So my wife has a CGM and is stuck with a fancy pump that is supposed to "automatically" coordinate with her sensor to deliver or reduce insulin when it detects her numbers are too high/low.
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.
> The FDA reports that Freestyle injured over 700 people and killed seven people with this bug. Spcifically, the bug caused the device to falsely report an extremely low glucose level. Advanced stage diabetics use low reading information to inform them that they may have too much insulin currently. The usual remedy is to eat something sugary to raise glucose in the blood. Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low)
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.
>Such should be done only with great care, as a false low reading can harm and even kill the patient (who eats a high-sugar-content item while glucose in the blood is, in fact, not low).
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.
I depend on a pump and CGM (currently that's a Dexcom G7 and Omnipod, but I've used other brands as well).
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.
"... wrongful death lawsuits are typically the only way to hold these companies accountable. Yet, there are very few people who have not agreed Abbott's toxic terms of their proprietary companion application ..."
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. Pairing subsequent sensors does not require taking it out of airplane mode.
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.
LOL that's crazy, but I would also recommend that any user of these devices who don't have an actual medical issue that requires the device to work, for whatever value of "work" it is capable of ... maybe consider doing that. Just like I put my modern TV in VLAN purgatory.
But if you actually have any form of diabetes... definitely do not do that. Unless you are also rocking some other brand. ¯\\_(ಠ_ಠ)_/¯
To me it's interesting that some type 1 diabetics prefer to manage the disease with a carbohydrate-restricted diet, but some type 1 diabetics prefer to use completely opposite strategy and choose to eat a low-fat diet instead. Here is an article written by a type 1 diabetic with a non-diabetic blood glucose levels on a low-fat diet:
I'm a T1 diabetic, have worked on open source diabetes-tech (OpenAPS), and have used a number of different CGMs (though not this one specifically). This story... does not make very much sense.
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.
This checks out with what a diabetic friends told me as to why he does not really uses tech: he preferred to take the time to learn "himself" and recognize the symptoms, because of such issues.
I suspected he was paranoid, but thanks for the rational explanation!
The FDA announcement make no statement in one way or an other about the cause, only that there is a problem with two monitor sensors under certain model numbers and serial numbers. It not a given that a single production batch include a multiple of model numbers and products. Assuming it is bad quality control of the chemistry is thus not supported by the FDA announcement.
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, depending on what the issue actually was.
Agree. The linked FDA recall said the 7 deaths are "associated", which could just mean contemporaneous. This article is written by a new diabetic who doesn't seem to understand the disease very well yet, and is sensationalist in its reporting (perhaps unintentionally). They are probably opening themselves up to a defamation lawsuit here and are certainly disseminating misinformation, sowing FUD in service of an agenda, however well intentioned.
I rarely do this, but I'm flagging the article in hopes of limiting its exposure to new readers.
The OP is hardly anywhere near as sensational as the latest AI generated github something-or-another typically posted here. I found the article extremely useful and would not be aware that it effected MORE THAN ONE product line. Please don't let @dang bury this IMO. If you have an alternative URL please post it!
He's not intentionally sensationalist, he's just flat out wrong. An uninformed piece like this does not belong here IMO without heavy context provided front and center.
I have two elderly relatives that use CGMs and both are at a stage in life now where they really cannot be expected to exercise common sense. I am pretty sure they've both been using CGMs exclusively and haven't been using finger sticks, at least not regularly, and one of them has a very hard time even understanding that apple pies are filled with sugar. No real intuition for which foods have or don't have sugar.
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.
Having high glucose levels won't kill you in the sort term, yes. But we cannot compare pre-diagnosis high blood sugar level (the body had that for months so it is accustomed to it) to the suddenty of it with cutting off insulin. In fact, things can spiral out quite quickly.
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?
Can anyone find the link to the document that claims 7 patients died as a result of these false low glucose readings? It’s strange that this article would go to great lengths to include footnotes and sources for various things except for the core of their claim.
