Seven Diabetes Patients Die Due to Undisclosed Bug in Abbott's Glucose Monitors
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A recent bug in Abbott's Freestyle Libre glucose monitors has sparked a heated discussion after the FDA reported that it falsely reported low glucose levels, resulting in seven deaths and over 700 injuries. As commenters shared their personal experiences with continuous glucose monitors (CGMs) and insulin pumps, a common theme emerged: the limitations and security concerns of proprietary medical devices. Many users have turned to open-source alternatives like OpenAPS, Android APS, and xDrip, citing the benefits of avoiding restrictive apps and improving device interoperability. The conversation highlights the tension between the need for reliable, secure medical technology and the potential risks of DIY or non-approved solutions.
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I've always been suspicious of the yahoos writing the software that controls these kinds of devices being a security guy and all.
But I also would love to participate in, contribute to or help in any way with reverse engineering, open sourcing, or in some other way making it so that my wife's life isn't dependent upon the quality of software developed by the lowest bidder they could outsource it to.
If anyone knows how I could help please let me know who to reach out to.
https://openaps.org/
Currently using Libre as sensor, luckily without their shit app. Dexcom was easier to set up.
The amazing developer Scott Hanselman built on a PalmOS app to store readings and if I recall correctly wore 2 pumps with fast/slow insulin... he had a cybernetic pancreas in the mid-2000's.
I've been a type I diabetics for over 25 years and I don't quite understand this one. Low blood sugar is an immediate life or death situation, but high blood sugar killing people? Just how high was it and for how long?
As someone that has a CGM I still calibrate it by using a blood test every couple of days because the CGM sensors can wander on accuracy.
See https://www.mayoclinic.org/diseases-conditions/hyperglycemia... for a discussion of both (in Emergency conditions)
Your argument completely ignores the massive, massive qualifier of "if not treated".
Low blood sugar is an acute emergency. Diabetics can die very quickly from low blood sugar (well anyone can, it's just diabetics are more at risk).
High blood sugar becomes interesting because it's generally systematic, untreated high blood sugar that leads to issues. For someone using a CGM and at least attempting to manage their blood sugar, it _should_ be hard for them to actually hit the high blood sugar emergency state. This condition is largely unique to people who have uncontrolled diabetes and have long, extended times of extreme blood sugar.
Caveat Emptor: I myself am not a doctor. I love to learn from my wife. I'm confident enough to present an argument on an internet forum, but I'm certainly not confident or qualified enough to give you or anyone _actual_ medical advice.
> I myself am not a doctor. I love to learn from my wife.
I suggest that you speak to your wife before correcting my unimpeachable explanation of why someone might die from being told, incorrectly by their CGM, that their blood glucose is low.
If there were other confounding factors then I'm wondering what their endo told them, unless this is one of those countries you could buy it without a prescription? Any endo with any training would have a fragile diabetic using more than one monitoring method and have them doing regular blood tests.
https://news.ycombinator.com/item?id=46395603
DKA is a common presenting symptom for new T1DM patients but that's definitely not the only time it occurs. And we also have HHS which can occur in T1DM and T2DM.
I do think my underlying point is generally, correct, though. And, implicitly supported by your retort. Low and high blood sugar are emergencies of different acuity. To be clear, by the time either of them turns into an emergency, they are both emergencies. However, the time frame for going from "my blood sugar is managed" to "I need emergency intervention" is generally different (and longer for high blood sugar emergencies).
I'm a bit frustrated by the number of people on this page who are saying that high BG readings aren't an emergency; the timeline to death isn't weeks or months or 'next time I get to urgent care' but instead 'later today' or 'early tomorrow'.
DKA may be precipitated by infection (like the seasonal flu), and in that setting, worsened further by an unreliable CGM.
Here are some case reports that relate to this:
- https://sci-hub.box/10.2337/diacare.6.6.622b (note two patients who were 'intelligent' presented with DKA despite multiple normal readings)
- https://pubmed.ncbi.nlm.nih.gov/40811481/ (pregnant women can have DKA irrespective of blood glucose readings due to changes in normal range attributable to pregnancy)
You can read many more of these kinds of cases:
https://pubmed.ncbi.nlm.nih.gov/?term=(diabetic%20ketoacidos...
My point still remains. Low and High blood sugar are different acuity of emergencies.
