As #WeAreNotWaiting solutions become more prevalent, how can healthcare professionals support users?

As #DIYPancreas systems become more prevalent, how can healthcare professionals support users?
As #DIYPancreas systems become more prevalent, how can healthcare professionals support users?

This is a question that has come up more frequently, as the prevalence of DIY systems becomes greater, and is seen even more commonly in Europe and Australasia, where there are no commercial alternatives. I’ll try and outline my view on what I think the support requirements are for Healthcare professionals, and how it fits in with the obvious concerns and issues.

Before we start, this is always going to be a tricky topic to cover. Working within a healthcare system comes with a set of rules, responsibilities and liabilities, and in the #WeAreNotWaiting community we understand this. We also understand the implications it has for our treatments and that is why it exists.

Moving on to the DIY systems out there then. What do we, as users, expect from healthcare professionals, and how, if at all, should healthcare professionals involve themselves in this community?

Expectations of Healthcare Professionals

Let me start by setting some background for the first question. In order to take on a DIY system, a potential user has to have made the decision that they are willing to put the legwork in to build it themselves. This usually entails that they need to have found appropriate hardware and researched what they might need to do to get going.

Community Ethos

The ethos of the community is that we will provide assistance to someone to help them build a loop. What does this mean?

  • Online support in both facebook and gitter to answer questions as someone sets things up for the first time
  • Advice as to where someone may be making an error and approaches that could be taken to fix it
  • Pointers about where to go in the documentation to work through key aspects of set-up
  • Run group sessions where potential users help each other, with current users on hand to provide face to face advice about how to do various things
  • advice will be provided around ongoing maintenance and troubleshooting where someone is unable to follow documentation

It’s important to note what it doesn’t mean (in the context of another person being a person of legally responsible age):

  • Members of the community should not supply a pre-built application or rig to another person
  • We should not sit next to a person and build it for them while they watch
  • We should not take on the role of supplier and undertake maintenance or updates for them

As I’ve previously mentioned, in the DIY community, the Ethos is to be able to look after what you’ve built yourself.

Healthcare Interaction

As a result of building these systems, and working to set them up, most of us gain a lot of additional insight into a number of factors, in fact, it becomes important for some of the systems that, as a user, you do. When things don’t follow expectations, there are often adjustments to various factors required. Some of the systems automate this, whilst others don’t.

It’s worth being aware that in the initial stages of using a DIY system, we tend to learn a lot about the common factors used to describe insulin use and effectiveness, essentially, Duration of Insulin Action, Insulin Sensitivity Factor, and Basal Rates. This is a function of how the systems work.

As a result, when we see a healthcare professional (HCP) in relation to our diabetes as part of the routine relationship between ourselves and them, we generally have a good understanding of what it is that we are doing and how our bodies work.

What we want from an interaction with the healthcare system is generally two-fold:

  1. Understanding that in our options for self-care we have taken the decision to move into a 21st century treatment paradigm, and as a result have invested our time and money to put in place a treatment regime that enables us to live better with diabetes.
  2. Assistance in accessing regulated medication and treatments that allow us to live better with diabetes.

It’s no more than that. We realise that the first of these is, for most people (with diabetes, involved in diabetes or otherwise), a huge, and in many cases scary, paradigm shift. As a result, we are very happy to take anyone who has to deal with us through what we are doing, how it works, and explain in very great detail what this means for us.

We’re ordinary people doing extraordinary things as a result of the efforts of a few brilliant people.

We want to share this with you and we’re very happy to. All we ask in return is that you don’t consider this prejudicially. Much as we would for any patient that is seen within a healthcare system.

So that’s where our expectations and needs lie. What of the healthcare system?

Healthcare system interaction with #WeAreNotWaiting

This poses some challenges in most jurisdictions across the globe. We understand the liability issues that come with medical devices, their use, and the responsibility for recommending them. But given the expectations of the users within the system, there are many things that can be done to get involved, understand and help users.

So let’s set up some questions and address them.

How do HCPs best support people using DIY systems?

Let’s start by making the assumption that we are looking at support of people that have elected to use a DIY system. To start with, we need to refer to the previous section and look at the expectations of users. What does this mean? It means that when a user tells a healthcare professional that they are using a DIY system, they have built it and are supporting it themselves. It means that they are involved with the community and therefore have a global support base that will assist them in using the system. They are not expecting an HCP to be an expert in the system.

To support us you can do the following:

  • Listen to us – feel free to ask questions. We’re happy to answer, and if it makes us think about what we’re doing, we are likely to take it back to the community and raise it. If we can’t answer it, we will.
  • Provide access to prescription only supplies in relation to the regulated devices or drugs that we use and you prescribe. Once we take it out of the office/surgery, how we use it is down to us. That holds true whether we are using a pen, syringe, pump, or DIY system. We make the choice and decision as to how we’re going to administer insulin, multiple times per day. This is an additional choice we have for doing so.
  • Dig into the data we provide . Learn about what the system is doing and how it interacts with us in relation to the various daily activities we do.

The essence of this is that to support someone using a DIY system, the expectation is the clinical best practice is followed. There is no need to be involved in supporting whatever system is being used, and from a professional liability point of view, it’s best not to be. That ownership needs to lie with the builder/owner.

But if someone turns up as a user, how do you learn more or even learn ahead?

