FDA authorizes first wearable device that monitors ketone and blood sugar levels (fda.gov)
323 points by sunnynagra 9 hours ago
madrox 6 hours ago
A friend died of diabetic ketoacidosis. He loved technology and seeing people succeed. Thinking of him with this news. Miss you Dan.
Grateful we're moving forward on so many fronts in the world.
dweekly 6 hours ago
He was my roommate in 2001 in San Jose.
We came up with the idea of having a place where nerds could come together to hang out and learn from each other and we decided to call the concept "Hacker Dojo". I had a sign laser engraved in 2002 at a state fair to memorialize the idea but we didn't actually get to open a Hacker Dojo until 2009.
There's a conference room in it called Kaminsky.
Dan was not a very good roommate but man, his brain worked in weird and wonderful ways, and it was inspiring how he could just rabbit-hole on stuff other people didn't find interesting until he MADE it interesting and found things nobody else had.
I miss him too. What a gift he was to the world.
borski 5 hours ago
Dan was a spectacular brain, and made contributions that still echo today.
He is one of two friends to have passed from DKA. Miss you, Zach. RIP.
Miss pwning with you.
lolsowrong 2 hours ago
madrox 3 hours ago
I wasn't sure how specific to be in my comment, but I'm glad the people who knew him know who it is. Speaks a lot of the man. I'm also 100% ready to believe he was not a good roommate by the condition of his car ;)
Cheers to Dan.
exolymph 6 hours ago
Thank you for sharing his memory with us.
dredmorbius an hour ago
Out of curiosity, Type I or Type II diabetes, if you (or others) are aware?
ijustlovemath 9 hours ago
Automated glucose control will be the next frontier in so many areas of healthcare. I'm still skeptical that anyone will be able to noninvasively and accurately sense blood sugar, but I'm glad people (especially kids with T1) will have one more tool to help them. I hope they can figure out the reimbursement side to get it into the most hands possible!
jamesgill 7 hours ago
Automated glucose control is already available via wearable insulin pumps combined with CGMs in a 'closed loop' system.
ijustlovemath 7 hours ago
None have been approved for hospital use as of yet, which is the next frontier.
lokar 5 hours ago
loeg 8 hours ago
> Automated glucose control will be the next frontier in so many areas of healthcare.
What areas do you have in mind outside of diabetes management?
jjk166 7 hours ago
Blood glucose levels affect lots of health functions. Diabetes represents an extreme end of the spectrum where the body's ability to regulate these fluctuations fails, but just because your body can get your levels in control eventually doesn't mean you won't suffer from the negative effects of it needing to do so.
Maintaining consistent glucose levels improves mental health, weight management, sleep quality, muscle recovery, systemic inflammation, cardiovascular health, and may even slow aging. There isn't much clinical data at the moment on how to use blood glucose measurements to control glucose levels outside of people with diabetes (there are lots of things that impact it besides just sugar intake), but there are definitely major theoretical benefits if it can be worked out.
Also, just reducing the incidence of diabetes would be no small accomplishment. About 3.5% of global disability adjusted life-years (DALYs) are due to diabetes. As of 2021 it was the 7th largest contributor of global DALYs.
agumonkey 7 hours ago
loeg 5 hours ago
ButlerianJihad 4 hours ago
ijustlovemath 8 hours ago
Cardiac surgery, burn units, ICU, neuro come to mind. All have been studied to show mortality and complications improvements with AGC, but unfortunately the commercial technology has not materialized yet.
sroussey 6 hours ago
andy_ppp 7 hours ago
I’m willing to bet we can see longevity improvements from better blood sugar control. Not 100% certain but extremely likely, this would include potential heart attack and dementia reduction…
novok 3 hours ago
malfist 7 hours ago
nemomarx 8 hours ago
Ketones have some dieting and weight loss applications, so I guess you could do better real time tracking of how you're digesting carbs and when it's okay to eat? maybe
hungryhobbit 8 hours ago
joelthelion 7 hours ago
Preventive medicine is a bit one. If your fitness watch could measure blood glucose, I think it would be a ton more impactful in terms of health outcomes.
malfist 7 hours ago
algoth1 7 hours ago
Also rare genetic issues like GSDs and FAODs may benefit immensely from dual glucose and ketone metering. Next we need potassium and magnesium meters and that will benefit the people with rare renal wasting syndromes like Gitelman and Bartters
ddorian43 7 hours ago
Metabolic psychiatry is rising, though very slowly. You do "epilepsy keto diet", and may work in bipolar/schizophrenia (need GKI 1-2, it's not keto for weight loss). But you don't need the continuous monitor, normal ketone monitor is fine, because the food list is very narrow.
