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A $250 Biohack That’s Revolutionizing Life with Diabetes (bloomberg.com)
317 points by rbanffy 9 days ago | hide | past | web | favorite | 155 comments





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 blamed if something goes wrong. But that in practice means kicking most of the important things to the end user and their physician, who can't do nearly as good a job as software can.

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 and a fix deployed, and, if somebody did something illegal or dumb, they can be sanctioned.

I wish your project success, but I think (and I've got a bit of experience) if you can't accept that regulation of health products is almost certainly necessary, and that not producing the "best" results is a reasonable if conservative approach, I will never trust your product.


The problem is that although regulation may be necessary, the regulators incentives are different than the users. Regulators are rewarded for being overly conservative. If they are making an assessment best on the riskiness of a device versus the benefits to its users, they should say what their criteria are.

Different users are willing to accept different amounts of risk for a given quality of life improvement. Besides differing between users, the tradeoff is almost certainly in favor of accepting more risk than a regulator would approve.


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 your carbohydrate intake and glucose at various times of day, and every 3 or 6 months you bring those devices to an endocrinologist's office where they print them out, a doctor looks at the printouts, and the doctor suggests tweaks to the parameters. This process works very poorly, first of all because 3-6 months is too infrequent, and second because calculating the correct parameter tweak requires a whole lot of math, not just looking at a printout.

The way it works in OpenAPS is that a program runs nightly, looks at historical data, figures out the correct parameter tweak, and applies it for the next day. This works much better. Much better long term health, much better quality of life, much lower short-term risk of death. But if someone dies, there's no doctor to pin it on. So device makers don't include that feature.

(This is the clearest example, but there are others as well. There are also things like where alert thresholds are set; too few alerts and you're at risk of failing to alert the user to something important, too many alerts and you cause alert fatigue and impact quality of life.)


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.


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?

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 <insert waiver here>" 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. :/


Chiming in to say that some data is available to the public as well, as these Open Humans users have shared their Nightscout data publicly: https://www.openhumans.org/api/public-data/?source=direct-sh...

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.


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.


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 over a lifetime. Even post-release monitoring for these things is potentially tricky, due to the poor interoperability of EHR systems and also, in many jurisdictions, unintended consequences of health care privacy laws.

Meaning that there is no amount of due diligence that will guarantee you can't get sued. Which is fine, you can always go for proportionality instead. But then, the amount of due diligence that's necessary is driven by what costs the legal system is willing and able to impose, and, at least in the legal regime I live under (USA), they've got their own entirely other set of procedures and incentive structures that they're working with.


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).


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

Yes, this is what I meant.

Thanks for being generous.


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 matter and it took years for the effects to become clear. Of course regulators did not test for things they didn't know about. Neither did the companies (not just one). Crucially the drug was NOT tested for the effect on pregnancies (and was therefore not to be taken by pregnant women, like many drugs and even some non-drug products like famously alcohol).

Furthermore: there is at least some amount of "guilt" on the part of some of the mothers: the medicine was NOT approved for use during pregnancy, and stated this.

Result: >10.000 crippled children.

Where is the guilt to be placed for this incident ? I would argue that the primary guilt is with the regulator (government) and a small amount with (most of) the mothers for taking unapproved medicine, with the rest of the mothers following doctors' prescriptions (which of course means those doctors prescribed unapproved medicine). Needless to say, the company was blamed, and forced to pay (essentially in trade for not going to prison). The German government denied any responsibility, and several other governments (famously Spain) went further: they denied anything had happened at all.

So let's say there is a timing bug in this "open source pancreas", and it starts pumping insulin into the patients bodies without cause, say at the unix epoch transition. I would guess that at least half of them won't survive.

What happens next ? Given the Thalomide incident we can make an educated guess: whatever the law says, and despite patients "accepting the risk", even when the patients explicitly make mistakes in the treatment, you can bet the government will go after whoever they can arrest, and force them to pay millions of euros, or throw them in jail for the rest of their life.

People cannot be trusted to accept responsibility for the result of picking their own treatments, even when fully informed about the risks.


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.

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 regulation process.

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.


That's not the endorsement. The endorsement is that it's okay for a single product to be suboptimal as long as the system is optimal. It's more optimal to prevent or slow down a number of innovations in order to protect the vast majority of people from the sort of mistakes and scams that other industries accept as standard.

[flagged]


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 simplest and most effective mechanism for keeping deaths at a minimum while allowing new products to reach the market.


You're actively ignoring the point and just being offended which is natural because it was put extremely bluntly. But you've just restated that the current state of affairs is "entirely reasonable" when the comment you are replying to explains why it's actively harmful. You've provided no argument for why it's reasonable, just taken offense and waved around cases of catastrophic failure.

I don't understand what's unreasonble about:

1) companies have a profit motive and they want to design and sell products

2) historically, we have seen that companies acting with profit motives often have incentives to ignore problems with their products and even actively suppress them

3) the government wants to incentivize companies to make new products that help people

4) but they also don't want large numbers of people to die, or even small numbers of people, due to errors of any kind.

5) we have ample evidence that when unregulated, errors occur and people die. Statistically across large numbers of drugs and medical treatments, we have enough data to make strong, but not perfect statements about which processes minimize negative problems while maximizing availability of product to sick people. In some cases, people die because executives explicitly chose to cut corners. With regulation, we can catch those executives and put them in jail.

6) in general, the one thing that comes out of all of this is that extensive record keeping is required for investigators to deal with problems when they occur. Most of regulation is just record keeping- what did we do, what happened when we did it- and change control. Literally, my job was to ensure that firmware updates didn't change the observable properties of a system that was making a drug that saved people. Yes, when a firmware of a machine that makes drugs is updated, and it has a bug, people can die.

7) given about a hundred years of experience in this area, enough people who work on "reliability" (like SRE in tech) people have developed a set of techniques, called regulation, which attempts to minimize the number of deaths, while still allowing products to reach the market. Like SRE, it's a combination of hard-won experience and a lot of intelligence, along with not enough monitoring data.

