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

[MacRumors]

The United States Food and Drug Administration (FDA) does not want consumers to purchase or use smart watches or smart rings that claim to measure blood glucose levels using non-invasive methods. In a safety warning shared today, the FDA says that smart devices that claim to check blood sugar without piercing the skin can lead to errors in diabetes management, including taking too much or too little medication.

No smart watch or smart ring that is intended to measure or estimate blood glucose values non-invasively has been authorized, cleared, or approved by the FDA. These non-invasive devices are different from continuous glucose monitoring devices (CGMs) that relay data through a smart watch app.

Apple is rumored to be working on a version of the Apple Watch that will be able to measure blood glucose non-invasively, but launch of such a device is still several years away. Apple has been exploring optical absorption spectroscopy using a laser to shine light under the skin to determine a person's blood glucose level, but as of 2023, Apple's work remained at a proof-of-concept stage.

As of right now, there are several low-cost smart watches and smart rings that claim to be able to monitor glucose levels without a skin prick or without integrating with a CGM device. The FDA says patients should avoid such devices, and doctors should warn patients about the risks of using unauthorized blood glucose measuring products.

Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin. They claim to use non-invasive techniques. These smartwatches and smart rings do not directly test blood glucose levels.

These smartwatches and smart rings are manufactured by dozens of companies and sold under multiple brand names. This safety communication applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of manufacturer or brand.

The FDA says that it is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smart watches or smart rings that claim to measure blood glucose levels.

If Apple does end up releasing an Apple Watch that includes a sensor for non-invasive blood glucose monitoring, Apple will need to get FDA approval before it is allowed to sell it in the U.S. Other companies like Samsung are working on similar technology, but there is no proven and approved non-invasive blood sugar monitoring method on the market as of right now.

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

 

[jz0309]

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

 

[jz0309]

and for this retirement, the AW will never (imho) provide CGM (continuous glucose monitoring) as that would make it a medical device (read very expensive). now they might make a "special edition", or, they'll negotiate with the FDA to provide "trends", lacking actual data, just saying high, low etc

 

[t0rqx]

Bye bye Apple Ring.

 

[dannyyankou]

There's nothing wrong with using this tech. But it shouldn't be a substitute. If my Apple Watch says my heart rate spiked, I verify with a blood pressure monitor that shows heart rate data.

 

[AndiG]

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 do is 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.

 

[axantas]

There's nothing wrong with using this tech. But it shouldn't be a substitute. If my Apple Watch says my heart rate spiked, I verify with a blood pressure monitor that shows heart rate data.

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.

 

[Arsenikdote]

The FDA wants their money of course, but also yikes when the FDA actually makes a comment on something like this. Does not bode well for anyone hoping for an advancement in this tech anytime soon.

 

[JFox]

As someone intimated above, if Apple ever rolls out this tech it will be as non-FDA-approved feature. Meaning it won't communicate with my pump like my Dexcom G7 does. Which is a shame (assuming they got it accurate enough), but I wouldn't blame them for avoiding the FDA red tape. Took forever just to get iOS app control of my pump (Tandem) approved.

 

[DoogH]

The FDA wants their money of course, but also yikes when the FDA actually makes a comment on something like this. Does not bode well for anyone hoping for an advancement in this tech anytime soon.

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.

 

[coolfactor]

Wouldn't it be sweet if Apple figured this out without using another company's patented tech? 😇

 

[JapanApple]

"The FDA says patients should avoid such devices, and doctors should warn patients about the risks of using unauthorized blood glucose measuring products."

Agreed, Apple devices or no Apple devices, these are only guesstimations at the least. Always use reliable methods.

 

[zakarhino]

I understand the concern but if a smart watch or ring can get me most of the way there it should still be considered a breakthrough. Sure maybe the devices we have right now are not very good but ultimately we'll be hearing more of this fearmongering once existing blood glucose gadget makers realize big tech are going to eat their lunch with all day, non invasive monitoring built into a smartwatch that is good for years of use.

 

[aperantos]

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.

Diabetics cannot see a doctor any time they want to eat! Glucose monitoring it an essential part of insulin management so it needs to be self monitored, which is why the FDA is issuing this warning. If something gives a reading that is either too high or too then you can risk your health taking the wrong dose. There are international standards on the safe margins of error that devices need to achieve to be certified.

 

[zakarhino]

There's nothing wrong with using this tech. But it shouldn't be a substitute. If my Apple Watch says my heart rate spiked, I verify with a blood pressure monitor that shows heart rate data.

That's how everyone in my family does it too. At least for prior Apple watch versions the heart rate sensor simply doesn't provide an accurate heart reading for my dad because his resting heart rate is like 40 bpm lol. Maybe it got better once he got an Ultra 2, I'll have to check, but he still uses traditional devices to get accurate data.