The continuous monitor should help until you get the hang of the diet, it's a bit hard to maintain, but if it works, worth it.
VLM 6 hours ago
"management" is the key word. Early diagnosis might help a lot not just with T1 but also T2.
Early diagnosis would save a lot of pain and suffering... and money.
I worked with an older T1 and apparently a bit less than half of kids diagnosed with T1 are diagnosed unconscious during a DKA event in the ER. "Treatment" cost, or at least requested revenue LOL, is at least $30K for an ER visit like that, and it also costs at least some months (years?) off their expected lifespan.
Figure about 0.5% of the population in the USA is T1, you read stuff like "about two million T1 diabetics" in the USA. So early T1 diagnosis would save the country overall about $30B just in DKA treatment alone at time of initial diagnosis.
If you could screen an entire population for less than $30B total lifetime cost, it would be financially rational to prescreen for T1 rather than waiting for ambulances to present incredibly sick kids. And potentially profitable.
Prescreening the entire population for metabolic disorders is quite plausible as a "tech startup idea" as the alternative is waiting for them to arrive in an ambulance while extremely sick/nearly dead. Lets say it could be done for $10B, leaving $10B for startup profit (charge insurance companies $20B which is not bad....) and $10B in lowered health care costs for the country in general, not to mention less suffering in the population. A win-win scenario.
IF blood sugar related disorders could be pre-screened for less than $10B total cost. A solid "maybe"? Plausibly a startup doing blood sugar prescreening would be a "multibillion dollar company" although not a trillion dollar unicorn. Still a good idea.
sublinear 7 hours ago
Metabolism, and the endocrine system in general, is very responsive to physical activity. Even in athletes, glucose can have significant ups and downs when it gets intense.
It would be interesting to see this technology branch out into monitoring hormones, minerals, vitamins, etc. For all of human history, the closest we've had to realtime monitoring is just our mood. It would be life changing for anyone to have this feedback.
SV_BubbleTime 8 hours ago
I wonder if there are any legs in an internal sensor that pushes out its reading every x? That seems pretty plausible.
zamadatix 8 hours ago
Invasive CGMs (Continuous Glucose Monitor) and minimally invasive CGMs exist. It's the non-invasive CGMs which are being worked on because managing an implant or having something always poking through you is a big annoyance+risk compared to wearing a watch, ring, or patch.
The problems for these non-invasive options so far is they either too easily fail to work, are bulky/expensive, give very ballpark accuracies, or some combination thereof.
flinner 8 hours ago
aarstid 7 hours ago
ijustlovemath 8 hours ago
There are 6 month implantable CGMs, they're just quite expensive.
dormento 7 hours ago
You got me thinking about possible hollow spots INSIDE my leg to put a sensor :P
copperx 8 hours ago
Internal as in swimming in the bloodstream?
jablongo an hour ago
I am a founder and researcher at https://replica.health and co-creator of https://metabo-net.org. This is super exciting and cant wait to see what we can learn once large datasets of overlapping ketones + glucose + insulin data become available.
One point I discussed with other researchers at ADA this year: in theory automated insulin delivery does not stand to benefit much from ketone sensors, since diabetic ketoacidosis will almost always be preceded by high blood glucose, which we already measure using the cgm. It will be interesting to see what this ketone data is actually used for.
andrewfromx 3 hours ago
just got the https://www.stelo.com/ device. Doesn't hurt at all to install under your arm. The applicator just does this big SNAP! when you press the button and the filament goes under your skin but it's painless and no blood, it's not a needle at all.
umvi 7 hours ago
Ketones are only going to be present if you are exceptionally bad (very high carb diet) or exceptionally good (very low carb diet) at managing your blood sugar. It's not going to be terribly useful for your average diabetic who has fairly good control over their blood sugars.
ggm 6 hours ago
A measure which acts as a high and a low pass filter on a band of less risk which can be monitored by other means, or subject to improvements on measurements and narrow the central zone?
