Noninvasive, with any sort of accuracy that can be used for anything, is most likely impossible.
So back to "invasive"... what can we do... embedding a device under your skin, right around where your watch goes, that can be powered and communicate with the watch. While also making sure the device is not rejected by the body and stays in place.. AND has no other adverse side-effects. I think this is where it'll ultimately end up for the people who want it. sub 10 min procedure to put it in and should last for quite some time (maybe dissolves after 5 years for upgrades?)
I'd get a tattoo, but I'm not interested in anything that has to be removed
Profit.
Well yes, but also substantial life saving interventions become possible.
We need significantly better power sources that are either have lots of energy capacity, xor some energy capacity and able to charge while inside the body.
Either version they need to be small enough that the procedure is cheap and the body doesn't reject the device. Additionally, anything like this would need to go through regulatory bodies for medical devices, and would not be approved for "healthy people" (i.e. significantly reduced adoption).
Roughly putting us back to non-invasive.
A can of worms.
But I do applaud the team for working on the technology nonetheless.
Biasing low would be the move if scared of risky downsides.
It’s not enough of a difference to be deadly, as the sibling comment suggests, and the clinician guidance is to always eat something if you are feeling hypo, and at or near that level.
The upshot is that I set my CGM-linked pump to target 1 mmol/L higher to compensate.
And the Libre3 is so much better than anything else I've tried before.
Another T1D here with 2 decades direct experience with Medtronic, Tandem, Dexcom, and Abbott. I'm an outlier, but that doesn't make this story less empirical. I've got many years of data to prove it and while I can't match real autonomy's millions-of-points-per-second firehose, I do have years of hundreds of point-per-day.
It's n-of-1 for sure, but one way of looking at that is just that there's a lot of latency on the data gathering, particularly in emerging stories in healthcare where the entire system is weaponized against the truth reaching wide audiences, but I digress. Back to the objective facts vs. the subjective reality.
I'd just like to confirm the findings here in that it's a wicked problem, just like T1D:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529400/
The fact that CGM or non-invasive requirements follow suit should be of little surprise to anyone.
It's challenging enough that I wore 2 CGM's concurrently over the past year: Dexcom G6 and Freestyle Libre 2. They both have poor data veracity, particularly at the times that I need them most - when fasting; that would be sleep, and exercise. Both critical periods for any diabetic. I should know because the former put my T1D brother-in-law in an early grave.
I realize that some people have great success with these devices and that's something we should celebrate. However, we should not celebrate the fact that there are legitimate lawsuits against these companies. I've been outspoken about the risks given my family history, exercise, and experience working in medical devices that have a history of injuring patients:
https://en.wikipedia.org/wiki/Therac-25#Problem_description
https://www.11alive.com/article/news/investigations/the-reve...
The amount of time that I spent on the phone with Dexcom support was excessive and frequently at all hours of the night since the problem would present with alarms that cannot be disabled and are able to disable do-not-disturb mode on the smart phone and sound like an alarm system from the Austin Powers series.
That leaves the patient with two choices: tolerance (which is unrealistic at 3 AM) and powering the phone completely off, which silences it while having the side effect that alarms can't save the patient from potentially life-threatening hypoglycemia given that alarms emanating from the Tandem t:slim X2 alone are not sufficiently intense to wake me.
Dexcom has responded to this crisis by following the letter of the law: since I first reported the problem, they have replaced 2-3 dozen sensors under warranty while following the typical corporate communication playbook of not admitting design flaws or any legal culpability while not admitting the rather serious problem of the fact that, when the G6 is used in concert with a hybrid closed loop system such as the Tandem t:slim X2, inaccurate sensor readings on the low side have the potential to underdose the patient, and inaccurate sensor readings on the high side have the potential to overdose the patient. This is because near-autonomous, near-realtime basal rate adjustment is responding to sensor measurement that can often be at odds with reality and not closely monitored at times like sleep and exercise.
This isn't just theory!
I've seen both of these scenarios play out while exercising and sleeping - two events that cannot be precluded, are frighteningly difficult to handle given failures in the aforementioned design of the alarm system, and no one at either Tandem or Dexcom seems to admit, document, or address which is distressing given that these are FDA-regulated devices in markets that aren't Therac 25 but have the potential to end badly in large populations.
I've tried to alleviate the problem by wearing two different CGM sensors concurrently. I wore an Abbott Freestyle Libre 2 from spring through fall 2022 in addition to my Dexcom G6 where I have little choice given the joint venture design chosen by Tandem. That has done little to alleviate the problem since both sensors tend to move in parallel showing the same inaccurate readings in fasted states around sleep and exercise.