8) I also feel pain and unhappiness that pharma doesn't move faster. It wasn't until I worked daily on product development and implementing regulation that I began to appreciate that this is a truly complicated problem with a lot of variables, incentives and players.

9) Even giving my best good faith effort, I simply cannot credit people who give anecdotal evidence about friends with diabetes. There are a number of reasons for this, but basically, if you do enough large-scale decision making, you'll find that anecdotes introduce bias that can lead to poor decision making. I see problems, also, in the DIY community where people sort of assume the best possible results; in science, after you run enough experiments, you get to see: it's easy to fool yourself and think what you've done is good, but it really has to percolate through the system and get evaluated and reproduced by many people before you can trust it.

If you don't think the above logic chain is reasonable, that's OK. Many people aren't happy with how slowly pharma and medical DX industries and FDA work. But, you should basically understand that the entire goal here is to ensure good products make it to the market without "too many unnecessary deaths".

The worst part of all of this is that I dedicated many years of my life to improving the speed at which drugs could be discovered and brought to patients, only to learn that the primary reasons we can't, are political, structural, systemic, and incentivized. If somebody had a better solution than what the current market has, I can point funding at them.


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


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 products and so I want to be very clear; the difference between "somewhat poorly controlled blood sugar" and just one really bad mistake in "tightly/ best-controlled blood sugar" is this

1) Poorly controlled - in a decade I will start to have some additional health problems (vision impairment/neuropathy/etc)

2) Tightly controlled w/dosing mistake - Coma/Brain Dead/Dead

There is a good reason to test this equipment and take a conservative approach.

Physical activity level and how much active or "on board" insulin you need when you are being active vs inactive can vary by 10x. As an example of this; before I do cardio workouts I intentionally do a carb load and let my blood sugar raise before starting to counter the effect the exercise will have on my blood sugar. Despite this on two occasions during running I have experienced double drops (super fast blood sugar drop to unsafe levels) to levels so low I started to black out.

Nightscout/OpenAps/Dexcom/Medtronic, it doesn't matter open source or closed source none of these devices can handle these scenarios so at the end of the day it is still on me to intervene and make decisions based on what I am going to do. Until something better than pump systems come along (and these "artificial pancreas" systems as they are calling them to day are still just pump systems; I will have to intervene no matter how sophisticated the algorithms.

In summary; just because you care about someone with diabetes, do not presume you know what is best for us.


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 many carbs you need to eat, and this notification will typically come quite a bit earlier than the low-glucose alarm the CGMS will eventually send.

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.


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 to that end.”"

I'm curious as to what form the investigation took. Are you aware of an online record of this investigation?

Are compatible pumps rare enough that the need to preserve them is constraining reverse engineering efforts?

---

Edit: For those wondering what these things look like, here is the FCC submission including internal photos. FCC is involved because of the integrated wireless link.

https://fccid.io/OH21510

https://fccid.io/OH21510/Internal-Photos/Internal-Photos-239...

Looks like a System-on-a-Chip with separate memory chips? Can't make out the numbers. Opening in GIMP, it looks as if the photo has been doctored to remove chip numbers? That 12-pin unpopulated footprint on the processor board is for a test/JTAG header?


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

As a "reverse engineering hacker" who is a diabetic with one of these pumps (The 670G to be specific) I have black boxed the shit out of it, but because it is doing a good job of keeping me alive and the cost of a new one is high I have yet to disassemble it and do a thorough RE of it. In ~4 years when the warranty is up an insurance is willing to replace it then I will be disassembling it and hacking the shit out of it.

What happens to all the pumps that break? Chances are that the mechanics break before the electrics, so there will be a bunch of broken pumps with intact electronics somewhere in the wild. Can they be had as freebies for reverse engineering? Many would get returned to Medtronic under warranty, but there would be exceptions?

I had one mechanically fail this summer and my options were turn it in or pay $3,600 and as much as I want to RE it I don't want to spend $3,600 on it. So far medtronic is doing a very good job of limiting the secondhand market on these. I do make regular ebay crawls looking for them through. so far nothing has really turned up :(

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.

Judging by the PCB photo's, that device is much more complitcated than I'd expected.

Anyway, I would love to help the community with some reverse engineering.


Thank you for this work. Do you know why the applicability to type two diabetes is not as clear as for type one? I'd love to read more about that.

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.

I live with someone who has a CGM (continuous glucose monitor) where the device came in a box with an insert saying "do not use this device to make medical treatment decisions." To see any of the readings you have to install an app whose start screen says it's experimental and, again, can't be used to make treatment decisions. But the user's manual has a chapter titled "Treatment Decisions" that tells you how to use it to decide when to take insulin and how much to take. It's frustrating that the messages have to be so contradictory.

A final question: how essential is it to be tech-savvy to use this technology? Is it sufficient to have somebody tech-savvy close to you who is available every day but not every hour of the day, or is it something that should only be in the hands of someone who understands how it works?


I'm not really an expert on T2DM (I'm T1), but I believe the main issue is going to be that insulin sensitivity is much more variable for T2s than T1s, and will change faster than autosens can keep up with.

The reason for the mixed messaging about treatment decisions is that the Dexcom G4/G5 (they're the same sensor with a different receiver) spent part of its product life not approved for use as a basis for treatment decisions, and was later approved for use as a basis for treatment decisions, but only under certain circumstances. There are some best-practices around CGM sensors that the manufacturers won't tell you about, like pre-soaking sensors, which greatly improve reliability. And, counter-intuitively, a closed-loop system is actually less demanding of sensor precision than a human giving correction boluses would be.

For OpenAPS, getting started involves installing Linux on an IoT board, setting up a server on Heroku, and monitoring log files. Tech savvy is definitely required, but mostly for setup, and occasional troubleshooting; if you have a tech-savvy person willing to put some time into it, the can set it up, show you how to monitor it, and then step away.