But neither that, nor is whether he should offer credentials the point. The point is you said this:
> > > Sorry to be crass, but this type of argument is exactly why non-experts shouldn't be talking about topics they aren't experts on.
I think there's a little recalibration necessary if the person you said this to turns out to be pretty well educated and capable in the subject.
I instead link to authoritative references.
It would be odd for a faulty sensor to cause an otherwise bad day into dka and death though. The sensor would need to be wildly off for hours and the user to not notice. Insulin delivery would need to be paused or greatly reduced for many hours. There are additional therapies like SGLT-2 that could make this more likely but they usually aren’t used with T1D precisely because they break the normally very strong correlation between inadequate insulin levels (leading to dka) and high blood glucose.
Even though I can’t think of an easy way for a false low(s) to turn into lethal DKA, that doesn’t mean it didn’t happen. Abbott sells a lot of CGMs. It could have been a contributing factor to several deaths even if the fault would almost always not be a significant issue.
Your comment was Dunning Kruger. Did you stay at a Holiday Inn Express last night?
I know nothing about the subject, just wanted to say your comment is exactly one I'd prefer to filter out - it adds nothing to the discussion, I haven't learned anything from it and reading it makes me feel like wasting my precious time on Reddit rather than on one of the very few remaining quality forums like HN.
1) Having enough basal or "baseline" insulin but eating too many carbohydrates. This will lead to a high blood sugar reading but no immediate danger (this will cause long term health issues like kidney failure, blindness, etc if you run a high average blood sugar over time.)
2) Not having enough insulin which is incredibly dangerous. This will often presents with high blood sugar but not always. Your cells are not getting enough glucose. Your body responds by releasing lots of short term energy stores. The stores that become glucose still can't enter your cells since there is not enough insulin so your blood sugar will often read high. Your body also breaks fat into ketones which use a different mechanism to enter the cells and don't require insulin. Ketones can provide the energy your body needs and keep you alive for the short term, but they are acidic and will kill if the concentration gets too high (diabetic ketoacidosis -- your blood pH changes enough that it interferes with the normal chemical reactions your body requires)
So the real test for dangerous situations when experiencing high blood sugars is to test your urine for ketones.
From the FDA article, it sounds like the CGMs were incorrectly reporting low blood glucose values for extended periods of time. The closed loop pumps respond to a low blood glucose by lowering the basal rate of insulin. The is dangerous if done for too long a time. Also note that insulin response varies wildly by individual.
From the pumps I use, there is a maximum basal rate adjustment allowed before the pump alarms and kicks you out of the "insulin auto-adjust mode". This was with both medtronic and tandem pumps.
I haven't used the abbot cgm or pump. I would expect there would also be limits to how much the pump will lower your basal insulin rates before alarming. I haven't seen any specifics, but I bet the software bug is allowing a lowered basal rate for too long under continued false low glucose readings and patients going into DKA. (IMHO bad sensors should be accounted for in software and user alerted under any suspicious circumstances)
Needless to say, this is a horrible situation and my heart goes out to everyone impacted.
That said, my mother in law, who had worse diabetes than me, went without her pump during our wedding (a bit of vanity about the pump showing through her dress). She was at 600+, and started feeling pretty ill that evening.
I like the technology, but you have to 1) know your own body and 2) verify if you are uncertain about the readings. Every time I've switched devices I've interacted with diabetes educators, and they pretty much always tell me to always be prepared to verify manually (with an old-school finger stick and test strips).
Additionally, it's not always the fault of the technology, but often where meatspace and technology interface. When you insert a CGM, there's always a risk of the canula not going into the skin correctly. (usually it's a spring-loaded insertion tool and shoot a needle into your skin quickly, but it can mess up if the amount of pressure applied is wrong etc) In such a case, the sensor that measures your blood will often, where you can't see, sit on top of the skin. This results in insanely low readings. That happens to me a few times a year (I swap out the sensor every 10 days), and you have to listen to how your body feels relative to the readings, and replace the sensor if necessary.
I wear a Freestyle Libre. Even during their mandatory onboarding, they warn about incorrect readings for the reasons you described and urge you to verify the glucose level with manual measurements when in doubt. Also, it's better to just eat glucose when the CGM shows a rapid decline or low level, even if it's due to an inaccurate measurement. This is in contrast to accidentally applying too much insulin and forcing a low glucose level. Of course, low levels often present with very obvious symptoms.
