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Open Source Artificial Pancreas Helps Engineer's Son Survive With Type 1 Diabetes
HughPickens.com writes: More than one million Americans live with Type 1 diabetes, an autoimmune condition in which the pancreas stops producing insulin, a hormone needed to turn sugar into energy. Now Kate Linebaugh writes at the WSJ that Jason Calabrese, a software engineer, followed instructions that had been shared online to hack an old insulin pump so it could automatically dose the hormone in response to his son's blood-sugar levels. The Calabreses aren't alone. More than 50 people have soldered, tinkered and written software to make such devices for themselves or their children. Initially, Calabrese worried about the safety of the do-it-yourself project. He built it over two months, and spent weeks testing. At first, he only tried it out on his son on weekends and at night. Once it performed well enough, he said it felt irresponsible not to use it on his 9-year-old son. "Diabetes is dangerous anyway. Insulin is dangerous. I think what we are doing is actually improving that and lowering the risk," says Calabrese. The home-built project that the Calabreses followed is known as OpenAPS. The only restriction of the project is users have to put the system together on their own. As long as the people tinkering with their insulin pumps aren't selling or distributing them, the FDA doesn't have a legal means to stop it. The system involves an outdated insulin pump that communicates with a small radio stick connected to a continuous glucose monitor, a computer motherboard and a battery pack. It is an outgrowth of another open-source project where caregivers developed software to remotely monitor blood-sugar levels. The size of the homemade system varies, and the one that Calabrese carries has come down from the size of a small shoebox to that of a headphone case. He wears his insulin pump and glucose monitor on his belt. "It is clearly for people who have some expertise in computer programming," says Bruce Buckingham. "What it shows is that people are anxious to get something going."
It's because of too much sugar and carbs. Get rid of the junk food!
And when a bug causes it to use all its insulin at once and the child goes into a coma and dies, you'll finally understand why open source and the medical industry do not belong in the same sentence.
When information is shared instead of hoarded by those shackled by intellectual property laws, non disclosure agreements, etc. then we may find cures. This might be because the cure is not in the best interest of some folks in this business. It won't surprise me one bit if major breakthroughs that have eluded big pharma for years are just around the corner - and might cost them their big earnings on chronic, incurable, lifelong illness.
Education and vigilant self-management. I can see where something like this might help someone who can't manage their own diabetes, but ultimately he would probably be better off to teach his son about how to manage his own diabetes with good diet, self testing and injecting when required.
Its good that they have done this, but its not for me. Personally I think we need to wait for the technology to get smaller, or the 'cell-in-a-box' type technology to come to fruition. The inconvenience of carrying around that much gear compared to a just an insulin pen and glucose tester which fits in my pocket just makes it not worth it. There is also something about using crusty old equipment with notes such as "use firmware version below X for compatibility" and especially something about javascript code feeding anything straight in to my bloodtream that just unnerves me. https://github.com/openaps/oref0/tree/master/bin
That's illegal. Now he should turn himself in. The law says "hacking" is criminal so now he is guilty and a criminal. It's the law!
Medical hacking is the way forward. The established industry will fight it, but there are so many engineers and other tech people out there that will come up with solutions to their own problems, or that of their families.
This is not the first time we hear about this. Many of the problems in the health industry is continously monitoring, and reacting upon values. This is just as much an IT discipline as a medical discipline. With low power computers (Arduino as an example), all types of sensors being available for cheap etc, we are almost where the computer industry was around 1975-80. engineers and hobbyists will hack together such devices. It is trivial to monitor blood glucose using a sensor on i2c. You could add 2 for redundancy. Then write code, and decide what to do with abnormal values.
The problem for the established industry is, that things will get invented by users before the medical industry gets there = no patents.
It's hacking. That's verboten. So it's criminal. People who do it are criminals. You wouldn't want criminals to play doctor on your body, now would you? Or on your children? Well?
