Apple's non-invasive glucose reader for Apple Watch may be 'years away'

AppleInsider

Apple is still developing a non-invasive glucose reader, but the technology might not show up in an Apple Watch for several years, a report said this week.

The company is "continuing research," according to the New York Times, which cited two sources familiar with the project. Industry experts consulted by the paper however suggested that Apple -- and other companies -- are likely years away from a commercial product.

Apple's interest in the technology has been rumored for some time, and is said by Times sources to date back to co-founder Steve Jobs, who in the last months of his life approved a research project because he disliked pricking his finger for blood sugar testing. The CEO was coping with diabetes at the same time as his battle with cancer.

The company reportedly considered trying the feature in the first-generation Watch, which shipped in 2015, but it was one of several health technologies the company ditched because it was either unreliable or forced compromises in size or battery life.

In its current incarnation the Apple Watch shares many of the same health features as rival devices from Garmin, Polar, Samsung and others, namely step and stand tracking, calorie burn estimates, and continuous heart rate tracking. The company is rumored to be working on adding an EKG monitor, triggered by squeezing the frame of a Watch.

Both that and a glucose reader will probably require approval by the U.S. Food and Drug Administration, which -- though fast-tracking may be available -- could complicate any launch.

roake

A non-invasive glucose meter built into the watch would be awesome, and would significantly drive up sales.  The following year, Samsung would have some flavor of implementation of the same thing, probably inaccurate, but they could list it as a feature.

ericthehalfbee

I have no doubts a non-invasive glucose monitor is extremely difficult to implementing could be many yes s away. I also have no doubts that if Apple released a Watch with this ability it would be nothing short of a medical breakthrough and Watch sales could rival iPhone sales.

NY1822

I'll place my bets on Apple vs "Industry Experts"...

gmgravytrain

Such a device must be hard for any company to make or it would have already been done. I only had hopes Apple could do it but they also probably can't do it. I'm not sure why there is a time factor attached to this device. It could be possible to do years from now or a breakthrough could happen in a week. For all we know, Apple could simply be secretive and not be telling that it's already possible. With as much money as Apple has at its disposal, almost anything is possible.

sandor

NY1822 said:

I'll place my bets on Apple vs "Industry Experts"...

you obviously don't work in the medical world & have to deal with the FDA processes.

macxpress

sandor said:

NY1822 said:

I'll place my bets on Apple vs "Industry Experts"...

you obviously don't work in the medical world & have to deal with the FDA processes.

I doubt work in that field either...You don't know anymore than they do. 

sandor

macxpress said:

sandor said:

NY1822 said:

I'll place my bets on Apple vs "Industry Experts"...

you obviously don't work in the medical world & have to deal with the FDA processes.

I doubt work in that field either...You don't know anymore than they do. 

almost 20 years now, on the clinical side, not the vendor side, but i work closely with the development processes of dozens of medical devices.
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.

zoetmb

sandor said:

macxpress said:

sandor said:

NY1822 said:

I'll place my bets on Apple vs "Industry Experts"...

you obviously don't work in the medical world & have to deal with the FDA processes.

I doubt work in that field either...You don't know anymore than they do. 

almost 20 years now, on the clinical side, not the vendor side, but i work closely with the development processes of dozens of medical devices.
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.

Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval, especially over the next few years as the current administration attempts to deregulate everything.  How would it be any different than a blood pressure gauge?  I don't think my gauge is FDA approved.   And unless there's a way to measure blood glucose via saliva, I don't see how it could ever be non-invasive anyway.  Of course there probably would be a way for a device to track the results from urine test strips, but it's the strip that's already doing all the work.  Unless they expect us to urinate on our phones or watches. 

I didn't know until now that Jobs also had diabetes.   It certainly wasn't a weight issue and from what we supposedly know about Jobs, he probably didn't eat processed foods with high sugar and fat content, although I think there was some anecdote about him demanding an ice-cream soda in a restaurant that didn't ordinarily serve them.  

sandor

zoetmb said:

sandor said:

macxpress said:

sandor said:

NY1822 said:

I'll place my bets on Apple vs "Industry Experts"...

you obviously don't work in the medical world & have to deal with the FDA processes.

I doubt work in that field either...You don't know anymore than they do. 

almost 20 years now, on the clinical side, not the vendor side, but i work closely with the development processes of dozens of medical devices.
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.

Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval, especially over the next few years as the current administration attempts to deregulate everything.  How would it be any different than a blood pressure gauge?  I don't think my gauge is FDA approved.   And unless there's a way to measure blood glucose via saliva, I don't see how it could ever be non-invasive anyway.  Of course there probably would be a way for a device to track the results from urine test strips, but it's the strip that's already doing all the work.  Unless they expect us to urinate on our phones or watches. 

