FDA stands against using smartwatches to monitor blood glucose

https://9to5mac.com/2024/02/21/fda-smartwatches-blood-glucose/

by alwillis • 2 years ago

43 66 2 years ago

The agency that approves medical devices warns people with serious medical conditions that using devices that haven't passed their standards is a risk. What a shocker.

As the article says, tech companies have been able to get FDA approval for the ECGs on smart watches. Tech companies should do the same for any other medical features they want to sell.

I am glad to have stringent standards that are upheld and enforced.

bluGill• 2 years ago

Approved for what? There is a difference between approved for people with and people without diabetes. If you have diabetes you may want this, but if it isn't very accurate it isn't going to do what you want. If you don't have diabetes though this could be a useful thing sitting on your watch, ready to give an alarm that you need to see a doctor because things are looking bad - people often go diagnosed with mild diabetes for a long time (depending on when their next physical is) and starting treatment for those people sooner can improve long term quality of life. Or if you do have diabetes maybe this can sometimes say do an extra blood sugar test at a time when normally you wouldn't (so long as there are not too many false positives)

lokar2• 2 years ago

It would be useful and probably safe for a diabetic that is not using insulin. Even pre diabetics, just understand how your blood sugar reacts to various foods and activities is really helpful for people trying to manage the disease.

renewiltord3• 2 years ago

Tech companies are doing that. It's legacy health companies that have been trying to sell glucose monitoring watches (Masimo, etc.). Apple is not marketing their device as that because their tech is not yet ready.

As usual you can count on modern tech companies to be better for everyone. Good for Apple.

FireBeyond5• 2 years ago

What??

Apple fans are still bitter at Masimo, evidently.

Masimo doesn't sell a glucose monitoring watch[1]. And is not trying to. The continuous health devices they do sell ARE FDA-cleared, because Masimo makes 99%+ of their revenue from selling accurate medical devices. That would be, to use a crude analogy, dangling your private parts within snapping distance of a crocodile.

Your whole statement is just inaccurate and derogatory.

The W1 watch doesn't do glucometry. It does heart rate and oximetry, with FDA clearance. The upcoming Freedom watch will also do hydration, pulse rate variability, respiration. And will do all of those with FDA clearance. And not glucometry.

Your whole stance is not grounded in reality.

FireBeyond5• 2 years ago

As the article says, tech companies have been able to get FDA approval for the ECGs on smart watches. Tech companies should do the same for any other medical features they want to sell.

The issue here is that the FDA has doubts that any of these devices, as they are currently, and also with some significant physiological challenges (think Theranos "this may just not be possible"), are able to do NIBGL accurately, not that "hey, just make sure you get approval, okay?"

(NIBGL - non-invasive blood glucose level)

advisedwang2• 2 years ago

That's just 9to5Mac's editorializing. The actual FDA article [1] reads to me like "guys' heads up that none of these are approved". I see nothing to suggest the FDA means "we will never approve one" or "we doubt the underlying technology can ever work".

[1] https://www.fda.gov/medical-devices/safety-communications/do...

JoeAltmaier• 2 years ago

Blood glucose is hard. Witness Theranos' attempt to do blook analysis without sufficient samples.

It apparently can be done from surface contact, with a special patch that measure interstitial epidermal fluid. Do these watches have that?

stop50• 2 years ago

No, they want to use light refraction to measure the glucose level.

Beijinger2• 2 years ago

"with a special patch that measure interstitial epidermal fluid."

Yes. Dexcom and Senseonics (Eversense)

"It apparently can be done from surface contact"

It can also be done without pircing the skin. https://quantune.com/

But more complex than Apple thought.

veidr4• 2 years ago

What's the TL;DR on that Quantune device? Does it achieve a new level of noninvasive accuracy?

(I did visit the website but there is no information (possibly because I'm in Japan which has regulations around public disclosure of information about medical devices that haven't been approved — which is enough of a hassle that sometimes companies just basically show a blank page).)

m4632• 2 years ago

I'm glad they are holding their ground.

Also, I remember reading "the glucose revolution" and I found it interesting that blood glucose is only part of the picture. We currently don't measure fructose level, and that might have effects separate from blood glucose levels.

Hopefully folks will go back to the drawing board and either lower the cost of the other continuous measuring devices, or move current tech onwards to acceptable accuracy.

doormatt• 2 years ago

We currently don't measure fructose level

Apologies, but I'm unsure if you're saying that no devices measure fructose level, or just the watch doesn't measure fructose level.

m4632• 2 years ago

as far as I know no continuous measuring device can measure your blood fructose level. It was mentioned in the book, saying that different kinds of foods might spike your blood glucose level in a similar fashion, yet behind the scenes blood fructose could be wildly different, with a different body reaction.

salad-tycoon2• 2 years ago

For anyone interested, other useful measurement are a fasting glucose and fasting insulin to calculate a homa-ir (insulin resistance). I personally think everyone , non diabetc, should get one. Not that expensive to buy it yourself at a direct lab consumer purchasing website (USA).

spandrew• 2 years ago

The title is more alarming than the substance of the article. Apple is investing in a novel technology that may be able to measure technology using light waves, but the article says it's still in early stages and there's no rush to market with it.

