FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels

[jicon]

A couple good reference points concerning MARD, and state of blood glucose meters available today... they're often not so accurate, so good luck with accuracy with a non-invasive device.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7189145/

https://www.liebertpub.com/doi/full/10.1089/dia.2021.0236

I had luxury of wearing two CGM brands a few times, and the differences between it, and other glucose meters are frustrating. Want to be confident of the time? Wear a watch. Want to have little confidence in the time of day? Wear two.

 

[Chazak]

so in other words, if you're not doing the necessary rigor and go the the FDA process and get approval/clearance - you're a scam.
I think I've seen posts here in the AW forums that some chines makers already offer this, so why is Apple behind? - for the above

So relying on inaccurate blood glucose measurement that do not meet scientific criteria for accuracy and taking action based on those measurements is okay with you? Just as someone else mentioned, none of these methods take the place of certified medical devices and mostly serve as alerts to consult a medical professional.

Also wondering where you get the scam stuff from. I read the article and the FDA news release and scam is not mentioned or inferred anywhere. The FDA's job is to protect us and enforce standards. They have no economic role in devices.

I am also interested as to what you think their motives are because if I follow what I think you are putting out there, it leads me to a dead end.

 

[SegNerd]

I’ve seen these watches on Amazon, and they are tempting. But I was already skeptical, so I watched a YouTube video of someone testing a watch against a real glucose monitor - and yes, the readings from the watch are pretty much meaningless.

It’s a bummer that noninvasive CGMs seem to always be just slightly out of reach. But think of it this way - as recently as 25 years ago, there were no CGMs at all. As recently as 50 years ago, there was no way to check your blood sugar at home. And as recently as about 100 years ago, diabetes was essentially untreatable. So it could be worse.

 

[Chazak]

It is a sad statement about the world we live in when people think the FDA is partaking in some kind of scam or has something to gain from warning people not to rely on devices not meeting the criteria to be an approved medical device.

 

[spazzcat]

so in other words, if you're not doing the necessary rigor and go the the FDA process and get approval/clearance - you're a scam.
I think I've seen posts here in the AW forums that some chines makers already offer this, so why is Apple behind? - for the above

Yes most likely, this is a requirement for all medical items for many reasons.

 

[G5isAlive]

FDA doesn't get paid for this.

The issue is that nobody has made a reliable blood monitor. Not even close.

I mean, check the oxygen sensor, mine regularly drops to 88% on my watch, but is never below 98% when I go to the doctor.

Not sure what you mean by 'this', but the FDA absolutely gets paid for evaluating products for approval. For example the 2023 fee for a BLA, Biologic Licensing Application, is $441, 547. And while the FDA is an organization, it is comprised of people that get paid by the government to review products for approval. It is literally their job. So yes, they are charged with protecting the public from snake oil salesmen, but its erroneous to say they don't get paid.

Now you bring up the Apple Watch Oxygen sensor. Great analogy. Apple takes great efforts to say their O2 sensor and their Heart Rate sensor are NOT FDA approved. They do not advertise it as such, or the FDA would be down their throats and report them to the SEC. But they do sell watches with those capabilities. And you are right, they are not as accurate as medical grade devices, but by and large if you learn to disregard outliers the trends are reasonably close so as to be useful. The trick is to take several measurements in a row.

So I assume that if they come up with a glucose monitor, probably by monitoring glucose glycosolation of hemoglobin resulting in a very slight spectral shift as compared to the huge spectral shift hemoglobin undergoes when binding oxygen (red) and being dexoxy (purple), Apple will be clear in their marketing this is not FDA approved.

The interesting thing to me is the FDA DID clear the two functions on the Apple Watch, which is very different from marketing approval... and yet they take this very anti-stance about glucose monitoring. They didnt take this stance before with the Apple Watch. The FDA is a very reactive organization, so my guess is they regret they let the genie out of the bottle with the heart rate monitoring feature even though it is more benign. My grandfather was a diabetic, and we had to measure his glucose before dosing him with his meds. My guess is that is what has the FDA scared, especially when they see the widespread adoptance of the Apple Watch health features by the public AND doctors, that people will trust their watches too much.

 

[Plutonius]

The FDA's track record doesn't see too great over the last few years so I'm not sure that I would listen to this advice.

