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FDA authorizes first wearable device that monitors ketone and blood sugar levels
- imglorp 22d agoWhat about all the other wearable sensors like https://www.stelo.com https://www.stelo.com https://www.hellolingo.com https://www.hellolingo.com
- Someone 22d agoThose ‘only’ measure glucose levels. As the article says, this is the first approved device that monitors both ketone and glucose levels.
- crisnoble 22d agoKetones 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 22d agoUm, no ? Ketones come from fat burning, not muscle. In T1D with no insulin, muscle break down from gluconesis will increase blood sugar in the blood even more. The absence of insulin also makes ketone production unrestricted, so you end up in ketoacidosis. Muscle is used when you don't have fat, or when you eat completely nothing (burn both fat & muscle). Like I've gained ~10KG of muscle while on keto diet. Blood sugar at 70-100 depending on scenario. Usually on the lower end.
- jvanderbot 22d agoNo FDA authorization I guess
- eej71 22d agoNope that was two years ago. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor https://www.fda.gov/news-events/press-announcements/fda-clea...
- ijustlovemath 22d agoThe 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 22d agoMy 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 22d agoDiabetic 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 22d agoIt can happen in people with uncontrolled T2D as well. My cofounder is a pediatric ICU doctor who has treated hundreds of DKA patients. Also there wasn't really a relationship of the keto diet to the rest of my post, just using it to contextualize a technical term with one that might be more familiar.
- ddorian43 22d ago> It can happen in people with uncontrolled T2D as well. My cofounder is a pediatric ICU doctor who has treated hundreds of DKA patients. Yes, but you have to work really hard for many years to achieve this! While on T1D it happens by default if you don't inject insulin. > while the new system also measures ketones, of keto diet fame, which are leading indicators of a really dangerous situation called diabetic ketoacidosis It was being said like ketones are bad, because they are known for this scenario, but should be noted that it only happens in these few scenarios, like in uncontrolled diabetes or organ failure or smth. In most other cases they should be good. But won't happen randomly unless you're explicitly doing keto.
- mapkkk 22d agoThese 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.
- cogman10 22d agoI 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.
- kotaKat 22d agoYou can read the Stelo out into XDrip with some settings adjustments, last I checked, so it is just some “light” software tweaks between sensors. https://navid200.github.io/xDrip/docs/Dexcom/G7.html https://navid200.github.io/xDrip/docs/Dexcom/G7.html
- dawnerd 22d agoI t Looked into the OTC ones and it does seem they’re binned versions. The failure rate appears to be higher too, which is more acceptable in a non life threatening device. It also probably gives the companies really valuable data.
- scheme271 22d agoI 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.
- unixhero 22d agoCan we have CRP while we are at it. Why in the world is that not something we are checking on a daily basis.
- Mugshelf 22d agoContinuous ketone monitoring could be a game changer for people doing therapeutic fasting.
- ck2 22d agobet 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-glucose-tracking/ 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)
- mikestew 22d agoThere 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 22d agoa 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 22d agoA few years back, there were a number of startups that essentially resold prescriptions of the ABT/DXCM CGM and provided personalized meal/exercise-response analytics on top. Seems like traction has been tough going, though. Dialing back from "anyone with potential metabolic issues" -- what's a realistic market? Something like high-level athletes and/or bio-hacker enthusiasts are the only folks who seem to care. On the low end, the OTC options are eating away as well.. they are less accurate, but probably solve the use case better for a pre-diabetic "once-a-year/occasional" wear use case. Talking to ultramarathoners and cyclists, I think lactate is a biomarker that is tracked (POC blood samples) and would be more immediately useful for training/performance. AID might be construed as a form of doping, IMO.
- ijustlovemath 22d agoAutomated 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!
- SV_BubbleTime 22d agoI wonder if there are any legs in an internal sensor that pushes out its reading every x? That seems pretty plausible.
- copperx 22d agoInternal as in swimming in the bloodstream?
- zamadatix 22d agoInvasive 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.
- petesergeant 22d agoI 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 22d agonon-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 22d agoI 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 22d agoFor abbott, no. But what about for Garmin, Apple, Samsung, or Google? Diabetics would snap up a smart watch which does accurate glucose monitoring in a heartbeat.
- ijustlovemath 22d agoThere is a major IP holder in the space who is asserting their ownership, so even if they could solve the technical challenges, they might not be able to come to market.
