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A $250 Biohack That’s Revolutionizing Life with Diabetes
81–90 of 162 posts
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#82Earlier quoted context omitted.
Somehow I can't help but read you've smuggled endorsement for: It's ok if the product is more dangerous when bundled with the benefit that we can blame it on some organization.
And what do you suggest we do when an open-source "biohack" results in something like this ? https://en.wikipedia.org/wiki/Thalidomide Note the mistake made, and just how subtle it was. During testing a somewhat more ad-hoc process was used to produce the drug that did not result in the bad isomere, and then it was sold with multiple isomeres in the actual drug. Regulators at the time thought that isomeres did not ma…
I have to add: Thalidomide is still prescribed today as it is a very effective drug. Also, as a response, the US has a much stronger system for evaluating drug safety.
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#83The article, strangely, leaves out the name of the project it's reporting on. It's OpenAPS, http://openaps.readthedocs.io/en/latest/ . I use it and have worked on the code. It's a massive health and quality of life improvement over anything that exists which is FDA approved. The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blam…
Hi- I used to work in regulated pharma and I want to be clear: " The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blamed if something goes wrong" is a misleading statement. The reason everything is regulated is that sometimes things do go wrong, and it's necessary to have root cause attribution so the problem can be remedied an…
These two explanations seem entirely compatible to me.
For better or for worse, in an environment where "root cause attribution" is such a preoccupation, it's not such a stretch to think that the agents acting in it would be strongly incentivized to minimize their opportunities to be the root cause - in other words, "be blamed if something goes wrong".
I don't think that needs to be interpreted as nefarious. It might just be that everyone looked at making them more automatic, and just decided that the costs to do all the research that would be necessary for CYA and regulatory purposes would be too great.
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#84The article, strangely, leaves out the name of the project it's reporting on. It's OpenAPS, http://openaps.readthedocs.io/en/latest/ . I use it and have worked on the code. It's a massive health and quality of life improvement over anything that exists which is FDA approved. The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blam…
They actually aren't leaving out the name of the project, it's called Loop - the system that she's on is not actually OpenAPS. I've tried both systems, OpenAPS lacks a clean, user friendly UI. As a result, most people (according to a recent survey) are running Loop instead of OpenAPS.
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#85The article, strangely, leaves out the name of the project it's reporting on. It's OpenAPS, http://openaps.readthedocs.io/en/latest/ . I use it and have worked on the code. It's a massive health and quality of life improvement over anything that exists which is FDA approved. The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blam…
From the docs: "One of the most frequently asked questions is “I have a 723 pump but it has version 2.5B software version. Has anyone figured out a way to make newer model Medronic pumps compatible? Like flash older version of software onto my 723 2.5B pump?” The answer is “No. The ability to downgrade software versions in the pumps does not exist. It has been investigated and nobody has made any successful progress…
Compatible pumps ARE that rare these days... I've seen them being sold online for anywhere from $500 - $3,000 depending on their condition. I've purchased a few as backups because it's not a question of IF my current one will fail, it's WHEN.
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#86The article, strangely, leaves out the name of the project it's reporting on. It's OpenAPS, http://openaps.readthedocs.io/en/latest/ . I use it and have worked on the code. It's a massive health and quality of life improvement over anything that exists which is FDA approved. The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blam…
Hi- I used to work in regulated pharma and I want to be clear: " The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blamed if something goes wrong" is a misleading statement. The reason everything is regulated is that sometimes things do go wrong, and it's necessary to have root cause attribution so the problem can be remedied an…
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Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#87One of my coworker has a DIY glucose monitor he uses to monitor his kids from work with a Raspberry Pi. He made a blog post about it. Here's the link if that can help anyone: https://www.robotshop.com/blog/en/xdrip-bridge-type-1-diabet...
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#88Earlier quoted context omitted.
Hi- I used to work in regulated pharma and I want to be clear: " The core problem is that the FDA-approved devices are optimized not for getting the best result, but for ensuring the manufacturer can't be blamed if something goes wrong" is a misleading statement. The reason everything is regulated is that sometimes things do go wrong, and it's necessary to have root cause attribution so the problem can be remedied an…
These two explanations seem entirely compatible to me. For better or for worse, in an environment where "root cause attribution" is such a preoccupation, it's not such a stretch to think that the agents acting in it would be strongly incentivized to minimize their opportunities to be the root cause - in other words, "be blamed if something goes wrong". I don't think that needs to be interpreted as nefarious. It might…
Yes. It is the "ensuring the manufacturer can't be blamed if something goes wrong" mindset that says, "it's necessary ... if somebody did something illegal or dumb, they can be sanctioned".
Another approach would be to focus on patients and ignore punishments. Which is what the hackers are doing: ignoring rewards and punishments that are driving professionals in the field.
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#89Earlier quoted context omitted.
And what do you suggest we do when an open-source "biohack" results in something like this ? https://en.wikipedia.org/wiki/Thalidomide Note the mistake made, and just how subtle it was. During testing a somewhat more ad-hoc process was used to produce the drug that did not result in the bad isomere, and then it was sold with multiple isomeres in the actual drug. Regulators at the time thought that isomeres did not ma…
I have to add: Thalidomide is still prescribed today as it is a very effective drug. Also, as a response, the US has a much stronger system for evaluating drug safety.
US regulators did not approve thalomide until after the risks were known. Their system for evaluating drug safety is the strongest in the world and that is why there were no thalomide induced birth defects in the US. Those problems, subtleties and failures of regulation were in European markets where thalomide was approved more quickly (and new manufacturing processes were less closely regulated than the drug itself). EU has stronger regulatory practices in place as a result.
Re: A $250 Biohack That’s Revolutionizing Life with Diabetes
#90Earlier quoted context omitted.
No matter who you are (T1, T2, neither), you die without insulin. It's the only way to remove glucose from the blood. Most T2's are resistant to the normal level of insulin in the blood, and must compensate by introducing ever more insulin until it reaches a high enough level to overcome the resistance and it acts to absorb glucose. Normally this is done through medications that either 1) increase the amount of insul…
No, you can also pee glucose away if over renal reabsorption capacity.
Renal treshold is around 180 mg/dL, at which point glucose level is alerady toxic and if not treated will lead to long-term complications.