I can't answer your questions from a clinical perspective, however I'll have a stab at them. I'm a type 1 diabetic, diagnosed when I was 9.

> Do you know why the applicability to type two diabetes is not as clear as for type one?

I'm only stabbing at this, and it's anecdotal, but I believe it is likely due to the lack of consistency across type 2 diabetics. Whilst there is variation in Type 1 Diabetes, it is largely limited to lifestyle but the basic principle is the same - you don't produce insulin yourself. Type 2 diabetes is often caused by insulin resistance, and I guess varies wildly based on the individual, their lifestyle, and their genes.

> I live with someone who has a CGM (continuous glucose monitor) where the device came in a box with an insert saying "do not use this device to make medical treatment decisions." To see any of the readings you have to install an app whose start screen says it's experimental and, again, can't be used to make treatment decisions. But the user's manual has a chapter titled "Treatment Decisions" that tells you how to use it to decide when to take insulin and how much to take. It's frustrating that the messages have to be so contradictory.

I haven't been given a CGM for longer than a few weeks (NHS rules are a bit restrictive in my area if your control is good). However the rationale for not using the CGM to make decisions is based around how it gauges your blood sugar. Because it's relying on blood glucose levels in the skin tissue I have been told that there is a delay, and basically the CGM operates about 15 minutes behind your current glucose levels. This is ok when you're using it to track glucose levels over a day, but not particularly safe if you're relying on it to make a decision for obvious reasons.

> A final question: how essential is it to be tech-savvy to use this technology?

This is a question I have asked myself a few times. As mentioned above, it's pretty difficult to get a pump and CGM on the NHS in my area without proving that you can't treat yourself adequately with regular injections. I am unwilling to sacrifice my health to have a pop at getting a pump, so I had a look at private options. Whilst initially I think there's a fairly steep learning curve, there is quite a lot of documentation provided, and the community is pretty active and helpful. I suppose it's also helped by the fact that there is only a few pumps on the market (relatively speaking). The issue is that if something goes wrong in your config, which is not uncommon for a homebrew solution, then you have to go back to manually adjusting your insulin.


My SO has a continuous glucose monitoring, and as you say, the reading lags behind by 15-30 minutes compared to measurement from blood. But the blood measurement is a single, instantaneous value while the GCM meter shows the last 8 hour glucose levels plotted and the current upward/downward trend. While it takes a bit of cross-referencing between blood and tissue glucose levels to get used to the readings, it actually provides better information to base decisions on (fast acting) insulin dosage.

The GCM (Freestyle Libre) has been a life-changer and improved long-term management of diabetes. In particular, it has been helpful for maintaining a reasonably flat glucose level throughout the night (because of better information for evening insulin doses), where they previously had high and low peaks (down to dangerous levels a few times).

I suggest you do everything you can to get a continuous monitoring system. Because you can see your glucose level history, you can then make decisions on whether you need an insulin pump or not. If your night time glucose levels are fine, you might not need one. If there are high or low peaks you can't manage, a pump will improve your life.


> it actually provides better information to base decisions on (fast acting) insulin dosage

Would you say that's because you can get a better idea of trends once you have enough data? My understanding has always been that the true value in a CGM is revealing those trends and patterns that are really unique to the person and that are hard to spot with regular glucose testing.

EDIT: I realise that this is basically what you've said. Apologies, brainfart.

> I suggest you do everything you can to get a continuous monitoring system.

I'm currently jumping through the hoops to get myself one now. I can get my hands on one via the NHS fairly easily, it's just the pumps which are hard to get. I've done a lot of work over the past few years to get my control to a place I am happy with (finishing uni and that awful realisation that you are in fact mortal). I also wanna say that I recognise that as someone who is able to control my diabetes using injections it would be wrong for me to demand a pump when there are others who for various reasons can't control their condition. In a perfect world it would be great, but hey, we work with what we've got, right.


Yes, exactly. When you wake up in the morning, you can get a plot of the last night's glucose levels which you normally don't know about with discrete blood measurements. This allowed my SO to adjust evening eating and insulin dose and their timing so that the glucose levels stay within the "good zone" all night (the GCM reader unit has a helpful graph with the good levels highlighted).

If you can't get the NHS to give you one, it might be worth it to get it for at least some period (say 3-6 months) out of pocket. By that time it should have given you insights on your treatment and allow you to better assess if an insulin pump is the right thing for you.


It helps with figuring out long-term trends, but it's also an improvement even for a single snapshot-in-time decision. If your blood glucose is 150mg/dL and you're trying to get it to 100mg/dL, the difference between "150mg/dL and rising 3mg/dL/min" and "150mg/dL and falling 3mg/dL/min" is the difference between wanting insulin and wanting carbohydrates.

> better

What happens when the sensor is not reading correctly? Isn’t that the biggest possible danger? The human “knows” it’s wrong but software?


How do you tell that the glucose reading measured from blood (the old way) is correct? You can't. The new method is not worse than the old in this respect.

And again, you get at least 8 hours of history graphed on the display now. If it doesn't look sensible (w.r.t eating and insulin doses), you need a backup. If the old fashioned blood glucose meter gives a wrong reading, you are much worse off.

Note that the sensors are tested and approved, not the DIY hack the article talks about.


Old way: you repeat the measurement nothing is in your body. and you konw di you feel e.g. hypo. New way: the sensor needle is simply a little off (in stays sticked). You don’t know, the software doesn’t know. The sensor is not magic that works 100% of the time, it ends in a needle sticked in your body, many ways to go wrong, even if it worked a while.

And the danger of “fully automatic” is there.


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 target (for me, 5.5 mmol/l during the day and 6.5 mmol/l at night). Here sudden wrong readings will not cause any harm or danger.

The new oref1 algorithm uses a method called super micro boluses, which can detect a sudden peak or unannounced meal, sees the first jump up, gives you a bolus so it borrows from the basals, setting the basals to 0%. The algorithm works really well for things such as eating a pizza, where you get about 50% of the carbs immediately and the rest + a bit more during the next five hours. So you take a bolus for the food, then when the fat hits in the oref1 will give you tiny boluses.