- nomel 22d ago> There is a major IP holder in the space who is asserting their ownership, Is it a secret? Why not name them?
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- grahar64 22d agoLooked 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 22d agoConsidering 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.html https://www.cdc.gov/diabetes/about/diabetic-ketoacidosis.htm...
- badc0ffee 22d agoDKA is what killed the legendary Dan Kaminsky.
- cogman10 22d agoI 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/S0168822725002918 https://www.sciencedirect.com/science/article/pii/S016882272...
- crisnoble 22d agoA 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.
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- riazrizvi 22d agoSo she was merely ahead of her time.
- yreg 22d agoThe use case was never the problem. The problem was that it did not work.
- Forgeties79 22d agoThat silly patch idea?
- refulgentis 22d agoWho?
- wqtz 22d agoTheranos lady.
- refulgentis 22d agoHuh, makes 0 sense to me, blood tests w/o much blood isn’t same as glucose checking, we’ve been able to do that w/o much blood for…a long long time.
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- EA-3167 22d agoYou 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.
- BeaverGoose 22d ago[flagged]
- dec0dedab0de 22d agoDoes 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?
- rootsudo 22d agoBasically 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
- jjk166 22d agoIt 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.
- cynicalsecurity 22d agoAs 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 22d agoI 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.
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- tiffanyh 22d agoI have to imagine Apple was pushing for similar functionality but probably got distracted over the last few years due to the lawsuits.
- MBCook 22d agoApple 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.
- batisteo 22d agoReminds me of this warning: https://youtu.be/S6Jiei4Wup4 https://youtu.be/S6Jiei4Wup4 (Youtube Short from the Drey Dossier)
- umvi 22d agoKetones 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.
- dotBen 22d agoWhich 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 22d agoIt 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.
- als0 22d 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 22d ago
- chermi 22d agoHow long has the tech existed to do this?
- cat-whisperer 22d agoscience is awesome
- nh43215rgb 22d agoFinally. I really dont want to buy yet another watch device unless it provides blood sugar detection.
- hn_throwaway_99 22d agoThere 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.
- madrox 22d agoA 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.
- dgellow 22d agoIf you’re reading that and don’t know who that is, his Wikipedia page is worth a read: https://en.wikipedia.org/wiki/Dan_Kaminsky https://en.wikipedia.org/wiki/Dan_Kaminsky
- newtwentysix 22d agoThanks! I was curious who this Dan is
- joncrane 22d agoThanks! His mom is a badass.
- exolymph 22d agoThank you for sharing his memory with us.
- dweekly 22d agoHe 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 22d agoDan 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.
- hacknews20 22d agoUnderstanding 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.
- NotGMan 22d agoIt's sad that this comment is downvoted. If root cause could be identified people wouldn't need insulin pumps and other complications anymore at all... But this is what you get with modern midwits running around everywhere....
- jablongo 21d agoThis is understood I think. It's just how to effectively prevent it or reverse it thats not known.
- nocodeexportcom 22d agoWhat 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.
- bilsbie 22d 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 22d agoYes.
- BrtByte 22d agoYes, it's minimally invasive rather than noninvasive
- FrustratedMonky 22d agoWell. this seems like a big detail to leave out for something advertised as 'wearable'.
- tantalor 22d agoPeople who know about and use continuous glucose monitors already understand what "wearable" means in this context. The devices are designed to be installed by the user at home, not by a specialist. You're more likely to get a reaction to the adhesive that holds the device on your skin than the sensor filament itself.
- FrustratedMonky 22d agoYeah, not being part of that market. I was viewing the headline more like an Apple Watch. That seems like the click bait of the headline, it sounds like a new feature that will be in a watch or something.
- EasyMark 21d agoI've worn one, you forget it's there fairly quickly. It really isn't a big deal. I wore it for a month (2 of them @ 2weeks each) and it wasn't a big deal at all. Ijust wanted to watch how my eating affected my glucose in almost real time.
- andrewfromx 22d agojust got the https://www.stelo.com/ 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.
- Parker_Fawcett 22d agoIs it trustable?
- MahiroHirakawa 22d ago[dead]
- itsryanlenk 22d agoso 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.
- jablongo 22d agoI am a founder and researcher at https://replica.health https://replica.health and co-creator of https://metabo-net.org 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.
