I’ve been closed looping now since September, so I’m coming up to my three months anniversary, and I couldn’t be happier. It’s the lowest variance and least thinking I’ve had to do in a very long time in relation to my diabetes. But I’ve also had my incidents with various aspects of the tech that have lead me to ask myself some interesting questions. Essentially using technology makes my life much easier, but I also know that it can go wrong and I need to be able to handle that. It’s not something I look forward to, but that’s also part of technology. It’s not 100% reliable.
Now, there’s no way that either OpenAPS or Loop could be described as “products”. They deliberately require a level of understanding that is likely to be beyond many people, but this is by design, as it means that those who do pick them up and use them can be responsible, and critically, liable, for them. What this also means is that they can be used to highlight the benefits and also the issues that commercial products need to address to make them usable by a larger cohort of people with Diabetes. That’s what I’m talking about here.
If we look at all the current non-commercial solutions, they do a fantastic job, but at their core, they are a forging together of a number of technologies that were never (really) designed to work with one another. In many way, if you work in technology, you might consider a lot of what goes into OpenAPS, Loop or NightScout as “middleware”, that has been built to interface with and allow these disparate technologies to function together. But that’s a well trodden path, discussing data and system interactivity and normalisation, and not one I want to tread right now. What it does do is multiply the issues that they can see due to this integration factor.
This has implications for the support and management of the technology and how it applies when we look at broader uptake.
In a hybrid closed loop model, there are multiple components that must interact with one another. Continuous glucose sensing technology, RF technology, bluetooth, the core “brain” and of course the pump. Any one of these can (and will) fail, and usually when you least want it to. What does this look like?
Pumps are the ones with which most people are familiar. Pump failures range from occlusions to battery compartment issues to buttons failing. There are helplines to get these things up and running, and if it’s an out of warranty pump, advice on the internet can help as well. It’s a fairly known issue and there are protocols in place to fix it. Of course, if it is a “total” failure, and the pump becomes unusable, then you are back to some form of MDI. Again, a known aspect of pumping, let alone using a loop.
But what about the rest? Within the closed loop, loss of any one component means you are essentially just pumping. Not a disaster, but keeping a clear reminder or information about what your approach was before looping is therefore important. If you need to fall back, then you need to remember what you were doing and be able to revert to it. Document everything you used to do, because, if you loop for long enough you will forget. And once you are looping, you won’t really want to go back.
In the context of the current available options, you need to be able to troubleshoot and identify whether you have bluetooth connectivity issues, RF connectivity issues, a pump failure, a badly inserted glucose sensor, whether the data is coming or going to the right place, whether you have configured things correctly, and the list goes on. But you signed up accepting this and knowing that this was what you were going to have to do.
Giving an all in one box to someone as an “artificial pancreas” means that the support teams at, say Medtronic or Roche, will need to also understand all of these items and the interaction between them. They will need to fully understand the variety of use cases, and part of the restrictions placed on the products themselves is to narrow down the range of failure scenarios to make this much more manageable.
But that’s for the now and the very near future. Given that we are more likely to see fully automated systems with very fast insulins before anything akin to a cure, it should also guide how we educate our kids and newly diagnosed as we go forward.
Some of the alternatives – the embedded beta cells, and smart insulins, biotech rather than medtech if you will, perhaps offer a different approach with regard to failure modes, but the questions about what can go wrong and how it needs to be dealt with remain. With embedded cells, we’ll need to remember to identify the signs of oncoming T1 and how to titrate doses. With Smart insulin? I’m not sure, but the safety tests on it, given the premise of injecting more than you need and it activating as necessary, are likely to be fairly tough, and the two obvious side effects are over- or under-activation.
When the default response to a T1 diagnosis is “an artificial pancreas”, it needs to be 100% reliable to not require a “treatment continuity plan”. We all know that technology, with the best will in the world, is not 100% reliable. Nuclear reactors go into meltdown, fortunately rarely, but often in association with human error. Moon missions suffer catastrophic failures. Computer systems lock up and crash regularly.
In the context of a treatment that is keeping someone alive, each person needs to be taught what to do in the event of it going wrong, and regularly reminded of this. The simple answer is that injected insulin remains a more reliable approach, as long as the user is minded to do it of course, than the tech options, and as a result, every single person needs to know how to use it, even if the first option is an automated system in the future.
Every business should have a business continuity plan in place. The “what do you do if something goes wrong” response. As technology becomes the go-to option in the management of all chronic diseases, so the idea of a “treatment continuity plan” needs to be included. Without it, the side effects don’t bear thinking about. Much as we may dislike it, those who are diagnosed with Type 1 diabetes will need to know how to finger prick and inject insulin for the foreseeable future.