Given Apple's history with ECG and other Apple Watch, FDA approved tech there's no nefarious scheme to deliver anything that doesn't pass approvals.

healsdata• 2 years ago

Honestly, the author of the article is purposefully creating controversy where there is none or ignorant of how the FDA works. The FDA isn't "against such technology" -- they just haven't approved any yet.

TeeMassive• 2 years ago

Imagine we could have a near real time effect of what we eat and then we discover that high fructose products are really really bad.

Also imagine that the corporations that produce those products are the worse when it comes to corruption through lobbying.

qup• 2 years ago

I don't know what really really bad means to you, but we can look around and see people who have eaten fructose their whole lives to no obvious effect. Almost every person I see.

So it's not going to meet my personal definition of really really bad.

It's already clear and well known that it's bad.

grecy2• 2 years ago

Cancer rates will soon be over 50%, and obesity and heart disease have never been higher.

rokkitmensch• 2 years ago

Funny, I look around and see people every day in terrible condition who have been consuming oodles of fructose their whole life.

candiddevmike2• 2 years ago

I don't think we will discover that. Fructose is pretty benign chemically (though it can be inflammatory as fructans). Instead, I think we'll find some kind of food additive or chemical is causing autoimmune issues that create a whole host of secondary effects like hypothyroidism, CFS, and cravings/obesity that potentially link to T2 diabetes.

mlhpdx• 2 years ago

I don’t think that’s true. People with normal endocrine response (not diabetic or otherwise impaired) don’t see significant movement in blood glucose. It would very likely be “in the noise” as far as the light based sensors go.

ravenstine• 2 years ago

Thing is most people don't actually care, and individual measurements are usually just vanity metrics. We already know that fructose is poisonous. We already know that processed foods are engineered to keep you hungry. But people eat this stuff anyway. I no longer use fitness devices, and the people I know who use them are almost always in suboptimal health and make no progress, no matter how many "steps" or "calories" their devices claim they are producing.

Stop eating poison and one's health usually improves – no tech needed. Better yet if you give your body adequate time to dig in to its own fat stores.

People want easy solutions and to feel smart. Smart watches and Oura rings claim exactly that. Don't research, don't think – just hit a reductive number so your watch can tell you you're "on track" and give you permission to eat some Cheetoes and coke.

nradov• 2 years ago

"Bad" in what sense? Continuous glucose monitors have been available for several years and can show blood glucose spikes (or lack thereof) after eating certain foods. But you're not going to get any useful data about fructose from a wrist device. The issues with fructose seem to be interrelated with sodium and uric acid.

https://peterattiamd.com/rickjohnson2/

Lately endurance athletes have been increasing their fructose intake during races and hard workouts in order to maximize energy availability.

https://www.trainerroad.com/blog/how-to-use-carbs-for-maximu...

siliconc0w• 2 years ago

As much as I think something like this would be a huge benefit, we might need more regulation for these bio-monitoring devices that all seem pretty unreliable in aggregate. In my experience sleep trackers, body fat % scales, calorie trackers, even heart rate meters are 'okay' but have all given ratings that were so bad that I just can trust them. A tracked yes or no question like, "Do I feel like I got good sleep last night?" seems way better than a sleeptracker that can basically only be relied on to tell if I'm in the bed or not.

There should be some requirement that you study and publish the correlation of your device to the current medical gold standard for a reasonable sized population. So a sleep-lab sleep score vs a mattress or fitbit tracked sleep score. Or a body-scale fat% compared to a hydrostatic weighing.

jimrandomh• 2 years ago

Typical usage of blood glucose monitoring (by diabetics) is simultaneously safety critical, and only borderline good enough accuracy. There's a standard metric for accuracy here, MARD (mean absolute relative difference).

There is a long history of companies promoting themselves to investors as having working noninvasive glucose monitoring technology, which, if you look at the actual accuracy scores, is only moderately correlated with glucose, nowhere close to the accuracy required. If Apple ships a noninvasive glucose monitor with an MARD of 20, the primary effect will be to set a trap for the stupid: diabetics will attempt to use it to save money, since it will be much cheaper than using real CGMs (which are consumable), and people who try to do this will die.

nosefurhairdo• 2 years ago

Alternatively, you allow this technology to be sold as a clearly labeled "not accurate enough for treatment of diabetes", and the profit allows more investment in the tech so that one day everyone can benefit from accurate, non-invasive blood glucose monitoring.

Or perhaps we should ban everything that can enable "the stupid" to harm themselves.

Retric2• 2 years ago

There’s far more options than just those two. It may not be physically possible to have non invasive glucose monitoring of sufficient accuracy, until it’s actually demonstrated we just don’t know.

The general point of the FDA is to prevent snake oil salesmen from conning people which makes this decision in line with their core mission.