I didn't know until now that Jobs also had diabetes.   It certainly wasn't a weight issue and from what we supposedly know about Jobs, he probably didn't eat processed foods with high sugar and fat content, although I think there was some anecdote about him demanding an ice-cream soda in a restaurant that didn't ordinarily serve them.  

actually, like all devices - but especially rampant in the low cost, high consumer sales areas, there are non-FDA or CE cleared blood pressure cuffs & FDA & CE cleared ones.

http://www.clinical-innovation.com/topics/practice-management/fda-grants-510k-clearance-caretaker-medical’s-blood-pressure-and-heart-rate-monitor
https://www.accessdata.fda.gov/cdrh_docs/pdf8/K080319.pdf
https://510k.directory/clearances/K970139
http://www.caretakermedical.net/fda-approves-caretaker-wireless-remote-patient-monitor-for-continuous-non-invasive-blood-pressure-cnibp-and-heart-rate-monitoring-using-patented-finger-cuff-technology/
https://www.businesswire.com/news/home/20160217005577/en/Masimo-Announces-FDA-510-Clearance-Root®-Noninvasive
http://www.massdevice.com/iphone-and-ipad-blood-pressure-app-wins-fda-clearance-massdevice-medtech-monday/

just because there are non-510k cleared devices doesnt mean that they *shouldn't* be 510k cleared.
and non-invasive devices are even more highly tested, and rightfully so, as they need to be proven effective, accurate & non-harmful on the general population.

bigmushroom

zoetmb said:

sandor said:

macxpress said:

sandor said:

NY1822 said:

I'll place my bets on Apple vs "Industry Experts"...

you obviously don't work in the medical world & have to deal with the FDA processes.

I doubt work in that field either...You don't know anymore than they do. 

almost 20 years now, on the clinical side, not the vendor side, but i work closely with the development processes of dozens of medical devices.
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.

Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval, especially over the next few years as the current administration attempts to deregulate everything.  How would it be any different than a blood pressure gauge?  I don't think my gauge is FDA approved.   And unless there's a way to measure blood glucose via saliva, I don't see how it could ever be non-invasive anyway.  Of course there probably would be a way for a device to track the results from urine test strips, but it's the strip that's already doing all the work.  Unless they expect us to urinate on our phones or watches. 

I didn't know until now that Jobs also had diabetes.   It certainly wasn't a weight issue and from what we supposedly know about Jobs, he probably didn't eat processed foods with high sugar and fat content, although I think there was some anecdote about him demanding an ice-cream soda in a restaurant that didn't ordinarily serve them.  

My guess is that the surgery he had to treat pancreatic cancer also damaged his ability to produce insulin. Surely it wasn't type 2 diabetes.

I am not sure that a non-invasive medical device exempts it from FDA approval. Approval is based on intended use and risk among other things:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

Clearly, a badly functioning glucose reader is risky for the patient. So I'd expect that the FDA would ensure that the accuracy of the device is high enough to be roughly equivalent to the older method (which is inconvenient but not dangerous and quite precise).

lkalliance

Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval, especially over the next few years as the current administration attempts to deregulate everything.  How would it be any different than a blood pressure gauge?  I don't think my gauge is FDA approved.   And unless there's a way to measure blood glucose via saliva, I don't see how it could ever be non-invasive anyway.  Of course there probably would be a way for a device to track the results from urine test strips, but it's the strip that's already doing all the work.  Unless they expect us to urinate on our phones or watches. 

It has to do with indications for use. Although a patient might use a reading from a blood pressure monitor to make personal healthcare decisions, he would more likely take that data to his doctor, I would think. A diabetic makes immediate decisions based on the readings from his meter.

From what I understand, potential non-invasive glucose measurement involves shining light through the skin and watching how that light gets diffracted. Therein lies a big challenge: glucose molecules are very basic things, and light reflected off one doesn't have a distinctive look to it. It could have bounced off of anything, not just glucose. Perhaps they find a way to measure some secondary substance. I don't know if it's still the case, but Continuous Glucose Monitors don't test your blood but rather the interstitial fluid between cells, which has a strong correlation. Strong, but not strong enough to use the data for insulin dosing: you need to actually test your blood for that. A non-invasive CGM would be really good...a non-invasive blood tester that I could use to set a dosage would be AWESOME.

sandor

lkalliance said:

Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval, especially over the next few years as the current administration attempts to deregulate everything.  How would it be any different than a blood pressure gauge?  I don't think my gauge is FDA approved.   And unless there's a way to measure blood glucose via saliva, I don't see how it could ever be non-invasive anyway.  Of course there probably would be a way for a device to track the results from urine test strips, but it's the strip that's already doing all the work.  Unless they expect us to urinate on our phones or watches. 

It has to do with indications for use. Although a patient might use a reading from a blood pressure monitor to make personal healthcare decisions, he would more likely take that data to his doctor, I would think. A diabetic makes immediate decisions based on the readings from his meter.

From what I understand, potential non-invasive glucose measurement involves shining light through the skin and watching how that light gets diffracted. Therein lies a big challenge: glucose molecules are very basic things, and light reflected off one doesn't have a distinctive look to it. It could have bounced off of anything, not just glucose. Perhaps they find a way to measure some secondary substance. I don't know if it's still the case, but Continuous Glucose Monitors don't test your blood but rather the interstitial fluid between cells, which has a strong correlation. Strong, but not strong enough to use the data for insulin dosing: you need to actually test your blood for that. A non-invasive CGM would be really good...a non-invasive blood tester that I could use to set a dosage would be AWESOME.

