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A $250 Biohack That’s Revolutionizing Life with Diabetes

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Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#121

Post by jimrandomh »

jimrandomh wrote: post #16

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…

Correction: It's Loop, which has some code overlap with OpenAPS but is a separate project. (Apologies to the Loop developers, your name was less Ctrl+F'able.)

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#122

Post by jimrandomh »

dekhn wrote: post #116
jimrandomh wrote: post #113

Earlier quoted context omitted.

I think it may help to have some specifics about what, exactly, the regulations are screwing up here. Every type 1 diabetic has some parameters that they use to determine how much insulin they need: an insulin to carb ratio, an insulin sensitivity factor, and a basal rate (or several basal rates for different times of day). The way these parameters are traditionally managed is that your devices collect data about you…

When you say OpenAPS "works much better", while I believe that in general is probably true, how exactly do you know? Is somebody monitoring the OpenAPS fleet and its users? If something did go wrong, would you be able to recover the decision process that led to the incorrect dosing?

Deep understanding of the system, plus personal experience. There is a repository of OpenAPS users' logs, accessible to a small pool of researchers, but (for medical privacy reasons) there isn't any central fleet monitoring. Each user has detailed logs of what their own install saw and did and why, and is expected to monitor it closely. (And we do in fact monitor them--not just as a precaution, but as a necessary part of the remaining decision-making we still do ourselves. The monitoring requirement is much more manageable and less time-sensitive than it would be in the alternative, without a closed-loop system.)

I have, in fact, had incorrect dosing happen, including the worst-case scenario of an incorrect large bolus at night. (That happened because of a bug on the git head branch, not a release version, which is much riskier. As a developer of the system that's a risk I knowingly accept.)

And that's not actually that bad. The important thing to realize is that the point of comparison isn't a zero error rate, it's the error rate a human would make. The worst-case scenario is quite well understood: excess insulin, up to a configured dosage limit. And that's an error which humans definitely make--it's not even a rare mistake, it's a mistake that a human doing everything manually will make multiple times per year, every year.

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#123

Post by candiodari »

dekhn wrote: post #100
daveguy wrote: post #89

Earlier quoted context omitted.

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)…

The narrative is more complicated than that, see https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey and https://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-af... . In particular: athough Kelsey did correctly identify issues, there wasn't legal support for that kind of regulation until her work led to https://en.wikipedia.org/wiki/Kefauver_Harris_Amendment which was necessary legal support for the FDA regulatio…

True, but the point is more about that the government (and the people) went after the producer of the drug, despite that producer not really having screwed up, and left the ones that had screwed up (state, mothers and doctors) alone.

Furthermore, the law did not really support these cases. But when you cripple 10.000 babies, law does not matter. Plus we all know they went after the company, not because it was at fault, but because they could band together against it.

If that were to happen to an open source project (and that seems a reasonable guess for open source "biohacks"/medicine when they screw up) ... the authors will go to jail for life and die bankrupt. It doesn't matter what license, it doesn't matter what contracts say, it wouldn't even matter if you have personal videos of every user saying they will never hold you responsible with a paper around it signed in blood by both the user and a public notary.

THAT's why we have the pharmaceutical industry we have.

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#124

Post by jimrandomh »

nutjob2 wrote: post #80
jimrandomh wrote: post #16

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…

You're sort of skipping over the bit where a bug in the software (or a hardware issue) kills the user. That's the crux of "being blamed" and regulation. You might say in response it will "almost never" happen, but when it happens to your loved one it most certainly matters a lot.

The risk-of-death is actually quite well understood. If a user gets too much insulin, and doesn't feel when their blood sugar is low and doesn't get a low-blood-sugar alarm or doesn't respond to the alarm, then they could die. So if the closed-loop system incorrectly commands too high a dose of insulin, that could be fatal.

But the alternative isn't that too-high doses of insulin never happen. The alternative is that all insulin doses are selected by a human, and subject to human error. And having a low blood sugar event due to too much insulin is not a rare occurrence for T1 diabetics at all.

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#125

Post by jimrandomh »

gumby wrote: post #10
ThJ wrote: post #3

Earlier quoted context omitted.

Why don't doctors recommend them for type 2 diabetes? Well, my general impression is that doctors live under this illusion that patients will somehow succeed in making lifestyle changes that will cause the disease to go into regression or disappear altogether. Also, they prefer to try medications like glucophage before they resort to insulin. There just seems to be less eagerness to finely manage type 2 diabetics, ma…

> my general impression is that doctors live under this illusion that patients will somehow succeed in making lifestyle changes > Also, they prefer to try medications like glucophage before they resort to insulin. A couple of points: 1- the targets set by associations like the ADA actually assume the patients won't be able to make significant lifestyle changes; for example the ADA A1C targets are higher than for heal…

Be warned! Type 1 diabetics, after they are first diagnosed and treated, have a "honeymoon period" in which their body is able to produce insulin and everything is fine. But you are NOT cured, and you will need insulin again in the future.

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#126

Post by bigtunacan »

jimrandomh wrote: post #115
bigtunacan wrote: post #111

Earlier quoted context omitted.

