Apple Watch Blood Glucose Team Gains New Lead

[msackey]

It's not just diabetes. Continuous blood glucose monitoring is way better than heart rate monitoring for physical training.

And, you shouldn't need FDA clearance for that, but I understand that allowing it might well tempt diabetics into using it when they shouldn't rely on it.

Are you familiar with FDA device regulations? Do you know if CGM devices could be considered general wellness devices, which are still FDA regulated but under enforcement discretion. I'd have to re-read this guidance with CGM in mind: https://www.fda.gov/regulatory-info...ents/general-wellness-policy-low-risk-devices

 

[5232152]

The level of innovation Apple has been lacking since Steve Jobs.

 

[jz0309]

I'll have to more carefully think through FDA device regulations but my first thought is that if the device is not intended to be used as a diagnostic device without the use of an approved separate device that would confirm the diagnosis, I wonder if the Watch (with glucose monitoring) could be considered a general health device which would then not need other FDA device classification control measures.

Also, unless this Watch is able to monitor glucose without an additional separate sensor that one has to wear elsewhere on your body, I too think this would be a separate product. Current CGM devices require you to wear a sensor, often on your upper arm and the sensor has to be changed after several days. With this kind of device, I do not see non-diabetics using a CGM regularly because having to wear a separate and somewhat bulky sensor that can be prone to falling off if you don't clean the skin and attach correctly is not a typical person's idea of convenient.

Type 1 diabetics depend on accurate blood glucose data for insulin intake. a "general" high or low doesn't do anything for them, it also does nothing for Type 2 diabetics, it might be useful for those with pre-diabetes though.
So for accurate CGM (continuous glucose measurement) it becomes a "life or death" medical device, thus high regulatory scrutiny.
The whole premise here is to not rely on intrusive sensors anymore, so sensor in the watch alone.

 

[jz0309]

Are you familiar with FDA device regulations? Do you know if CGM devices could be considered general wellness devices, which are still FDA regulated but under enforcement discretion. I'd have to re-read this guidance with CGM in mind: https://www.fda.gov/regulatory-info...ents/general-wellness-policy-low-risk-devices

today's CGM devices, eg Dexcom, are NOT general wellness devices. they are only available by prescription and Type 1 diabetics need accurate data for Insulin intake.

 

[Crowbot]

I'll have to more carefully think through FDA device regulations but my first thought is that if the device is not intended to be used as a diagnostic device without the use of an approved separate device that would confirm the diagnosis, I wonder if the Watch (with glucose monitoring) could be considered a general wellness device which would then not need other FDA device classification control measures.

Also, unless this Watch is able to monitor glucose without an additional separate sensor that one has to wear elsewhere on your body, I too think this would be a separate product. Current CGM devices require you to wear a sensor, often on your upper arm and the sensor has to be changed after several days. With this kind of device, I do not see non-diabetics using a CGM regularly because having to wear a separate and somewhat bulky sensor that can be prone to falling off if you don't clean the skin and attach correctly is not a typical person's idea of convenient.

My guess is that Apple is shooting for a spot device. It's more in line with what people are doing now with finger sticks. And it would consume much less power than a CGM.

 

[NoSoup4U]

On a watch, Fantastic. But it's a smash hit before it gets that small.

If they got the size of the glucose monitoring device down to the size of a watch, how many people would wear it *instead* of a watch?

Boatloads.

 

[CarpalMac]

Waaaaay back when they first launched the AW, and I was berating it as an expensive fashion item, with a limited lifespan once the battery dies, a colleague at work was quick to tell me that over time it would become a health device and how it was poised to be a serious game changer.

He specifically called out that he expected it to be able to read glucose levels, eventually.

It is taking a long time but if they do pull this off then just, wow.

 

[3xBoom]

I wish Apple hurried up with this thing, I’ve wanted to get one for my type 2 diabetic mum from the moment I heard about it years ago!

Why wait for Apple while Dexcom is already available and quite likely covered by your mom's insurance.

 

[TheLisnakFactor]

I'll have to more carefully think through FDA device regulations but my first thought is that if the device is not intended to be used as a diagnostic device without the use of an approved separate device that would confirm the diagnosis, I wonder if the Watch (with glucose monitoring) could be considered a general wellness device which would then not need other FDA device classification control measures.