Sounds bloody useful to me.
als0 7 hours ago
> your average diabetic who has fairly good control over their blood sugars
I think it's huge for diabetics. It's a mental toll for them. They hate having to constantly prick themselves to take readings. It's awkward, inconvenient and you have to do it multiple times to be sure you got a good reading. And worse of all, it's possible to forget to take a reading when you need to.
hn_throwaway_99 6 hours ago
I don't understand. All of the diabetics I know personally (one type 1 and two type 2 diabetics) use continuous glucose monitors and have for some time, so they rarely need to prick their fingers anymore. Ketone levels can be checked with a urine test.
scheme271 4 hours ago
umvi 2 hours ago
Well I'm a T1D and I'm not generally worried about DKA because I wear a CGM and keep my blood glucose below 140 mg/dL
dotBen 7 hours ago
Which makes me think the market for these is diet-focused folk. Get the FDA to clear it on medical grounds for a specific usecase then sell it more broadly.
This already happens with CGMs. The bulk of the sales is with people who want them for lifestyle monitoring even though they're only medically cleared for diabetes use.
hn_throwaway_99 3 hours ago
It would be beyond stupid for a healthy "diet focused" person to want to use this. They're not at risk for ketoacidosis, and there is zero evidence that continually measuring ketones would be useful in any sense. That's different from the purported use of CGMs, which is to monitor for glucose spikes in response to specific foods (and even then, the evidence that monitoring glucose spikes in healthy people has any benefits is really thin).
If someone really wanted to measure their ketone levels there are simple urine tests that do it - there is no need to measure it continuously for healthy people. And if they want to see if they're in ketosis it's pretty easy to determine - if they're on an ultra low carb diet and their breath smells like shit, it's a good sign they're in ketosis.
bilsbie 4 hours ago
“Wearable” seems misleading. It looks like this is inserted into the arm like a cgm? Or am I looking at the wrong product?
bakul 4 hours ago
Yes.
fchicken 34 minutes ago
Any word on how it works? Couldn't find any info
imglorp 9 hours ago
ijustlovemath 8 hours ago
The difference is that these only measure blood sugar, while the new system also measures ketones, of keto diet fame, which are leading indicators of a really dangerous situation called diabetic ketoacidosis. It's treatable with a hospitalized IV insulin drip, but can be avoided if you have some advance notice.
bsimpson 7 hours ago
My mom had T1D onset in her 50s. (It's usually thought of as a children's disease.)
She figured it out because she recognized the symptoms of ketoacidosis. That sent her to the hospital, which has thankfully allowed her to outlive her pancreas.
ddorian43 7 hours ago
Diabetic ketoacidosis only happens in T1D, or when you have something extremely wrong going on metabolically (like failing organs, etc).
Normally it should never happen. It happens at ketones like ~10+ mmol, and it's ~impossible to go more than ~6 for a healthy human even eating 100% fat and fasting for a week+ and doing marathons or whatever all at the same time.
The keto diet, can actually help in T1D, by keeping blood sugar more stable overall, but you still need insulin, just less.
ijustlovemath 7 hours ago
Someone 8 hours ago
Those ‘only’ measure glucose levels. As the article says, this is the first approved device that monitors both ketone and glucose levels.
crisnoble 7 hours ago
Ketones don't come from nowhere, they come from your body breaking muscles down in a last ditch effort to control sugars after they are dangerously elevated for extended periods of time, I'm talking 500+ over weeks. It's sort of like adding a "your car has been completely out of gas for one week" monitor to your "gas tank level" monitor.
ddorian43 7 hours ago
mapkkk 8 hours ago
These are the same CGM technologies (Dexcom = Stelo and Lingo = Libre), just aimed at the over the counter "health and fitness" market.