If I was thinking about getting a monitor, I would have a discussion with my doctor instead.

 

[onenorth]

As far as I can tell, this is just a warning. A warning that should be taken seriously, but still just a warning.

Off-label uses occur because FDA approval is expensive and time-consuming and, apparently, now subject to the whims of federal judges.

If we could only obtain products that were FDA-approved, then the marketplace would be even smaller and more expensive than it already is.

 

[iGeneo]

Word! This is not going to work anytime soon or at least it is not going to work in a way you would expect.

What Apple COULD and SHOULD ist to cooperate with the manufacturers of CGM systems like Freestyle Libre 3 to make those devices even smaller and more precise and offer an iOS integration, so always get realtime display of current glucose value.
But glucose level monitoring using light is simply not precise enough for diabetic treatment.

I just ordered the Ultrahuman M1 that will do just that. I believe they are using the FreeStyle Libre CGM. Their app will push the data to Apple Health. Apparently the Freestyle does not...

*Not a diabetic, just interested in a little biohacking data

 

[picpicmac]

As far as I can tell, this is just a warning. A warning that should be taken seriously, but still just a warning.

To what are you referring?

 

[dannyyankou]

There is another solution for both cases: Just let a doctor check it…
It is as easy as that. Then you get an approved diagnose.

Ok, obviously if you don't feel well see a doctor. But I'm talking about if you feel perfectly fine and the Apple Watch tells you something. If my Apple Watch says one thing and an FDA approved medical device I have at home says another, and I feel fine, why waste my time and a copay at the office? Not to mention, some people's plans don't have copays, thy just get coinsurance once the deductible is met and they have to pay more.

 

[onenorth]

To what are you referring?

https://www.fda.gov/medical-devices...blood-glucose-levels-fda-safety-communication

 

[CookItOff]

It is a sad statement about the world we live in when people think the FDA is partaking in some kind of scam or has something to gain from warning people not to rely on devices not meeting the criteria to be an approved medical device.

I'm not sure about the FDA but there is a lot of precedent for this. I mean, Bernie Madoff wrote most of the rules and guidelines the SEC used to police finance. But here we are with the biggest pyramid scheme in history being ran by Madoff. All because the government SEC agents had stars in their eyes every time they audited him, and also they really didn't understand finance on a level like that.

Government workers are great and a backbone for nations. But the top 30 percent of any graduating class goes into the private sector, the remainder work government.
Disclaimer: I'm a former government employee.

SEC was charmed by Madoff and failed to act quickly, here's why:

The Securities and Exchange Commission esteemed him as a Nasdaq Stock Market chairman and prominent Wall Street figure, failing to detect fraud despite receiving warnings and credible complaints over 10 years.

fortune.com

 

[scrapesleon]

Nobody cares what the fda says with their bogus information

 

[swsm]

uhmmmm... duh! Maybe someday.

 

[swsm]

Nobody cares what the fda says with their bogus information

yeah cause big tech companies are so much more honest and reliable than the G. they both suck and lie. Common sense should rule. Use tried and true medical protocols to stay alive. Duh!

 

[aperantos]

My guess is that is what has the FDA scared, especially when they see the widespread adoptance of the Apple Watch health features by the public AND doctors, that people will trust their watches too much.

The warning is nothing to do with Apple which sales no such technology, it is aimed at products that exist now and are being sold with unreliable claims about their abilities.

MacRumors has only reported on it because it is a market area which Apple hope to operate one-day.

 

[DunedinD]

Word! This is not going to work anytime soon or at least it is not going to work in a way you would expect.

What Apple COULD and SHOULD ist to cooperate with the manufacturers of CGM systems like Freestyle Libre 3 to make those devices even smaller and more precise and offer an iOS integration, so always get realtime display of current glucose value.
But glucose level monitoring using light is simply not precise enough for diabetic treatment.

You already get continuous updates to iPhone even from Libre 2 As long as the Bluetooth connection isn’t interrupted. You don’t even need to keep scanning the sensor with iPhone NFC component.

If by real-time updates you mean actual current glucose level, not 15 minutes behind like Libre currently provides, that would require CGMs to overcome biological limitations, since the invasive part samples from interstitial fluid rather than directly from the bloodstream.