However, the FDA announcement warns about constantly low measurements. Unfortunately, the announcement does not explain what 'low' means in this context and what the actual issue was (it might be technical with the sensor or with the applicator). If it means that glucose levels are too low in terms of 'alarming low', this should prompt manual measurements. However, if the measurements show incorrect levels within the 'normal' range, this is a much bigger issue with these devices. This could explain why affected people have changed their diets or medication plans. These changes should always be discussed with a physician, though. Disease management programs can catch this (e.g. quarterly measurements of HbA1c).
CGMs are helpful. But they require knowledge about their limitations, especially for people who need insulin. They helped me to bring my glucose levels back into normal range without the need for any medication. I hope, I can keep my insulin intolerance at bay for a long time this way.
I (a non-diabetic interested in athletic performance) use an Abbott CGM sporadically and I have absolutely not agreed to any terms of service nor any other agreement of any kind - legal or otherwise.
I bought a purpose-specific, old model iphone from "Back Market" with no SIM card, very briefly allowed it wifi access long enough to download the "Lingo" app, then set the phone to airplane mode. Dedicated, throwaway email and AppleID.
It has never left airplane mode and it works perfectly.
Further, I have no legal relationship nor have I made any agreement of any kind with Abbott.
I highly recommend that any user of these devices do the same.
For example a service I use a lot recently changed their terms of service - there was no way to keep using the service without agreeing.
Might be different for devices or services that don’t need internet to function; but even for those you have some “activation” step nowadays that forces you to agree before “unlocking”
Yeah ?
Who agreed to that ToS ? Abby McAbbott ? With no phone number ? A throwaway email address ?
As I said: I have not entered into any agreements of any kind with Abbott. You should not either.
I don’t think this matters in the way you think it does. If they can demonstrate that you have to click through the ToS to use the device and app, then the burden would be on you to show that you did not accept the ToS to use the device. But therein lies the catch: If you found a way to circumvent their setup process, you wouldn’t be using the device as designed or intended.
My parent implied (probably correctly) that their ToS is toxic. I am pointing out that there is no reason for you to enter into that ToS.
Are you suggesting that I, an anonymous piggyback user of their service, would blow up my anonymity (and all of the protections and peace of mind that it affords) by attempting to reestablish some form of legal contact ?
No. It's easy come, easy go and that's just fine with me.
Ok? Then it doesn’t matter if you accept or not.
The ToS doesn’t come into play unless there’s legal action. If you’re never going to enter into legal action with the company then it doesn’t matter if you accept the ToS or not.
Merry Christmas!
Liability is not as simple as you posit. Severability and judge discretion are but 2 ways that immediately can invalidate this line of argument. The cause of actual damages are almost always scrutinized, meaning the company would have to prove that the legal agreement could somehow have prevented the damage. At least, that's been my experience.
The actual terms of the ToS will always be evaluated in court. You can’t, however, go into court and argue that the ToS doesn’t apply because you put a fake name into the app and left it in airplane mode.
Related, Abbot previously had problems with their freestyle lite test strips. There were lawsuits, fines and most insurance dropped them from their covered diabetic suppliers.
You know, Kind of like a real contract.
You technically do have this option. You can send your own terms to a company’s legal team.
The answer will always be no. A law enforcing them to respond in a certain period of time won’t change that. Always no.
It is never cost effective to have lawyers review individual contracts for relatively cheap devices.
None of this actually matters if you went through the steps to use the app. The app is designed such that you agree to the terms before you can use it.
You can use all the throwaway emails, devices, VPNs, and other tricks in the world, but unless you can reliably demonstrate to a court that you were utilizing the app in a way that didn’t involve accepting any terms of service then they could simply demonstrate that it’s part of their app flow.
Even using tricks to utilize the device outside of the app wouldn’t help, because they could simply demonstrate that you weren’t using it as designed or intended.
I can't speak to, nor do I have any interest in, legally pursuing this random vendor.
The op implied, correctly I assume, that the Abbott terms are "toxic".
I am simply restating, as I very commonly do, that this vendor is not a government agency. They are not the IRS. They are not law enforcement. They are an adversarial party until proven otherwise and you owe them nothing.