This is not verified info, but I would assume these are either A) the exact same device, just with different marketing B) "binned" production runs that did not meet the accuracy threshold for clinical/prescribed use, but are otherwise "good enough" for someone looking to healthmaxx.
scheme271 4 hours ago
I think they are the same with some software differences. I believe that the sampling rates and tolerances are different. For example, dexcom displays 5 minute samples while the stelo shows 15 minute averages (it internally gets a new sample every 5 minutes like the dexcom). I think the official accuracy is a bit lower for the Stelo as well, although in practice it's probably close to the dexcom.
cogman10 8 hours ago
I can all but guarantee you they are the same device. IDK if they are even binned differently. The software is the main difference.
The "real" device gives you what it measures as your real highs and lows while the OTC devices won't report high highs or low lows.
I have a Stelo (I was curious and diabetes runs in my family) while my wife has the Dexcom.
dawnerd 8 hours ago
kotaKat 8 hours ago
jvanderbot 8 hours ago
No FDA authorization I guess
eej71 8 hours ago
Nope that was two years ago.
https://www.fda.gov/news-events/press-announcements/fda-clea...
nocodeexportcom 5 hours ago
What a remarkable legacy. I hope this technology helps prevent others from being lost to DKA. May Dan’s memory live on through the people he inspired and the communities he helped create.
dec0dedab0de 8 hours ago
Does anyone know if something like this is required to be approved by the FDA? Like if someone were to make one for the hobbyist/weight loss market, would that even be legal?
jjk166 7 hours ago
It depends on intended use. If it is to diagnose, cure, treat, or prevent a medical condition then it is a medical device that may need approval. If it's not intended for anything medical, it doesn't need FDA approval. For example, clinical thermometers are class II medical devices, lab thermometers aren't medical devices at all. If the device were genuinely only marketed for general wellness, it would be exempt.
rootsudo 8 hours ago
Basically yes, take a look at the not for human consumption drug, sorry medicine market.
Was analogs in the 2010s, Obama had to pass the analog act low… now it’s back with peptides and glp 1 which aren’t scheduled but..
Yeah I guess make enough money and then lobby for the benefit of your audience base or for future proscuation
tiffanyh 8 hours ago
I have to imagine Apple was pushing for similar functionality but probably got distracted over the last few years due to the lawsuits.
MBCook 8 hours ago
Apple would want to make something non-invasive. I don’t think this is non-invasive. It looks a lot like the existing CGMs, but it does more.
chermi 7 hours ago
How long has the tech existed to do this?
itsryanlenk 3 hours ago
so weird this is at the top. I just wrote an article yesterday about zuck and the masterclass that the meta ray-ban glasses are.
Wearables ain't going anywhere but up.
ck2 9 hours ago
bet marathoners and ultra runners will start using this to improve performance
(don't have a problem with that, but it's predictable)
too bad it's not "wearable" like a watch but that might be coming eventually too since Garmin has a patent on it
* https://the5krunner.com/2026/02/06/garmin-non-invasive-blood...
(btw Fenix 9 launched today but it's same hardware as Fenix 8 and no glucose feature)
crisnoble 7 hours ago
Amateur cyclists already wear CGMs, and as a type 1 myself, they see mine and start asking all about CGMs. It must be so boring for them to worry about fluctuations between 85 and 120.
kccqzy 7 hours ago
I don’t think amateur cyclists will have much to gain from this other than satisfying their curiosity.
Before buying one, just know that fit cyclists will appear glucose intolerant on a CGM. See Fig. 1 at https://pmc.ncbi.nlm.nih.gov/articles/PMC10933193/
mikestew 8 hours ago
There has been talk, but as one who hangs around those circles I've not heard of anyone actually doing it. But I'm sure someone is. At the same time, what I'm reading is that CGM won't give a non-diabetic any actionable information.
ijustlovemath 8 hours ago
a regulated blood sugar level aids massively in cellular repair, inflammation reduction, and immune response. These are well studied and established. I could absolutely see a top athlete using AID in the future as part of a recovery routine, but I can also understand reluctance to adopt anything new or weird.
eoamk 8 hours ago
francisofascii 8 hours ago
I am curious how this will help. During training? During the actual race, the strategy is to eat a much as you can without puking.
anthomtb 8 hours ago
I am aware of the "eating wins races" strategy for endurance sports.