FWIW CVS did sent out a letter via USPS (I use their mail order service) about the recall and the risk. I'm not sure what the "undisclosed bug" refers to.
Tidepool is a non-profit focused on diabetes. Among other things, they are working on an algorithm (loop) that does insulin dosing: https://www.tidepool.org/tidepool-loop
If one wants to separate the hardware (insulin pump, CGM) from the algorithm that controls them, seems like Tidepool is one org to talk to.
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).
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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.
"Globally, Abbott has received reports of 736 severe adverse events (57 in the U.S.) and seven deaths (none in the U.S.) potentially associated with this issue."[1]
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 sugars 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 (fastest reduction in blood glucose level) of the common insulin, in the way we dose it, peaks 90 - 120 minutes after the dose. The long tail is about 5 total hours of action from the point of dosing. 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 after dosing for peak action.
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 tiny 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 to replenish the baseline sugar trapped in circulation.
8. Diabetes management is 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.
There is no such thing as "diabetes", people should start distinguishing between type 1 diabetes and type 2 diabetes - they are different diseases. Type 1 diabetes is an autoimmune disease with no cure, not caused by food, lifestyle or weight, and is an absolute living hell; while type 2 diabetes is caused by excessive weight and can sometimes be put into remission or even fully cured through weight loss.
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.
Once 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 the same logic, there's no such thing as "cancer", a "cold" (or more accurately: upper respiritory illness), or a broken leg, since each of these have many distinct causes.
All models are wrong, some models are useful. And some are based in at least part on historical accident and sequence of understanding. Diabetes (etymology, Greek diabetes, excessive discharge of urine), is one such of these.
Of the multiple distinct types of diabetes currently recognised (types 1 & 2, which you note, gestational, MODY, 5, and possibly several others), there is a commonality of primary symptoms (unregulated, often high, blood sugar), treatments (most must or may be treated with supplemental insulin), monitoring (of blood glucose levels typically by finger stick or CGM, as well as HgA1C for longer-term status and progression), of healthcare providers specialising in the diseases (generally endocrinologists), and of long-term complications: high blood pressure, heart disease and failure, neuropathy, poor circulation, various infections, and often peripheral limb amputations.
Thus the medical literature notes that diabetes is a group of common endocrine diseases all sharing high blood sugar levels, though of distinct types having distinct causes but largely similar treatments.
In the same sense, treatment for a broken leg largely doesn't distinguish on the cause of the fracture (blunt trauma, falls, osteoperosis, gunshot), treatment of respiratory illnesses is similar despite different infectious agents, and cancers, whilst varying greatly in prognosis and treatment, share the commonality of unregulated growth and metastases, with similar end-stage consequences.
All labels and concepts are human constructs to simplify a complex world. Absolutism over definitions tends not to be especially enlightening. Or useful.
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, stab them with needles multiple times a day no matter what, and inject them with a insulin - where, if you miscalculate, will cause a seizure within an ~hour and death within a few hours. From a single typo.
Nothing will cure them, their life will be much shorter, filled with work and pain and expense with absolutely no relief, and nothing could've avoided it.
Now compare to Type 2, where you basically cannot get it if you maintain a reasonable diet and a reasonable weight.
Once you start showing symptoms, if you listen to your doctor and reform your diet (particularly with the 5% shock weight loss approach), you will almost definitely avoid it.
You will avoid it for the rest of your life just by eating well, which has the added benefit of extending your lifespan and healthspan and saving you money.
These things have nothing in common, for the sufferer or their family.
I understand that low BG is typically much more capable at making itself fatal than high BGs (T1 myself, like half the people in this thread.)
> > 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.
I might have experienced one of these deadly bugs, although I got way to high measurements, not too low.
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.
There is another post here stating a German article saying 'false highs' which is a whole lot more dangerous than false lows. This can cause people to overcorrect and go low. This said, the same CGM should have warned about the low.
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.
FOSS can be written the same as any other software, and there's plenty of FOSS that fails to meet modern best practices.
