91–100 of 162 posts
ketogenic diet is what is revolutionizing life with diabetes, by, you know, curing it (not type 1 though). automating the process of releasing a chemical that is roughly speaking the cause of the disease is hardly revolutionary.
The 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…
Context: I spent five years dating someone who was diabetic and relied on insulin pumps after spending years working closely alongside a good friend who used manual injections. The latter friend is now someone I work with again, and he has since moved through mere pumps to these closed loop systems.
The concept that it is a "conservative" approach to not achieve the "best" result with glucose control is clearly nothing more than an intentional misunderstanding of the long-term side effects of even moderately poor blood glucose control designed to allow you to feel better about the downsides of the specific regulations at play here.
That you also seem to miss that there are serious acute ramifications for lapses of attention is just... it's just evil and calculates is what it is: people with diabetes have a fundamental life-maintenance process on complete manual control, and even minor lapses of attention can have consequences.
Your "conservative" attitude is directly harming people I love, and is only "conservative" from your perspective, not theirs, as it is pushing responsibility that could be taken by a device on to the patient, when even a risky device is almost certainly less risky than their own control.
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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…
Someone should issue a challenge to hotz et al. My guess is that this the intersection between diabetics and reverse engineering hackers is only a very small number of people, so this kind of device or impact it could have on people might not even be generally known in the community
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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…
FWIW, your comment has now made me despise your industry. Just thought you should understand that you aren't convincing. At all. (And to be very clear, before reading your comment I would have just assumed incompetence, but now I am going to go so far as claim active malice.) Context: I spent five years dating someone who was diabetic and relied on insulin pumps after spending years working closely alongside a good f…
That's pretty amazing. You're accusing me of active malice for explaining the (entirely reasonable) thought process behind the government's legal system for regulation that pharma must comply with to operate.
I think when you move from the realm of anecdote to dealing with statistics, products with 100 million users, and historical cases (Therac-25), you gain a perspective that regulation is probably the simplest and most effective mechanism for keeping deaths at a minimum while allowing new products to reach the market.
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Can you please stop spamming idiotic comments all over this thread?! And read the article! It’s about diabetes Type I, which cannot be cured by diet, as it’s caused by too little insulin in the body, not too much as with Type II.
There do seem to be a decent number of T1D patients who use keto diets to keep their blood sugar flat and reduce insulin requirements.
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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.
The more generous interpretation is: We value life and try to reduce the risk of severe damage when making drugs. And regulatory bodies exist to combat the incentive to just ship whatever works without adequate regard for what could go wrong
Thanks for being generous.
Can you imagine how much money big pharma could make if they pulled their fingers out and actually created and supported a solution? If a bunch of parents on the internet can hack it together, it's hardly impossible (I'm not trying to detract from the awesome work these people have done, but my point is that they have nowhere near the same kind of resources as pharmaceutical companies). As a Type 1 Diabetic it's real…
I can imagine people will think this after reading this article, but in my opinion this is not how it is in reality - which is why this article is very poorly written/exaggerated. The article presents this comparison as black & white: DIY = simple and cheap, whereas pharmaceutical companies = difficult and expensive. The reality however, is not black and white.
In a nutshell: You and me can drive around in a car without wearing seat belts our entire life and in the end, this article would say "see nothing terrible happened, it's been completely safe to drive around and seat belts are ridiculous".
It all comes down to statistics, and i believe that the people doing this DIY stuff are unaware of the risks they are taking.
Does anyone happen to have a Medtronic device on the compatibility list that they are looking to sell?
I am involved in this, what i want to say is that openaps are not the best option anymore, and pumps of metronic are not required anymore, android app & other pumps what we use right now.
Most non-technical people using this DIY solution are probably not even aware of this...
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FWIW, your comment has now made me despise your industry. Just thought you should understand that you aren't convincing. At all. (And to be very clear, before reading your comment I would have just assumed incompetence, but now I am going to go so far as claim active malice.) Context: I spent five years dating someone who was diabetic and relied on insulin pumps after spending years working closely alongside a good f…
Wow. That's pretty amazing. You're accusing me of active malice for explaining the (entirely reasonable) thought process behind the government's legal system for regulation that pharma must comply with to operate. I think when you move from the realm of anecdote to dealing with statistics, products with 100 million users, and historical cases (Therac-25), you gain a perspective that regulation is probably the simples…
Earlier quoted context omitted.
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)…