://www.questhealth.com/product/cholesterol-lipid-panel-...

You cannot do this in certain states like NJ and NY. You will need an MD to order the tests. Same with other things like ordering insulin syringes or whatnot. Means I have to buy stuff from out of state or fly out of state to do my bloodwork.

Same issue as before. The medical establishment always trying to find a way to get a cut on everything when it’s entirely unnecessary.

Quest excludes AZ, AK and HI, but it does include NY and NJ.

You should be able to do this in NY - but I think the phlebotomist has to go to your house. I know people in NYC who get at-home blood work. Your situation may be different, but maybe the laws changed and you should check again if you care.

Yes! I've actually done this (several companies offer this service now). I think this is great if you have a family pre-disposition to something, or want to regularly check for a specific issue. It's also great because many doctors are hesitant to provide blood tests without a diagnosis.

I don't think it has the same use cases as at-home monitoring devices though. To use the example of cholesterol, you can be morbidly, dangerously high in your LDL levels, where doctors will put you on medication that day and warn you to basically stop eating. But you can also just have levels that are high - but where lifestyle change alone is effective. Ideally, you'd want to be able to reflect daily/weekly and adapt. The tighter that feedback loop, the better.

Quest charges $70 for a cholesterol panel, which for many, is too high for a regular purchase to build a positive feedback loop. Its probably in the "purchase quarterly" and maybe "monthly" range, but I doubt many would be able or willing to go weekly.

There is a theme of extreme gatekeeping in several comments for this article. In fact, such gatekeeping is a common experience in healthcare. The strong conflict of interest is obvious. Don't let it stop you from taking power in your own hands.

Can anyone here verify that Dexcom has updated their iPhone app to cease collecting customer metadata?

As recently as three months ago, Dexcom's G7 app made hundreds of daily connections both to dexcom's own servers and third party metrics servers. Note that this was the case regardless of whether you opted out of their online services (like sharing).

I checked my firewall logs before I posted this comment, and suddenly I no longer see these queries. Since I have two years history of monitoring and blocking similar Dexcom traffic, it's hard for me to believe they actually stopped.

I would welcome stronger laws to stop this sort of behavior. I'm essentially a captive audience to a maker of expensive medical gear, and it's a lousy feeling to have them slurping up data about me every time I check my blood sugar.

...and the skepticism was justified. Today I see hundreds of attempts in my logs to connect to:

• shareous1.dexcom.com

• *.dexcom.siteintercept.qualtrics.com

...and many, many others. Dexcom: slurping up patient data because hey they can.

I bought and used this new one during August for £35. The connection to Apple Health worked well and I used a glucose monitor app (MyLevels) without any issues.

For non-diabetics, I strongly encourage measuring HbA1c instead of glucose. It will tell you all you need to know in this regard, at a cheaper price too, at home, and without the need for fasting. Optimizing HbA1c will for most people indirectly automatically optimize glucose. Keep it below the prediabetic range.

How do you test this “at home”?

CVS sells a kit. Results in 5 mins. My wife uses it

If you go to Amazon and search for "a1c test" (by pts Diagnostics), the pack of twenty is cheapest per test. You will also need a pack of disposable lancets, a finger lancing device. You will also optionally alcohol swab to sanitize your finger without contaminating it, but soap and water work too. Remember to shake it well when testing, otherwise the result is an error. Always discard the lancet after use. You need to test only once every 1-3 months. Refrigerate everything, but let it warm to room temperature before testing. If I remember correctly, the result number is like an exponential moving average over about three months. If you're in the prediabetic range, things like avoiding high-AGE foods, processed carbs, and red meat should help bring it down, as should consuming ceylon cinnamon, flaxseed, and berberine. Of course cardio also will easily bring it down. Every factor contributes in the ballpark of 0.1, so one needs a lot of changes to gradually bring it down into an optimal zone.

If you’re worried about developing type II diabetes, yes, A1C is probably as much data you need. However, there are plenty of other reasons to want to measure blood glucose. Just one example I see: Endurance athletes already use these off-label to keep an eye on fueling.

That's not really accurate. HbA1c is essentially an integrator of blood glucose over time. But it doesn't tell you anything about instantaneous blood glucose which is what CGM users typically want to know. The non-diabetic CGM users are generally trying to fine tune their diets by measuring their response to different foods or feeding times (they're seldom fasting for extended periods). And there is a significant genetic variance in the hemoglobin turnover period which skews HbA1c results for some patients.

Both assays have value but they're really for different purposes

> fine tune their diets by measuring their response to different foods or feeding times

Needing to get such feedback from diet is completely unnecessary. It is very easy to estimate the rise in glucose using these factors: percentage of fiber, how processed the food is, how it was cooked (high-heat (bad) vs low-heat (good)), whether the carbs are complex carbs (fibrous) or simple carbs (starch), and whether the meat is red or white.