Context: I am a type 1 diabetic. As far as doctors are concerned I am an exemplary patient who has shown blood glucose controls as good as they come (A1C of less than 6.5 for more than a decade now for those that know what it means). I regularly hear from "concerned" people how they know someone else who's blood control isn't as good and they should do better, etc..., etc... I have personally used some of these DIY p…

OpenAPS doesn't mean you never have to intervene, nor does it claim to. It does mean that the interventions needed are less frequent and more predictable. Ie, in the case of exercise--if it's only a small drop, shutting off basal is enough to counteract it, so it'll do that, and you don't have to do anything. If it's a larger drop, you need to eat carbs to counter it--and it'll send you a notification telling you how…

Yep; I'm aware of all of that.

I'm glad that the open source community is getting involved and I want to see these things help move the industry forward.

My comments were to the parent who presumes

1. To know what is best for diabetics 2. The device is inherently less risky than current options

Nightscout absolutely would not get through FDA approvals today if for nothing other than catastrophic failures. I love the features and think it's way more robust than what is provided by Dexcom, but at the end of the day, I switched back to Dexcom's receiver and app because it doesn't crash.

OpenAPS is great, but requires a level of research and effort than many patients aren't capable of. Then on top of this OpenAPS has this nice disclaimer as an opener, "By proceeding to use these tools or any openaps repositories, you agree to abide by the copyright agreement and release any contributors from any liability."

Now I understand why that statement is there, but when someone dies using this "product" that hasn't been approved by the FDA; well let's just say I hope all parties involved have really good umbrella policies, because I'm not too sure that's going to hold up in a court of law.

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#127

Post by jamestimmins »

dekhn wrote: post #94
saurik wrote: post #92

Earlier quoted context omitted.

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…

In some ways, I think the FDA is a victim of its own success. If I'm not mistaken, it was created in part because of the 100+ deaths around Elixir sulfanilamide. But since the FDA has helped prevent things like that from recurring, we underestimate the potential dangers of under-regulating.

Not that the FDA couldn't be more efficient (possibly considerably more so), but it's clear that most products that go into production work, and that can't be discounted.

https://en.wikipedia.org/wiki/Elixir_sulfanilamide

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#128

Post by jimrandomh »

amluto wrote: post #11

Why exactly is a phone app involved? If I were designing this thing, DIY or otherwise, the CGM would talk to a dedicated micro controller, which would in turn talk to the pump. A phone, if used at all, would get an extremely limited API to read the glucose level, see the pump history, and perhaps change the control parameters within a narrow range. The point would be that no input from the phone should be able to kil…

You need something with a screen somewhere in the system to be able to monitor it and input data, which means a phone app or a web app. In the case of OpenAPS, it works mostly as you described: an Intel Atom SoC talks to the CGM and to the pump, and syncs with a webapp (called Nightscout) for monitoring and user input if internet access is available, but continues to operate autonomously if it isn't. The webapp sends an alert if the microcontroller hasn't connected for awhile (30 minutes), which is how you find out if it's lost communications or powered off.

Users have to be able to input when they're eating carbs. It's possible to do that through the pump (that's how I do it), but there are some ways in which that's not ideal. Most people enter carbs through the webapp. This is capable of creating a dangerous situation for the user (not of killing them). It's a security risk, but also a practical necessity.

Some peoples' setups are more internet dependent than that, though. For certain models of CGM, the way you get data from them is by giving them an internet connection and using a web API provided by the CGM maker. (This is built on abusing APIs that were intended for eg family members monitoring glucose values of children who might not be close by.) And, in the case of Loop, the decision algorithm executes on a phone.

These setups aren't ideal, but they're all made by hackers with limited time and resources desperate to get something that works, because the market isn't providing anything acceptable.

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#129

Post by cadr »

jcims wrote: post #41
keymone wrote: post #40

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.

Do you know if any communities of folks managing T1D with keto diet? I looked into it for my daughter when she was first diagnosed but had a hard time differentiating fact from keto evangelizing and medical community hand wringing.

I don't know of communities, but I've done it since being diagnosed 4.5 years ago, and am still in the honeymoon period, so I haven't gone on insulin yet.

I don't know what I'll do once I actually do need to go on insulin.

(Note to anyone reading this - please don't take the word of a random on the internet - talk to your endo.)

Re: A $250 Biohack That’s Revolutionizing Life with Diabetes

#130

Post by arendtio »

mcherm wrote: post #79
arendtio wrote: post #59

So some people are concerned that their cars have an internet connection and others connect their bodies to it (via the smartphone) and at the same time, both have good reasons to do so :-D Sometimes it is a strange world we are living in. While I admire open source and DIY solutions in general, they often lack the quality assurance a company specialized in medical equippment is used to. So I hope that soon there wil…

You want the quality assurance, yet you don't think that it is acceptable to pay more than 4x the cost of parts. How do you expect that these tests (which are insanely expensive and take decades to run in some cases) will be paid for?

Well, I think for a device like this the most important thing is a very reliable, high quality software (the hardware components are already out there and have been tested already). As the software is the same for all devices, I would expect that it should be possible to cover the overhead of software development, QA, etc. by the number of devices you would sell.

After all, we are not speaking about running medical studies here, just about letting a secure software bridge the different components. So building a software which is well tested (in terms of software tests) and does not inject you when its not supposed to do so, should not be that impossible.

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