Sorry to be off-topic on the glucose monitoring front, but the back plate of my Watch (the one with the sensors) has started to fall off! Essentially, it sticks to the charger magnet when I slide it off in the mornings. I can (sort of) stick it back in, but the Watch stays locked all the time.
Anyone else having this issue!?
Is the battery swelling, this pushes out the front (or back ). If so, Apple has something about that.
If Apple is able to bring a glucose monitoring solution to market now, then that is great and would really catapult Apple Watch into the health market.
The bigger part, if true, is bringing smart bands to market with this AW version 3. I think this is the most important feature they could add to really take Apple Watch to the next level and leave competitors in their dust. Its platform capabilities expand immensely. Just offering a battery band would enable functionality like always on watch face, power for cellular, sleep tracking without compromise, extended GPS use, week-long use, etc. The potential becomes clear then to the broader populace, as well as the market. Smart bands could have dedicated uses, or possibly multiple sensors per band.
Such smart bands would only work with a gen 3 & future versions of Apple Watch. A new interface (contact only) is needed for the exchange of data and power. I am thinking a more compact version of the Smart Connector on the iPad Pro.
Sorry to be off-topic on the glucose monitoring front, but the back plate of my Watch (the one with the sensors) has started to fall off! Essentially, it sticks to the charger magnet when I slide it off in the mornings. I can (sort of) stick it back in, but the Watch stays locked all the time.
Anyone else having this issue!?
I recommend taking it in to an Apple Store for repair
Good luck. The face of my wife's AW came loose. Took it to the Apple Store and they just offered to repair it for something like $150 (and suggested we just try gluing it).
Sorry to be off-topic on the glucose monitoring front, but the back plate of my Watch (the one with the sensors) has started to fall off! Essentially, it sticks to the charger magnet when I slide it off in the mornings. I can (sort of) stick it back in, but the Watch stays locked all the time.
Anyone else having this issue!?
It happened to me, with my ss series one. Had no issues at all for 10 months, even with regular showering and yoga classes. But then one day the screen got a bit of water damage, and a couple weeks later the sensors poped off, possibly due in part to the battery swell issue. Apple replaced it.
Then I bricked it by swimming in the ocean one time. Apple didn't replace it that time lol.
I've been recklessly using my Nike series two since launch, with no issues.
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
In order for the watch to have any diagnostic or health related function, it will probably need FDA approval (or similar in overseas markets), but if they sell it just as a guide, and claim it has no diagnostic value, then they may not need approval, provided it's not invasive in any way.
I don't think Apple are interested in having it just as a guide. I think they want to claim it as a diagnostic tool, and have the data accessed in HealthKit for proper medical purposes, and so I expect they will put it through FDA approval. There's also the risk that, if they market it just as a guide the FDA will decide it is a diagnostic tool, or that it might easily be mistaken for one, and insist on approval anyway. So, from Apple's point of view, probably best to get approval straight off.
Some other companies, however, would probably chance their arm to bypass FDA approval. And might even get away with it.
Why does it need to be a medical, diagnostic tool? They don't claim that for the heart rate monitor; nor can they -- because it is simply not accurate enough.
If Apple is able to bring a glucose monitoring solution to market now, then that is great and would really catapult Apple Watch into the health market.
The bigger part, if true, is bringing smart bands to market with this AW version 3. I think this is the most important feature they could add to really take Apple Watch to the next level and leave competitors in their dust. Its platform capabilities expand immensely. Just offering a battery band would enable functionality like always on watch face, power for cellular, sleep tracking without compromise, extended GPS use, week-long use, etc. The potential becomes clear then to the broader populace, as well as the market. Smart bands could have dedicated uses, or possibly multiple sensors per band.
Such smart bands would only work with a gen 3 & future versions of Apple Watch. A new interface (contact only) is needed for the exchange of data and power. I am thinking a more compact version of the Smart Connector on the iPad Pro.
Even the original watch may already have that connector. Look under your band. A connector is already there. The question is: will it serve the purpose?
If Apple is able to bring a glucose monitoring solution to market now, then that is great and would really catapult Apple Watch into the health market.
The bigger part, if true, is bringing smart bands to market with this AW version 3. I think this is the most important feature they could add to really take Apple Watch to the next level and leave competitors in their dust. Its platform capabilities expand immensely. Just offering a battery band would enable functionality like always on watch face, power for cellular, sleep tracking without compromise, extended GPS use, week-long use, etc. The potential becomes clear then to the broader populace, as well as the market. Smart bands could have dedicated uses, or possibly multiple sensors per band.
Such smart bands would only work with a gen 3 & future versions of Apple Watch. A new interface (contact only) is needed for the exchange of data and power. I am thinking a more compact version of the Smart Connector on the iPad Pro.
Even the original watch may already have that connector. Look under your band. A connector is already there. The question is: will it serve the purpose?
