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How long until Apple Watch measures blood sugar and blood pressure?
- Thread starter Silly John Fatty
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Many years. The Apple Watch is clearly not a serious medical device although their marketing campaigns try to make consumers think otherwise.
I'll never forgive Apple for faking the FDA approval. That was quite a scam on their part. I hope the industry never forgets it.
I'm not sure. I thought we were playing a fantasy game in line with the "not a medical device" thing and I didn't want to feel left out.
In reality, no, Apple did not fake FDA approval, and the Watch is a real medical device with real health tools available. Some of those are here:
Healthcare
Apple creates healthcare technology that helps care teams work efficiently, connect with patients remotely and conduct medical research.
www.apple.com
I doubt the Watch by itself will ever monitor glucose and BP.
However, we may see something strapped to your upper arm that could measure glucose and then send the data to your Watch/iPhone.
These are just really hard measurements to make just optically from a small device like a Watch.
If your Watch does make a BP measurement it might be suggestive, not accurate. You might get a warning saying that your BP might be high so you should check it with a sphygmomanometer.
However, we may see something strapped to your upper arm that could measure glucose and then send the data to your Watch/iPhone.
These are just really hard measurements to make just optically from a small device like a Watch.
If your Watch does make a BP measurement it might be suggestive, not accurate. You might get a warning saying that your BP might be high so you should check it with a sphygmomanometer.
Wrist-worn non-invasive glucose sensors about the size of an Apple Watch exist now, and though it may not take long for the tech to be miniaturized further enough to fit in the Watch, it would need regulatory approval which can take years and that’s assuming Apple has similar tech already or is legally allowed to implement that tech at all.
The numerous variables of taking readings with light on a more casual device do make it more difficult to parse the data but the data can be better adjusted using other sensors and Apple is well positioned to add machine learning cores to a future Watch CPU to efficiently handle such extra processing, which is the main technical hurdle. Apple wouldn’t be able to guarantee that the feature could replace glucose meters for those who need it most but like heart rate and blood oxygen; the readings may be able to get close enough and Apple is best poised with their R&D and custom silicon to make it a reality.
As for blood pressure, not sure that’ll ever consistently, reliably happen without some sort of inflated band around the arm.
The numerous variables of taking readings with light on a more casual device do make it more difficult to parse the data but the data can be better adjusted using other sensors and Apple is well positioned to add machine learning cores to a future Watch CPU to efficiently handle such extra processing, which is the main technical hurdle. Apple wouldn’t be able to guarantee that the feature could replace glucose meters for those who need it most but like heart rate and blood oxygen; the readings may be able to get close enough and Apple is best poised with their R&D and custom silicon to make it a reality.
As for blood pressure, not sure that’ll ever consistently, reliably happen without some sort of inflated band around the arm.
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LOL, fortunately I can’t be fired if I’m wrong. I‘ve read some of the review papers about this technology and it just seems really hard. More likely they would put the tech in a separate box that wouldn’t burden the Watch. Maybe in the far future the tech could be made really small, but by then we may no longer be using the Apple Watch.
Glucose is only about 0.8 to 1.3 percent of blood. That means you have lots of interfering signals to deal with. It would be one thing to just detect glucose, but to quantify it with a noncontact technology is asking a lot.
I also hope those come soon, but it doesn't seem like they'll be included for awhile. I think blood glucose monitoring is closer than blood pressure, which I assume would require watch band involvement(?). But still awhile out and, like the ECG, unlikely to be as reliable or detailed as a test on dedicated medical equipment, just good enough for general monitoring purposes.
Apple will not seek FDA certification of the Apple Watch as a medical device because of the regulatory burden. You cannot have a medical device running user downloaded apps and other stuff with frequent updates. That means any possible blood glucose assessment will be retrospective and imprecise. Expect a 'you were in ideal range for 75% of the day' kind of insights appropriate for a type 2 diabetic. Apple cannot and will not give real time blood glucose continuous monitoring. I am a type 1 diabetic using a CGMS working in the tech/health field. Do not expect this.
It doesn’t have to be a CGMS replacement but if such a way to have simple, non-invasive access to blood glucose levels launches on a Watch, there will be tens if not hundreds of thousands of people discovering that they may be diabetic or pre-diabetic and it’ll change the world. Someone that doesn’t know they’re diabetic isn’t going to be seeking out blood glucose readings until things get noticeably bad. Totally worth it for that alone.
As for the other hurdles, Apple is in a better position than the rest of big tech with the handling of medical hardware and user data; even with third party apps on the device the user or apps are unable to modify the health sensor stack, all health data is actually encrypted (unlike other platforms where that’s turned out to be a lie), said health sensor stack is updated much less frequently likely due to regulatory approval, and the sharing of any health data requires explicit consent from the user. They’re still getting approval for ECG in other countries going on for years now, seems they’re okay with regulatory burden.
Oh, and if it does end up existing, they would no doubt play up the athlete angle as well. Glucose monitoring in those groups is growing ever more popular. Saving lives and somehow using it for even more granular fitness metrics? Fits into the reasoning of the Watch like a puzzle piece; almost too perfectly.
As for the other hurdles, Apple is in a better position than the rest of big tech with the handling of medical hardware and user data; even with third party apps on the device the user or apps are unable to modify the health sensor stack, all health data is actually encrypted (unlike other platforms where that’s turned out to be a lie), said health sensor stack is updated much less frequently likely due to regulatory approval, and the sharing of any health data requires explicit consent from the user. They’re still getting approval for ECG in other countries going on for years now, seems they’re okay with regulatory burden.