These devices are really great for giving you rough trend data but we're not at the point where they can entirely replace the real thing. I think we'll get there eventually but people with real heart conditions (or diabetes once this Apple watch comes out) need to understand these are still not anywhere near perfect.

 

[Dremmel]

It will be incredible if Apple can pull this off. 24/7 blood glucose monitoring would be a game changer. I'd ditch my mechanical watches for this.

 

[Arsenikdote]

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.

One of my good friends has been working in the FDA space their entire 30+ year career. If you think the FDA does not receive funding based on companies getting approvals than you do not know the space very well.

 

[JordanCautious]

Pretty sure this is just preparation for when Apple releases a product that does it without having to deal with competitors who say they do the same thing for less. Clearing the market, if you will.

 

[Madhatter32]

People relying on a glucose monitor could mean the difference between life and death. So, yeah, no one should rely on a watch measurement.

 

[lkrupp]

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

Apple is behind what exactly. Those Chinese watches sold on Temu for $39.95 are complete frauds and do not work

 

[MarkNewton2023]

The United States Food and Drug Administration (FDA) does not want consumers to purchase or use smart watches or smart rings that claim to measure blood glucose levels using non-invasive methods. In a safety warning shared today, the FDA says that smart devices that claim to check blood sugar without piercing the skin can lead to errors in diabetes management, including taking too much or too little medication.

No smart watch or smart ring that is intended to measure or estimate blood glucose values non-invasively has been authorized, cleared, or approved by the FDA. These non-invasive devices are different from continuous glucose monitoring devices (CGMs) that relay data through a smart watch app.

Apple is rumored to be working on a version of the Apple Watch that will be able to measure blood glucose non-invasively, but launch of such a device is still several years away. Apple has been exploring optical absorption spectroscopy using a laser to shine light under the skin to determine a person's blood glucose level, but as of 2023, Apple's work remained at a proof-of-concept stage.

As of right now, there are several low-cost smart watches and smart rings that claim to be able to monitor glucose levels without a skin prick or without integrating with a CGM device. The FDA says patients should avoid such devices, and doctors should warn patients about the risks of using unauthorized blood glucose measuring products.

The FDA says that it is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smart watches or smart rings that claim to measure blood glucose levels.

If Apple does end up releasing an Apple Watch that includes a sensor for non-invasive blood glucose monitoring, Apple will need to get FDA approval before it is allowed to sell it in the U.S. Other companies like Samsung are working on similar technology, but there is no proven and approved non-invasive blood sugar monitoring method on the market as of right now.

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

Although I love Apple products, I will not use or trust them for health and medical purposes. I only trust FDA approved devices for these reasons. Keep calm, live healthy and be happy with FDA/government health agency approved devices for health and medical reasons. 😊 Life is too short to be unhealthy and unhappy! 😊 Enjoy life to the full with healthy life 😊

 

[jz0309]

Apple is behind what exactly. Those Chinese watches sold on Temu for $39.95 are complete frauds and do not work

my reference was to what others have posted, not my assessment that Apple is "late", sorry that wasn't clear.

 

[Naraxus]

Apple is behind what exactly. Those Chinese watches sold on Temu for $39.95 are complete frauds and do not work

He wasn't saying Apple is behind, rather that some posters here are saying Apple's behind. At least that's how I read his post

 

[el-John-o]

I feel like checking blood glucose levels for diabetes management is a very different thing than checking it for general health.

It's just like the Apple EKG feature on the watch. Nobody uses that to diagnose severe heart issues but it could provide an indicator that ultimately leads to getting the right diagnosis with the right equipment.

If you have diabetes and you need to regularly monitor your blood sugar then you should do that in a method your doctor thinks is appropriate. But people like my grandmothers, who is Diabetic but does not have to regularly monitor her blood sugar (it's well under control and has been for a very long time), could absolutely get an indicator that might suggest to her that she should check using her regular glucose meter.

And blood sugar varies with non-diabetics, too (I mean, if it doesn't you've got something wrong.) I'm someone who sometimes forgets to eat and will get suddenly light headed or sick feeling due to low blood sugar. It would be silly for me to stick my finger all the time (If I could remember to do that I could remember to check my watch and realize it's 4PM and I haven't eaten all day). But I bet a device like this could give me a little alert if my blood sugar got lower than usual...

 

[Fuzzball84]

Medical devices have to meet stringent requirements... I think it starts to become blurry where smart devices such as Apple Watch etc are concerned... which features can you rely on, which features are certified... for regular consumers it can be hard to know what or who you can trust regards medical features.