IMO, no. That is a diagnostic "port", which would be extremely difficult to utilize with easily swapping bands. A new interface would be needed is my view.
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
90% accuracy may be good enough for mapping trends, which is perhaps what people will be using it for. I imagine most medical monitoring needs to be provably accurate in order for people to make dosing decisions against the results.
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
90% accuracy may be good enough for mapping trends, which is perhaps what people will be using it for. I imagine most medical monitoring needs to be provably accurate in order for people to make dosing decisions against the results.
Do you need absolute accuracy really? You need to be close enough to make a proper quick decision, say 5%. There is enough variance due to when people decide to sample their blood sugar that just getting a continuous read on it may well be worth much more than having an absolutely precise reading. Not monitoring properly because of inconvenience (which I see A LOT) is a lot worse than getting a slightly off reading. That's the thing people often miss about these things.
By the time you actually get your precise sample, you may already be in the danger zone and put yourself at risk. I know a lot of people with diabetes that are terrible at getting readings themselves and so they manage their conditions very poorly, damaging their organs, fainting, etc. My grandmother was like that and died from a heart attack (she had at least 10 previously... and died at 80 but hey, she was built like a tank).
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
90% accuracy may be good enough for mapping trends, which is perhaps what people will be using it for. I imagine most medical monitoring needs to be provably accurate in order for people to make dosing decisions against the results.
Do you need absolute accuracy really? You need to be close enough to make a proper quick decision, say 5%. There is enough variance due to when people decide to sample their blood sugar that just getting a continuous read on it may well be worth much more than having an absolutely precise reading. Not monitoring properly because of inconvenience (which I see A LOT) is a lot worse than getting a slightly off reading. That's the thing people often miss about these things.
By the time you actually get your precise sample, you may already be in the danger zone and put yourself at risk. I know a lot of people with diabetes that are terrible at getting readings themselves and so they manage their conditions very poorly, damaging their organs, fainting, etc. My grandmother was like that and died from a heart attack (she had at least 10 previously... and died at 80 but hey, she was built like a tank).
Those are all reasonable points. But, in the world of medicine, reason has no value. Instead, physicians want perfect assurance that their prescription is correct and, more importantly, medical device makers influence the approval process by making near perfect accuracy a requirement. And, they all profit from that obsession with accuracy.
A good example is blood pressure: even though it is well established that home monitoring is far better than that done in the physician's office, few physicians will accept their patient's readings if they conflict with their own.
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
90% accuracy may be good enough for mapping trends, which is perhaps what people will be using it for. I imagine most medical monitoring needs to be provably accurate in order for people to make dosing decisions against the results.
Do you need absolute accuracy really? You need to be close enough to make a proper quick decision, say 5%. There is enough variance due to when people decide to sample their blood sugar that just getting a continuous read on it may well be worth much more than having an absolutely precise reading. Not monitoring properly because of inconvenience (which I see A LOT) is a lot worse than getting a slightly off reading. That's the thing people often miss about these things.
By the time you actually get your precise sample, you may already be in the danger zone and put yourself at risk. I know a lot of people with diabetes that are terrible at getting readings themselves and so they manage their conditions very poorly, damaging their organs, fainting, etc. My grandmother was like that and died from a heart attack (she had at least 10 previously... and died at 80 but hey, she was built like a tank).
Those are all reasonable points. But, in the world of medicine, reason has no value. Instead, physicians want perfect assurance that their prescription is correct and, more importantly, medical device makers influence the approval process by making near perfect accuracy a requirement. And, they all profit from that obsession with accuracy.
A good example is blood pressure: even though it is well established that home monitoring is far better than that done in the physician's office, few physicians will accept their patient's readings if they conflict with their own.
Mine did, after I monitored it at home and found it to be much lower/normal. He didn't believe the device was accurate until I tried it in front of him in the office, and it was elevated again. Apparently, that's called "white coat hypertension" to which his advice was to "avoid doctors".
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
90% accuracy may be good enough for mapping trends, which is perhaps what people will be using it for. I imagine most medical monitoring needs to be provably accurate in order for people to make dosing decisions against the results.
Do you need absolute accuracy really? You need to be close enough to make a proper quick decision, say 5%. There is enough variance due to when people decide to sample their blood sugar that just getting a continuous read on it may well be worth much more than having an absolutely precise reading. Not monitoring properly because of inconvenience (which I see A LOT) is a lot worse than getting a slightly off reading. That's the thing people often miss about these things.
By the time you actually get your precise sample, you may already be in the danger zone and put yourself at risk. I know a lot of people with diabetes that are terrible at getting readings themselves and so they manage their conditions very poorly, damaging their organs, fainting, etc. My grandmother was like that and died from a heart attack (she had at least 10 previously... and died at 80 but hey, she was built like a tank).