> variance in the hemoglobin turnover period

Whether there is variation or not, it is still the thing to optimize. Your point is like saying there is significant turnover of how people spend money, so they don't have to bother looking at their bank balance. Also, I hope you're not claiming that the reference range is vastly different for certain people.

Unless one is diabetic or an athlete, given basic nutritional knowledge, there is no benefit to a CGM over HbA1c.

It's not about reference range. There are significant individual variances in postprandial blood glucose response to specific foods based on genetics, gut microbiome, time of day, recent activity level, etc. Empirically it seems that serious endurance athletes have been able to gain a performance advantage by using a CGM to optimize their diets.

The benefits for other people are questionable. But if a CGM gets them to be more mindful of what they're ingesting then that seems like a positive.

That's fine, but it can be misleading at times. For example, metabolic damage to fasting glucose from red meat and high-AGE foods can develop over time, and it won't show immediate results via the CGM. Not all things that cause diabetes show an immediate rise in blood glucose, only some do.

https://archive.ph/n1eNl

And is this usable for Person with T1d? Seems So, https://www.diabettech.com/cgm/dexcoms-stelo-by-numbers-coul...

You should not use this if you have Type-1 diabetes. It's (supposedly) not cleared to the same FDA standards, and if you tell the app you're diabetic, it locks you out from using this. I'm under the impression the Stelo (OTC version) is the same as the G7 (prescription version) with a different logo and box. I think the only practical difference is that this version has a longer lifespan (15 vs <10 days), and that it's not configured to actually alarm when it detects something dangerous. I'm not sure if any science showed the last 5 days have reduced accuracy, but I wouldn't risk my health on it if there were alternatives available.

If you have T1d, you've been able to get the prescription-variant of this product for years with insurance, so there really is no reason to get this unless you're un-insured.

The lack of a hypo alarm is the reason the Stelo is not past FDA, yet.

Luckily, there's xDrip4iOS and xDrip++, not to mention Suggah and others, who will happily do the alarming part for you. Not to mention, that to many of us T1D, the CGM is just a secondary data point for our loop, which has a CGM already built in.

I beliebe xdrip is not (yet) steel compatible. Also interesting to see if this thing really sends data only every 15mins or is it done in the app. 15min is way too much for looping.

Surely you’re not a US resident, because “covered by insurance” is definitely not a good enough reason on its own to not consider this here. 30 days of CGM device coverage from our insurance costs more than this.

That said, one actually legitimate reason a T1D may be better off with their prescribed device is if Dexcom doesn’t readily replace the OTC versions the way they do for prescriptions.

This happens way more often than I imagine most who are unfamiliar would think. Anecdotal from an internet stranger, but just last night, we had a third G7 in a row fail well before the 10 day timeline. And speaking of insurance..they wouldn’t cover the early refill we tried to get a week ago when we hadn’t yet received replacements from Dexcom.

Each insurance is different, of course, and it depends on the patient. It also varies if you’re type 1 or 2, and if you’re prescribed insulin. I’m not either, so I don’t know for sure. The American healthcare system (which I am part of) is pretty opaque.

That said, I’ve heard people quote an insurance price of about $100/mo for a g7 (which is the same as this), and Medicare should cover it outright. I’ve seen companies sells the G7 for ~$200/mo if you don’t have insurance, but without a prescription I’ve never actually gone and bought one so I don’t know if I’m missing something.

The opaqueness is exactly why

> If you have T1d, you've been able to get the prescription-variant of this product for years with insurance, so there really is no reason to get this unless you're un-insured.

is dishonest at face value.

The OOP cost can wildly vary per insurer. As important is whether or not the insurance company covers it when you need it.

Typically insurance only covers 30 days at a time. That means on day 29, insurance will refuse to cover the cost at the pharmacy.

Real world schedules, flukey tech and devices, fluctuating pharmacy inventory, and occasionally needing an endo to confirm that you still aren’t the first person in human history to reverse Type 1 diabetes, etc. make “this was covered by prescription insurance” a flimsy-at-best argument against T1Ds considering this.

I am not entirely clear what changed in the CGM device or FDA guidelines. Though I am happy to see an OTC of this now approved. If we could do the same for CPAP then that would be another step in the right direction.

CBGM is important for the category of type-1 diabetics who also have dysregulation of increasing blood glucose sufficiently and carry a rescue glucagon autoinjector.

I once spoke to Scott Hanselman [1] on a conference. He is diabetic and also makes talks about IT and diabetes. I liked one point he made: people without diabetes should not buy these products, as it only brings the prices up, meaning that not everyone by can afford them.

Edit: forgot to specify link. 1: https://www.hanselman.com/

It is complete nonsense. In fact, it is scale that drives competition, and it is competition that brings prices down.

Moreover, the product models for diabetics are different.

Competition is usually good for bringing prices down (basically discouraging price-gouging by the manufacturer), but scale in itself can bring costs down too. The manufacturer has to amortize their development and regulatory approval costs across devices sold.

Or you could say that competition reduces the price ceiling, whereas scale reduces the price floor.

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