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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

#151

Earlier quoted context omitted.

Not necessarily even illegal or dumb. One of the things about testing drugs and medical devices is, you really can't cover all your bases. It would be too expensive to construct a clinical trial with the statistical power necessary to reliably detect very rare side effects. I don't think anyone wants to delay releasing all new drugs to the market by 40 years so that we can be sure about what happens if you take it ov…

Insulin is incredibly expensive and is manufactured by some of the companies making these devices. I wonder how much less insulin people use with these devices?

There is no overlap between companies that manufacture insulin and companies that manufacture diabetes-related devices. (Not for any fundamental reason, it just happened to work out that way.)

Also, the amount of insulin used is not significantly different with a closed-loop system vs. not. Although closed-loop systems do increase the benefit of faster-acting insulin relative to slower insulin, and the fastest-acting insulins are more expensive (especially inside the US).

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

#152
post #132

Earlier quoted context omitted.

When you say The worst-case scenario is quite well understood: excess insulin, up to a configured dosage limit. Is the configuration software controlled? IE, if you had a bug in your configuration or in your microcontroller, could that bug lead to exceeding the configured dosage limit? Or is there a hard limiter (fixed amount of insulin, a physical limit switch, etc) that prevents that.

There's a software limit, selected by the user, in the microcontroller. There's a per-bolus limit, selected by the user, in the pump. There's a physical limit, in the amount of insulin that is loaded into the pump at a time (typically 2-5 days worth).

OK. Based on what you said, I see numerous situations in which a user could receive very large doses simply due to software errors. Have you had external auditors test your design from an adversarial point of view?

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

#153
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…

> Users have to be able to input when they're eating carbs

I’m not diabetic, so I’m probably missing something, but why? I would have expected the CGM to detect the extra glucose quickly enough without any extra input from the user. Kind of like how people with pacemakers don’t have to tell the pacemaker before they start jogging.

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

#154
post #144
post #131

Earlier quoted context omitted.

Thanks. Readers should also note that the main topic is about the closed loop apparent "revolution." In reality it really can be dangerous, exactly because of the explained sensor problems which are real. To clarify to those that don't know: The sensors are big things with the needle permanently in your body. You don't want three needles permanently to be sure that at least 2 from 3 work. If you have only one, you ha…

I'd say that I myself making all the judgements caused way more harm to my body than what the computer can do. It is that much better. Before I used to have nights when my sugar was in a dangerous hypo for hours during the night, luckily not causing too much brain damage. Now all of these problems are gone. Almost all of the scary hypos are gone. My A1c came down from 7.5% to 5.5%. I'm 88% of the time in range, 10% a…

Thanks a lot. My question is: is the techology as reliable that somebody who is without any technical background (e.g a child on vacation without the parents) able to depend on it?

I know that most of the population is actually not technical, and that they can easily understand “correct when high, eat when low” but complex technical reasoning can’t be expected from them. In that context, sensors not functioning as in ideal lab conditions is a big issue.

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

#155
post #143
post #112

Earlier quoted context omitted.

Just to clarify, we were only discussing monitoring and sensors in this subthread. Not closed loop pump systems. A sensor failure in closed loop is dangerous. I do not know how the control software detects and deals with this. I have no experience with them.

A closed loop uses the oref0 algorithm, which tweaks your basal levels and therefore cannot react to fast peaks or cause a hypo not easily fixed by having two candies (or giving an alarm if you're not awake). What it does is it detects an upward trend for the last X measurements, sets something such as 300% temporary basal rate, detects the trend reaching the peak, sets a 0% basal rate until you hit the predefined ta…

Which closed-loop system do you use which can provide both boluses and basals? Can you share? Also do you think Dexcom sensors can be always trusted? Searching, I find something like:

https://forum.fudiabetes.org/t/dexcom-out-of-range-calibrati...

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

#156
post #154
post #144

Earlier quoted context omitted.