Also, unless this Watch is able to monitor glucose without an additional separate sensor that one has to wear elsewhere on your body, I too think this would be a separate product. Current CGM devices require you to wear a sensor, often on your upper arm and the sensor has to be changed after several days. With this kind of device, I do not see non-diabetics using a CGM regularly because having to wear a separate and somewhat bulky sensor that can be prone to falling off if you don't clean the skin and attach correctly is not a typical person's idea of convenient.

All these devices also say to check with a finger prick in the event of a big drop or alert.

However this happens, this technology can potentially change the world as much as their iPhone did.

 

[TheLisnakFactor]

Why wait for Apple while Dexcom is already available and quite likely covered by your mom's insurance.

The biggest differentiator right now with apple is apple can do it through the skin. Everyone else requires a needle or implementation and something to stick on the skin.

As a diabetic, this doesn’t work for me because I’m allergic to adhesives. So I can’t have a sensor stuck on my skin because I break out. Wearing a watch would be a game changer.

 

[MrTemple]

If they pull this off, 99% of people do not understand what a game changer this is going to be and is prob. why Tim insists apple will be known as a health company by the end of his tenure.

Absolutely. And not just for people with illnesses!

It'll be a game-changer for fitness too.

I'm a healthy, fit individual who plays sports a TON. I'm highly attuned to my physical performance, especially with regard to reaction time (hockey goalie, and pickleball). It's taken me many years to continue to tune my nutrition loading and in-activity onboarding (especially for those 6h pickle sessions!).

Having a device on my wrist that with instant feedback for me to map my blood glucose to my performance will let me get 10x better approach almost overnight, not with years of secondary and tertiary sensation of how I think it is and may be affecting.

 

[DaveSanDiego]

There are two things that I think Apple could (should) do to shorten this timeline

1) they say they have a working model the size of an iPhone. So make IT a product, unless it needs to be "strapped" on

2) Create a system that uses sensors like the Dexcom and Libre do. An iphone can read them, why not the watch (or can it do THAT already)

 

[Blackstick]

Would be a game changer for diabetics everywhere.

 

[Kierkegaarden]

I imagine this feature will only be available on the largest Watch made. Maybe they produce a non-Ultra version that is about the same size as the Ultra without the ruggedness? Regardless, anything that would give a diabetic useful information regarding their condition would be major, major innovation. It sounds like they’ve been working on this for a number of years, no doubt filing a plethora of patents along the way. Interesting to see how some companies act when they have the utmost confidence in their future — Apple seems to be that sort of company.

 

[one more]

The Verge has a good article on this, highlighting most of the challenges that need to be overcome before this can become a reality:

If you’re diabetic, don’t wait for your smartwatch to replace your needles

Noninvasively monitoring blood glucose is a whole other ballpark.

www.theverge.com

 

[citysnaps]

The level of innovation Apple has been lacking since Steve Jobs.

Now that's a real knee-slapper!

 

[srknpower]

It will certainly be a game changer but I wonder how they will shrink it into a size of a watch. I think it will give results like wrist temperature. There will be a baseline amd we will see the trend of our blood glucose level. Also I believe there is high possibility Blood Pressure monitoring might come with Series X.

 

[Crowbot]

I imagine this feature will only be available on the largest Watch made. Maybe they produce a non-Ultra version that is about the same size as the Ultra without the ruggedness? Regardless, anything that would give a diabetic useful information regarding their condition would be major, major innovation. It sounds like they’ve been working on this for a number of years, no doubt filing a plethora of patents along the way. Interesting to see how some companies act when they have the utmost confidence in their future — Apple seems to be that sort of company.

If it is done optically, size shouldn't be a factor. Battery life will. Maybe Apple can figure out a way for the watch to "steal" power from other functions (compass, barometer, etc).

 

[Kierkegaarden]

There are two things that I think Apple could (should) do to shorten this timeline

1) they say they have a working model the size of an iPhone. So make IT a product, unless it needs to be "strapped" on

2) Create a system that uses sensors like the Dexcom and Libre do. An iphone can read them, why not the watch (or can it do THAT already)

Analysts are claiming all kinds of things, but this is the sort of product/feature that would only be worked on in their secret labs around the world — no way the analysts have any idea when this will be released. It could happen much sooner than most think.

