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Is there a way you can make the same product and market it as a non-medical device?

For example, Nonin and Masimo make pulse oximeters that they sell to the public without a prescription, and they sell those exact same models with a prescription, as well. It depends on how they market it, I think.

Apple could say something like, "It's for monitoring carbohydrate transport in healthy individuals," so that they don't indicate it's for monitoring a particular disease.
I won't begin to claim expertise in marketing medical devices, as it's not my speciality. That said, it's my understanding that a company probably could market health-related tech in a way that seems non-specific (e.g., your example seems correct). I don't Apple choosing this route, as they had to get regulatory approval for just the HR tech in the current Watches.
 
Add a caloric intake sensor that alerts the wearer: "It's time to stop eating."

Stop diabetes before it begins.

Try again. Many diabetics (even Type 2's) are not overweight and there are lots of people who don't realize they're diabetic because they think that's not something they need to worry about because they're in good shape.
 
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100 years ago, when your kid got T1 Diabetes, you might as well start planning their funeral, then Banting and Best discovered insulin.
45 years ago, when I got T1D, it was "you're going to die before you reach 30" It was Regular and NPH for me.
Blood sugar tests were too expensive for home use. I did the Clinitest, with the fizzy tablets and urine.
Then, came the BG strips.
Then came the BG meters.
Then came Novolog.
Then came insulin pumps that were affordable.
Then came CGM, which you couldn't dose by, but everyone that is diabetic did. (BTW, my Cgm is usually 1-3 mg/dl from the fingerstick reading)
Then came CGM, which you can "legally" dose by.
Now, Dexcom is working on a CGM that has to be calibrated every 1-2 weeks (don't have the exact number)

My vision for this is to have the sensor not penetrate the skin, like the Dexcom/Minimed/others, but be on the surface. You calibrate it, until the technology becomes so that you don't have to.

I guess it comes down to hope, which is the most magical and irrational of things. It sees the good in the bad, and the promise of better things to come. It drives our minds to be creative and not see things how they are, but how they should be. Our minds are even more incredible. In the last 6000 years, we have come from the caves with life expectancies of 20-30 years to seeing people that are 100 as not that uncommon.

Thank you, sir! Your last paragraph reminded me of the old Apple Think Different commercial "Here's to the crazy ones..." Apple may fail at this effort, but I hope they succeed. The thing is that even if they fail, there is value in the knowledge gained through the effort. When I hear people talk about how crazy, impossible, and/or futile this effort is, I think of all of things we have that were previously considered impossible.

BTW, my 17 year old son is Type 1. He was diagnosed two years ago, and I hope his life will be improved by this kind of technology. When I hear about people like yourself who have persevered through a variety of complex and difficult treatment options, I am more grateful to those willing to pursue better options. Hang in there, sir! And thanks for being an example to people like me and my son.
 
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"Many health-related sensors that Apple wanted to include in the original Apple Watch were reportedly dropped because the technology was not consistently accurate"

Health related sensors are supposed to be the unique feature of the watch. Viewing your messages or your calendar might be a convenience, but don't really warrant buying it for most people. This is the reason the watch hasn't been "the new iPhone" in terms of sales.


"Apple CEO Tim Cook has since said that Apple does not want to put the Apple Watch through the FDA approval process, something that would need to happen for more advanced healthcare features, so it is not clear if this is a feature Apple foresees being added to the wrist-worn device."

SMH.
 
"Many health-related sensors that Apple wanted to include in the original Apple Watch were reportedly dropped because the technology was not consistently accurate"

Health related sensors are supposed to be the unique feature of the watch. Viewing your messages or your calendar might be a convenience, but don't really warrant buying it for most people. This is the reason the watch hasn't been "the new iPhone" in terms of sales.


"Apple CEO Tim Cook has since said that Apple does not want to put the Apple Watch through the FDA approval process, something that would need to happen for more advanced healthcare features, so it is not clear if this is a feature Apple foresees being added to the wrist-worn device."

SMH.
....An entire industry in the biomedical field has been racing to miniaturize this technology and get it reliable enough to get to market. What Cook said several years ago that your quoting is related to the initial launch of the Apple Watch. Anyone that's been keeping an eye on wearables and the medical device industry knows these two are headed for a massive collision.

I don't get how your out of context and irrelevant quotes are worthy of shaking your head....
 
Not only good for diabetics but really good for healthy people who could check their blood sugar to prevent insulin resistance.
Yes, being healthy myself, my first thought was wondering if access to this information could be useful to understand how my body responds to different foods. I'm not sure if there's really any benefit or not, but perhaps
 
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You mis-spelled "fitness". If people in general were more aware of how what they *ate* affected their blood sugar levels, and insulin response - we might be able to reduce the obesity epidemic, and increase the general health of the population.
Oh, most definitely!

I have yet to convince my wife to wear the CGM ( I have a spare transmitter and receiver) to show her how what she eats affects her.