The good thing is that NIRS (near-infrared spectroscopy) has been around for many decades, and has benefited from digitization of detectors in the '90s and onward.
This has led to a shrinking of the medical devices both in size & price thus leading to a greater number of applicable scenarios including oxy/de-oxy blood levels, glucose & material differentiation.

https://www.ncbi.nlm.nih.gov/pubmed/?term=near-infrared+spectroscopy

avon b7

It is very difficult to do but I'm sure a way will be found. The sooner the better of course for Type 1 diabetes. Google is trying to do the same through contact lenses I believe.

tallest skil

The thing about something like this is it has to be perfect. I mean, fucking PERFECT. The fact that it would be used outside a controlled medical context means that it has to be even more accurate. This isn’t “the number of cell reception bars isn’t being reported correctly”, and it isn’t “the phone is slower because the battery is dying”. This is “get it right or you could have a death that people point to you about.”

Never mind that you know the media will be screaming “FAULTY APPLE WATCH CAUSES DIABETIC COMA” simply because the guy who went into a coma was wearing one at the time. And by the time it’s discovered that he ate an entire box of Krispy Kremes and that the Apple Watch was working perfectly, the PR damage will have been done.

seanismorris

roake said:

A non-invasive glucose meter built into the watch would be awesome, and would significantly drive up sales.  The following year, Samsung would have some flavor of implementation of the same thing, probably inaccurate, but they could list it as a feature.

Nope.  As the other poster has said.  It’s a medical device requiring FDA approval that normally takes years.

If it’s inaccurate, there is no way it’s getting approved.  Most people without diabetes don’t realize monitoring blood glucose is a life and death thing...

It wouldn’t surprise me if building and getting approved a non-invasive meter takes another decade.  

If this wasn’t Jobs legacy, Apple probably would have already abandoned the effort.  It would be amazing if it worked, but it wouldn’t surprise me if the effort ends up costing 10 billion plus.  They are better partnering (investing) with someone like Dexcom with Apple’s contribution being HealthKit.

Samsung doesn’t have anything to worry about for now.  They are probably smart staying out of it.  It’s not quite a pipe dream, but it’s close.

lkalliance

tallest skil said:

The thing about something like this is it has to be perfect. I mean, fucking PERFECT. The fact that it would be used outside a controlled medical context means that it has to be even more accurate. This isn’t “the number of cell reception bars isn’t being reported correctly”, and it isn’t “the phone is slower because the battery is dying”. This is “get it right or you could have a death that people point to you about.”

Never mind that you know the media will be screaming “FAULTY APPLE WATCH CAUSES DIABETIC COMA” simply because the guy who went into a coma was wearing one at the time. And by the time it’s discovered that he ate an entire box of Krispy Kremes and that the Apple Watch was working perfectly, the PR damage will have been done.

Welllllll...the bar for "perfect" isn't infinitely high. Current home-use blood glucose monitors aren't perfect, either: there's some level of reliability they have to reach regularly when compared to lab equipment. I don't remember what that figure is, but I remember it surprised me when I heard it. Within 20% either way, perhaps?

But there is some use even if it's not right on with lab equipment: if it can be validated to be off by a consistent amount, then at least you can get a reliable reading on whether your blood sugar is going up or down over the course of the day, and make adjustments to your daily insulin regimen. This is the value in CGMs currently.

MplsP

Noninvasive glucose monitoring is something *many* people have been working on for quite some time. Anyone expecting Apple to be able to waltz in and invent a revolutionary device and have it on the market in short order is not familiar with either the physiology and technology of blood glucose monitoring or the details or medical device regulations.

lkalliance

MplsP said:

Noninvasive glucose monitoring is something *many* people have been working on for quite some time. Anyone expecting Apple to be able to waltz in and invent a revolutionary device and have it on the market in short order is not familiar with either the physiology and technology of blood glucose monitoring or the details or medical device regulations.

lol, cue Ed Colligan: “We’ve learned and struggled for a few years here figuring out how to make a decent phone,” he said. “PC guys are not going to just figure this out. They’re not going to just walk in.”

But seriously, you're right, the scientific hurdles are formidable. But at least it's nice that tech companies as large as Apple and Google, with considerable resources, are trying to clear those hurdles. Gives us something about which to dream! 

sflocal

seanismorris said:

Samsung doesn’t have anything to worry about for now.  They are probably smart staying out of it.  It’s not quite a pipe dream, but it’s close.

Of course Samsung has nothing to worry about.  Samsung will do what it always does.  Samsung will wait for Apple to spend hundreds of millions (if not billions) of dollars on the next great thing, then take it apart and copy it.  Apple is Samsung's free R&D department.  Samsung will then make billions in stolen tech and spend a decade stalling in court and pay pennies as the tech has become outdated by then.

just watch.  They have conference rooms full of thieves just waiting for Apple’s next thing.

maciekskontakt

Yes. Now preganancy test please as well just because those electronic devices are communicators that need some extra features. Let the wisdom prevail.