No thank you. I have to wear these devices 24/7 to keep me alive, and it was a huge quality of life improvement when I was able to control them all from my phone. I see literally no benefit to doing what you suggest.
I think you might be conflating some things.
But if you actually have any form of diabetes... definitely do not do that. Unless you are also rocking some other brand. ¯\\_(ಠ_ಠ)_/¯
https://www.youtube.com/watch?v=uHaYPEDGaro
Beth McNally & Amy Rush - 'TCR in Practice: Navigating Insulin for Protein & Fat in Type 1 Diabetes'
At the end of the video there is some strategies described with automatic pumps.
And the graph a t=174 is kind of eye opening:
https://youtu.be/uHaYPEDGaro?t=174
Equally dramatic, in my experience, is the effect of exercise in modulating glucose spikes. It quickly became apparent that if I walked or worked out at the gym within 30mins of a meal, dGlucose/dt and subsequently max glucose would be dramatically reduced. Eventually, I got into the habit of planning exercise post high-GI meals as a way eliminate spikes.
It was an effective weightloss strategy for me as opposed to strictly a glucose regulation method and a positive experience as a whole as I got to develop an intuitive understanding of a physiological process I had only a theoretical understanding of before.
1. It would have been nice to see a labeled abscissa[2][x-axis].
2. https://en.wikipedia.org/wiki/Abscissa_and_ordinate
We've managed to keep our sons A1C in the 6-7% window after we changed our diet to be heavily carb controlled.
I understand it means an extra burden for all; but to me, voluntarily doing something challenging together for a family members' benefit seems preferable to facing each adversity largely independently.
As an aside, while likely much better than uncontrolled, 6-7% A1C still seems on the high end for lifelong. You probably already know this, but exercise immediately after carbohydrate consumption can also help - e.g. family walk after dinner (another thing my partner isn't interested in)
Especially with kids, it's difficult since you don't control how much they decide to eat making pre-bolusing meals challenging (part of why reducing carbs tends to be helpful for people is it reduces the need to pre-bolus and makes it less risky since you need less up front meal insulin).
We would like to get him in the 5's, and I believe we'll get there. Between honeymooning and growth hormones, it's difficult to keep him in range from 10pm to 3am, while also not triggering a low after his stomach is empty.
A researcher with T1D and present online:
https://andrewkoutnik.com/ https://x.com/AKoutnik/
Interview:
https://www.youtube.com/watch?v=CG8UU7P8FBU Can Keto Transform Type 1 Diabetes Treatment? A Decade of Insights from Dr. Andrew Koutnik
https://www.masteringdiabetes.org/type-1-diabetes-diet/
I'm not sure what explains the discrepancy. The medical guidelines seem to recommend the same diet for type 1 diabetics as anyone else.
CGMs (of any brand) are not, and have never been, reliable in the way that this story implies that people want them to be reliable. The physical biology of CGMs makes that sort of reliability infeasible. Where T1s are concerned, patient education has always included the need to check with fingerstick readings sometimes, and to be aware of mismatches between sensor readings and how you're feeling. If a brand of CGMs have an issue that sometimes causes false low readings, then fixing it if it's fixable is great, but that sort of thing was very much expected, and it doesn't seem reasonable to blame it for deaths. Moreover, there are two directions in which readings can be inaccurate (false low, false high) with very asymmetric risk profiles, and the report says that the errors were in the less-dangerous direction.
The FDA announcement doesn't say much about what the actual issue was, but given that it was linked to particular production batches, my bet is that it was a chemistry QC fail in one of the reagents used in the sensor wire. That's not something FOSS would be able to solve because it's not a software thing at all.
If it had read too high, it could result in an insulin overdose, which can indeed bring coma followed by death in fairly short order.
Agreed. This story is clearly pushing an agenda to an extreme degree. They spent a lot of time linking to different things and past stories, but the claim of having killed seven people gets almost no coverage in the story. Can we at least get a source to where they’re getting that information?
Fourth paragraph of the article, first sentence, the hyperlink text says, "the US FDA announcement". The link[1] contains the following under the heading, "Reason For Early Alert":
> Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses. These decisions may pose serious health risks, including potential injury or death, or other less serious complications.
> As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.
[1]https://www.fda.gov/medical-devices/medical-device-recalls-a...