Besides, I want to see how the muggles do it, so i can learn how to manage my diabetes better.
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Yes, being healthy myself, my first thought was wondering if access to this information could be useful to understand how my body responds to different foods. I'm not sure if there's really any benefit or not, but perhaps
Yeah, the science of glycemic index is pretty new.

I know, if I eat a bowl of steel cut oats, my blood sugar will rise, and stay about 40-50 mg/dl higher than if I didn't eat. However, start throwing other things in there, like a piece of cheese, or an egg, or a piece of fruit, then the BG readings get more unpredictable. I wish it was as easy as X+Y=BG, but body types, activities, emotions, and illnesses play a factor as well.
 
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Yeah, the science of glycemic index is pretty new.

I know, if I eat a bowl of steel cut oats, my blood sugar will rise, and stay about 40-50 mg/dl higher than if I didn't eat. However, start throwing other things in there, like a piece of cheese, or an egg, or a piece of fruit, then the BG readings get more unpredictable. I wish it was as easy as X+Y=BG, but body types, activities, emotions, and illnesses play a factor as well.

I could definitely see myself overanalyzing my BG readings to an unhealthy level and just getting frustrated because it's not clear cut. But perhaps if it just passively collected that data in the background and then notified me if anything appeared to be a concern or if there was a particular trend or good/bad period of time...
 
I could definitely see myself overanalyzing my BG readings to an unhealthy level and just getting frustrated because it's not clear cut. But perhaps if it just passively collected that data in the background and then notified me if anything appeared to be a concern or if there was a particular trend or good/bad period of time...
Unfortunately, I'm an engineer, so that kind of stuff is an ever-learning process.

Luckily, my wife understands my condition, and she is coping. I'm speaking of being an engineer, of course...
 
This would also be a boon for people with non-diabetic hypoglycemia. Set an alarm for when blood sugar drops below 70, so the user has a few minutes to eat something before the crash gets so bad that the brain fog prevents the user from being able to help themselves.
 
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Oh yes... and 1/2" stack of papers, and an 11 page letter to OKC.

It only took 11 months to get, from original appointment to issuance.

But I am grateful to those that reviewed my application and saw that I was able to control my diabetes.

Yikes. I went Light Sport a few years back. I don't have any chronic conditions but was told I'd be in SI hell for a long time after a major surgery. I understand the process is actually easier to get through now than it was ten years ago or so, and of course we have the big changes to the 3rd class requirements coming up.
 
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I could definitely see myself overanalyzing my BG readings to an unhealthy level and just getting frustrated because it's not clear cut. But perhaps if it just passively collected that data in the background and then notified me if anything appeared to be a concern or if there was a particular trend or good/bad period of time...

I agree. I'm a very mild Type II and rather devoted follower of the glycemic index method of keeping my BG in line. Even if a non-invasive sensor is just moderately accurate, I'd find it helpful just to spot trends. I'm probably what you'd consider as someone with an excessive concern about numbers and stabbing yourself a dozen or more times a day gets old (and expensive). Even if they can only get it within 20% accuracy, it'll probably allow me to cut down on the number of pokes I give to myself to a few a day.
 
Sign me up!

(Type 1 Diabetic for 45 years)
(And before you go there, I was 3 when I got it. T1D is when your pancreas stops producing insulin)
(Oh yeah, I have a Class 3 Medical from the FAA too...)
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or Dexcom... as well as Tandem Diabetic Care...
Same here. Dexcom is my go to for now, and really the only thing keeping me in the Apple ecosystem (no android app). If this comes to pass, I'll definitely never be going anywhere in the foreseeable future. If Apple can utilize something such as a sensor on the watch that I purchase one time to use for many years, that will save a ton of money over current CGM costs.
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I wish this type of information didn't get leaked. Samsung and Microsoft are now going to rush crappy imitations to market and say they did it first.
Won't matter. If they don't work well, it will be widely known. Being someone who's tried Medtronic's CGM system, I can tell you all CGM are not equal. Also, the FDA would never allow a product to control someone's medication to be released into the market without rigorous testing.
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There is no "dexcom insulin pump", though there is at least one that will show the value from a dexcom sensor on the screen. The dexcom g5 sensor (the current one) is being used on all of the automated insulin pumps that are being trialed except the medtronic one. I had a medtronic one before and it was always off and a lot of sensors had to be tossed because inserting them made me bled. I've been happy with dexcom, I've been using them through 3 generations of their products.

The current dexcom g5 works on its own, sending the blood sugar to your iPhone and then to your apple watch if you have one. It pairs to your phone via bluetooth. After you change the sensor you attach the transmitter to it and hit a button in the app, after 2 hours it asks you to calibrate it with 2 blood sugars. After that it needs to be calibrated twice per day. The sensor needs to be replaced every 7 days though they can be restarted. Lots of people have luck going 2-3 weeks with the same one but I haven't gotten more than 10 days out of one before it went wonky.

Their software can generate reports which also suggest some patterns that need adjustment. I would never go back to syringes but it would work just fine without a pump. Insurance companies don't like to cover it but medicare just approved coverage of it and usually the insurance companies will follow medicare's lead.
That medtronic sensor is trash. Team Dexcom for sure.
 