- terminalcommand 22d agoKetoacidosis can also happen with stable blood sugars if you don't get enough insulin. There were people rationing insulin due to cost and some of them died of DKA even if their blood glucose was perfectly stable. Another possibility of DKA with good blood sugars is when you are sick. I think this data would be helpful.
- jablongo 21d agoYea I'm all about finding the uses for this after the fact. However, it seems unlikely that people who are struggling to afford (or get insurance to cover) insulin would be able to afford a cgm or cgm/ckm in this scenario. Also not sure how it's possible to ration insulin and keep your bg stable, but I wouldn't put it past the most skilled T1s out there. In the sick w/ flu case, thats true, but then whats the treatment action? I still think euglycemia + DKA is an edge case.
- terminalcommand 21d agoTo ration insulin you limit eating carbs. If you don't eat, you need less insulin. Treatment for DKA as far as I kmow is to give glucose insulin and potassium. For example if you have a stomach bug and can't keep down anything you are at risk of developing DKA even if your BG is normal. The thing is how do we know we are starving the body of fuel. Most diabetics (me included) are told not to exercise if bg is higher than 250mg/dl, but that is it. We hit over 250 mg/dl frequently and sometimes stay there for multiple hours (infusion set problems, fatty food etc.). T1D athletes report that they eat a lot and take a lot insulin before/after training and they say they get tired very easily if they don't. They thought this as restoring the glucogen reserves in muscles but maybe it is about fueling the body. I sometimes feel uneasy even my bg is okay and it had led me to panic attacks. Now when I think it could be raised ketones, or just anxiety. Knowing the ketones would be helpful. https://journals.sagepub.com/doi/10.1177/11795514261431390 https://journals.sagepub.com/doi/10.1177/11795514261431390
- fchicken 22d agoAny word on how it works? Couldn't find any info
- bobowzki 22d agoI think these are very common in Sweden? Pretty much every type I diabetic I've met here have a sensor and insulin pump. Is this a different type of sensor?
- waveBidder 22d agoketone monitoring is pretty unusual
- BrtByte 22d agoCGMs and pumps are already common; what's new here is continuous ketone monitoring alongside glucose
- civvv 22d agoThis has been done by the open-source community for a decade+ already. https://github.com/LoopKit/Loop https://github.com/LoopKit/Loop
- looperhacks 22d agoThis has nothing to do with continuous ketone measurements
- BrtByte 22d ago[dead]
- madhu_ghalame 22d ago[dead]
- vilius 22d agoIn Europe there is ketone-only continuous meter SiBio that goes for 86 EUR for 2 weeks. A healthmaxxer goes with CGM to the left arm; CKM to the right arm and gets his glucose and ketones data for roughly 200-300 EUR per month. I did consider running this out of curiosity. Having 2-in-1 is much nicer. Esp if you are diabetic. [1] https://www.sibiosensor.com/products/sibio-ks3-ckm-continuous-ketone-monitoring-system https://www.sibiosensor.com/products/sibio-ks3-ckm-continuou...
- WorseIsBetter 22d ago[dead]
- civvv 22d agoMy younger brother has been using the open-source system Loop for his diabetes T1 since he was six years old. It automates the bloodsugar monitoring and insulin delivery. All running on his iPhone. This technology has permitted him to live almost as if he did not have the condition. Truly revolutionary, and the project is being developed by an amazing community of volunteers (total heroes!).
- pranav_tech26 22d ago[flagged]
- znpy 22d agoSince we're talking blood sugar and ketones, does anybody know if there is any line of such products that lets you export your data? I'd love to start monitoring my glucose level, but i'd like to have the data in my own database so that maybe i can correlate that with other things.
- hndbwksam7 22d agoSlow clap
- FrustratedMonky 22d agoBut in todays FDA, is this real, or just what an Influencer wanted to see? Isn't the FDA run by a health care influencer, that would love to hype products they can get a cut from?
- GNR_Radio 22d ago[dead]
- pierreortega 21d ago[dead]
- guerby 22d agoInteresting device for those using diet to induce ketosis for diabete or mental illness care. One great thing about the keto diet is that it is the only diet where you can be sure you follow it correctly ... by measuring your ketone levels. And for glucose since different people will react very differently to various forms of carbohydrate (and associated foods) a CGM is always a must. (1) (1) https://www.nature.com/articles/s41591-025-03719-2 https://www.nature.com/articles/s41591-025-03719-2