Almost all deaths are associated with dietary factors. !== eating causes death.
This has been my impression. I briefly used an Abbott Lingo to help me understand some health issues I was experiencing.
It's always been clear to me (including in the app and documentation) that CGMs are an extremely convenient tool as a first line - but struggle in extreme circumstances. And, let's be clear, if you would generally know if your body is in one of these extreme circumstances. You'd probably be feeling like shit.
That's not to mention the device in question, the Freestyle Libre, is (to my understanding) by far the most popular insulin-dependent diabetes CGM available.
This article is equivalent to calling the Boeing 737 unsafe because it's had the most Full Lost Events while completely ignoring it's flown 238.84M flights (which is basically more than the entire rest of the list combined).
> This article is equivalent to calling the Boeing 737 unsafe because it's had the most Full Lost Events while completely ignoring it's flown 238.84M flights (which is basically more than the entire rest of the list combined).
It sounds like you aren't actually diabetic but feel comfortable explaining how people experience using the equipment they use to manage their disease?
Imagine: "Ugh, Linux sucks and the one time a webpage timed out and it said it was running GNU/Linux, I knew that Linux could never work on my desktop."
maybe when we reach like 10k deaths it’d be OK to report it?
One could look at this story case-by-case and what happened to the affected individuals. Did the device directly lead them to harm? Of the wide coverage of this story, I see no testimonials from affected people.
We're left with the statistical perspective. I don't see the math supporting this story. I expect that as many or more people would have been harmed by diabetes during the time period without this bug.
I think it is more harmful to perpetuate the lack of context or analysis that brings crowds to look at statistical noise and agree that something must be done about it.
If you include in the count a new model which arguable should never have been allowed to be called the same plane, then yes, your prior good record looks ok. Over various generations the hull loss rate had come down to 0.18 per million flights while the MAX is at 1.48 per million flight.
Not sometimes. "Over an extended period".
"Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings. If undetected, incorrect low glucose readings over an extended period may lead to wrong treatment decisions for people living with diabetes, such as excessive carbohydrate intake or skipping or delaying insulin doses."
Months of high blood glucose level can worsen patient's condition or if high enough even put them into hyperglycemic coma in weeks(?).
[0] https://www.fda.gov/medical-devices/medical-device-recalls-a...
I use the G7 and the directions say to always use a finger stick to celebrate the unit, especially at high and low readings.
Did these people also not see and endocrinologist to get things like A1C?
Diabetes is very unforgiving as you get older or are a fragile diabetic. If they were just dependent on the CGM alone then it's likely a lot of other mismanagement was already occurring.
Typo. Perhaps you meant to celibate.
"A new monk arrived at the monastery. He was assigned to help the other monks in copying the old texts by hand. He noticed, however, that they were copying copies, not the original books. The new monk went to the head monk to ask him about this. He pointed out that if there were an error in the first copy, that error would be continued in all of the other copies.
The head monk said, ‘We have been copying from the copies for centuries, but you make a good point, my son.’ The head monk went down into the cellar with one of the copies to check it against the original.
Hours later, nobody had seen him, so one of the monks went downstairs to look for him. He heard a sobbing coming from the back of the cellar and found the old monk leaning over one of the original books, crying.
He asked what was wrong.
‘The word is ‘celebrate,’ not ‘celibate’!’ sobbed the head monk."
I suspected he was paranoid, but thanks for the rational explanation!
There are a few problems with this. I'm a T1D and your sugar level can change very rapidly and you can be near a critical situation before you feel it. Even worse is an issue after you fall asleep. Tell your friend you'd rather not find him dead in the morning.
It could be the software freedom conservancy assumed software bugs, with the same limited knowledge as the assumption being made here about chemistry quality control, so readers will have to decide which sounds more likely. The article do state later that "We also will probably never know whether this issue was in hardware or software... the public deserves to know the technical details ". We can make a favorable interpretation here that they acknowledge the possibility of it being software, hardware or QC. Making accident reports public information is a common step in other areas in order to allow people to learn from mistakes and produce better products.
I will add that blaming faults on human error has generally been shown to be a dangerous route when dealing with fatal accidents in all human endeavors. Correct training and behavior by patients can help to reduce fatal accidents, but one should always be careful to put blame here as a culture of blame generally produce more rather than less fatal accidents. Human-computer interaction is a complex subject and its very possible that the accident rate of those specific CGMs could have been reduced or prevented with better design.