I'd say that I myself making all the judgements caused way more harm to my body than what the computer can do. It is that much better. Before I used to have nights when my sugar was in a dangerous hypo for hours during the night, luckily not causing too much brain damage. Now all of these problems are gone. Almost all of the scary hypos are gone. My A1c came down from 7.5% to 5.5%. I'm 88% of the time in range, 10% a…

Thanks a lot. My question is: is the techology as reliable that somebody who is without any technical background (e.g a child on vacation without the parents) able to depend on it? I know that most of the population is actually not technical, and that they can easily understand “correct when high, eat when low” but complex technical reasoning can’t be expected from them. In that context, sensors not functioning as in…

Here in Germany we have a group of diabetics helping each other with the system. Most of us are not so technical, for everybody the system has been a massive improvement compared to their own judgement.

As a type1 you must have a lot of knowledge to be able to survive. The software is a tool you must learn how to use, but takes away lots of burden from the decision making.

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

#157
post #155
post #143

Earlier quoted context omitted.

A closed loop uses the oref0 algorithm, which tweaks your basal levels and therefore cannot react to fast peaks or cause a hypo not easily fixed by having two candies (or giving an alarm if you're not awake). What it does is it detects an upward trend for the last X measurements, sets something such as 300% temporary basal rate, detects the trend reaching the peak, sets a 0% basal rate until you hit the predefined ta…

Which closed-loop system do you use which can provide both boluses and basals? Can you share? Also do you think Dexcom sensors can be always trusted? Searching, I find something like: https://forum.fudiabetes.org/t/dexcom-out-of-range-calibrati...

The oref1 smb is in AndroidAPS release candidates and in OpenAPS. You can't trust anything 100% ever, but you start recognizing when they have problems and can cope with the errors.

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

#158
post #156
post #154

Earlier quoted context omitted.

Thanks a lot. My question is: is the techology as reliable that somebody who is without any technical background (e.g a child on vacation without the parents) able to depend on it? I know that most of the population is actually not technical, and that they can easily understand “correct when high, eat when low” but complex technical reasoning can’t be expected from them. In that context, sensors not functioning as in…

Here in Germany we have a group of diabetics helping each other with the system. Most of us are not so technical, for everybody the system has been a massive improvement compared to their own judgement. As a type1 you must have a lot of knowledge to be able to survive. The software is a tool you must learn how to use, but takes away lots of burden from the decision making.

> Here in Germany we have a group of diabetics helping each other with the system

Can you give some more details please? I ask for a friend of mine. Thanks.

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

#159
post #152

Earlier quoted context omitted.

There's a software limit, selected by the user, in the microcontroller. There's a per-bolus limit, selected by the user, in the pump. There's a physical limit, in the amount of insulin that is loaded into the pump at a time (typically 2-5 days worth).

OK. Based on what you said, I see numerous situations in which a user could receive very large doses simply due to software errors. Have you had external auditors test your design from an adversarial point of view?

Well, the bloomberg article mentions that Medtronic has accepted this new uprising (which is great), but there's nothing mentioned about if the new relationship has meant the DIYers have a clear path to controlling pumps that doesn't rely on hacks.

The chances are this is unlikely, for legal reasons: Medtronic creates regulated medical devices. I wonder whether it would be possible to add something along the lines of "push this (software/hardware) button to allow non-regulated 3rd-party hardware and software to begin controlling your medical device, but doing so will bind you to " and get such functionality to pass FDA approval. I somehow suspect not, although I would be very happy to hear otherwise.

As things stand now, though, it sounds like (as the article suggests, with the picture of a "hacked pump") people are still relying on methods and techniques that it sounds like anyone can use. So yes, unfortunately everyone's in a situation where any adversary within Bluetooth range could probably take the device over, and (depending on the severity of the vulnerability being used) perhaps modify the pump itself to pump too much or too little regardless of inputs, or similar.

Quite an uncomfortable situation from a security perspective. :/

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

#160
post #158
post #156

Earlier quoted context omitted.

Here in Germany we have a group of diabetics helping each other with the system. Most of us are not so technical, for everybody the system has been a massive improvement compared to their own judgement. As a type1 you must have a lot of knowledge to be able to survive. The software is a tool you must learn how to use, but takes away lots of burden from the decision making.

> Here in Germany we have a group of diabetics helping each other with the system Can you give some more details please? I ask for a friend of mine. Thanks.

It's just a loosely connected group of people in Berlin, going to the same doctor's office and being interested in tech.
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