Worse, the only evidence I've seen that anyone in the mobile software design side of equation understands the problem is xDrip and the various people working in OpenAPS:
https://scholar.google.com/citations?user=rt1_gOgAAAAJ&hl=en...
I don't believe they are getting the attention, credit, or remuneration they deserve.
I hope that the situation does not turn out like American insulin pricing, where the first person to perish not being able to afford insulin was documented several years ago:
https://www.snopes.com/fact-check/alex-smith-died-couldnt-af...
If we think social media needs regulated, I'm pretty sure what we call healthcare in the United States qualifies for better regulation than that given FDA's lack of oversight.
In contrast, the Libre3 transmits via Bluetooth, and does so once per minute, without me having to do anything else. The non-insurance retail cost is about $70 per sensor. With insurance, it can be much lower.
For me, the size difference is a real game changer. This thing is so much easier to wear and live with.
For me, the automatic update once per minute is also a real game changer. I don't need to tap the sensor with my phone to get a reading, I just open the app on my phone and the data is already there.
By all accounts, the Dexcom G7 is about the same size, and because Dexcom plays nicer with other devices, that's the way you want to go if you're trying to close the loop on the CGM plus automatic insulin dosing.
For now, I'm super happy to have the Libre3. The app needs some improvement, but this is already a World Series + Super Bowl winner.
https://www.wareable.com/wearable-tech/movano-ceo-on-its-rf-...
Movano plans to ship an Oura-style smart ring this year, but it won’t have the glucose monitor. (One might suspect the “moonshot” glucose RF chip story is meant to keep investors excited through the zero-revenue stage until hopefully the more ordinary smart ring takes off.)
A ring form factor is too aggressive and difficult of a target.
up until now there has been zero financial incentive for stakeholders to promote a method of blood glucose measurement which bypasses the need for consumables, and every incentive to prevent such a solution.
https://www.fiercebiotech.com/medtech/abbott-ceo-ford-unveil...
If we knew how to do this, but valid patents blocked the broader commercialization of it, then we would not be reading stories about breakthroughs in basic implementations. We’d be reading stories about how companies have products ready to go once the countdown timer hits zero.
That's not 100% true, at least for the US:
https://slate.com/technology/2018/05/the-thousands-of-secret...
So, pharma companies trying to obtain "non-invasive glucose monitoring" patents like crazy, to stop other companies from creating such things, because they want to keep selling pinpricks which rely on a consumable model.
Having said that, now that everyone's into "bullshit subscription models", perhaps the era of "bullshit consumables" may be coming to an end.
I've worked in this space for 5 years now, and this is not news to any of us. Today, a tiny, noninvasive device, that is accurate enough to make insulin dosing decisions, is pure science fiction. It's probably not impossible, but we'll literally be able to use stem cells to regrow human pancreases and straight-up cure people of diabetes before this tech becomes a reality. (We're much further along that path.)
What is interesting about this though is the possibility of using this device for non-diabetics who don't need extremely accurate glucose readings. A rough approximation of someone's blood glucose levels is enough to learn how your body reacts to different types of foods and exercise, and would be helpful for amateur athletes who can't afford to purchase real continuous glucose monitors, as well as pre-diabetics for whom CGMs aren't covered by insurance.
Could you give us an ELI5 of the basic principle of how it would work (or at least the direction being pursued), and what the main obstacle is, and why we think we'll be able to overcome it to some degree?
Besides athletes, I can't help but think it could be a huge step forwards for weight loss as well. I'm aware of the concept (for non-diabetics) of only eating once your blood sugar is below a certain level, and never eating so much that it goes over a certain higher level.
vs
"useful enough signal for general population / those at risk of type 2 diabetes / those with diabetes who don't require insulin treatment / etc" (much larger market for Apple w/ greatly reduced requirements)
And I didn't just check the bog standard 98% measurement but also tried to hold my breath etc.
On the contrary, the Apple Watch ECG is quite accurate, not quite enough to replace the system the doctor makes me wear, but enough that apple can get a general idea of any defects and tell you to go to the doctor. The "regular" hear rate sensor isn't anywhere near good enough to be taken seriously, but its leaps ahead my previous samsung.
I dream of the day where my Apple Watch can replace the myriad of annoying wires and sensors I have to wear to monitor myself. Even then, the Apple Watch has greatly helped me out when I've fallen and need assistance, and I've gifted several to my family just in case.