Yes, you can thank the "computer security" industry poser s'kiddies for this. The losers have won, so we all lose. Share and enjoy!
I'm sure the FDA is wracking it's brains looking for a way it can jump in and snatch defeat from the jaws of victory.
I wish they didn't call it an artificial pancreas as insulin is only one of hormones secreted by that organ. It also has to be re-filled with insulin while the pancreas does not. It is an automatic insulin pump not an artificial pancreas. It is a great device and does not need the hype.
I've no problem with open sourcing it, this kind of thing has been an Iphone app for years with certain brands of insulin pump and continuous glucose sensor. There are certain classes of error that have ocurred, even with human handling of my own pump.
* Missetting a standard basal rate, which can easily be 4 times the standard dosage, or 0.
* Suspending the pump and forgetting about it.
* Ignoring a recent bolus and applying an extra manual bolus, so you get up to the maximum bolus of insulin. This is typically on the order of 10 units: not enough to be immediately lethal, but enough to bring a very high blood sugar down to normal or even lower, and enough to cause convulsions if your blood sugar is not already quite high.
* Missetting a temporary basal to 0% or 200%.
* Misentered blood sugars leading to wildly large boluses or suspension of the pump.
* Misentered amounts of food (typically recorded as grams of carbohydrate).
Also note that the amounts of food is error prone: it's awfully tough to measure the carbs of takeout food.
Insulin pumps are much better than injections because they allow a far more flexible and dynamic response to tests, to exercise, and to food. But insulin pumps are basically like portable iron lungs for polio victims. *None* of the continuous sensors is very accurate over time, they *all* require frequent recalibration with a standard glucometer, and the pump site iinfusion kits and continuous sensors are quite expensive over time. Figure that they basically double or triple the price of daily insulin treatment, then add in roughly $3000 for the pump itself, and it's a very expensive set of tools. There has never been a good continuous sensor for blood glucose. They all involve an injected needle drawing body fluids osmotically for chemical testing, hurt, they're all prone to confusion and drift, because *they're not consistently accurate*. They all drift over the few days they're worn.
By the way, there have been multiple attempts to make spectroscopic sensors. None of them worked well, and the vendors of all of them were convicted of stock fraud for basically lying about their accuracy. (Look up the Dreambeam, the Futrex, and the Diasensor if you don't believe me!) And it' not a matter of money and development time: the spectroscopic spread of other components in blood and tissue, overlapping with the spectral response of glucose, made reliable measurements impossible.
For real treatment for Type 1 diabetes, you need to look at Dr. Faustmann's work at Mass. General Hospital. Her lab found that you can treat the auto-immune problem directly, and it cured Type 1 diabetes in lab animals. They formed new insulin producing cells from adult stem cells, which the immune system no longer attacked and cured the diabetes. They're gathering funding for their second round of human testing, (See http://www.faustmanlab.org/) And the treatment? It's BCG, the tuberculosis vaccine in use worldwide. It's applied in small doses every day for 30 days, with very tight blood sugar control. That's why it never showed up as a miracle cure for Type 1 diabetics visiting 3rd world countries. It's also why no one could replicate Dr. Faustmann's work for years, because the lab animals at MGH got much tighter blood sugar control than most test animals. (Blood sugar tests are *expensive, about $1/test with the cheapest test strips!)
Certain brands of continuous glocose sensor, insulin pump, an insulin pump with glucagon instead of insul, and iPhone app already provide this commercially.
* http://www.imedicalapps.com/20...
It's very interesting that open source software is available and I applaud the father for his involvement with his son's medical issues. I'd urge him to be very careful indeed: many programmers of my acquaintance fail to properly sanitize their inputs, and not to properly handle edge cases. And remote controlled insulin pumps do present profound security risks, so I'd urge caution for any Type 1 diabetics with genuinely malicious and cunning enemies.
