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.
Replace "glucose monitoring device" with "Apple phone" and it is why I firmly believe that Apple is the only company with the means of making being able to "waltz in" and figure this out.
Sure, FDA regulations is an entirely new hurdle to deal with but I believe Apple investing so much into the health-care arena with the watch will one day get something like this going, or help assist with some unidentified 3rd-party medical device company to make it a reality.
The day this happens, it will be even bigger than the iPhone in many ways. I firmly believe this to be Apple's next "big thing".
I was diagnosed a few months ago with diabetes and it sucks, especially considering that I am in very good shape and always took care of myself. I have not had the need to get an Apple Watch, but I will be first in line if they ever get a non-invasive glucose monitor setup going. It will be the event heard around the world. The market possibilities of such a device is limitless.
GlucoTrack has been tested through official clinical trials, collecting thousands of data points from hundreds of diabetics, in order to improve the device and to achieve CE Mark approval. All trials have been conducted by a third party at Soroka University Medical Center (Beer-Sheba, Israel). According to the clinical trials, 97.3% of the readings of GlucoTrack, fall within the clinically acceptable zones (A+B zones in the Clarke Error Grid).
One hurdle mentioned in their FAQ is the monitor that clips onto your earlobe will need to be replaced every 6 months to ensure proper measurements. This will likely not be an option for Apple unless they use smart bands as an aftermarket purchase for glucose monitoring so you can replace them periodically.
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.
Yes. One of the great things about CGMs is the ability to detect problems while you sleep. Many people wake up by themselves before things get bad but over time your sensitivity drops and a CGM gives you peace of mind. A non-invasive CGM would be far cheaper in the long term and be a huge boost in the quality of life of anyone that needs regular glucose level checks.
Why would a non-invasive (and from the little biology I know, I don't see how it could be) device require FDA approval
FDA screening of drugs covers two things: Does the product do what it says it does, and does it have any scary side-effects like thalidomide.
For medical devices, the latter case isn't (as) important, but the former still counts. Since people are trusting their health and potentially their lives to some of these devices, the screening is still rigorous and time-consuming.
For this among other reasons, I think it's likely that we'll never actually see tech like this built into the watch, the last thing Apple needs is FDA clearance for every new generation of Apple Watch. Stuff like this will go into watch bands and accessories.
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.
In answer to your question people can die as a result of inaccurate blood sugar reading. Imagine taking an insulin injection for a reading of 300 when the real value is 80.
As an aside ive been working in the regulated world since 1984. Just about every FDA regulation has resulted from somethng bad happening in the past. It isnt wise to resist the regulation as liability is massive.
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.
Imagine taking an insulin injection for a reading of 300 when the real value is 80.
How many people have died or even developed Type II Diabetes because we don't have the technology to look for early warning signs? Does an Apple Watch have to be as good as a professional medical device for it to say "You may want to check this out"?
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.
Imagine taking an insulin injection for a reading of 300 when the real value is 80.
How many people have died or even developed Type II Diabetes because we don't have the technology to look for early warning signs? Does an Apple Watch have to be as good as a professional medical device for it to say "You may want to check this out"?
In short, yes.
If it was a no-name knock off brand, perhaps they could get away with skirting the laws with quasi-medical devices. A company like Apple, Google, Microsoft, IBM, Siemens, GE... they are huge players & need to follow the rules & set the bar.
There have been a few reports on the non-invasive diabetes testing technology that Apple has been working on. It’s currently in progress with a few companies actually - Sweat based testing. Perfect for the Apple Watch but no easy obviously.
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.
Diabetes can be either Type 1 which is a lack of insulin production by the pancreas or, Type 2 which is insulin resistance where the body can't use the insulin the pancreas produces. Type 2 is mostly caused by fat. Type 1 used to be called "childhood diabetes" where the beta cells of the pancreas get killed off in an auto-immune attack.
Steve had pancreatic cancer that spread to other systems. But it is likely that his pancreas was compromised by the cancer and he had Type 1.
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.
"Current home-use blood glucose monitors aren't perfect, either" That's not only true of home use monitors -- but those used in hospitals as well! The most accurate is done with a full blood draw and measured on equipment in the blood lab.
It seems that everybody is hyperfocusing on glucose monitors used by diabetics. And yes, that would have an obvious use.
But there is another very separate use nobody has mentioned: Endurance Sports. And that becomes more interesting when you remember that Apple is really targeting endurance athletes with their Apple Watch.
Specifically, endurance athletes (runners, cyclists, triathletes, etc...) need to closely control 3 things. In order of importance they are: 1) Hydration 2) Glucose levels 3) Electrolytes
If/when your body runs out of either of the first two -- which it can easily do after about an hour, it stops. Your body just stops -- or, at minimum, your performance is severely impacted.
Endurance athletes have known to self monitor thirst and to drink before they get thirsty, Glucose is a little trickier because it tends to impact the athlete without much warning. It even has a name: Bonking.
A way to monitor glucose levels while running would be a major feature for serious endurance athletes. ... And, the good news is it probably would not require FDA approval.
Comments
I was diagnosed a few months ago with diabetes and it sucks, especially considering that I am in very good shape and always took care of myself. I have not had the need to get an Apple Watch, but I will be first in line if they ever get a non-invasive glucose monitor setup going. It will be the event heard around the world. The market possibilities of such a device is limitless.
edit: GlucoTrack is currently on the market in several countries (but not the US).
From their FAQ:
One hurdle mentioned in their FAQ is the monitor that clips onto your earlobe will need to be replaced every 6 months to ensure proper measurements. This will likely not be an option for Apple unless they use smart bands as an aftermarket purchase for glucose monitoring so you can replace them periodically.
For medical devices, the latter case isn't (as) important, but the former still counts. Since people are trusting their health and potentially their lives to some of these devices, the screening is still rigorous and time-consuming.
For this among other reasons, I think it's likely that we'll never actually see tech like this built into the watch, the last thing Apple needs is FDA clearance for every new generation of Apple Watch. Stuff like this will go into watch bands and accessories.
As an aside ive been working in the regulated world since 1984. Just about every FDA regulation has resulted from somethng bad happening in the past. It isnt wise to resist the regulation as liability is massive.
In short, yes.
If it was a no-name knock off brand, perhaps they could get away with skirting the laws with quasi-medical devices. A company like Apple, Google, Microsoft, IBM, Siemens, GE... they are huge players & need to follow the rules & set the bar.
More info:
https://phys.org/news/2016-10-bioengineers-sweat-based-sensor-glucose.html
Steve had pancreatic cancer that spread to other systems. But it is likely that his pancreas was compromised by the cancer and he had Type 1.
That's not only true of home use monitors -- but those used in hospitals as well!
The most accurate is done with a full blood draw and measured on equipment in the blood lab.
But there is another very separate use nobody has mentioned: Endurance Sports. And that becomes more interesting when you remember that Apple is really targeting endurance athletes with their Apple Watch.
Specifically, endurance athletes (runners, cyclists, triathletes, etc...) need to closely control 3 things. In order of importance they are:
1) Hydration
2) Glucose levels
3) Electrolytes
If/when your body runs out of either of the first two -- which it can easily do after about an hour, it stops. Your body just stops -- or, at minimum, your performance is severely impacted.
Endurance athletes have known to self monitor thirst and to drink before they get thirsty, Glucose is a little trickier because it tends to impact the athlete without much warning. It even has a name: Bonking.
A way to monitor glucose levels while running would be a major feature for serious endurance athletes.
... And, the good news is it probably would not require FDA approval.