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Non invasive? You need the actual blood to get accurate blood measurement.
Really?? Needed a specimen of blood to determine oxygen saturation in the years past. Then Pulse Oximetry came along, shining a light non-invasively through a finger! And inexpensive.
 
I wonder whatever happened to Google's contact lens based non-invasive teardrop glucose sensor from 2014?

google-contact-glucose.jpg

I know they got a patent in 2015, and that it was undergoing testing, but haven't heard anything lately.

(It's possible that tears don't reflect the body's glucose level accurately enough.)
 
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More sensors in the watch like ones that measure glucose are definitely something I want. I'm not afflicted by diabetes but I know how something like that would be life changing to those that are.
Well I don't have diabetes, but I'm totally interested since I try to stick to a low carb diet and this feature would be useful.
 
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I wonder whatever happened to Google's contact lens based non-invasive teardrop glucose sensor from 2014?

View attachment 696028

I know they got a patent in 2015, and that it was undergoing testing, but haven't heard anything lately.

(Detractors say that tears don't reflect the body's glucose level accurately enough.)
My guess is the roadmap for it to be commercially viable (after getting the testing done and the hardware accurate enough, which takes years) is still quite a ways out there.

Also, as someone who wears contacts occasionally, I can't imagine grandma being able to stick something in her eye to be able to monitor her sugar levels.
 
Coming up on 28 years for me in June, diagnosed when I was 12. I would LOVE LOVE LOVE this technology. How it can be approved sans FDA is a mystery to me, but let's go!
Type 2, 30 years in, this would be great. I will guess they would put this device in the watchband, thus the band can go through the FDA while the watch needs not - plus I can add it to my current watch. Win win!
 
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Yikes. I went Light Sport a few years back. I don't have any chronic conditions but was told I'd be in SI hell for a long time after a major surgery. I understand the process is actually easier to get through now than it was ten years ago or so, and of course we have the big changes to the 3rd class requirements coming up.
Yeah, my mistake was going to an AME, think that it would be "easy". I should have done an AME consultation first, collected the info, then gone in for my medical after that.
 
Sigh...

I'm an Anaesthesiologist/Anaesthetist. I cannot see any way that blood glucose can be measured directly and accurately in a non-invasive way. Not physically possible and you sure as hell aren't going to detect glucose with 'light' in vivo.

Pulse oximeters measure the differential absorption of two wavelengths of light through the pulsatile component of blood to determine the haemoglobin saturation (which doesn't tell you the full story about actual oxygen carrying capacity - ie. you might be anaemic). To properly check 'blood oxygen levels' you absolutely, positively need a blood sample.

The sensor on the Apple Watch simply measures the pulse by the varying absorption of light with each pulse (green or infra-read) and it's far from perfect. Are we going to suggest that we can base clinical decisions (or patient's can manage their insulin regime) with a non-medical-grade device? I don't think so...

Even if it were possible it's one thing to collect the data, and another thing entirely working out what to do with it all. For diabetics it's useful. For the rest of the population it's a complete waste of time. You don't need to constantly measure your blood glucose levels during the day.

All this just reeks of techno-narcissism with a good dollop of the Dunning-Kruger Effect helping drive it.

Check out SugarBEAT. Apparently they are making progress in that field. Sad to see someone that is obviously smart (you) rejecting scientific advancement out of hand because it doesn't fit what you know. If all scientists, inventors, engineers etc. thought like you, we'd still be riding horses to work and lighting our houses with fire.

As a parent of a child T1D, I'd love to see SugarBEAT get approval in the US. She hates doing site changes for her Dexcom, but that device is the only reason my wife and I can sleep at night.
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Better...

Add a caloric intake sensor that alerts the wearer: "It's time to stop eating."

Stop diabetes before it begins.
Only T2D. T1D is caused by an immune system malfunction. Similar malfunctions cause thyroid problems and Celiacs disease. They now routinely test for all three one a child presents with one.
 
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Sigh...
All this just reeks of techno-narcissism with a good dollop of the Dunning-Kruger Effect helping drive it.

i know for a fact that apple have hired practicing endocrinologists to work on this problem. the non-invasive thing might be incorrect but the dexcom g5 and the freestyle libre are not super invasive. you can't even feel them going in and at least the libre can be self-installed. the dexcom is a little harder and usually requires a 2nd person to help you put it on. if apple did their own sensor in this style it would be great - both the dexcom g4 and libre don't integrate super well with mobile devices.
[doublepost=1492106379][/doublepost]by the way i wore both a dexcom g4 and a freestyle libre simultaneously and the feedback was immensely helpful. i lost 2 pounds in a week when i realized eating bread was raising my BG for prolonged periods, and stopped eating it. its true that obsessing on the exact numbers is bad, but knowing the trends is super useful
 
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If this is anything like the heart rate monitor in the Apple Watch... I'll pass.

It would probably report incorrect numbers 95% of the time when exercising causing me to die.
 
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