Under the Anti-Tampering Act of 2009, it is illegal to tamper with a medical or consumer device in any way, shape, form, or fashion, if that tampering has the potential to cause bodily harm or death.
DMCA 2 may stop that but if it has jail/prison time then the uses win as when they are in lockup the state is on hook for there medical costs.
Open Source is FULLY compatible with medical industry. (except for the industry's business model)
Tinkering often has a key difference with the medical industry in the fact that the industry does rigorous risk assessment and reduction. The process of risk assessment (like described ISO12100:2010) is not embedded in much machine design in the US (contrary to Europe, where many directives and standards require a risk assessment and reduction process). Medical gear (and probably others like offshore) is an exception, as that does require you to do assessments in the US as well, but your average tinkering American engineer is not accustomed to it a lot. This means that many tinkerers may miss a lot of hazards, and the design may be less safe because of it.
Tinkerers that can bring to the table a high enough level of competence (comparable to that of the medical industry and their auditors) on 'what could possibly go wrong' can achieve a higher level of safety than the industry could.
Just like in software, many open source hardware designs are made by the same professional engineers as in industry, only in their spare time.
"Artificial pancreas" implies that it makes its own insulin, not just a repurposed insulin pump and controller with some additional software.
And I wouldn't test my own DIY insulin pump without a cadre of test engineers and thousands of hours of trial runs. It's just too easy to screw up with a fractured cam sourced from a dodgy supplier or a badly placed divide by zero. Human lives are worth the expertise of, well, experts.
The people / community behind NPR are going to HATE this! It's going to cause massive conniptions to their control freak personalities.
I LOVE it. Good job engineer!
Good to see people do an end run around the hellthcare industrial complex to save theirs and their loved one lives lives. Too bad they HAVE to do this.
Good to see people do an end run around the hellthcare industrial complex to save theirs and their loved one lives lives. Too bad t hey HAVE to do this.
If there are several people with these homemade systems, could a study be done cheaply on them to get FDA approval and some company could start making these for people without engineering degrees?
...he will give himself a colonoscopy with a Raspberry Pi camera attachment..
"At first, he only tried it out on his son on weekends and at night".
That sounds incredibly dangerous. If he were to become hypoglycemic because of excess insulin, then he would be asleep and not notice symptoms and so could not respond (like take in oral glucose). If you are awake, you know something has gone wrong when you become lethargic or diaphoretic or tachycardic. If you're asleep, you just slip into a coma. Home experimenting with a device is an interesting concept, but realize you are testing a home-built life-support system and if you make a mistake (like testing a machine when somebody won't notice symptoms of failure) you can kill yourself or your loved one. To me, making the decision to do this for your son crossed an ethical line by putting him at risk.
Clearly there is a market, why hasn't American Style medicare identified and kickstarted this already?
Oh, it's because the profit isn't BIG enough. It's too open source.
Chew on that for a while next time you vote in the old USA.
---Up Up Down Down Left Right Left Right B A START
"As long as the people tinkering with their insulin pumps aren't selling or distributing them, the FDA doesn't have a legal means to stop it."
You're experimenting on your 9 year old son. The FDA might not stop you, but I'm pretty sure Child Protective Services would like a word with you...
Yeah, except that the level of care given in correctional facilities is terrible.
A friend of mine died shortly after being released from prison (they released him because of his medical condition btw) because they wouldn't care for his leukemia properly.
My eyes reflect the stars and a smile lights up my face.
I really hope that I don't sound like a jerk - I am seriously not trying to be one - but my wife is a diabetic and already has an insulin pump that has a wireless connection to a glucose meter. I'm not really sure what I am missing, but it sounds like just a DIY project for something that already exists.
Maybe in your country but not the USA.
The FDA has lawyers, which means they have the legal means. In addition, having or not having the law on their side means nothing to washington bureaucrats since there are no consequences to abusing the law.
There's an exemption to DCMA for medical device research, see http://cyberlawclinic.berkman....