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.
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.
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.)
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.
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.
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. :/
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.
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.
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.
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).
Thanks for being generous.
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.
Your scary hypothetical is not possible. As if to agree, my pump just beeped at 10PM, announcing that the temporary basal (which can't kill me at maximum setting) expired and a new one was chosen. It's best choice is actually to suspend basal entirely when it knows I've dosed too much, which makes it a very legit safety improvement.
Oh, and a company created the example, which waters down your point - what convinced you that the very capable hands of people affected by the disease directly with a strong desire for data to back every thing up is anything like an accident waiting to happen? There's no profit motive here! (PS: it runs a direct test suite on install, and has cloud CI)
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 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.
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.
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.
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.
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.
"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.
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?
A specific X-and-below is required because the RF protocol was reverse-engineered, presented at DEF CON 19 (2011), and the manufacturer locked it down immediately (PSK, gg). The new protocol has not been reverse engineered (this is for Medtronic Minimed)
A newer style of RF pump from a different manufacturer (Insulet OmniPod) has been de-capped and had its protected-mode firmware scanned, and has been disassembled and picked through - and re-flashed firmware has been sent to that pump and works fine, and we understand the cryptographic protection algorithm (we can talk to them) and a great deal of the protocol. That still leaves a massive "forward engineering" and integration efforts that must be non-commercial by nature (because laws)
edit: there are literally 7 of us that have access to the RE'ed firmware repo (it's a private github repo) - PM me if you're interested (there's a really irrelevant NDA that is involved, which I think is spooking wider sharing)
Pump manufacturers are not technology leaders and have no forcing function to create open systems. There is no reason they could not publish the protocol and also allow me to enroll a key (knowingly voiding affected aspects of the warranty) and interact with a device that is legally part of my person.
Of course, this is mostly a USA problem: for other jurisdictions there are open compatible pumps (http://www.sooil.com/eng/product/) that have this, but they are not available (including for insurance support of the consumables) in the USA
Anyway, I would love to help the community with some reverse engineering.
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?
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.
> 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.
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.
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.
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.
What happens when the sensor is not reading correctly? Isn’t that the biggest possible danger? The human “knows” it’s wrong but software?
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.
And the danger of “fully automatic” is there.
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.
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.
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 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.
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.
Can you give some more details please? I ask for a friend of mine. Thanks.
read similar stories on r/medicine
advanced surgeons coming into the operating room with their lawyer in mind, entirely logical, totally sad
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.
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.
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 might say in response it will "almost never" happen, but when it happens to your loved one it most certainly matters a lot.
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.
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!
> 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.
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".
Right now I'd recommend getting the newer DanaRS and a Dexcom G6 for the best possible support.
> 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 would really like to know more about how you and your doctors cured your condition.
I’m fascinated by endocrinology and rheumatology. We know so little!
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.
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.
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.
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 , 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) .
As a disclaimer, I am not an endocrinologist or internal medicine guy at all.
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
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.
Only asking as it would be helpful for others.
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.
Maybe sub with alcohol sugars if needed.
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.
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.
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.
And the controller would beep if communication were lost.
There would not be an Internet API to change any parameters at all.
Your solution is surely better, but the current one exists.
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.
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 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.
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."
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 :-)
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)
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.
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.
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 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.
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).
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 definitely need to know what you're doing though. But AndroidAPS saved my life.
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.
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 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.
Most non-technical people using this DIY solution are probably not even aware of this...
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.
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.
automating the process of releasing a chemical that is roughly speaking the cause of the disease is hardly revolutionary.
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.
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 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 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.)
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.
Common sense in this case turned into potentially dangerous unqualified medical advice.
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.
Though insulin is important for your body. The need for insulin is largely related to glucose metabolism.
In short eat less sugar.