I'm using a $70 Amazfit right now but previously I had a Samsung, neither is very good.
https://en.wikipedia.org/wiki/Google_Contact_Lens
For something that has to be monitored very closely, nothing beats an actual blood sample. And to get a blood sample, it can't be non-invasive.
To be fair, the Verily folks did design the algorithm that predicts where your blood sugar will be in X minutes in Dexcom CGMs, which lives on. Dexcom now owns the patent.
> nothing beats an actual blood sample
Technically, interstitial fluid can get you pretty dang close, which is considered minimally invasive.
https://iopscience.iop.org/article/10.1088/2516-1091/abe6f8#...
Seems like spectroscopy seems particularly promising, and according to the article, that's the approach Apple is taking. (Makes sense for a watch.)
And from the paper, the challenges with spectroscopy are signal interference -- scattering, water absorption, and distinguishing between glucose and other sugar components. So it ultimately sounds like a fiendishly complex signal processing problem. Which is exactly the kind of problem that is very very hard yet maybe not impossible.
We - at DiaMonTech - working on a solution with mid-infrared spectroscopy and showed good accuracy in a published paper in the "Journal of Diabetes Science and Technology". We plan another clinical trial this year, but yes, this took some time. We started in 2015 and still have some work to do.
The reason it's your comment I'm replying to is because you indicate you actually worked in this field.
Whenever these discussions surrounding noninvasive monitoring of blood solute concentrations come up I keep wondering why anyone is surprised taking a hard route is hard, and why there seems little attention to seeking easier routes of noninvasive optical sensing.
Please do shoot my comment if it is nonsensical, so that I can stop caring next time I read such a discussion, but I would like a mechanistic explanation why the lips wouldn't be easier.
From an a priori perspective, it would certainly be desirable to have any type of noninvasive monitoring in the form factor of a watch. There is nothing wrong with dreams or hope. Yet to me it sounds like a dream was interpreted too literally: starting from some hypothetical dreamer exclaiming "imagine testing concentration X or Y, but noninvasively! sure wearing a device would may come with some inconveniences, but if the advantages outweigh the inconveniences, it would find a niche" and "after all people have been wearing watches too".
An idea that started as an analogy: just like a personal wearable watch had advantages compared to an immobile pendulum clock, perhaps we can devise the analogous personal wearable device that performs the duties of some large inconvenient measuring setup, workflow, discipline,....
I can't shake the feeling that the analogy has been taken too literally, as if the original dream insists the blood glucose meter has to be integrated into the watch and located on the same or similar place on the body...
Blood is red.
Lips are red.
The color of the lips is the color of the blood.
Acknowledging the inconvenience of mounting a device or perhaps an optical fiber to your lips, it may constitute a more tractable milestone.
What is the reason all the 'failed' startups avoid the lips and make life hard on themselves by choosing to do spectroscopy (in the widest sense: plain, Raman, ...) through the highly variable noisy medium of skin (different pigmentations by genetics, different pigmentations by varying exposure to sun within an identical individual, different states of skin like sweating, the intinsic noise incurred by imaging through a robustly thick layer of skin, scattering like mist, ...).
It almost looks like attempting an artificially troubling tour de fource, akin to painting a masterpiece... with your toes. I think its possible eventually, fundamentally speaking, but it doesn't sound like a wise choice to make, at least not initially.
(I wrote failed in quotes, because in reality after bankruptcy IP is transferred, experience was gained by employees, some of which end up at different companies in the same space, others end up in new disciplines where they gain a new applicable insight that nobody previously connected to blood glucose monitoring, etc...)
Then there's the social issue of the first iterations of the tools potentially working better for less pigmented skin...
**
I have some serious question marks surrounding the near-term viability of stem cell regrown organs.
As an unethical thought experiment consider freshly born twins, and removing their pancreas and putting each in a chamber where you would otherwise grow the artificial pancreas. How fast would you notice harmful levels of sugar purely from observation of the kept-alive pancreas? (without cheating and using knowledge of healthy blood sugar levels). If it would take many many experiments or very long durations to detect these problems (for glucose or otherwise), then one doesn't really have the engineering confidence of how long it would last, what the side effects are, ... i.e. blanket statements that stem cell derived organs will arrive earlier than affordable democratized noninvasive sensing could be true, could be false, but isn't proven by a blanket statement. The burden of proof doesn't lay with the reader.
There are decades of research with all kinds of wild wearable devices in all kinds of form factors that can do amazing things. They have gone over like a lead balloon with the consumer.
Socially, it is acceptable to wear exactly one piece of technology on one wrist. People with very dangerous medical conditions might be convinced to wear a well hidden device under their clothes but it's a big ask and compliance won't be as high as you'd expect.
