The risks adherent in Diabetes Technology – why #wearenotwaiting is the right thing to do

The risks adherent in Diabetes Technology – why #wearenotwaiting is the right thing to do
The risks adherent in Diabetes Technology – why #wearenotwaiting is the right thing to do

Over the past 18 months I’ve spent a lot of time looking at diabetes technology, mainly as a result of the massive step forward that the Freestyle Libre presented (as we shouldn’t underestimate how big a deal it is – affordable Continuous Glucose recording is a paradigm shift for self-managing this condition).

What is clear is that up until very recently, diabetes tech has moved forward at a snail’s pace as the med world really wasn’t interested in it, and this I suspect was down to the available profit margins on a small population. Then the med tech world woke up and realised that T1 isn’t the be all and end all, and that the mega-population of T2s was also a valid target consumer audience. That and the explosive growth that it was seeing. And all of a sudden, the developments appeared to snowball as people realised the profit potential. That leads to a announcements of products like non-invasive blood glucose monitoring “systems”, many of which are not real products yet, and all of which may be used by both T1s and T2s,

But even then, the pace of change in the T1 world remains terribly slow, and many people outside of the diabetes on-line community are painfully unaware of the innovations taking place (which is good for the insurers and the healthcare providers as they don’t have to pay out as much). But even if they were, they might, like me, take a look at these and think “My, isn’t it slow”.

Why is it slow? The main reason, as I see it, is Liability. If you are an organisation providing a diabetic product, and it goes wrong, especially in the US, you will have your pants sued off. This isn’t a great place to be and doesn’t encourage fast paced innovation. Instead it encourages a massive amount of testing, more testing and even more testing, such that innovation can take a long time to appear.

Why is this important? It is important because assessment of risk is taken out of the hands of the individual. You know that if you are using a product that has been through EMA and FDA approval then it has been risk assessed and found to be mostly safe. But let’s just be clear here. Mostly safe does not mean that it 100% can’t and won’t go wrong. It just means that it isn’t too likely to go wrong in a way that will kill you. Now, let’s think about that for a second…

Type 1 diabetes requires you to be your own pancreas and to make hundreds of decisions a day about what you will eat and how you will manage it, assisted by what is a fairly rudimentary toolkit. Replacing injections with a pump? Well the risks have changed, but are not vastly different. If things go wrong you end up high or low, and at risk.

Most people don’t look at T1D in this light. You don’t consider that when you eat a bag of jelly babies that you are taking a risk, and that by taking a certain amount of insulin, you are mitigating that risk. But that in making that mitigation decision you are also incurring further risk due to changes in insulin absorption or food absorption that you are not immediately aware of. There is a large amount of unmeasured risk in T1 diabetes that many T1Ds simply aren’t either aware of or considering. And probably don’t want to know about.

So how does this relate back to technology? Well the “Liability” question is important. In the UK you can’t go and buy a pump off a company that sells them without the clinic that you use confirming that they will look after you and train you to minimise the liability of the provider. Now let’s be clear here, if you are buying a pump yourself, you are likely to be able to manage to use it, because:

  • You will be spending a lot of money upfront
  • You will be committing to spend a lot of money over the lifetime of the pump
As a result, this risk assessment seems arse about face. It does, however, highlight why things like artificial pancreases are taking a long time to come to market.
But this is also why products like Nightscout and OpenAPS exist. Why? Because diabetic service providers didn’t want to put themselves at risk of user legal action. So the technical community has had to step in and take their place. And they have done so admirably. 
Nightscout is a fantastic answer to how to deal with monitoring those who require additional care, and as the sensor arrays that can be used on people improve, so, I’m sure, will this monitoring solution provide additional capabilities..
OpenAPS, on the other hand, is a phenomenal achievement in demonstrating that this stuff isn’t impossible. It’s 270 lines of core code is a masterpiece of technical design and it is changing the way that medical regulators look at the artificial pancreas. Why? Because people using it have assessed the risk themselves and decided that they will go ahead and do it anyway. That the benefits in lifestyle far outweigh the risks that are encumbered. And that there are enough of us out there doing our own “My Diabetes Science Experiment” to warrant doing it.
Whilst I understand that these things are not for everyone and that risk assessments are different, that we live in a world where it is possible to build technology like this in your own bedroom and to then use it to improve your life has to be applauded. That it also shows that risk assessment shouldn’t be the domain only of regulators and healthcare professionals is even more important. 
What we see is that the appetite for risk amongst those with chronic conditions is very different amongst the population but also from the average Joe, and this is often ignored. 
Now, with #wearenotwaiting, we have a way for the less risk averse to engage, make a difference, and drag the rest of the world along, whether they like it or not!

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