The latter is more sensitive to sensor failures, so it is on only when you told the system you have some carbs in your body, or if you happen to have a Dexcom G5 or G6 sensor with good noise readings, it will be on all the time and the system knows when the reading is faulty.


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.

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 have a real problem if you trust it blindly.

Yes, it's good that some people try. But there are real risks, due to the current limitations as explained.


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% above the 8.5 mmol/l and 2% hypos (none of them at night) which I can correct fast due to alarms.

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.


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.

For anyone interested, Scott Hanselman wrote about the open diabetes ecosystem (including OpenAPS) a few years ago:

https://www.hanselman.com/blog/ThePromisingStateOfDiabetesTe...


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.

And if you have different hardware (Combo, DanaR/RS), AndroidAPS gives a clean and nice UI and is based on the OpenAPS algorithms.

> optimized not for getting the best result, but for ensuring the manufacturer can't be blamed

read similar stories on r/medicine

advanced surgeons coming into the operating room with their lawyer in mind, entirely logical, totally sad


> 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

No, they're optimized for reducing risk as much as possible. The amount of scrutiny on a commercial product from a Fortune 200 company is about 2 orders of magnitude more than any DIY project would ever get.


You're both saying the same thing from different worldviews. Regulations work to minimize risk, but in the process they can and often do also reduce effectiveness and/or progress in a field.

To take a less sensitive example, NASA refused to allow SpaceX to do retropulsive soft landings for their Dragon crew/cargo capsules without a whole slew of regulatory work, which was just not a very effective allocation of resources for SpaceX. So instead of coming down retropulsively, similar to how they now regularly land their massive first stages with, the capsules come down using parachutes and a not-so-soft 'soft' landing as we've been doing since the 60s.

So you could argue this is safer. But that's not clear. What is entirely clear is that the cost and time effort that would be required to abide the regulatory requirements resulted in the entire idea being scrapped, derailing technological progress on that front. Perhaps with some irony, the capsules will still have the thrusters on the capsules to be used in case of an emergency abort - they just can't use them to enable genuinely soft landings.


It's the difference between risk of death, and risk of getting sued. The DIY project has a much lower risk of death, but (if a corporation were to do the same thing) a much higher risk of getting sued.

I disagree those two are decoupled. The DIY project has a much lower risk of getting sued, true. But lower of risk of death is highly dependent on edge cases and corner cases, and I'd challenge you to produce evidence that there is an overall lower risk of death.

None of this is to say I'm against any effort to develop an artificial pancreas. I used to work at Medtronic Diabetes. The slothful pace with which this endeavor is proceeding, despite the mountains of money behind it and the obvious and profound unmet clinical need, pains all of us. But "why was it taken so long?" is a question to which there is no simple answer. And though FDA is very much in the corner of "let's get it done" now, that was not always so.

For instance, the quote from the director at FDA re: "you can do everything but manage diabetes on your phone, you should be able to do that as well" masks the history of the med device industry for years trying to get applications on the iPhone approved by FDA and not being able to do so because you couldn't lock the iPhone down (i.e. prevent programmatically anyone from running any other program).


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.


Strikingly similar to a buddy of mine's story who was underground to the point he became known as "Bigfoot": https://www.bigfootbiomedical.com/the-legend/

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.)

This comment finally explains what article is about. Thank you.

Reading around, it's the controller software that is DIY, and it's grown to the point where a DIY device has been built to run the controller software. The sensor and pump/actuator are proprietary Medtronic devices, connected to the controller via wireless links.

The DIY controller came about because Medtronic didn't secure their wireless traffic and the protocol was reverse egnineered. New units now come with a secured wireless link, but the existing units remain unsecured. Consequently the project is constrained by the number of unsecured units remaining in the field?

Reading the project's website the FDA has been in touch with the project and so far the interaction has been constructive. The makers seem keen to have the safest system they can and the FDA seems to want to engage. I'd guess the project's future lies in being able to team up with someone who can provide ongoing access to sensors and actuators?

Wishing them much success!


Near the end of the article:

> A European team recently created an app for Android phones and cracked the code in a popular pump from Roche Holding AG

So even if they don't find a partner, they'll probably find pumps they can use.


A friend of mine "automated" his infusion pump (not diabetes) by 3D printing an arm and actuators attached to the physical buttons of the pump and controlling that remotely. Basically most actions consisted of automated sequences of button presses in the correct order.

How feasible is this for an insulin pump? I know it adds bulk to a device that has to be worn constantly and inconspicuously but it may be a worthwhile trade if you can't find a compatible pump.

As long as it can be controlled by the wearer's finger it should be possible to automate it with an "artificial finger".


I'm currently using the AndroidAPS and it works great. Roche has said the warranty is off if you use the Combo pump for looping, but the maker of the other supported pumps DanaR and DanaRS said that looping is OK.

Right now I'd recommend getting the newer DanaRS and a Dexcom G6 for the best possible support.


I have type 2 diabetes and I've always been a bit envious of insulin pumps, not because I love having a machine plugged into my body (I don't), but because they offer better control of blood glucose peaks, since they use fast-acting insulin exclusively. The pancreas secretes insulin in pulses and pumps can mimic that. What has turned me off from pumps (apart from doctors generally not recommending them for type 2 diabetes) is the lack of a sensing mechanism. This DIY system sounds absolutely perfect. It could keep my blood glucose perfect at all times. At the moment, I'm injecting in the mornings and the evenings and have little control over my peaks apart from adhering to a strict diet (and we all know how hard that can be), and every peak does a little bit of damage to my eyes, nerves, etc. I've always wanted to have a more sophisticated treatment option, and this may be it.

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, maybe because it is felt that the patient is partly to blame for the disease, whereas type 1 diabetics are innocent victims of their own immune systems. I honestly don't know what they're thinking. An artifical pancreas would vastly improve the situation for type 2 diabetics too.

