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Report Claims iWatch Awaiting FDA Approval, Will Feature Blood Glucose and Sweat Sensors
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But you're not ruling it out
Nope, of course. :roll eyes: It will be difficult but if the product is good and useful why not.
Neigh, sweat/sweat and perspire/perspiration essentially mean the same thing whether a horse or human. The only usage difference is that perspire/perspiration tend to be more formal.
The reason those devices didn't catch on is they were $150 pedometers.
Fuelband's metrics are actually arbitrary, not based on anything quantifiable.
True health tracking in a watch form factor will have value. Something that can not only count steps, but tell when you're moving in place, over a distance, up stairs, or on a bike. Something that can track your pulse without you putting your fingertip on a camera. Add this to cell notifications and a customizable, stylish watch face, and you'll have a product with appeal.
I read rumors about this watch every day, but I still feel I have no clue what it will be... Doesnt matter though, Ill probably buy it, simply because it will be shiny and made by apple.
I live with type 1 and I agree! I currently have the Dexcom G4 along with my Animas PING insulin pump.
I would be interested on how it would test my glucose? my Dexcom is 24/7 monitoring but with a nice bulge in my pants.
It would be surprising if Apple submitted to any deep approval by the FDA. That might require a code review and testing of iOS itself.
If there is a glucose sensor on the watch itself, it would most likely not be directly readable, but merged with some other info for a general condition report.
The last thing Apple would want to do is open themselves up to lawsuits. That's why the iOS 7 terms of use say this:
OTOH, I think Apple could do something like encourage an outside company to make a dedicated set of FDA approved sensors that interface with the Apple smartwatch.
All IMHO, of course.
If there is a glucose sensor on the watch itself, it would most likely not be directly readable, but merged with some other info for a general condition report.
The last thing Apple would want to do is open themselves up to lawsuits. That's why the iOS 7 terms of use say this:
OTOH, I think Apple could do something like encourage an outside company to make a dedicated set of FDA approved sensors that interface with the Apple smartwatch.
All IMHO, of course.
I have a Medtronic system but I only use it for wirelessly monitoring my b/g's. I test 10-15x/day and take insulin based on time of day/meal/physical activity. I found the pump too difficult as I weight lift/swim/etc and my days are constantly sporadic (like a normal persons day). I've read many articles throughout the years on infrared devices, etc. yet they never came to market. Either didn't work well/weren't consistent (although b/g meters have always had an inconsistent range, come +/-40) or got "buried" as pharm companies would lose billions on test strips (why do you think they practically give their monitors away? hook em into your system and one more lifetime customer, and strips ain't cheap).
This could seriously change everything (though I'm certain traditional b/g testing will be needed to "calibrate" the device daily, it'll be a lot less and much more accurate for 24/7 reads).
Love the whole iWatch concept and can't wait to see what it turns out to actually be... but as a professional in the medical device world I have to say that the 'blood glucose' part of this is BS. It may be able to take a number (manually or automatically) from an approved device but it will not be sampling blood glucose itself. At present the gold standard for that is an invasive test (whole blood) and a proprietary strip... non-invasive BG is the holy grail at present and we're not there yet as a consumer product - if it was you would be buying it from Roche, Bayer, Abbott etc... not Apple.
Add to that that I've not noticed Apple become 13485 approved yet and they are not going to be designing and manufacturing a Class II medical device (perhaps working with the data one produces but that's all - for now)...
Did anyone notice if they acquired a BGM company anytime recently?
The FUTURE however looks really interesting!
Add to that that I've not noticed Apple become 13485 approved yet and they are not going to be designing and manufacturing a Class II medical device (perhaps working with the data one produces but that's all - for now)...
Did anyone notice if they acquired a BGM company anytime recently?
The FUTURE however looks really interesting!
Love the whole iWatch concept and can't wait to see what it turns out to actually be... but as a professional in the medical device world I have to say that the 'blood glucose' part of this is BS. It may be able to take a number (manually or automatically) from an approved device but it will not be sampling blood glucose itself. At present the gold standard for that is an invasive test (whole blood) and a proprietary strip... non-invasive BG is the holy grail at present and we're not there yet as a consumer product - if it was you would be buying it from Roche, Bayer, Abbott etc... not Apple.