If this thing is to be of any use to diabetics, then yes, you need the accuracy. If it's kinda so-so, it gives a general idea of when something is amiss - which every diabetic is attuned to anyway. If you still need a medical sensor or the finger prick to get accuracy, the Watch is pointless. Lack of accuracy can kill you when it comes to insulin.
No way Apple could do this without FDA approval could they?
Supplements do not need FDA approval as long as they are not marketed as medicinals.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
90% accuracy may be good enough for mapping trends, which is perhaps what people will be using it for. I imagine most medical monitoring needs to be provably accurate in order for people to make dosing decisions against the results.
Do you need absolute accuracy really? You need to be close enough to make a proper quick decision, say 5%. There is enough variance due to when people decide to sample their blood sugar that just getting a continuous read on it may well be worth much more than having an absolutely precise reading. Not monitoring properly because of inconvenience (which I see A LOT) is a lot worse than getting a slightly off reading. That's the thing people often miss about these things.
By the time you actually get your precise sample, you may already be in the danger zone and put yourself at risk. I know a lot of people with diabetes that are terrible at getting readings themselves and so they manage their conditions very poorly, damaging their organs, fainting, etc. My grandmother was like that and died from a heart attack (she had at least 10 previously... and died at 80 but hey, she was built like a tank).
Those are all reasonable points. But, in the world of medicine, reason has no value. Instead, physicians want perfect assurance that their prescription is correct and, more importantly, medical device makers influence the approval process by making near perfect accuracy a requirement. And, they all profit from that obsession with accuracy.
A good example is blood pressure: even though it is well established that home monitoring is far better than that done in the physician's office, few physicians will accept their patient's readings if they conflict with their own.
I think any calibrated home use device with reasonable accuracy is very helpful for pattern awareness. A change in readings (everything else being more or less the same) should be enough to prompt the user to visit a doctor.
Accuracy will improve over time.
Error margins will always exist. I have the same spot check glucose meter as they use in my local hospital and readings will also vary in the results of lab based tests.
The problem for non medical grade measuring equipment is the difference between the ones that work consistently we'll and the ones that are very erratic. That's why many often try to get approval from different associations in the hope that they can plunk a 'recommended by ...' on the box and distinguish themselves from the pack.
In medical grade equipment that isn't an issue as it already has certification to warrant professional use.
Comments
The bigger part, if true, is bringing smart bands to market with this AW version 3. I think this is the most important feature they could add to really take Apple Watch to the next level and leave competitors in their dust. Its platform capabilities expand immensely. Just offering a battery band would enable functionality like always on watch face, power for cellular, sleep tracking without compromise, extended GPS use, week-long use, etc. The potential becomes clear then to the broader populace, as well as the market. Smart bands could have dedicated uses, or possibly multiple sensors per band.
Such smart bands would only work with a gen 3 & future versions of Apple Watch. A new interface (contact only) is needed for the exchange of data and power. I am thinking a more compact version of the Smart Connector on the iPad Pro.
Then I bricked it by swimming in the ocean one time. Apple didn't replace it that time lol.
I've been recklessly using my Nike series two since launch, with no issues.
Likewise, Apple could market this not as a medical device for diabetics but as a way for athletes to monitor their blood glucose levels -- which, for endurance athletes running ultra marathons, marathons and even half marathons is of critical importance. The runner's body burns its glucose stores as fuel and, when those stores run low the runner (or cyclist) "bonks" or even loses consciousness or at least the ability to think clearly (because the brain is being deprived of its own fuel).
Knowing and planning how and when to refuel is critical to the success of the long distance endurance athlete. A way to monitor glucose levels would greatly aid that effort.
(Likewise, real time monitoring of oxygen levels could help as well).
The difference is: are these "medical devices" or simply an aid for athletes? The accuracy bar for medical devices is far higher.
Another example is heart rate: a study done by the Cleveland Clinic showed that the Apple Watch was the most accurate wrist based heart rate monitor at 90% correctness. A medical device requires far more accuracy.
By the time you actually get your precise sample, you may already be in the danger zone and put yourself at risk. I know a lot of people with diabetes that are terrible at getting readings themselves and so they manage their conditions very poorly, damaging their organs, fainting, etc. My grandmother was like that and died from a heart attack (she had at least 10 previously... and died at 80 but hey, she was built like a tank).
A good example is blood pressure: even though it is well established that home monitoring is far better than that done in the physician's office, few physicians will accept their patient's readings if they conflict with their own.
Accuracy will improve over time.
Error margins will always exist. I have the same spot check glucose meter as they use in my local hospital and readings will also vary in the results of lab based tests.
The problem for non medical grade measuring equipment is the difference between the ones that work consistently we'll and the ones that are very erratic. That's why many often try to get approval from different associations in the hope that they can plunk a 'recommended by ...' on the box and distinguish themselves from the pack.
In medical grade equipment that isn't an issue as it already has certification to warrant professional use.