Rumors are Apple has made major progress on the holy grail for continuous glucose monitoring.
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3.00Disclaimer: This comment was automatically generated by gpt-manifold using gpt-4.
Based on the information available, there are both reasons to be optimistic and skeptical about Apple's chances of receiving FDA clearance for a no-prick blood glucose monitor by the end of 2024.
On the optimistic side, Apple is known for its innovation, and the company has a strong history of investing in health-oriented technologies. Additionally, the potential for continuous glucose monitoring without the need for skin pricks represents a significant improvement for people with diabetes or other conditions requiring frequent glucose level checks, making it an attractive area for investment and development.
On the skeptical side, medical device development and FDA clearance can be a lengthy and complex process. Given that the most recent data available for GPT-4 training is from September 2021, there may be information gaps that hinder accurate assessment of Apple's progress on this front. Additionally, existing non-invasive glucose monitoring technologies have struggled to achieve the same level of accuracy as invasive methods, which may pose challenges end for Apple's attempts.
Taking these factors into consideration, the current probability of 50.89% seems relatively appropriate. While Apple's track record lends some confidence to their ability to develop a no-prick glucose monitor, the potential complications and limited available information make it difficult to confidently predict their success.
Therefore, I would choose to from placing a bet on this market.
How are you defining “blood glucose monitor”? Because Apple isn’t building a blood glucose monitor; their monitor attempts to estimate blood glucose from interstitial fluid levels.
Another important thing to keep in mind is what kinds of applications Apple receives FDA clearance for. The holy trial would be something close to a continuous glucose monitor that could be used to dose insulin. However, a major limitation of non-invasive monitoring technologies like these are the difficulties in accurately estimating blood glucose during hypoglycemia. This means that it is unlikely to receive approval for use to manage dosing insulin, but could be useful for pre diabetics as they say in the article. Notice the article does not directly state that Apple has made any claims about benefits for those with diabetes.
I would say though that if Apple were to find a successful application, it almost certainly would need to be cleared by the FDA, and that process can take a long time depending on what Apple wants to market it for. I doubt glucose monitoring could go the “wellness” route like pulse ox but I don’t know for sure.
Here is a good article on FDA and Apple Watch: https://www.theverge.com/2020/10/7/21504023/apple-watch-ekg-blood-oxygen-fda-clearance
@MaggieDelano Fair points. Continuous glucose monitoring is what I had in mind. Do you think the type of tech described would require de Novo or breakthrough device clearance, or is there a good predicate to support prior equivalency? Apple's previous clearances weren't related to any specific use cases, I don't believe, which is why the watch tells you all the things it definitely won't do to save your life before you can use the newest health sensors continuously. Do you think this is the type of tech Tim Cook is thinking of when he says Apple's greatest impact with be in healthcare?
@BTE I was about to make a third comment but then held off and you asked so one other point.
If this tech is truly ground breaking, it would take even longer for approval, yes, since there would be no comparison device for a 510k approval. A 510k approval would be at least 6 months for reference.
i might be way off here but I think you’re overthinking it
Apple produce product that estimates blood glucose, without necessarily reading it how we expect them to (they’re still reading it, just differently). You could “monitor” salt levels in the ocean by watching how many birds are there, the method doesn’t really matter.
They can test that product against the existing methods of reading blood glucose, and compare the accuracy
If it’s accurate enough, FDA will approve, if it’s not, FDA will not approve
I don’t think there will be much else to it. Compare to existing tech, if it’s not as reliable/accurate, FDA will take a lot longer and press them for serious vocabulary restrictions (like you outline, not advertising to diabetics).
I’m betting that apple will manage to target the product to whatever group necessary to get it approved and push it to market, because that’s the best way to test & improve the product. Even if it’s extremely limited in marketing/sales, they’ll get approval somehow
@Gen First off, the market says “by the end of 2024” so it isn’t asking if they will eventually get something approved or not.
The rest of my comments are about what actually could reasonably be approved, which I wanted to raise because the market as written is vague and I also think people would find it interesting.
I also think you’re underestimating how difficult it is to get something to the point where it even makes sense to submit to the FDA. Apple has deep pockets but even they don’t have infinite money. I do agree that they will probably submit something watered down if they can, my point is to demonstrate how even a fairly low bar is challenging. And the article itself says it’s still the size of a phone and years away from any approvals.
@MaggieDelano Yeah I appreciate that, I do find it interesting! Mostly because I wouldn’t have considered that the method of measurement would impact the definition of what’s being monitored (but I understand, it could be interpreted as you have)
Apple has $50b in cash and another $150b in their investment firm. Of course they will need to keep a lot of this on the books as they expand into banking, but they are as close as any company could ever be to “infinite money”
I definitely could be off on the FDA timeline, but if it’s not invasive, and it is tested for accuracy, I can’t see why they wouldn’t approve at least a watered down version. There are loads of Apple Watch health tools packed with disclaimers, I expect this would just be another one.
It’ll be interesting to find out though, if the tool will have mass availability, I’m sure the benefits of that will outweigh the risks of decreased accuracy (for non-diabetics) like the ECG tool on the watch (“not for
I’ve put a small order at 50% if you want to fill it. I’m not as confident with my wallet as my words 😆🤣
@Gen I think the method matters because it places a bound on how accurate a measurement system can be. Apple is probably throwing a lot of circuitry and algorithms at a problem lots of other people have tried to solve, but if it’s the same method there’s a ceiling to that accuracy. The question is where that ceiling is. We almost certainly know it’s won’t work for type 1, but maybe it works out for other use cases. And then the question is will the tech be more than just a novelty /nice to have? Will it have real clinical utility? We have had continuous HR for years now and Afib detection, while very important, is it’s only clinical application. The rest is just wellness (basics like resting heart rate or zones during exercise). I used to be very deep into self-tracking stuff and I still work on wearables but I’m a bit of a skeptic about the hype :)
The data ceiling question is analogous to arguments in AI about whether or not scale is all we need for performance improvements. More garbage in -> more garbage out (at least in measurements).
@MaggieDelano Yeah, not discounting your perspective, I have no doubts that everything you’re saying comes from a place of industry knowledge and historical truths.
However, I believe in the apple machine to push whatever crazy shit to market they want to, and I think the FDA is not immune to apples unimaginable power
Either way good luck!!! Hope you’re wrong 🤣🥰