Add to that that I've not noticed Apple become 13485 approved yet and they are not going to be designing and manufacturing a Class II medical device (perhaps working with the data one produces but that's all - for now)...
Did anyone notice if they acquired a BGM company anytime recently?
The FUTURE however looks really interesting!
A proprietary strip. Who would ever want to get rid of that gold mine. I mean if you were making and selling them..
I have no idea of the tech involved or if it will ever be possible, but hopeful someone does, Apple whoever.
Yes, and this is done by clearly communicating the product's features and benefits.
There have been studies out there that used sweat to monitor glucose. Other studies out there uses sweat as an indicator of low glucose. Whatever the application is it can be made possible by aapl, a company that has over 8 billion in cash. Keep in mind that most of these studies were from limited university funds and research centers that do not have $8B to toss around.
Correlation between sweat glucose and blood glucose in subjects with diabetes.
Authors
Moyer J, Wilson D, Finkelshtein I, Wong B, Potts R.
Journal
Diabetes Technol Ther. 2012 May;14(5):398-402. doi: 10.1089/dia.2011.0262. Epub 2012 Feb 29.
Correlation between sweat glucose and blood glucose in subjects with diabetes.
Authors
Moyer J, Wilson D, Finkelshtein I, Wong B, Potts R.
Journal
Diabetes Technol Ther. 2012 May;14(5):398-402. doi: 10.1089/dia.2011.0262. Epub 2012 Feb 29.
yea, my Dexcom sensor is off at times, by a lot. I calibrate it twice a day and at times I feel it's wrong. I don't mind the pump and to me, it's better than shooting up 5+ times a day. easy to correct bolus if my first one didn't quite do the job for what I ate. I've had mine since 2009 (diagnosed in 2008) so it's pretty normal now. It's annoying at times that I have it but got used to it. I'm waiting for the new Animas VIBE to replace my Dexcom receiver (one less device to carry).
Yep, it's working at lab level for sure, but sensitivity and specificity in general public use scenarios are not there yet.... yet...
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Oh it (Non Invasive BGM) will come... I'm sure of that... but everyone from Medtronic to start-ups have been working on it for years... it's a work in progress not a commercially mature tech... yet.
Doesnt have to be. There is no onus for Apple to ONLY make the next big thing.
As long as its done right, can be a cool successful product.
In the U.S. ordinary people sweat and uppity people perspire.
Honestly, no U.S. dictionary I've ever looked at or vocab test I've ever taken has limited sweat to non-human beings. Maybe it's one of those quirky U.K.-U.S. english things where one word means something different on either side of the Atlantic like Lift:Elevator.
More than likely it integrates with a cgm and allows you to input readings, carb counts, etc.
I said sensitive; not gay. Plenty of straight sensitive men out there that have feminine traits but still love women and tight blue jeans with small pockets. Just saying that the majority of guys don't care about health especially after getting married or after their prime. Its only when problems pop up do we start to take action. Don't see people buying this watch for the health benefits unless they want to get fit or that their so unhealthy that they need to start monitoring this crap anyway.
I know plenty of women that are fat but then want to lose weight after a divorce. It's only human to slip into a comfort zone.
If it receives FDA approval as a medical device it might not be covered by insurance, but it would be tax deductible as a medical expense.
Spot on. Why do you think so many medical device companies buy out patents for non-invasive systems and let them sit? Not unlike another industry we know (cough*auto*cough*cough)
Just wait until the iWatch is widespread and doctors' offices become like Macrumors Forums.
"My heart rate drops slightly when I am resting but increases when I walk around. Do I need a heart transplant?"
"My blood pressure is really high at 120/80. Is this normal?"
"I sweat more when it's 95 degrees outside. Please help!"
"My heart rate drops slightly when I am resting but increases when I walk around. Do I need a heart transplant?"
"My blood pressure is really high at 120/80. Is this normal?"
"I sweat more when it's 95 degrees outside. Please help!"
Disagree completely. There just hasn't been the correct device to justify the need. A 24/7 device that measure the correct things will come along and make it worthwhile. Fitbit is a glorified pedometer.
There has been huge demand for a sleek wearable that constantly measures HR, blood oxygen levels, activity, etc.