> 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 healthy patients. The diet changes they preach are not that radical, e.g. cake is bad for you but you can have a really tiny slice and offset it by not eating bread. This belief isn't that unreasonable; FDA requires that medical labeling be targeted at a 5th grade reading level.

2 - And glucophage is much easier for patients to manage than insulin both in dosing regime and simply caring for the drug.

3 - Finally the insurance companies' actuaries have figured out that maintenance therapy of this nature has the best cost/outcome ratio.

To that last point: I had "adult onset type 1" due to an autoimmune condition. The endocrinologist I was sent to was only interested in maintenance therapy and not at all in looking for root cause, even though I presented with a body fat of about 14%. She finally admitted that even if she did look into it the insurance companies would hassle her for going off the reservation without a good excuse.

But my no-insurance primary doctor and I and a rheumatologist were able to dig into root cause and now I am "cured" (of diabetes at least) thanks to treating the underlying condition (note: this is glossing over a lengthy period of unpleasant work). Which is actually cheaper for the insurance companies, but honestly how many patients have the training to be able to be involved in their care to this degree?


I have latent autoimmune diabetes in adults (LADA), sometimes called type 1.5 diabetes. Onset was in my early 40s, and I am now insulin dependent. I have reasonably good control (estimated A1C about 6.5) without a continuous glucose monitor and insulin pump. I have been looking into the Freestyle Libre glucose monitor to get better monitoring of my glucose levels, but the cost is still quite high.

I would really like to know more about how you and your doctors cured your condition.


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.

I think quite a few people will be interested in knowing how did you cure yourself.

If you don’t mind me asking, what was the underlying condition?

I’m fascinated by endocrinology and rheumatology. We know so little!


I’ve heard that Type 1 diabetes is due to lack of insulin (malfunctioning pancreas) while Type 2 diabetes is caused by too much insulin (leading to insulin resistance.)

If this is true, insulin pumps for Type 2 diabetes don’t help, because they can only add more insulin, when the fundamental problem isn’t lack of insulin, but lack of response to insulin.


That's more or less it on the dot!

Edit: I'd add that type 2 is associated with increasing insulin resistance, causing the pancreas to work harder. Over time, this can cause the pancreas to essentially burn out, at which point exogenous insulin would be needed. Type 2 diabetics who are able to manage the associated risks - namely diet and exercise, almost universally focused on losing weight - can often improve or even reverse the disease altogether.

I'll also add that this is not the entire discussion of diabetes. There's an increasing recognition of forms of diabetes outside of the known definition of type 1 and type 2. A so-called "type 1.5" is being further delineated and may explain why some type 2s don't behave the way we think they should.


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 insulin your pancreas secretes, or 2) decrease your insulin resistance (via the liver, IIRC).

As such, most T2s maintain a higher continuing level of insulin than non-T2s. Thus an insulin pump like that in the article will work for both T1s and T2s alike, but the insulin dose for T2s simply will be higher than for T1s.


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.

That is the general characterization, though insulin is prescribed for some "type 2" patients, so the situation is more subtle than that.

Along with what others have noted, there is also risk associated with insulin therapy from hypoglycemia (low blood sugars). Low blood sugars can be deadly for type I diabetics, killing as many as 1 in 10[1]. This is at least one of the factors leading to insulin being a tool of last resort, and in fact, insulin is prescribed to type II diabetics with especially strong insulin resistance.

http://care.diabetesjournals.org/content/35/9/1814


From a 2013 [1] paper, one obstacle may be getting the government or private insurance to pay for it outside of type I DM. Exceptions noted were France and Israel. In the U.S. only an exceedingly limited percentage of patients would be able to pay for the device and long-term supplies out of pocket. Until that changes, there may be little motivation for widespread adoption (until for example a large study is published in NEJM or JAMA showing extreme benefit).

Many patients are able to achieve stable control of their glucose and HbA1c on metformin (Glucophage) alone. However especially for type II DM patient needing insulin, finely controlling glucose levels might reduce long term risks as mentioned above and in the paper [1], and a pump might indeed be far superior to the typical injected insulin regimen. Interestingly, there are trials on clinicaltrials.gov about pumps in type 2 DM sponsored by MedTronic (which makes sense) [2].

As a disclaimer, I am not an endocrinologist or internal medicine guy at all. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3920779/ [2] https://clinicaltrials.gov/ct2/show/NCT01182493


This is mainly because of the total cost. Pills and (minor) insulin intake is usually sufficient, especially if combined with some minor lifestyle changes. Big changes can probably delay the requirement of most medication if detected early. But most people go to doctors way too late if it's not free and thus causes more damages in the end.

This is simply a cost question. In countries where the healthcare gives out the required pumps/injectors and medication for 'free', it is usually a cost/benefit tradeoff.

On the other hand: Not providing proper insulin dispensers costs a lot more in the end. The world has moved from simple throw away injectors (i mean the ones with no proper dosage dispensers and bottles as a storage medium) for years and the benefits far outweigh the cost of relatively simple modern injectors or pumps.

> maybe because it is felt that the patient is partly to blame for the disease

Since there is a very big spread in onset age even for overweight people it would be very bad for a doctor to have these kind of thoughts


It's not entirely an illusion. Some patients do succeed in making lifestyle changes that cause type 2 diabetes to go into remission. But the best results have been achieved with healthcare providers actively helping patients make dietary changes on a frequent basis.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

https://link.springer.com/article/10.1007%2Fs13300-018-0373-...


> 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.

Well in the last 3 months, I DID learn new eating habits, lost 15 kilos and had my meds cut from 6.5 tablets per day to 0.5 tablets a day working with a doctor and having good control on blood sugar. The big AHA is that progressive changes have to be made in how you eat rather than necessarily so much in what you eat.

In general, unless you have significant beta cell death already, it IS possible to mitigate or reverse effects of type 2 diabetes and this is vastly preferable to pushing organs beyond limits through drugs or insulin.


