Apple's non-invasive glucose reader for Apple Watch may be 'years away'
Apple is still developing a non-invasive glucose reader, but the technology might not show up in an Apple Watch for several years, a report said this week.
The company is "continuing research," according to the New York Times, which cited two sources familiar with the project. Industry experts consulted by the paper however suggested that Apple -- and other companies -- are likely years away from a commercial product.
Apple's interest in the technology has been rumored for some time, and is said by Times sources to date back to co-founder Steve Jobs, who in the last months of his life approved a research project because he disliked pricking his finger for blood sugar testing. The CEO was coping with diabetes at the same time as his battle with cancer.
The company reportedly considered trying the feature in the first-generation Watch, which shipped in 2015, but it was one of several health technologies the company ditched because it was either unreliable or forced compromises in size or battery life.
In its current incarnation the Apple Watch shares many of the same health features as rival devices from Garmin, Polar, Samsung and others, namely step and stand tracking, calorie burn estimates, and continuous heart rate tracking. The company is rumored to be working on adding an EKG monitor, triggered by squeezing the frame of a Watch.
Both that and a glucose reader will probably require approval by the U.S. Food and Drug Administration, which -- though fast-tracking may be available -- could complicate any launch.
The company is "continuing research," according to the New York Times, which cited two sources familiar with the project. Industry experts consulted by the paper however suggested that Apple -- and other companies -- are likely years away from a commercial product.
Apple's interest in the technology has been rumored for some time, and is said by Times sources to date back to co-founder Steve Jobs, who in the last months of his life approved a research project because he disliked pricking his finger for blood sugar testing. The CEO was coping with diabetes at the same time as his battle with cancer.
The company reportedly considered trying the feature in the first-generation Watch, which shipped in 2015, but it was one of several health technologies the company ditched because it was either unreliable or forced compromises in size or battery life.
In its current incarnation the Apple Watch shares many of the same health features as rival devices from Garmin, Polar, Samsung and others, namely step and stand tracking, calorie burn estimates, and continuous heart rate tracking. The company is rumored to be working on adding an EKG monitor, triggered by squeezing the frame of a Watch.
Both that and a glucose reader will probably require approval by the U.S. Food and Drug Administration, which -- though fast-tracking may be available -- could complicate any launch.
Comments
I have had to write IRB protocols for non-approved devices & we have been a clinical site for FDA data gathering pre-approval as well.
we can wait 12-18 months for software algorithms to make their way through the FDA, hardware can be years in the testing & approval phases.
I didn't know until now that Jobs also had diabetes. It certainly wasn't a weight issue and from what we supposedly know about Jobs, he probably didn't eat processed foods with high sugar and fat content, although I think there was some anecdote about him demanding an ice-cream soda in a restaurant that didn't ordinarily serve them.
actually, like all devices - but especially rampant in the low cost, high consumer sales areas, there are non-FDA or CE cleared blood pressure cuffs & FDA & CE cleared ones.
http://www.clinical-innovation.com/topics/practice-management/fda-grants-510k-clearance-caretaker-medical’s-blood-pressure-and-heart-rate-monitor
https://www.accessdata.fda.gov/cdrh_docs/pdf8/K080319.pdf
https://510k.directory/clearances/K970139
http://www.caretakermedical.net/fda-approves-caretaker-wireless-remote-patient-monitor-for-continuous-non-invasive-blood-pressure-cnibp-and-heart-rate-monitoring-using-patented-finger-cuff-technology/
https://www.businesswire.com/news/home/20160217005577/en/Masimo-Announces-FDA-510-Clearance-Root®-Noninvasive
http://www.massdevice.com/iphone-and-ipad-blood-pressure-app-wins-fda-clearance-massdevice-medtech-monday/
just because there are non-510k cleared devices doesnt mean that they *shouldn't* be 510k cleared.
and non-invasive devices are even more highly tested, and rightfully so, as they need to be proven effective, accurate & non-harmful on the general population.
I am not sure that a non-invasive medical device exempts it from FDA approval. Approval is based on intended use and risk among other things:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
Clearly, a badly functioning glucose reader is risky for the patient. So I'd expect that the FDA would ensure that the accuracy of the device is high enough to be roughly equivalent to the older method (which is inconvenient but not dangerous and quite precise).
It has to do with indications for use. Although a patient might use a reading from a blood pressure monitor to make personal healthcare decisions, he would more likely take that data to his doctor, I would think. A diabetic makes immediate decisions based on the readings from his meter.
From what I understand, potential non-invasive glucose measurement involves shining light through the skin and watching how that light gets diffracted. Therein lies a big challenge: glucose molecules are very basic things, and light reflected off one doesn't have a distinctive look to it. It could have bounced off of anything, not just glucose. Perhaps they find a way to measure some secondary substance. I don't know if it's still the case, but Continuous Glucose Monitors don't test your blood but rather the interstitial fluid between cells, which has a strong correlation. Strong, but not strong enough to use the data for insulin dosing: you need to actually test your blood for that. A non-invasive CGM would be really good...a non-invasive blood tester that I could use to set a dosage would be AWESOME.
This has led to a shrinking of the medical devices both in size & price thus leading to a greater number of applicable scenarios including oxy/de-oxy blood levels, glucose & material differentiation.
https://www.ncbi.nlm.nih.gov/pubmed/?term=near-infrared+spectroscopy
Never mind that you know the media will be screaming “FAULTY APPLE WATCH CAUSES DIABETIC COMA” simply because the guy who went into a coma was wearing one at the time. And by the time it’s discovered that he ate an entire box of Krispy Kremes and that the Apple Watch was working perfectly, the PR damage will have been done.
If it’s inaccurate, there is no way it’s getting approved. Most people without diabetes don’t realize monitoring blood glucose is a life and death thing...
It wouldn’t surprise me if building and getting approved a non-invasive meter takes another decade.
If this wasn’t Jobs legacy, Apple probably would have already abandoned the effort. It would be amazing if it worked, but it wouldn’t surprise me if the effort ends up costing 10 billion plus. They are better partnering (investing) with someone like Dexcom with Apple’s contribution being HealthKit.
Samsung doesn’t have anything to worry about for now. They are probably smart staying out of it. It’s not quite a pipe dream, but it’s close.
But there is some use even if it's not right on with lab equipment: if it can be validated to be off by a consistent amount, then at least you can get a reliable reading on whether your blood sugar is going up or down over the course of the day, and make adjustments to your daily insulin regimen. This is the value in CGMs currently.
But seriously, you're right, the scientific hurdles are formidable. But at least it's nice that tech companies as large as Apple and Google, with considerable resources, are trying to clear those hurdles. Gives us something about which to dream!
just watch. They have conference rooms full of thieves just waiting for Apple’s next thing.