 

[MrTemple]

Now this is one reason I would finally buy my first Apple Watch

I bought my wife one years ago, she loved it. I never thought I'd find any use for it.

She bought me one that Christmas. I was neither over- or under-whelmed. Didn't think I'd use it and love it the way she did immediately.

The thing about the Apple Watch is that it's the sneakiest bit of tech. I use the thing ALL THE TIME. But not in ways that I can describe in a way that makes it seem important even to me! 🤣

If I forgot it at home (ha, fat chance!), I'd go back for it. And I'm well past the beginner phase where closing the rings and getting achievements occupies any of my headspace.

It's just so damn useful. From Siri, to timers, to glanceable leave-the-phone-in-the-pocket moments (the weather, texts, my calendars), to navigation on the wrist (with subtly different taps for left and right as you're nearing your turn), to workouts. Holy heck the fun with workouts... And paying! I haven't had to pull anything out of my pocket to pay in YEARS. Oh man if I thought on it for an hour, I'd keep finding more and more things.

Edit: Oh wait, I just remembered the number of times I've been busy/dirty/hands-full and have been able to reply to a text or answer a phone call (using my nose to tap!) without a free hand...These are things that sound crazy, but are actually crazy convenient!

Edit 2: Oh and how can I forget the sleep tracking!! That's a feature I look at almost every morning. Holy smokes was my idea of how much sleep I was getting off of what I was really getting. And having that knowledge and history of the last few days of sleep (often deprivation) has really helped me tune and adjust activity for the physical/muscle stressors and aches until I force myself to get to bed and get under early for a couple nights.

Edit 3: How I could forget that it unlocks my mac, finds my phone where I left it in my house, warns me if I forget my phone/wallet/backpack somewhere!

All these things I go to my watch for instead of my phone. I *could* use my phone (edit: not for all of them!), but I just don't. 🤷‍♂️ It just nails that extreme convenience, such that using the phone for SO MANY things is just not a question. It's that seamless blend on the continuum of attention + interruption with Apple Watch > iPhone > Mac.

And I've seen this repeated when I got one for my sister. Then again when she got one for her husband who didn't want one.

It's just one of those surprisingly ineffable, 'when you know, you know' sort of things. 🤷‍♂️

 

[Crowbot]

It will certainly be a game changer but I wonder how they will shrink it into a size of a watch. I think it will give results like wrist temperature. There will be a baseline amd we will see the trend of our blood glucose level. Also I believe there is high possibility Blood Pressure monitoring might come with Series X.

Non-invasive BP is really difficult in extremities. And accuracy is an issue as the measurement device has to be at the same level as the heart. And movement is a major issue. NIBP requires constriction. And that requires power. I think I read that Apple may be working on a watch band with constrictive properties.

 

[macmac30]

I would love to know what interests Apple had, if any, with Rockley Photonics. Rockley had an investor slide deck that heavily suggested they were deep in bed with Apple (as well as many other tier 1 companies) on the development of their non-invasive blood glucose monitor solution. I believe they stated Apple had spent $75M investigating this with Rockley. Then Rockley went bankrupt and all my shares went "poof"...

 

[wilhoitm]

This plus the ability to measure blood pressure would be real innovations, not that silly double tap function already available in Accessibility.

The double tap is for their Apple Vision Pro Spatial Computing headset. Not using controllers is actually really innovative. Also the headset will use Machine Learning to detect other hand gestures but it will be good to use double tap with the Apple Watch when your hands are obstructed.

 

[scheinderrob]

this would be an incredible feature for the watch. a massive breakthrough.

 

[jimbobb24]

As a Type 1 this would be great. I've got FreeStyle Libre 3 CGM that syncs with my iPhone and its made my life so much easier. No more guessing what direction my BG is going, no finger sticks, or carrying around a tester, buying stripes, etc.

My brother has one of those. Type “1.5” likely autoimmune from a recent vaccine. Perfect health big time runner. Uses the data to eat perfect. Discipline I can only dream of.