Glucose and ketone monitoring seems a natural, more precise extension of that strategy. Isn't the point of carb-cramming to get more glucose into your blood stream, where your muscles can convert that into forward motion?
ordersofmag 8 hours ago
loeg 8 hours ago
> to improve performance
How? Like, what is the mechanism where this is useful?
flinner 8 hours ago
Monitoring glucose and ketones can help you develop metabolic flexibility and let you grok how easily your body cuts over to ketones. Knowing your personal realtime glucose and ketone levels helps you understand just how much carbs will kick you out of ketosis or keep you in it. Glucose monitoring will help you avoid large crashes that can lead to low energy. Among other things!
More on metabolic flexibility: https://www.levels.com/blog/what-is-metabolic-flexibility-an...
loeg 8 hours ago
ifwinterco 8 hours ago
Parker_Fawcett 3 hours ago
Is it trustable?
petesergeant 9 hours ago
I thought this was going to be a non-invasive sugar-level device, but it looks like in fact the innovation here is that a popular CGM line can now do ketones?
ijustlovemath 9 hours ago
non-invasive continuous blood sugar measurement is mired in patents and technical challenges. Turns out it's really difficult to disambiguate the absorption lines of glucose from other similarly shaped molecules when you're also dealing with untangling skin conductivity, transmissivity, sweat, inflammation etc.
johen8 8 hours ago
I also think there's no financial incentive from incumbents to develop something like this. Why would abbott develop something that works "forever" if they can milk people buying new sensors every 10~14 days.
cogman10 8 hours ago
jakefromstatecs 9 hours ago
Seems to be the case, yeah
batisteo 7 hours ago
Reminds me of this warning: https://youtu.be/S6Jiei4Wup4 (Youtube Short from the Drey Dossier)
cat-whisperer 7 hours ago
science is awesome
cynicalsecurity 8 hours ago
As someone who has to deal with type 1 diabetes every day, this is marketing nonsense. No one needs ketones in the sensor - we need high-quality sensors, and Abbott's are only mediocre at best. They are not as bad as Dexcom, which is appalling, but they are still far from the superior quality of Medtronic/MiniMed which measure glucose exceptionally well.
Ketones are rare. They can kill you, but before that happens, your blood sugar usually rises enough for you to realise you may have ketones and start using test strips to measure them. Instead of this marketing gimmick, Abbott should have focused on improving the quality of their glucose sensors which is far more important.
lolc 6 hours ago
I tend to agree that making the sugar measurements more robust is worth more than measuring the ketones at all. However, low sugar and high ketones can happen. And just getting notified when ketones pick up can be worth something too. The additional measurement is not useless seen from my perspective.
As an example: I was on a study that gave T1D patients Dapagliflozin (Farxiga). During the study, while on a long hike, I was hovering at low sugar and consequently insulin supply was mostly cut off for an extended period. As I started to to feel unwell, I measured ketones. I was briefed as preparation for the study to measure ketones when something seems wrong. Otherwise I wouldn't have thought of measuring ketones. Might not even have carried the kit.
On that occasion, the ketones were way above 1 mmol/l: a very high value. Protocol would have required me to call the study doctor due to the high level. Since it was a Sunday, I spared her, shot some insulin, ate a sandwich, and continued my hike. I could do that because I was not alone on that hike. I knew that if my situation deteriorated, somebody would be around to call rescue.
At the study debriefing I mentioned the incident and they said that adding to the effect of the Dapa, I was probably dehydrated, which led to the rare situation of both low sugar and high ketones.
All in all I think that if the sensor makers exhaust possible improvements for the glucose, it can make sense to add the ketone measurement as a safeguard. Having high sugar can have many reasons, and it often takes me a while to get to measuring ketones. Getting the signal of rising ketones, I would react faster a few times a year in situations where my insulin supply is broken.
croemer 5 hours ago
What's so bad about Dexcom and Freestyle compared to Medtronic CGMs?
nh43215rgb 6 hours ago
Finally. I really dont want to buy yet another watch device unless it provides blood sugar detection.
hn_throwaway_99 6 hours ago
There are and have been continuous glucose monitors available for some time, and you can even get one if you don't have diabetes - I'm wearing the Lingo one right now.