Analemma_• 2 years ago

That's the Standard Libertarian Reply, and in some cases it's the one I stand with, but... no, not for this. A label which everybody knows will be ignored (when was the last time you read the EULAs of your software start-to-finish) by people who then inevitably go on to die because their smartwatch gave them a wrong number should not be allowed.

Or perhaps we should ban everything that can enable "the stupid" to harm themselves.

Once again this is a case of people holding absolutist principles when there is no need, or benefit, to do so. We can and should use rational cost-benefit analysis to decide what to allow and what to forbid. What's the benefit of allowing non-diabetics access to inaccurate blood sugar measurements? Minimal: a couple people have mentioned speculative uses about mood or energy level, but that's about it. What's the harm? Colossal: it's a near-certainty that many people will die. This is a no-brainer.

Note that by contrast, the calculus for allowing somewhat-inaccurate EKG measurements on the Apple Watch is in favor of allowing it: nobody is going to live or die on an inaccurate heartbeat trace from their watch, as they can for a blood glucose measurement, so, sure, why not. Again: black-and-white principles is not the correct mode of analysis here.

veidr4• 2 years ago

Well, you are describing the maximally absurd end of that spectrum to make your point, but in the US the FDA does indeed ban all kinds of stuff to prevent both its sale, and use (i.e. to stop "the stupid" from using it).

Blood glucose monitors are sold without a prescription in many countries, and you can buy them with varying degrees of accuracy and use them for whatever you want; not in the US, though, because they are regulated as medical devices.

The same is true for lots of other stuff that could be used in non-medical or less-dangerous medical contexts, like nebulizers.

You can make a reasonable argument for your position, regarding this specific device or more generally. But the FDA has consistently rejected it.

smitty1e• 2 years ago

Or perhaps we should ban everything that can enable "the stupid" to harm themselves.

Quite a bit of capitalism is predicated on the market not being very bright.

gorb3142• 2 years ago

Just my two cents, but as a type 1 diabetic: I either want very accurate blood sugar readings, or none at all. And from what I know about people who don't suffer from diabetes: there is almost no reason to try and find out what your blood sugar is doing, because your body regulates it so well.

So I just don't see the point of this. Non-invasive glucose monitoring just doesn't seem feasible, the accuracy doesn't help diabetics and it certainly doesn't help non-diabetics.

I'm a naysayer on this, but I do hate having to continuously test my sugar and buy expensive CGM gear. Please prove me wrong?

jwagenet• 2 years ago

I’m not diabetic, but I can have intense energy/mood swings likely related to blood sugar. Non-invasive monitoring does sound nice to have a better understanding of what’s going on.

gorb3142• 2 years ago

If I were in your situation (which granted I am not) and mood swings related to blood sugar was a concern, I would pick up a simple finger-prick blood testing kit. It is fast, safe and most of all very accurate. That would then either put my mind at ease or convince me to see a doctor.

Again, having what might be very inaccurate measurements of blood sugar won't help in this case either, I fear.

joshstrange• 2 years ago

I don’t understand this view point at all. Widely deployed tech that is not as accurate has a chance to uncover trends no one was monitoring for and to improve over time as they have more data and iterate on the tech.

If we took your approach with literally anything in the tech world we’d have nothing since the v1 wasn’t perfect.

How does it hurt you at all if people have access to a rough estimate of their blood sugar levels?

cosmin800• 2 years ago

Going to buy more Eli Lily stock, that thing will never go down this way.

Keeping people from seeing their real-time blood glucose levels is just a move to keep them from becoming aware of how bad their sugary foods are and their pre-diabetic health.

Fructose is way worse than glucose.

faeriechangling• 2 years ago

Glucose is still rather bad, but I'm on a fructose limiting diet anyways.

pedalpete2• 2 years ago

I believe the correct approach is to create a non-medical label for the test. Our watches have heart-rate monitors, not EKGs. An EKG is a medical device with highly accurate measurement of heart-rate for medical purposes. A heart-rate monitor, gives a decent approximation, not good enough for medical purposes.

Nobody calls an EKG a heart-rate monitor. The correct term would let a consumer have some insight into their blood sugar levels, but a diabetic would clearly not be confused into thinking this was a replacement for the monitoring they require.

kevingadd• 2 years ago

My fear is that "a diabetic would clearly not be confused into thinking this was a replacement for the monitoring they require" is an impossible bar to clear. We've seen how good ordinary people are at using technology even when it has clear documentation.

Another post on this article also points out that traditional monitoring costs money on an ongoing basis, which would create a temptation to try and 'get by' with tech like this even if it's not adequate.

pedalpete2• 2 years ago

These are good points, but we can't ignore that this technology is valuable for non-diabetics. We also know that "preventing" technology from being used is a losing battle - though I'd be happy to hear of examples contrary to this.

If a diabetic is going to attempt to use the device as a diagnostic, but they are aware that it is not fit for that purpose, that is their own choice. Like injecting insulin by "feel".

Perhaps a better approach would be that insulin be delivered in collaboration with a certified device. That would close the loop on the amount of insulin being injected.

I'm no expert on diabetes though, so i don't know the actual implications of that.

FDA stands against using smartwatches to monitor blood glucose

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