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Apple's Noninvasive Blood Glucose Technology for Future Apple Watch Reaches 'Proof-of Concept' Stage

The sensor technology is nearly there and as always Apple isn’t pioneering that push. Incorporating it into an AW shouldn’t take more than a year or two, but the big challenge will be getting it clinically validated and then the biggest hurdle of all, regulatory approved by the FDA and EMA.

This isn’t a gimmicky Sp02 pandemic marketing strategy, or even the halfway house FDA “endorsed” 1-lead ECG feature to detect/warn of AF. Neither of those solutions will suffice here.

No, this is one area where, as a doctor, I’d really want to see Apple partner with leading pharma players in this field (Abbott, Novo Nordisk etc) as a collaboration to bring the tech through much quicker for the benefit of patients.

Won’t happen under Tim Beancounter Cook though sadly.
 
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Don't get you hopes too high.The feature is intended for screen. Even if AW fails 50% of the times it still does a good job finding the other 50% prediabetics. Just like their heart monitoring features.

Unfortunately, I very much doubt they will be able to measure accurately enough at a given time point to adjust the given insulin dose, which over- or under dosed gives severe consequences. Some of those of with diabetics have highlighted this.
 
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Blood pressure is still not on iWatch. I don't think it will be on iWatch in the coming 5-8 years
 
After reading this I didn’t believe they would be able to fit this into the small chassis of Apple Watch. At least I am sure it is years away. Bu this will be the biggest change in the Apple Watch history. Maybe in the Apple history.
 
I hope it works well, my wife is T1 diabetic and is using finger sticks and a continual glucose monitor that has a needle under the skin. She's found those work better and she's been thru a lot of frustration with a different company's CGM. This tech has to be REALLY accurate and reliable. It's incredibly frustrating to get even on a finger stick different readings within minutes of each other. I will not be holding my breath for this to be a perfect solution, I feel it's still too far away to be reliable 99.9% of the time.
 
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Amazing. I have friends that need to test their blood multiple times a day. This would be so much more convenient and prevent damage to their organs that occurs when their blood sugar levels get out of control. And for the people in general it would be a way to easily monitor their blood and see if they're starting to develop diabetes and prevent years of damage. One can imagine the Watch becoming a health monitor in the near term. Bravo Apple.
 
Veinticinco said:
The sensor technology is nearly there and as always Apple isn’t pioneering that push. Incorporating it into an AW shouldn’t take more than a year or two, but the big challenge will be getting it clinically validated and then the biggest hurdle of all, regulatory approved by the FDA and EMA.

This isn’t a gimmicky Sp02 pandemic marketing strategy, or even the halfway house FDA “endorsed” 1-lead ECG feature to detect/warn of AF. Neither of those solutions will suffice here.

No, this is one area where, as a doctor, I’d really want to see Apple partner with leading pharma players in this field (Abbott, Novo Nordisk etc) as a collaboration to bring the tech through much quicker for the benefit of patients.

Won’t happen under Tim Beancounter Cook though sadly.
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I not sure they think they should partner with big pharma. As someone that worked for these companies they tend to work at a completely different pace. Also, the accounting and marketing departments often has a lot to say about which research moves forward.
 
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As most have said, WERE this to be possible on the Apple Watch directly, it would be quite revolutionary for the world that most of the west lives in today where many western countries have obesity rates that are over 40%. It’s crazy, not surprising but still crazy and represents one of the most impactful health cost crisies that these countries will experience. As for Type 1 Diabetes directly, this would be great, but the actual numbers of ppl with Type 1 are VERY small comparatively. This would be great for them, but in the US as an example the actual number of people who rely solely on insulin - and blood glucose measurement is less than .05% of the population.

