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FDA Warns Consumers Not to Use Smart Watches or Rings That Claim to Measure Blood Glucose Levels
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If, and when, it is available on your Apple Watch you:
1. Save money, assuming you have insurance co-pays.
2. If your Apple watch lasts 5 years that is $5K that insurance would not have to pay. When you have thousands of people saving that much then that gives your insurance options to cover more expensive drugs or drop their rates. Confess I don't know how the German system works though.
3. Avoid the inconvenience and minor infection risk of inserting it every couple of weeks
4. It would be right on your wrist. No need to pull out your phone to tap the sensor for a reading
Just a few advantages off the top of my head.
Not at all. It is an extremely difficult technical issue.
Supposedly they have been able to get it to work with lab sized equpment. The challenge is getting a room full of equipment into the watch. Suggested timeframe I've seen is 5 years.
Yes, and if there was a warp drive, we could all travel to Mars in no time at all, but there isn't one. So what?
Yes it would gorgeous if something like this would exist and it would be even better if research figures out how to use stemcells in the correct way. Also the google contactlenses that should have monitored you glucose level have been canceled.
Another point is that CGM how it is implemented, works everywhere and everytime. During sports, also swimming is possible. You don't have to stop, press your AW against you wrist for a minute. But even if this would be possible it would be a cheap alternatice.
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Elizabeth Holmes already has figured out how to do non-invasive CGM.
Glucose monitoring is completely different than blood pressure or heart rate monitoring.
Yes, that is where the problems show up. For me it is super accurate and differs by maybe 10mg most of the time (you have to take the 10-15 minute latency into account).
But everyone is different and has different results. That is why AW would have to solve a calibration puzzle that is even more complicated. So maybe if you could train you AW sensor for a month or a year, it could be correct at least somehow. And additionally you will have to follow a certain procedure to get accurate results - maybe not sufficient to control a closed loop system (CGM + insulin pump).
The other thing to note, Apple Watches are NOT medical devices. Apple warns users to always verify the information with a healthcare provider before taking necessary action against their health.
If I receive an alert that my heart rate is above /below normal, you better believe that I’m going to an urgent care then booking an appointment with my cardiologist.
They didn't ban the devices, so you can get them if you want them.
I'm not sure I trust the FDA anymore. Not saying they are wrong in this instance, but I would not just automatically assume they are right either. I wonder how many medical device manufacturers see this as a threat and using their government connections to eliminate it? The truth is, with the government "following the money" seems to be a worthy endeavor.
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See this is the problem with a lack of critical thinking in the population. The error can be both ways, so it is possible that you have "heart rate is above /below normal" and the watch or ring does NOT report it.
I mean, you should have ditched mechanical watches decades ago, they're obsolete and have been since the 1970s.
True, which is why you should always write down the symptoms that you are experiencing and constantly check in with your primary physician. No at-home device is a substitute for a professional
The FDA is a mess.
The mRNA COVID vaccines were developed in about a week once the virus was sequenced. It took nearly a year for the FDA to approve them, and that was considered extremely fast. But when an extremely profitable drug clearly doesn't work, as most of us knew all along about phenylephrine, it takes them many years to even admit it, and they still haven't pulled it off the market even though they know it's no more effective than placebo.
I don't know if Apple has a working blood glucose monitor ready for the watch yet. But with the pressure from the entrenched medical device manufacturers, once they do have it ready it'll take years for the FDA to approve it, and that means many unnecessary years of daily painful finger stabs for millions of people.
How long have you worked with the FDA? I gave my first product description to them in 1993. Ouch I am old LOL. But, did you read my whole text? Because I make it clear that I realize Apple hasn't gone for full approval with the HR and O2 sensors, and hence 'general trend' as you call it, but they DID communicate with the FDA prior, and they DID receive FDA 510(k) premarket clearance for that technology so I do know what Apple's regulatory game is.
And whether FDA mentioned in their release Apple by name or not (in this case, not), any comment they make in a field is a signal to the whole field. In particular, my field was elective surgery, but because a competitor of ours got into trauma, FDA made us ALL address trauma. This came out in any PRIVATE meetings we had, but subsequently in a written guideline that didn't name companies but did affect us all.
So two things, you better believe Apple is already in discussions with them regarding their regulatory strategy, and they are taking this announcement seriously. It impacts the whole field of glucose monitoring. Not just a few bad apples (ha, see what I did there?). This is exactly how the FDA sends signals.
See above. I disagree this has nothing to do with Apple. It will impact their future plans. Disagree if you will, but tell me how long have you worked with the FDA?
Do you have any idea how much that would cost for Americans (I'm assuming you're not, because who does that here)? Constantly checking in with a doctor would be insane unless you have absolutely amazing insurance.
Yeah, I'm just gonna take the alert as a reminder that I forgot to take my meds last night. No point in bothering a doctor about it.
I'm definitely not going to call my cardiologist, can't get that appointment for 6 months anyway, by which point I'll have already had the regular appointment. And I'm definitely not blowing $120 for urgent care to tell me I forgot to take my meds that I already knew I forgot, not from a single high heart rate alert.
FDA is underfunded. Maybe we can debate whether they are inefficient, but still they need more resources to do all of the things we ask of them. FDA asked for more money last year but Congress still has not approved the FY2024 budgets. So it is kind of a catch-22: we don't fund (or trust) them and at the same time complain that they don't do enough things right.
The FDA’s point seems to be that there is no non-invasive device yet that can safely be relied upon to even make that suggestion.
Please the FDA is so corrupt at this point. All they care about is ensuring the lobbyists stuffing their pockets get a cut of revenues for any such technology. Until an FDA preferred vendor offers up a solution they won’t back it and will try and scare everyone into not using it.
This isn’t medical advice but I would take what the FDA claims about safety with a grain of salt.
This isn’t medical advice but I would take what the FDA claims about safety with a grain of salt.