My mom has diabetes. I am interested in knowing what diet changes did you make.

Only asking as it would be helpful for others.


Here is a recent book on the topic by Dr. Joel Fuhrman: "The End of Diabetes: The Eat to Live Plan to Prevent and Reverse Diabetes".

A more general book with good advice on nutrition that is perhaps easier to follow -- but not specific to diabetes -- is "The Whole Foods Diet: The Lifesaving Plan for Health and Longevity" by John Mackey , Alona Pulde, and Matthew Lederman.

Good luck to you and your mom! It helps a lot in making lifestyle changes when family, friends, and neighbors are supportive. See also the book "The Blue Zones of Happiness: Lessons From the World's Happiest People" for a bigger picture view on that.

Good sleep is another part of the puzzle -- see Matthew Walker's book "Why We Sleep: Unlocking the Power of Sleep and Dreams" on that. Essentially, good sleep gives you better self-control during the day -- as well as helping your health in many ways including regarding diabetes.


Basic principle is to try to build new habits of how we eat gradually changing only 1 or 2 things every week and re-enforcing what works/cutting what doesn't. Typical diets (in my community) are 70 percent carbs, 30 percent veggies. We started by basically reversing this ratio. We also completely eliminated sugar & processed carbs (ie. flour - basically no breads & only whole grains) - but apart from this, I didn't fundamentally change what I ate. Then we progressively started reducing eating window over 10-12 weeks to < 6 hours in a day and started adding 2/3 day fasts. However, there are many routes & it works best if customized to individual.

keep it simple..Start with cutting out processed sugars and carbs/bread/rice.

Maybe sub with alcohol sugars if needed.


> will somehow succeed in making lifestyle changes that will cause the disease to go into regression or disappear altogether

Well, isn't that a sane first approach ?

I mean, yes, if it fails, find a workaround. But I don't see how __healing__ is a bad objective for a doctor.


Why don't more people realize this one simple logical conclusion: pumping more insulin into your body is going to end-up killing you.

Sure, it will kill you more slowly than you'd die if you didn't get that insulin in the short-term, but it's definitely not a "solution". Diabetes is caused by insulin resistance. What do you think more insulin is going to do to your body in the long-term?

The ultimate/only good solution is to make you insulin sensitive once again.


That's a commendable goal with type 2 diabetes. Still, therapy will start with insulin to normalize glucose levels.

Sad fact: patients that don't manage to change their liefestyle or are too far into the disease will stay on insulin until they die.


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 kill or incapacitate the user.

And the controller would beep if communication were lost.

There would not be an Internet API to change any parameters at all.


The current solution requires no manufacture or distribution of custom hardware. It's all software that exploits hardware the users already have.

Your solution is surely better, but the current one exists.


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.


> 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.


The latest medtronic offering (mentioned in the article) does this. The microcontroller and pump are integrated and there's no communication to an app.

The lack of communication is a bit of a downside for people who are used to monitoring their levels on smartwatch, but overall the auto-mode features more than make up for that.


One 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...

Headline: "The $250 Biohack That’s Revolutionizing Life With Diabetes"

Article: "Sydney, now 15, is still using an updated version of that DIY system, which, because a fellow DIYer donated the pump, cost only $250 to make."


A continuous glucose monitor (CGM) uses a very thin gauge wire to sense interstitial fluid as a proxy for blood sugar.

My kids have tried Dexcom G4 CGMs a couple years ago. The G4 was never approved to dose insulin directly off the CGM reported value, we would confirm with a finger prick before dosing a correction. The G4 also required “calibration” where you would type in the reading from a finger stick and it would shift the curve a bit in that direction if it was off base.

We would routinely find the G4 reporting numbers up to 100 points off, or simply dropping out and reporting “???” for hours at a time. Bad or unreliable data being worse than no data, we discontinued using the G4.

The Dexcom G5 kept the same sensor but switched the transmitter (which connects to the sensor and sits on your body) to use standard Bluetooth to communicate the glucose readings. This is when Nightscout was really able to step in and intercept the glucose data and do neat things like put it in the cloud so you could watch your kids’ blood sugar throughout the day. And with the addition of a programmable pump, also try to build a “closed-loop” system which constantly adjusts basal insulin dosages to react to highs and lows.

The problem is the underlying sensor of the G5 was still not approved for direct dosing, a finger-stick still being the only method accurate enough. You don’t want to dose to correct a 250 blood sugar level and then discover you actually were 150 all along and now potentially heading for a dangerous low.

Early this year we started buying Freestyle Libre sensors which use a NFC reader to poll the latest readings on demand. This is a less ideal method because it can’t independently alert you of an impending high or low without you actively swiping the reader up against the sensor on your arm. Accuracy was significantly better (reading would often be within 15-30 points, and we didn’t see any that were more than 60 points off from a finger stick reading) and there were a couple times when it would stop reporting data but dropouts where much less common than what we experienced with the G4.

Fast forward to last month when we got brand new Dexcom G6 CGMs. These are FDA approved to dose directly off the readout, and the accuracy is frankly unbelievable. We have regularly had finger sticks exactly match the CGM display, and even finger sticks have variation when you test multiple times back-to-back. The G6 does not require daily calibration (although you have the option if you find the numbers are off). It is not perfect, and once we did find it was 40 points off, but after 60 days of use my experience is that with the G6 we have finally arrived at a stable, trustworthy, reliable CGM which I would feel comfortable driving a closed loop system.

The only failing I have with the G6 is that we were promised it would work directly with an Apple Watch running the Dexcom app and syncing with the sensor over Bluetooth. In fact, as of now, a full fledged iPhone is required to pull data from the sensor, and then it can relay from the phone to the watch. I’m told that the FDA is pending approval of a stand-alone Watch operation, which would be exceedingly useful in my case. The goal is for the kids to wear LTE Watches which can read from their sensor directly and push glucose data to the cloud for us to watch on our phones. This would mean just the $5/mo cost to add a Watch to the plan versus having to add lines and gives full fledged iPhones to the kids in order to track their numbers remotely.