I’ve consulted with several companies over the past 20 years that have been trying to develop some sort of transdermal capability to get accurate and reliable readings in this way - so NOT a direct blood reading - which in or itself is laggy - and it’s NEVER going to be the same reading, so there is always some type of heuristic interpretation and large size INDIVIDUAL dataset that needs to be built and used to inform future readings, etc. THAT is certainly something where apple and todays technology can be very influential and successful.

What I would somewhat RATHER see is Apple partnering with someone like Abbott or GluCo or another CGM monitor device (even MORE laggy than Blood Glucose, but close within about 15 min) company, leveraging what they have already developed for VERY SMALL, decent term (up to 14 days of on body use) sensors, but coming up with some local area, BTLE, NFC some type of very low power short range distribution (the wrist is “interesting” and close by!) and then develop the type of applications, monitors, alerts and INFORMED feedback through the watch and phone for the user.

We of course already HAVE small CGM monitors, and wireless updates - although not constant and real-time they are more often than not triggered by the individual, but being able to have more periodic frequent monitoring AUTOMATED for the user, enabled by better technology, power utilization, data analysis and user communications now THIS is where I think apple could still bring something CLOSE to revolutionary to the market while waiting for some type of transdermal capability to be more realistic and actually be IN the watch.
 
dtm84 said:
This isn't for type 1 diabetics. That would require medical device approval by FDA which Apple does not want.

This will not replace glucometers. That would require medical device approval by FDA which Apple does not want.

This is for retrospective analysis and identification of trends relating to prediabetes and type 2 diabetes time in range.

Think: Today your blood sugar was in range for 80% of the time!
Not: Right now your blood sugar is 5.6mmol
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I don't think Apple will be able to market a device that reads blood sugar WITHOUT obtaining FDA approval. As for Apple not wanting FDA clearance, I disagree with you because (a) Apple already has clearance for the ECG in the Apple Watch as an FDA-cleared Class II medical device and (b) the Bloomberg article specifically states that Apple is already working with FDA on the glucose sensing capability.
 
Picklefoot said:
Incredible that we’re at a point now where people love this idea because Western society is incapable of controlling their sugar intake.
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Some of us like it because our pancreases stopped working, not because we cannot control our sugar intake.
 
dtm84 said:
The FDA regulatory burden on medical devices is way too high for the Apple watch to provide any kind of real time information. It takes years of work to get approval for a medical device with many studies required. The Apple Watch or Phone cannot fundamentally be a medical device because there is no assurance that the other things they are doing will not impact the medical function. Medical devices tend to be low tech, with few functions, and very reliable. A watch that runs many different pieces of software, is refreshed every year, has access to the internet, and has a lot of user control is absolutely never going to be evaluated as such. It takes years for new Dexcom or Libre devices to just get clearance and approval to enter a new market - nevermind be refreshed or updated. And what insurances are going to offer reimbursements for Apple devices? None.

I am T1D and wouldn't use my Apple watch to action my insulin based on its blood sugar measurements. That's insane.

Apple isn't a medical device company. They are a health trends and insights company. There is a very specific difference here that is not clear to many laypeople. The latter is profits, the former is massive risk and liability. Apple nor its investors are interested.
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I think you have overlooked that the ECG on the Apple Watch is already an FDA-cleared, Class II medical device.
 
dampfnudel said:
He was a visionary. I wouldn’t be surprised if he looked at one of his cars one day and said to himself maybe Apple should sell cars. I’m not sure how good of an idea that would be, but I wouldn’t be surprised if it crossed his mind. However a watch that monitors your health is definitely a project I can see Steve getting actively involved with years ago.
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Oh he did want to build a car... it says it in the Walter Isaacson biography. That was always one of his dream projects.
 
This is the most exciting new thing for me by Apple in a while. This is a really big deal. Also just excited for the blood pressure.
 
The only true blood glucose reading is one via finger stick. Even the Freestyle Libre I use isn’t accurate as it doesn’t measure blood level.

Apple has a huge uphill battle if they want to join in with Dexcom and Freestyle in reading BG levels.
 
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