Excellent, to avoid killing a few people a year, you've killed thousands.
If you're not a diabetic or if you have no medical experience around this kind of device, kindly butt out and mind your own business. Low blood sugar in the middle of the night is an immediately deadly condition that needs treatment or the patient can end up with brain swelling. It's also not a condition that will wake the person experiencing it up. Having a CGM blare and alarm has saved countless people and given them a far better life from better sleep, less anxiety, and not randomly dying while resting.
Every CGM comes with directions telling you to calibrate the unit often and do blood stick tests to ensure the unit is working properly. Any diabetic should also be under the care of an endocrinologist as it's a complicated and deadly disease with lots of terrible ramifications.
There's a certain overlap here. It's not completely orthogonal. Having worked on safety critical systems before a lot of effort is put into detecting hardware errors in the software. E.g. random bit flips, ALU hardware issues, RAM writability issues, hash check of the loaded software being ok, plausibility check with (partually) redundant sensors.
You can detect a lot of hardware/QC issues on the software level. While it's still a hardware issue, better software can sometimes at least detect it
I rarely do this, but I'm flagging the article in hopes of limiting its exposure to new readers.
If CGMs are so unreliable and need double checking, I am quite confident that many patients don't understand this, even if it was carefully explained to them by their doctors.
Don't let perfect be the enemy of good when good is increasing lifespans and reducing bad outcomes.
You see false low glucose figures, that last, you start reducing your slow acting insulin, you skip some fast acting insulin. Within 24h, ketoacidosis starts and you can start feeling nauseous. At some point, if you eat, you vomit. You are cornered: you don't have the carb intake to inject insulin, and you can't eat. Even worse, at some point, if you drink, you vomit, so you dehydrate, and it's a matter of hours to live. Shit happens fast, things can get critical is a few days.
Diabetes management is complicated, this is far from exact science, and having a good knowledge of everything is hard. I was already bitten by this cycle of nauseous feeling with slow acting skipped a few month after my diagnosis. I learnt to never ever skip slow acting insulin, even when blood sugar is through the floor. Prepare some apple juice and still go on.
I have Freestyle Libre 2, and it is quite a disappointing thing software-wise. I have to reverse engineer another app to get an API for my data, I have to go through Internet to get my blood sugar level (for a standalone display for example, so I can't make one that works "off grid", like... in my plane), they do sparse updates, they lag behind OS version by dizains of month for their apps, they have 10s of apps/websites, it is hard to understand. So I'm not surprised by poor bug management.
I wish some big names invest in a CGM device. Don't make it medical (even medical grade ones like Abbott & co say you have to check with a finger thingy device, so why bother), make it $500 one time plus $10-20/month, make it open about the data and you'll get everyone. Maybe no one want to invest because in 10/20 years Diabetes will be a thing of the past?
So you don't die in the middle of the night.
I sometimes wonder when typing this if you ever remember life before a CGM?
I thought this article would try to sell us on the benefits of formal software verification or something... Though of course, you can't formally verify complex human biology.
https://www.fda.gov/medical-devices/medical-device-recalls-a...
On one hand, this is a very, very bad bug. On the other, the article is almost of hit job to try to prove FOSS would have solved this issue. There are also a lot of completely factually incorrect statements and wild assumptions.
If my understanding is correct, the device in question, the Freestyle Libre 3, is the most popular continuous glucose monitor (GCM) in production. And, one of only a few approved GCMs available. By the very nature of being an extremely popular device that helps manage a chronic, high effort disease (diabetes management is a massive, massive mental drain) - you're going to have failures.
Not to mention, I've always been under the impression that GCMs have some faults and IF the device reports do not match your expectations, you should confirm with an alternative method (like a finger prick) or seek emergency medical attention (which should have been sought in these extreme circumstances, anyways).
-----
Here's the thing for me. FOSS essentially assumes that the user is going to be willing to understand the underlying details to know when FOSS fucks up. Yes, when FOSS fucks up. That's simply not realistic for any consumer product. If your argument for FOSS relies on users being able to read raw data and interpret things that are only learned by education, that's not a consumer grade solution.