What information/support is available for HCPs?

The information available to HCPs is exactly the same as that available to users. Usually the one big difference is that the HCP isn’t a T1D so has a different perspective on living with diabetes. With that in mind, if you want to know more, I’d recommend starting at the following two locations that give background and further information:

This provides links to all the current DIY platforms documentation and online discussion channels. We are also working on clinician specific documentation to allow you to better understand the algorithms and how it all works.

You should also join the “Looped” Facebook group. We welcome participation from industry professionals, whether that be healthcare or medtech, and interact with many people in both these groups already. The mantra is “share the knowledge”.

The other thing to do is to reach out to members of the community and ask them for help. We’re happy to come to training days or meetings and talk through what we do, how things work and the various aspects of living with these things. Many of us are doing it already. Please feel free to reach out!

Who should be involved in writing best practice guidelines for the use of AP systems – DIY or otherwise?

This starts to move into a more difficult realm. For commercial systems, there are significant limitations as to what you can do, and these will vary by system. There is also a lack of commercial systems, so producing anything that could be considered best practice is, at the moment, an impossibility in the commercial world.

For DIY, once again, due to the different systems, with different algorithms and significantly more ability to vary aspects of the system, best practice is not a simple answer. What we always recommend as a community is that everyone getting going with a DIY solution should start by going “open loop” to get a feel for what the system is doing and how it works, and perhaps identify what changes they might need to make.

Then, when you’re ready to close the loop, go and read the document that Dana and Scott wrote to provide a “Good Practices” view. This can and should be described as best practice for closing the loop and the advice that it offers is still spot on.

Once there are more commercial offerings available, the question about best practice comes down to how these will be provided and implemented. The information above is open source and would be a good place to base any formal best practice, but it’s also worth remembering that each individual manufacturer’s system will have its own best practices and foibles and writing a common standard will be a challenge for HCPs, PWDs and healthcare bodies alike.

Legally, where do HCPs stand in terms of supporting use of systems that are not FDA/NICE etc approved?

Current Model

Much as I’d like to, I can’t give a legal opinion on this. All I can do is reiterate what I’ve said earlier. In the current model, HCPs are not expected to be supporting DIY pancreas systems. The design of the model is that this is done by the PWD or carer of the PWD with the assistance of the community. If, on the other hand, an HCP feels that they’d like to, there is also nothing stopping them from doing so, and indeed, the community welcomes it.

Our point of view is that if you are acknowledging that we are making a treatment decision and supporting us in our self-care making treatment decisions, as we do when using MDI, then you are meeting your clinical requirements.

It’s a reality that these systems exist and that people are using them. They should be acknowledged in the same breath as using a pump as “Something that people are doing” and could be left there. We live in an age where Google will find something for people if it isn’t mentioned and as a result, it can make it look like something is being hidden.

Having read the GMC Good Medical Practice guide, it is hard to argue that supporting someone who is knowingly engaging in an activity that is likely to improve the key indicators of long term outcomes in a chronic disease and doesn’t appear to compromise safety breaks the rules of medical practice.

Each and every healthcare system needs to draw its own legal conclusions as to what constitutes support, but I for one would be happy to sign a waiver that stated that no healthcare professional was involved in my administration of my self-care to myself, nor the decisions about how I chose to use whichever self care option that I had selected. To the extent that I’d stand up in court and argue against a healthcare professional having responsibility for me deciding to do things to myself.

But as I mention, it’s down to each healthcare system that is looking at this to seek their own legal advice and understand the structure of the community as part of that to make their own determination, so I encourage engagement with us if you seek to do that.

What if clinicians were to recommend DIY systems?

In the current environment, what level of responsibility does a healthcare professional have if they recommend to someone they go onto a DIY system? Another difficult question, and one that has been posed by HCPs and charities. The JDRF’s answer is to support the greater involvement of DIY with its Open Protocol Initiative.

From a healthcare involvement there is also a clear need to understand the impact of recommending that someone looks at a DIY solution. I’d still argue that once a recommendation has been made, the PWD cannot move on to a system unless they then take ownership for it. They still need to engage, build and understand how it works. They are not out of the box solutions, but as healthcare professionals, an understanding of appropriateness would be required and a feel for how capable someone is of engaging.

With regard to liability in this context, I’d suggest that local legal advice would be needed.

Something that has been raised in response to this is the possibility of some sort of “Safety” study showing how various forms of self-treatment result in different outcomes. Whilst this is a nice to have, it is also fraught with some interesting hurdles. Regardless of these, it’s something that could be considered and there are groups of people considering how to structure this type of engagement. In the meantime, there are a number of outcome studies available on the OpenAPS website where professionally conducted studies have provided evidence.

Walking a fine line

On the other hand, is there a good reason not to mention in a chat with a PWD that doesn’t know, that there are people out there that have built their own AP systems, and that they’re getting good outcomes? You don’t need to provide links, and it’s not a recommendation nor are you suggesting to someone that they go out and build it.

Is sowing the seed in someone’s imagination that there might be something better out there that would help them, and that it’s not hard to find, a bad thing? Once the seed is there, they still have to do the legwork to get something that works.

For certain though, if someone is interested and a healthcare professional is too, as Aaron Kowalski said at ATTD 2018, “Just Do It”.


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