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.
> 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
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).
You don’t get many people calling the MAX a good plane.
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.
That is odd. A too-low reading would result in less insulin and a high blood glucose, which can be extremely uncomfortable but is not immediately deadly.
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.
Theoretical you can get a hyperglycemic coma but for that to happen you need continued and sustained high blood sugar in the way your toilet would smell like a sugar factory for quite a while.
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.
Ok but then that would seem to absolve the manufacturer of liability. If you sell someone a hammer and they try to eat it the manufacturer isn’t liable for the damage.
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?
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!
>and recognize the symptoms, because of such issues.
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.
One of the main uses of these technologies is precisely because some type 1 diabetics can become unaware of the symptoms over time either through chance adaption or over-exposure, for instance, hypo-unawareness.
>If a brand of CGMs have an issue that sometimes causes false low readings
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(?).
While true, you would have to ignore all other indicators for quite an extensive period of time. Like excessive urination and hypersensitivity being obvious ones. Not impossible but I have the strong sense there is more to this story than reported in the FDA disclosure.
>incorrect low glucose readings over an extended period
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.
Muscle movement will cause different reading in mine. They are great for trend monitoring but not reliable for real values. ... Neither are finger measurements as in lower and higher regions they also differ quite a bit. But as usually more measurements by more different methods get you a better image.
I found having the monitor on my left arm results in a more reliable connection and consistent readings. This isn't just during the day either, so can't be explained by lifestyle patterns?
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.
>the possibility of it being software, hardware or QC
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 agree with you that the Fundamental Attribution Error typically wins the day. If people are making a mistake, find the systemic solution. But, it's critical to include Education as one of the potential components. If false readings are always a possibility, the alternative to expecting people to double check results is that we don't allow devices like this on the market.
I'm not a diabetic, but even I was skeptical of the title "Seven Diabetes Patients Die Due to Undisclosed Bug"; this draws a very direct 1-to-1 association when in reality, we know that a death would be the result of multiple failures/oversights.
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.
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!
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?
> 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.
>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.
That seemed odd to me as well (also diabetic). When I'm not being responsible, I can ride out a BG of 300-400 for hours and mostly I'm just lethargic.
That said, my mother in law, who had worse diabetes than me, went without her pump during mine and her daughter's wedding (a bit of vanity about the pump showing through her dress). She was at 600+, and started feeling pretty ill that evening.
It depends on what the true blood sugar value was: if someone were already at the high end of normal and a 'brittle diabetic', you can end up in 'diabetic ketoacidosis' for T1DM individuals or—less likely—'hyperosmolar hyperglycemic state' generally.
High blood sugar should be considered a symptom. High blood sugar can be caused by:
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.
I’m bound to get type 2 some day. So I learned quite a bit about diabetes now. And low sugar is very bad. So a false low sugar tells the patient to eat sweet things. A high sugar causes lots of damage, but I have never heard of it causing death. Usually something gets amputated first. This finding was strange.
Let’s remember this writer is someone who has diabetes and an axe to grind. This is not news. This is a rant.
That’s not true at all. It only reported false lows, not false highs. False lows and false highs are only equivalent if you do not understand the basics of diabetes management.
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.
"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]
Thanks. That’s very different than the headline claim that the issue killed 7 patients. The “associated with” is a broad term in cases like this that means the device may have been used at the time, not that the bug specifically caused the death.
> 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.
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)
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.
Readit News
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 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).
Dead Comment
Dead Comment
You don’t get many people calling the MAX a good plane.
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.
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.
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?
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 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.
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.
Deleted Comment
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.
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 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.
I rarely do this, but I'm flagging the article in hopes of limiting its exposure to new readers.
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...
Dead Comment
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.
That said, my mother in law, who had worse diabetes than me, went without her pump during mine and her daughter's wedding (a bit of vanity about the pump showing through her dress). She was at 600+, and started feeling pretty ill that evening.
See https://www.mayoclinic.org/diseases-conditions/hyperglycemia... for a discussion of both (in Emergency conditions)
Dead Comment
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.
Let’s remember this writer is someone who has diabetes and an axe to grind. This is not news. This is a rant.
Dead Comment
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.
[1] https://abbott.mediaroom.com/press-releases?item=124718
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...
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)
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.
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