Both our kids use OmniPods as their insulin pumps, which AFAIK have not been hacked yet to allow 3rd party control of the pump. OmniPod is a self enclosed pump which sticks on your arm an auto-injects a cannula, and you control it wirelessly with a dedicated remote which is like a 1990s PDA. OmniPod has an ongoing study with their next-gen “Horizon” product which adds Bluetooth control and interfaces with the Dexcom G6 to automatically adjust basal rates.

Last thing I’ll mention is that this is not by any means an “artificial pancreas”. Even with a closed loop system you still must bolus (administer insulin) before meals in the correct ratio based on the number of carbs, and the glycemic index (speed of absorption). The closed loop is more rather a slight adjustment in the baseline insulin which is being automatically dosed every few minutes to cover your basal metabolic rate. If the CGM sees you are high or low, a closed loop system will temporarily increase or decrease the basal insulin rate to try to subtly move the needle so-to-speak and bring blood sugar back in range. This works best overnight when no new carbs are being eaten and blood sugar is usually more stable. So the idea is with a closed loop you are more likely to wake up with a blood sugar around 100 because it’s been working to gently bring you to that level all night long.

As the article states, this means a better nights sleep for both parent and child :-)


Does the G6 interface with OmniPod at all or do you just use it like a continuous finger-prick test?

My youngest (now nearly 16 years old) was diagnosed about two years ago. She's currently on Medtronic's closed loop system (860), but honestly it's so finicky I'm starting to look at switching systems. My daughter is basically at the point of burnout and sees the whole thing as nothing more than a major annoyance. She regularly lets her sensor expire, goes without calibrating for hours and hours or will look at a mid-day reading of 280 and just do nothing. It doesn't help that she seems to have acquired a profound craving for carbs that has her sneaking food and binging when she's unsupervised.

I'm thinking that maybe a system that doesn't purport to be automatic at all will make her role in the process more clear and hopefully get her in a better place to self-manage before she heads off to college. As it stands right now I can't imagine leaving her to her own devices for more than a couple of days. (FWIW we also have her working with a therapist to help manage some of the emotional aspects of this, but we really need to find one that is experienced dealing with T1D patients)


Yes, the OmniPod has no direct connection to the Dexcom CGM, I have to observe BG moving up and enter the number into the OmniPod for it to calculate a correction dose. So, for example, overnight this could still mean programming multiple corrections throughout the night after a slow-carb hard-to-dose meal.

For the last year we’ve been going to Clara Barton camp which is for kids with T1D. Most of the counselors are also living with T1D and one night they did a panel with several of them and a room full of parents.

We got to hear some very important perspectives, but one thing we consistently heard is that every kid with T1D will go through these burn out periods.

While of course it’s a health concern and we never want to see those high numbers, there will be time periods where blood sugar control slips and the A1Cs head up and it’s a totally legitimate reaction as a teenager to be seeking some space from this condition which just never lets up and insists on setting us apart from our peers multiple times throughout the day.

Just like us software engineers will hit a wall and “burn out” from pushing too hard for too long, I think it’s not possible for the human brain, certainly an adolescent brain, to handle the constant never-ending burden of carb counting, dosing, checking, correcting, day in and out.

Switching devices might help, but of course is also a massive investment in time and energy to come up to speed on a new system, nevermind the financial side of it.

One thing we heard from several of the counselors was that in those periods of burn-out, they didn’t need their parents to “fix” anything and often rushing in to try to make changes to fix it ended up counterproductive because it’s ultimately not something that can be fixed but just be overcome. They didn’t need to hear how important it was, they knew that better than we as parents even. Burn-out is a real thing that they are entitled to do. Listen, let them vent, let them cry, let them cheat even if it causes a temporary high, not because that’s the lifestyle you want to encourage but because somehow you have to find these moments to get space and control and feel like it’s not the T1D dictating everything all the time.

Even with OmniPod which is a neat little device, there are weeks when one child will just say, “You know what, I just really don’t want a pod on this week” and we pull out the Lantus from the back of the fridge and do injections for a few days, and yeah BG control goes to shit, and then we go back to the pods with renewed appreciation for the convenience, yes, and the trade-offs.

The Dexcom CGM is cloud connected, and of course you configure which devices can see your BG and also what times of day it’s shared. So we also heard some interesting and at times hilarious stories about the power struggles of college kids sharing (and not sharing) their BG numbers with their parents.

Most importantly just know burn-out is universal and inevitable and also will pass.


Wow. Thank you so much for this perspective. My youngest has another issue where her uncorrected vision is incredibly bad, so I think at times she just feels like her body is trying to punish her.

I had never considered a camp. It looks like the Clara Barton program has wrapped for the summer but it or something like it might be just what she needs. Will continue to look at options like that.

I can see the weary in her eyes when things get out of hand and know she's at that point you describe. I like the idea of not being able to 'fix' it but to overcome it, and will start incorporating that. I've definitely backed off of handling things as much and am finding that I only have the 3 hr sleep cycle about once a week now rather than every day.

I'll also talk to her about moving back to MDI for a little while. We discussed it previously and she wasn't super game, but it might not be a bad option. Someone a while back said that they were surprised how much the fact that they were tied to a little device by a tube made them feel infirm, so going old-school for a week might help in a few different ways (will definitely have to work with our endo on that though)

Again, thank you so much for your words. They have been immensely helpful.


Someone wants to lose a foot and become bionic!

I don't have diabetes, and I don't really understand what it's like to live with diabetes. But, I found this story to be very powerful: https://tink.uk/losing-sight/

You might be on to something...

I use a tandem pump and a Dexcom G5 (g6 sensors in the mail though). The update for the real closed loop system is supposed to be released in about a month or two. Cannot wait! Was dubious about the g6’s purported accuracy. Your report gives me confidence though

Have you looked into, or have any thoughts on Virta Health as a potential for your kids?

https://www.virtahealth.com/


This looks to be a treatment for Type 2, the parent comment's talking about multiple children, so, probably Type 1. At least, I hope so.