But a software building code might have saved lives. The same way building codes save lives around the world every day, by ensuring safety-critical things in the world aren't slapped together haphazardly, and are tested for safety.
Ask your representatives in government to assemble a professional body to set software building codes for the software that could potentially kill you.
What the f is ‘early stage’ and ‘advance staged’ diabetic?
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.
Let's not fool ourselves in thinking open source would solve this problem here
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)
> As of November 14, 2025, Abbott has reported 736 serious injuries, and seven deaths associated with this issue.
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.
Bugs are going to happen in any software project. I’m more concerned that their QA missed the issue. Seems like they should’ve had some inkling given how easy it is to test blood glucose.
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[ 2.9 ms ] story [ 64.8 ms ] threadI'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.
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.
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.
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. Pairing subsequent sensors does not require taking it out of airplane mode.
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.
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
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.
I suspected he was paranoid, but thanks for the rational explanation!
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, depending on what the issue actually was.
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.
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?
If one wants to separate the hardware (insulin pump, CGM) from the algorithm that controls them, seems like Tidepool is one org to talk to.
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).
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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.
[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 sugars 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 (fastest reduction in blood glucose level) of the common insulin, in the way we dose it, peaks 90 - 120 minutes after the dose. The long tail is about 5 total hours of action from the point of dosing. 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 after dosing for peak action.
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 tiny 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 to replenish the baseline sugar trapped in circulation.
8. Diabetes management is 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.
Once 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.
All models are wrong, some models are useful. And some are based in at least part on historical accident and sequence of understanding. Diabetes (etymology, Greek diabetes, excessive discharge of urine), is one such of these.
Of the multiple distinct types of diabetes currently recognised (types 1 & 2, which you note, gestational, MODY, 5, and possibly several others), there is a commonality of primary symptoms (unregulated, often high, blood sugar), treatments (most must or may be treated with supplemental insulin), monitoring (of blood glucose levels typically by finger stick or CGM, as well as HgA1C for longer-term status and progression), of healthcare providers specialising in the diseases (generally endocrinologists), and of long-term complications: high blood pressure, heart disease and failure, neuropathy, poor circulation, various infections, and often peripheral limb amputations.
Thus the medical literature notes that diabetes is a group of common endocrine diseases all sharing high blood sugar levels, though of distinct types having distinct causes but largely similar treatments.
In the same sense, treatment for a broken leg largely doesn't distinguish on the cause of the fracture (blunt trauma, falls, osteoperosis, gunshot), treatment of respiratory illnesses is similar despite different infectious agents, and cancers, whilst varying greatly in prognosis and treatment, share the commonality of unregulated growth and metastases, with similar end-stage consequences.
All labels and concepts are human constructs to simplify a complex world. Absolutism over definitions tends not to be especially enlightening. Or useful.
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, stab them with needles multiple times a day no matter what, and inject them with a insulin - where, if you miscalculate, will cause a seizure within an ~hour and death within a few hours. From a single typo.
Nothing will cure them, their life will be much shorter, filled with work and pain and expense with absolutely no relief, and nothing could've avoided it.
Now compare to Type 2, where you basically cannot get it if you maintain a reasonable diet and a reasonable weight.
Once you start showing symptoms, if you listen to your doctor and reform your diet (particularly with the 5% shock weight loss approach), you will almost definitely avoid it.
You will avoid it for the rest of your life just by eating well, which has the added benefit of extending your lifespan and healthspan and saving you money.
These things have nothing in common, for the sufferer or their family.
> > 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.
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.
FOSS can be written the same as any other software, and there's plenty of FOSS that fails to meet modern best practices.
But a software building code might have saved lives. The same way building codes save lives around the world every day, by ensuring safety-critical things in the world aren't slapped together haphazardly, and are tested for safety.
Ask your representatives in government to assemble a professional body to set software building codes for the software that could potentially kill you.
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...
Any diabetic person must have heard and read this recommendation a thousand times.
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.
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)
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.