Anecdotally, I used use Abbott's Lingo CGM a few months ago to help get me more data on a health issue I was having. I would never, ever, in my wildest dreams have trusted FOSS to get this right. There's simply too much money/effort/rigor involved in getting these biomedical devices correct to believe that the FOSS community could simply create a better product without actually doing any trials or studies. Not to mention, the recommended app (Juggluco) has a terrible UI. This just isn't going anywhere.
To be clear, this is a deadly bug and Abbott should be held accountable - but claiming the solution is some untested, untrailed, terrible UX is not the answer.
Maybe, maybe not. We know nothing about the bug. It's impossible to judge this based only on the outcomes.
For all we know it could be something very innocuous, like a simple translation mistake.
I actually blame Abbott for there not being a better app. People fear litigation from Abbott and don't work on any.
[1] https://abbott.mediaroom.com/press-releases?item=124718
1. Insulin helps get sugar into cells. Glucagon gets stored sugar out of the liver into the blood. Diabetes management in 2025 only deals with supplying external insulin.
2. There are several variants of diabetes. Type 1 is an autoimmune disorder where the body attacks the cells that make insulin.
3. Too much insulin equals all the sugar getting sucked out of your blood and lymph and into cells. This is really bad in an acute way. Your brain cannot run without sugar. Accidentally give yourself too much insulin for the carbohydrates and wind up dead or in a coma in short order.
4. Highs are also bad, but generally in a less acute way. There are exceptions, but being too high with blood glucose for a period of time doesn't have the acute risks of being too low. Diabetics (or their caregivers) carry around quick absorbing sugar sources to help against a low.
5. The peak action of the common insulin, in the way we dose it, peaks 90 - 120 minutes after the dose. The long tail is about 5 hours of action. So you should give insulin in advance of when you expect digestion to move glucose into your bloodstream. This is tricky. Also, as insulin ages, the peak of the action happens later. If a new vial is 90 minutes, an nearly empty vial might be 120 minutes.
6. CGMs, the on-body instrument in question here, are both flakey and amazing. There's a novel of good and bad here. I'm glad they exist, they can be cantankerous. They are a tint potentiostat, if that is something you happen to be familiar with.
7. Very high blood sugar is treated with extra insulin to overcome the osmotic pressure of having too much glucose in the bloodstream. There's also a lot of chemistry here (glycocalyx to get you started). If your blood sugar is high you generally need more insulin to get past the hysteresis effects. Once the blood sugar starts to come down, that extra insulin is still around, and can cause a dramatic low. CGMs let you observe this, and "catch the low" by eating sugar.
8. It's a challenge every day, multiple times a day. Especially with small child who doesn't communicate to you about what they believe about their blood sugar. This is my personal circumstance.
9. Endocrinologists have suggested some wild stuff to my wife and I. For instance, keep a tube of cake icing around, as you can administer it rectally to a child who is passed out (or worse) from a deep low blood glucose. This is how poor the standard of care can be.
Father of 4.5 YO son with Type 1 diabetes, and materials engineer by education.
Learn about type 1 diabetes to understand why this distinction matters.
Type 1 diabetes is not caused by food or weight. It results from an autoimmune reaction that completely destroys insulin-producing beta cells. No one understands what causes type 1 diabetes, but generally it's believed to be caused by viruses and infections. Sometimes you can read about "genetic factor", but overall majority of people with type 1 diabetes have no family history of this disease.
The incidence of type 1 diabetes has been increasing in many countries, and researchers do not yet understand why. It most often appears in children and young adults and currently has no cure.
One again: type 1 diabetes appears to be random and has no cure. It's not caused by food or weight in the slightest. And your life (of life of your child and yours too) suddenly becomes an absolute living hell. Think about it for a second.
For some unknown reason public awareness of type 1 diabetes is hugely limited compared with other incurable diseases. For example, in the UK more people live with type 1 diabetes than with HIV, yet until someone is directly affected, they usually know nothing about this disease. It hits them like a train.
By default, people assume "type 2" when they hear "diabetes." They don't understand that type 1 is a completely different disease - and an absolutely terrifying one. Type 1 and type 2 are as different as day and night. It's like having runny nose vs having no nose.
This confusion harms awareness of type 1 diabetes. It undermines the urgency of finding a cure and shifts attention away from type 1.
