This question seems relatively straightforward to answer. Surely it’s just to provide a way of delivering insulin automatically, leading to less user intervention and making managing diabetes easier? But I think it very much depends on the point of view of the person answering the question. There is a huge risk that that point of view will skew the value based decisions that will then be made as to availability of these systems.
But where do we start with this? Let’s consider the points of view that potentially might come up. I see these as:
- The clinician
- Those who pay for it
- The companies providing the tech
- The person with T1D
And there is a good reason why they are listed in that order.
Let’s start with the clinician. In the Medpage Today’s “2016’s Top 5 Advances in Endocrinology“, there is a quote:
Although experts suggest greater research on the clinical benefits of the closed loop system is needed, they overwhelmingly agreed that it is a major step forward for the management of diabetes.
The questions around clinical benefits relate to better glucose levels and variability (which many of existing studies already point to), but also reduction in longer term complications from better management. Whilst there is an agreement that it’s a “big step forward”, is there a risk that clinical outcomes will become the be all and end all of introducing commercial artificial pancreas products? Given the difficulties that some have had simply getting their hands on pumps, will clinicians use clinical criteria as the measure and hoop by which they recommend candidates for these things? I’d argue that for a clinician, this is a tool to enable better management by T1D under their care.
What about those who pay for it? In many countries, those are state sponsored in some way, and of course in the US they are mostly insurance based. What we know is that across the European healthcare system, access to funded CGM is heavily restricted, due to the cost of an A&E visit being much lower than the equivalent in the US.
In the US, it costs 10 times what it does in Europe, so funding CGM as a mechanism to avoid this is worthwhile. In Europe, we have a model which is much more about those with the greatest need for CGM getting provision, but not necessarily anyone else easily.
If we look at the cost of CGM (and it’s the single most costly part of any APS) then it works out at around £3,000 per year (if we use the sensors as per the instructions, based on current available systems from Medtronic and Dexcom). That’s an extra £1bn needed to fund all Type 1s in the UK with CGM, and by proxy, an artificial pancreas. On that basis, anyone paying is going to balk at supplying an APS to all T1Ds. It certainly sustains the view that Clinical need will be used as the hoop to jump through. This comes back to an article that was published recently (behind a paywall) that raised the question as to whether the DIY projects created a two tier system where those who could afford it got, effectively, better care. I’d argue that given the current evidence, that’s something that’s already here.
For those who pay then? What’s the purpose? A difficult question to answer really. Technically it should be related to reduced severe side effects (DKA and Hypo) that would reduce immediate costs, and to reduce long term costs by reducing complications, but we know full well that this latter point is rarely considered in the cost model.
The companies providing the tech? They are an interesting mix. From Medtronic, a giant in the Med Tech world who are clearly a traditional company driving shareholder returns, to Betabionics, who are a public benefit corporation, which technically means that they are beholden to stakeholders as well as shareholders. One assumes that they will not just be giving away the tech and will need to make a return. The question for me is what the balance between uptake and returns will look like? At this stage, with no pricing yet available, it’s a very hard one to work out.
For these companies, ultimately, whilst the improvement in life for those living with T1D is a crucial aspect of what the purpose is, at the end of the day, it has to be about adding to the return to shareholders, and that means profiting from them.
Finally, those with T1D. At the bottom of the pile, because they are the ones who need to have everything above lined up if they’re to use commercial artificial pancreas systems. What is the purpose for them? We have a huge stake in the improved clinical outcomes aspect. Fewer lows and DKA instances are always welcome.
But there’s another aspect to an APS that fits into none of the above (with maybe the exception of a some of the execs at Bigfoot and Betabionics). From my perspective, the main purpose of the APS is not the clinical benefits, it’s an improvement in quality of life and ease of management of T1D. As those of us that use the current DIY systems have found, there is a freedom with using an AP system that shouldn’t be and can’t be ignored. There is less concern over what you need to do next. I took a look at how much time I was spared, and I recovered a day a month from dealing with diabetes. That’s a 5% increase in productivity during a working month (okay, I know that’s stretching it a bit, but you get the point). Can this net benefit to the economy be factored in to the cost of supplying these systems? It would be great if it could!
Taking a look back then, the purpose of an APS may, at a high level look to be very obvious. Make diabetes easier to manage. At a lower level, I think there is more to it than that. More importantly, some of the constraints of the “system” will also make it relatively difficult to get into wider circulation in a number of jurisdictions.
However you look at it, given the constraints that commercial systems will face, I think the DIY systems will remain in use for a much more significant period than anyone originally envisaged. All may ultimately have the same purpose, but not all have the same accessibility.