All this device adds is a simultaneous ketone check, which is really only relevant to diabetics and not as much of a benefit because ketone levels are often checked with a urine test.
riazrizvi 8 hours ago
So she was merely ahead of her time.
yreg 8 hours ago
The use case was never the problem. The problem was that it did not work.
EA-3167 7 hours ago
You should understand the difference between taking a single drop of blood and trying to run a battery of tests on it, and sticking a probe into your extra cellular matrix to continuously monitor changes. It’s small, but it’s having a constant shifting flow of fluid at all times so it’s getting far more than one drop.
refulgentis 8 hours ago
Who?
wqtz 8 hours ago
Theranos lady.
refulgentis 8 hours ago
Forgeties79 8 hours ago
That silly patch idea?
grahar64 9 hours ago
Looked after my son who has T1D for now 5 years, checked keytones maybe 20 times. Compared to blood glucose which we check look at every 5 minutes.
Maybe this is more for Type 2 or other diabetes, or for people prone to DKA. Or it is for people with a working pancreas who think looking at their blood sugars (and now keytones) tells them something like soothsayers reading tea leaves
happyopossum 9 hours ago
Considering that DKA accounts for 160k hospital admissions a year, your lived experience translates poorly to such a flippant dismissal.
[0] https://www.cdc.gov/diabetes/about/diabetic-ketoacidosis.htm...
jablongo 33 minutes ago
In diabetics, DKA is preceded by hyperglycemia. Meaning, a CGM would tell you earlier that you are at risk for DKA than a CKM, a CKM would only tell you after you got it. Hence grahar64 is absolutely correct that as far as we know now, this provides no benefit to people at risk of DKA that a CGM does not already provide. I'm sure there will be some benefits but its really not clear at this point.
cogman10 8 hours ago
I agree, but there are a lot of factors going on to contribute to that number.
For example, about 20% of that number is because someone is finding out for the first time they have T1D [1].
Insulin costs and monitoring costs are also going to be a pretty big contributing factor. CGMs and finger sticks aren't cheap.
IDK how often it happens that ketoacidosis happens when glucose appears to be fine, I assume it's pretty rare.
[1] https://www.sciencedirect.com/science/article/pii/S016882272...
crisnoble 7 hours ago
A CGM that has ketone levels is quite literally pointless. If you have a CGM in the first place you would know if your sugars were high enough for long enough to get DKA.
badc0ffee 8 hours ago
DKA is what killed the legendary Dan Kaminsky.
cynicalsecurity 8 hours ago
Mate they won't understand. People generally are exceptionally ignorant about type 1 diabetes and also eager to fall for marketing gimmicks like this one. They have no idea what type 1 diabetes is.
For anyone who doesn't get it: glucose is checked every five minutes because it changes very often, jumping or falling dangerously. It's a nightmare. Checking glucose is 1000 times more important than ketones which are almost never a problem. If you get accurate glucose readings you are highly unlikely to ever experience ketoacidosis in the first place. Before ketones become a problem, glucose has to stay high for hours. Abbott is pulling this marketing trick instead of improving the quality of their sensors. Libre 2 is absolute crap. Libre 3 is somewhat okay and sometimes even mediocre - which is still a pretty bad situation. Bad glucose sensor is a nightmare and it can kill a person or a child much likely than ketoacidosis. It will actually lead to ketoacidosis by showing incorrect glucose readings. Now I wonder whether they added a ketone sensor as a failsafe for their low quality glucose sensors.
No one asked them to add a ketone sensor as an add-on to their glucose sensor, except maybe their marketing department. People want higher quality glucose sensors that fail less often and are more accurate. Glucose sensors, not ketones!
hacknews20 5 hours ago
Understanding why children's pancreases stop delivering insulin in the first place, which remains one of the big medical mysteries, would be a huge breakthrough for preventative medicine.