When people are diagnosed with type 1 diabetes (or, more often, when their toddlers or children are), they get furious that this confusion exists at all - and that they knew nothing about type 1 diabetes beforehand.
While the other person replying is not technically wrong about why these things are grouped, it is kind of offensive to sufferers of Type 1.
In one case, a 3yo starts randomly getting sick one day, worse by the day, and will be dead if they don't get a diagnosis soon. From that day forth, their parents need to manage every single bite of food they have,
I bought one of these monitors for fun, because I wanted to see how my blood sugar reacts to different foods. The freestyle libre 3 plus.
After wearing it for some time I woke up one morning to sky high blood sugar, talking 13+mmol/l. My manual measures showed around 4.9mmol/l.
The device was essentially not functioning anymore. I sent the company an email, filed out a report, returned the device and received a new one in the mail.
As always if your expected blood sugar isn't matching up with measured sugar levels do a finger stick as recommended by the manufacturer. There are a lot of potential device to human interface issues that can happen.
My wife is a T1D - you’re either diabetic or not.
Freestyles are not reliable to be used purely for managing immediate levels of glucose - it is more about trends and give an idea of whether it is going up or down.
This appears to be an education issue, for the users and also for the writer.
But even Type 1 people will have a different experience in the early days versus years later - you don't lose all beta cell function in one moment.
For high glucose you inject insulin, but if you don't really have high glucose you end up with dangerously low levels leading to coma or death.
https://www.bfarm.de/SharedDocs/Kundeninfos/DE/10/2025/42777...
The actual scenario to worry about is if the number is too high and a close loop system make so the pump injects too much insulin.
As a result, my most recent A1C was 7.1, even though the pump software calculated it should have been 6.3 based on the CGM data being fed into the system. While 7.1 is not too terrible, I have not been above 7.0 in many years.
You might ask why I don’t switch to Dexcom to see if it performs better. Unfortunately, with my insurance coverage, Dexcom would cost nearly seven times more per month.
I'm struggling to understand how occasional false low monitor readings would cause any significant problems?
> > Abbott Diabetes Care stated that certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors provide incorrect low glucose readings.
My understanding is the problem is probably the same, or likely related to, the pressure low - where basically if you eg lie down on the side of the sensor, it can produce a false low sugar reading.
Presumably, this could push some (already sick) people towards DKA. DKA can go from "slightly bad" to "crazy bad" in a span of hours. (Don't, or do ask me how I know.)
Add in reluctance of people to go to the hospital in the US, and I can totally see how people might've died because of it.
It's a bit of a swiss cheeshole/perfect storm - poor BG management, likely not well enough to afford a hospital, possibly already sick - and unfortunately I'd imagine economically struggling people are likely to have a significant overlap of many of these at the same time. Tragic, but realistic, given the sheer scale of many people use these devices.
It's a stretch to go from "associated with 7 deaths" to "killed 7 people". These devices are worn by millions. So coincidental deaths will happen irrespective of causality.
Would be good to have more details on the cases. Kind of hard to see how low readings would cause deaths. You eat, then notice things don't go up, then do a finger stick test and notice it's off.
To die you'd have to end up with ketoacidosis - there are ways to notice. Sure it's bad to have falsely low values but very unlikely to kill.
And I'm glad the text agrees
> It's hubris for activists to guarantee that harm would be prevented if Freestyle had publicly released the hardware specifications and the complete, corresponding source code (CCS). FOSS isn't immune to bugs — even dangerous ones
> We also will probably never know whether this issue was in hardware or software
That being said
> Specifically, the bug caused the device to falsely report an extremely low glucose level
Aren't people cross-checking this with how they're feeling?
People on low glucose won't be feeling normal. If you really had an abnormally low reading maybe double check with a strip meter and calibrate with how you feel
Medical devices are hard. There are hundreds of variables causing variations in measurement
> As a public policy and public health matter, the public deserves to know the technical details (software and hardware) of both the functioning device and the failed device
Yes. 100% this
(I'm all for OSS for reading calibrated data and processing it the way you prefer of course)
Seems relevant
I bet almost everyone with a device with that bug was injured more or less, because high blood sugar is a silent damager of many organs resulting in cumulative damage without overt short term symptoms of injury. For example, slow damage to eyesight, kidneys and nerves in the feet.