Oh, and if it does end up existing, they would no doubt play up the athlete angle as well. Glucose monitoring in those groups is growing ever more popular. Saving lives and somehow using it for even more granular fitness metrics? Fits into the reasoning of the Watch like a puzzle piece; almost too perfectly.
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Seems most likely at least 3+ years away and I suspect that when it comes out, it will be a derivative measurement and not an absolute measurement like the current “body temperature” measurement. This means you may be able to know whether you are having a peak/low of sugar/sudden higher pressure rather than telling you what is your current value. And then it might be only measuring when you are at rest like not moving at night, etc.. it will be very limited and very constrained.
There is nothing new coming to the apple wrist iPhone for the foreseeable future.
There is nothing new coming to the apple wrist iPhone for the foreseeable future.
I don’t recall that. What happened? Links to article?
I don’t think Apple Watch is cleared or approved as a medical device. It’s cleared as a fitness device. Different regulatory standards are applied to the device depending on what kind of use is being sought for FDA clearance or approval.
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I don’t think Apple Watch will for a very long time able to measure blood glucose or blood pressure.
The only watch-like device that I know of that measures blood pressure is from Omron and it requires the user to be still when measuring and is essentially an inflatable wrist cuff. Both are significant restrictions on the user or you could call them limitations. Blood pressure monitoring at the wrist is a lot more finicky and less reliable than measuring at the arm.
Glucose monitoring seems to be a whole other thing. I only know of invasive glucose monitoring devices. All require some kind of prick. Continuous glucose monitoring is not even measuring blood glucose. It’s measuring a proxy, interstitial bodily fluid which isn’t blood and there’s only one device on the market that is cleared as a diagnostic device that does not require an alternate device to confirm diagnosis.
I believe noninvasive glucose monitoring are in the works but currently all investigational.
The only watch-like device that I know of that measures blood pressure is from Omron and it requires the user to be still when measuring and is essentially an inflatable wrist cuff. Both are significant restrictions on the user or you could call them limitations. Blood pressure monitoring at the wrist is a lot more finicky and less reliable than measuring at the arm.
Glucose monitoring seems to be a whole other thing. I only know of invasive glucose monitoring devices. All require some kind of prick. Continuous glucose monitoring is not even measuring blood glucose. It’s measuring a proxy, interstitial bodily fluid which isn’t blood and there’s only one device on the market that is cleared as a diagnostic device that does not require an alternate device to confirm diagnosis.
I believe noninvasive glucose monitoring are in the works but currently all investigational.
The watch is very basic in regards to being a medical device though. My wife was having irregular heart rhythms and used the ECG feature to record certain episodes. She had to buy a dedicated ECG monitor as her consultant said the Apple watch simply wasn't accurate enough. The marketing Apple use does suggest otherwise, but in practice it is very different. Nice to have features though on a watch and I have been an AW wearer for more than 6 years now.I'm not sure. I thought we were playing a fantasy game in line with the "not a medical device" thing and I didn't want to feel left out.
In reality, no, Apple did not fake FDA approval, and the Watch is a real medical device with real health tools available. Some of those are here:
Healthcare
Apple creates healthcare technology that helps care teams work efficiently, connect with patients remotely and conduct medical research.www.apple.com
I think the recent advancements in A.I. will actually speed up the development of these AW features.
One part of this will be from the dev and r&d teams having a.i. assistance when creating the hardware and software algorithms.
Secondly, a.i. will to some extent be able to compensate for subpar hardware and correct bad readings to fit within something more reasonable
I think even WatchOS 11 or 12 will have a.i. assist with health sensor readings, hopefully without having to buy a new(er) Watch.
However, there's always the feasibility of all this:
Even with all this speculation and perhaps faster advancements, AW is still just as much about profit margins as any other Apple product:
It's not just about getting the tech to work and fit into the body of an AW.
Having it all come together into a product turns a profit is Apple's first priority.
One part of this will be from the dev and r&d teams having a.i. assistance when creating the hardware and software algorithms.
Secondly, a.i. will to some extent be able to compensate for subpar hardware and correct bad readings to fit within something more reasonable
I think even WatchOS 11 or 12 will have a.i. assist with health sensor readings, hopefully without having to buy a new(er) Watch.
However, there's always the feasibility of all this:
Even with all this speculation and perhaps faster advancements, AW is still just as much about profit margins as any other Apple product:
It's not just about getting the tech to work and fit into the body of an AW.
Having it all come together into a product turns a profit is Apple's first priority.
Could they partner with already existing medical under-the-skin implants that monitor blood sugar levels to transmit the data to the Watch? That would be helpful and Apple would not have to rely on any unreliable sensor on the Watch itself.
Really, which ones? FDA or otherwise medically approved and with a decent MARD score? Please tell us more!
Apple could hook up with Abbott or Dexcom, both are the leaders in the CGM field, but what would those two companies get from Apple?
It certainly is basic, it's no tricorder.
I wonder what incentives the consultant had, if any. I know healthcare is not monetized in the UK to the same extent as the US, for example, but it would not be unheard of for some upselling to go on. The AW EKG is only a 1 wire EKG, but compared to "real" EKGs in 1 wire mode it is relatively accurate, according to the studies I've seen. Certainly it does not have the same information as a 12 wire EKG.
It's a medical device, but a basic one. And it's from what I've read it's meant for for detection of deviations against the norm in healthy people. It's not meant for problem diagnosis or for use with people who already have heart conditions. The Watch actually stipulates that it's not meant for people who have been diagnosed with Afib, but it's accurate enough that people who found out that they have Afib via the AW and then had it diagnosed in a professional setting.