 

[ShelSingh]

Can't wait until this is perfected.

 

[Pezimak]

The only reliable sensors on the Apple Watch are the heart rate sensor and the ECG because they use the same tech as medical grade sensors, heart rate sensor uses light to measure and is pretty accurate, ecg uses diodes that measure electric signals, both have been none invasive for years.
But to monitor glucose levels from outside the body by reinventing the way it has been done for years and put it in a watch and using an algorithm to guess as opposed to a sensor measuring your blood I’m not so sure will work. And considering the FDA also think that I’m guess I’m right. I imagine it’s something that will take many many years to get right.

 

[Klagarde]

Word! This is not going to work anytime soon or at least it is not going to work in a way you would expect.

What Apple COULD and SHOULD ist to cooperate with the manufacturers of CGM systems like Freestyle Libre 3 to make those devices even smaller and more precise and offer an iOS integration, so always get realtime display of current glucose value.
But glucose level monitoring using light is simply not precise enough for diabetic treatment.

Yet, but can be in the future. Photonics chips are coming in the next 3 years or so and can be reliably used for more than blood glucose monitoring.

 

[jz0309]

So relying on inaccurate blood glucose measurement that do not meet scientific criteria for accuracy and taking action based on those measurements is okay with you? Just as someone else mentioned, none of these methods take the place of certified medical devices and mostly serve as alerts to consult a medical professional.

Also wondering where you get the scam stuff from. I read the article and the FDA news release and scam is not mentioned or inferred anywhere. The FDA's job is to protect us and enforce standards. They have no economic role in devices.

I am also interested as to what you think their motives are because if I follow what I think you are putting out there, it leads me to a dead end.

I suppose I worded my comment poorly. What I meant to say is that the FDA basically says that these cheap smart devices that offer blood glucose monitoring are in reality a scam, cause they do not really measure blood glucose.

and yes, FDA as a regulatory body is there to protect consumers.

not sure about your last question - the motives of those companies advertising that they have blood glucose monitoring in a smart watch - sell their product for features it doesn't have, that to me is a scam.

 

[jhwalker]

There is another solution for both cases: Just let a doctor check it…
It is as easy as that. Then you get an approved diagnose.

Sure ... because you really SHOULD only check your heart, blood pressure, sugar level, etc., every six months or so ...

 

[jz0309]

The only reliable sensors on the Apple Watch are the heart rate sensor and the ECG because they use the same tech as medical grade sensors, heart rate sensor uses light to measure and is pretty accurate, ecg uses diodes that measure electric signals, both have been none invasive for years.
But to monitor glucose levels from outside the body by reinventing the way it has been done for years and put it in a watch and using an algorithm to guess as opposed to a sensor measuring your blood I’m not so sure will work. And considering the FDA also think that I’m guess I’m right. I imagine it’s something that will take many many years to get right.

The technology (to measure blood glucose levels without pricking) is there, or almost there. In order to make it viable, the device has to go through FDA rigor, and that takes years, but those devices will be bailable in the future.

Think body temp measurement, started with putting something in your behind, then mouth, and nowadays your forehead is scanned - enabled through technology...

 

[jz0309]

The interesting thing to me is the FDA DID clear the two functions on the Apple Watch, which is very different from marketing approval... and yet they take this very anti-stance about glucose monitoring. They didnt take this stance before with the Apple Watch. The FDA is a very reactive organization, so my guess is they regret they let the genie out of the bottle with the heart rate monitoring feature even though it is more benign. My grandfather was a diabetic, and we had to measure his glucose before dosing him with his meds. My guess is that is what has the FDA scared, especially when they see the widespread adoptance of the Apple Watch health features by the public AND doctors, that people will trust their watches too much.

The FDA comments have nothing to do with Apple. FDA advises that people should not use smart watches that claim to measure blood glucose levels - cause they don't measure blood glucose levels.
When/If Apple releases a device that measure blood glucose, it will either be a "general trend" and thus not require the whole FDA approval process, or, it will be a device that provides accurate data so that type 1 diabetics can adjust their insulin intake accordingly, and that device will be an FDA approved medical device. IMHO the 2nd one will never be integrated into an AW ...