Yes, kids have T1D. A T2D treatment would be entirely useless if not harmful.

My exact thought, but still, why have multiple sick children?!

Type 1 usually doesn't mean a child is Born sick. There's usually some triggering illness and then the immune system decides that it's time to fuck up the pancreas.

While there's a genetic element to it, there's usually nothing saying some specific kid is going to get it.

So, you get a cold sometime between the ages of ~2 and 18 and suddenly you're islet cells go bye-bye.


I can't help but wonder what it would take to develop a legitimate artificial pancreas that fits the standards precisely. Would animal testing even be that useful or required given precedent of other insulin pumps?

I suppose being able to adapt to a wide range of pancreas removed animal sizes and life-states could help to show some adaptability but I'm uncertain of how much that would help humans since diverse curve fitting may not be a good thing. Since for instance for humans protein is bad for the kidneys at too high of a percentage even if say cats wouldn't have problems with it.

I'm curious what the back of the envelope budget sizes, time tables, and liabilities would be for organic pancreases as opposed to an official approved smart insulin pump pancreases.


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 will be more devices from established manufacturers at reasonable prices. I would consider everything above $1k unreasonable if the hardware alone costs just $250 (for consumers).


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.


You have to understand that for people like me, who didn't sleep many good night sleeps for almost a decade, this is the only available solution right now to fix the issue. I prefer taking the risk and sleep without worry any day.

You definitely need to know what you're doing though. But AndroidAPS saved my life.


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 really frustrating seeing how stagnant treatment technology is.


> If a bunch of parents on the internet can hack it together

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.


I agree with you, and frankly, hacking something together on your own or in a small group is not necessarily going to produce a product that you can then sell, especially considering the potential ramifications due to faults or misconfigurations, specially if you start using the data to automatically adjust your dosages. I suppose what could be nice is if the manufacturers could open up roads to hacking your own gear, but I think that this is highly unlikely as creating an 'official' route to 'mod' is going to open you up to all kinds of liability.

I get frustrated by the lack of visible innovation in diabetes treatment technology, because in most other areas of our lives we are surrounded by tech which is constantly innovating. Unfortunately it's a reality that if you are designing systems and technology that manage critical functions then they are going to take a long time to develop, let alone test, distribute, and support.


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.

With the poor state of Android security at the moment (in a nutshell, Android 9 Pie was just released while the previous Oreo release is installed on only 12% of devices), i cannot imagine anyone would want to connect a device that "can easily kill you" to an Android phone.

Most non-technical people using this DIY solution are probably not even aware of this...


The way it works make in sort that it can't kill you easy at all, the system does not regulate bolus insulin which is without a limit, but a basal rate which is basically a rate of insulin distribution from slow to fast, even the fastest mode will not kill you, and if the system disconects for some reason pump uses a default average speed.

> the system does not regulate bolus insulin which is without a limit

I understand that but the issue remains;

all a hacker would have to do is set basal rate to 100000% and then you have a "bolus that kills you".

Call it basal or bolus, it doesn't matter. The pump just pushes out insulin, and the amount can be controlled if you can hack the system.



As a med student with a CS degree I wish we were further along with making this a reality for every child with DM. If anybody knows who in Aust is working on this - hit me up!

God bless Scott Leibrand and these folks.

How much are the continuous glucose monitors alone now? You could use it for dieting.

No, it's not usable for dieting for healthy (non-diabetic) individuals because the pancreas will adjust glucose/insulin levels to a pretty flat level.

When a non-diabetic person says "I need some blood sugar" when they're hungry and cranky, their actual glucose levels are pretty much at the same levels as usual.


So what is happening when you stand up quickly and your vision goes slightly black when you haven't eaten for a while?

I don't know. Sounds like something related to blood pressure. Hunger affects hormones and that affects lots of things.

Anybody knows of other projects like this?

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 WAS focused on type 1, though, where there is no cure, from diet or otherwise. It's absolutely revolutionary for those of us with type 1.

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 used keto diet for first 1.5 years after diagnosis. It only suits sedentary lifestyle, what you can eat is very limited and I got a lot of issues like severe constipation and acid reflux. Blood glucose was virtually always in normal range (meaning non-diabetic) and very easy to control though.

Now I just do a lot of strength training which ensures my muscles are almost always in a state of glycogen deficit. In that state they can absorb glucose from blood without any insulin which makes having normal blood glucose levels easy even when eating all the carbs (so I can eat truly normally and without the digestion issues). My hb1ac tests are the same as they were when using keto diet (healthy person values, not diabetic values).


I'm not aware of any groups so this is entirely anecdotal too: My doctor is quite happy about how I manage T1 on low-carb. I went back to some-carb after talking to their nutritionist who plugged beans and lentils.

I don't see the point of going keto, but reducing carbohydrates to a very low amount simplifies therapy a lot. Now I eat carbohydrates in the evening only.


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.)


unfortunately no, i don't know any.

it is frustrating indeed that keto is being appropriated by fad evangelists. it's a diet that needs lots of reading and preparation.

i'm not a doctor, but common sense tells me that a diet that reduces the need for insulin should also help managing t1d, but obviously it's better to consult a professional.


Keto diet done wrong may have lethal or life changing consequences for T1D patients. Done right it might have positive effects but that is afaik not backed by research at the moment.

Common sense in this case turned into potentially dangerous unqualified medical advice.



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.

Yes, but you still need insulin on keto. In fact, starting keto can be dangerous for a T1D at first until you find out what your new, lower, requirements are. You put yourself at risk of hypoglycemia, so you have to be extra careful with dosing while you're figuring it out. Because of that, a closed loop artificial pancreas could be incredibly helpful for a T1D going on keto as well.

Your parent is trying to imply a way to survive on less insulin. Which is basically eating less to no sugar.

Though insulin is important for your body. The need for insulin is largely related to glucose metabolism.

In short eat less sugar.




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