That's just how people are, so as engineers we have to make products to fit that.
It just can't look too unusual.
It makes it very hard for a business when, for instance, very few men are willing to wear your bangle or people can't wear your glucose monitoring hat inside nice restaurants.
It's likely that different wearable forms will become more common and accepted, but that is one of those predictions you hear every year for the last thirty years and it's true to an extent but also there is a long way to go.
Maybe one day it will be common for men to wear bangles on each arm, or for hat wearing to be common indoors via their actions.
For example, no one carried around headphones out-and-about before the Walkman.
"You are currently already by necessity accepting the monitoring of blood glucose invasively with device X, here is a less invasive device Y that sits under your lip, or perhaps has a fiberoptic cable running up to your lip. Would you switch to this lip-oriented device today? Or would you rather profusely refuse to use this device Y until some more distant unspecified future date where the technology Z finally robustly works through thicker layers of skin while continuing to use the more invasive device X?"
I don't claim but tend to believe they would take improvement Y over X while waiting for Z.
You actually claim they wouldn't.
I say let the patients speak for themselves.
Perhaps your claim is correct and no suitably large niche of patients would switch to the lip-oriented device.
Perhaps you are wrong and you have confirmed my suspicion of the miscommunication between patients and engineers.
Your rebuttal does not prove compliance of a less invasive lip oriented device would be lower than current invasive devices.
There is a lot (a lot) of history here that I think would help you test your assumptions on this.
A 2017 survey found only 32% of the US population wears a watch daily, so for a large fraction wearing a glucose monitor in the form of a watch would also constitute a change, and correlate with diabetes patients. Under the lip or monitoring the inside of the cheeks, etc may be even less conspicuous than wearing a watch. Perhaps you might wish to test your assumptions too, and again, neither me nor you should be the arbiters in this matter: the patients ought to be the ultimate arbiters.
https://www.jckonline.com/editorial-article/most-consumers-d...
I don't understand why a person would contort themselves into less defensible or self-contradictory stances. It would seem engineers or others involved in the field would welcome the suggestion that perhaps there is a more tractable way, that might simultaneously be more acceptable by the patients themselves.
Observe I don't accuse you of causing the miscommunication. Everyone is prone to following the herd, including me.
While it isn't proven the patients would prefer a miniaturized device under the lips (or somehow reversibly attached to a teeth in a way that it doesn't interfere with eating, kissing, etc..) let us suppose for a moment that it actually turned out to be the case, after a survey or after actual trials.
In this case it's not the fault of the average employee or engineer in the field that they were designing thick-skin CGM devices before the survey or trials were done.
The real question in that case is: who was or wasn't aware before the survey that the red mucous membranes were easier? If not why not? It's obvious these tissues are redder due to better visibility of blood. Those that were aware before the eventual survey: did they yes or no tell their superiors? why not? if they did, they are absolved, but the line of questioning now transfers to the superior. Why didn't they order a survey asking for patients concerns about the idea, and if they would consider switching to such a product if properly executed? Why didn't they consult the patients?
I can't prove it, but I think it actually makes a lot of sense. The interstitial CGMs like Libre/Dexcom are invasive (brief pinch on application) but they last up to 2 weeks and you can set and forget. I'd think any other non-invasive device that requires carrying it around, running wires, and being even a little pro-active would lose on convenience alone.
You could get some traction I'm sure, but the majority of people are going to gravitate towards the easiest solution, and applying a patch once every 10-14 days is pretty darn easy. Even if Apple could check glucose I'd still prefer a CGM patch so I don't have worry about always wearing the watch.
One potential solve is watch-only for non-diabetics and a more invasive watch + patch solution for those that need high accuracy.
They don't currently send data directly to Apple watches (it goes through the iPhone first), but that's largely a regulatory approval issue, not a technical one.
> Apple’s system — more than 12 years in the making — is now considered to be at a proof-of-concept stage, said the people, who asked not to be identified because the project is confidential. The company believes the technology is viable but needs to be shrunk down to a more practical size.
> Engineers are working to develop a prototype device about the size of an iPhone that can be strapped to a person’s bicep. That would be a significant reduction from an early version of the system that sat atop a table.
…
> Before shifting to TSMC, Apple had worked with Rockley Photonics Holdings Ltd. to develop the sensors and chip for the technology. In 2021, Rockley publicly disclosed its work with Apple, stoking interest in the supplier. Apple later ended the partnership, and Rockley filed for bankruptcy last month.
[1]: Related conversations: https://hn.algolia.com/?dateRange=all&page=0&prefix=false&qu...