Recently The Lancet Diabetes and Endocrinology published a consensus statement on the use of do-it-yourself (DIY) closed-loop automated insulin delivery (AID) systems – “Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals“. (The full article is available free but requires registration to access.) The issue is worth exploring because it raises a host of issues relevant to SBM, involving the relationship between scientific evidence, professionalism, regulation, and self-care.
The specific practice at issue here is the increasing use among those with Type 1 diabetes of DIY AID systems – open-source software to control insulin pumps connected to glucose monitors. Continuous glucose monitoring involves a small sensor wire inserted under the skin that can measure glucose levels in interstitial fluid. This is covered by a patch so that it can be worn continuously, even in the shower. Systems typically provide a glucose measure every five minutes 24 hours a day. When glucose monitoring is connecting to an insulin pump and controlled with a computer algorithm that is called a closed-loop system (or colloquially an artificial pancreas).
There are commercial systems available that are tested and approved. However, they are also quite expensive, and there are many people with Type 1 diabetes who cannot afford or do not have the insurance to cover these systems. As a result, in recent years a community of people with diabetes have developed open-source software that can control the insulin pumps based on data from the continuous glucose monitor. Open-source software is free for anyone to use and update, it is crowd-sourced without any central control. Because it is free it has made AID systems available to thousands of patients who could not afford a commercial version. Many of these systems run on smart phones, and have a higher level of control and customization that their commercial counterparts.
The emerging question for professionals has been – what are the ethics and legal considerations of patients using unapproved AID systems, and what are their professional responsibilities as their doctors? This is the purpose of this international statement – it essentially supports the DIY community and encourages physicians to work with and support their patients who use open source AID devices. This is very clarifying for physicians in this situation, but the statement is also very open about the limitations and trade-offs here.
First and foremost – there is a distinct lack of scientific evidence for the safety and efficacy of DIY devices, specifically there are no double-blind placebo-controlled trials. There are real-world observational studies which support the safety and efficacy of these devices. The obvious solution here is to do more studies, but this field is a moving target. Which DIY system do you study and which version? These systems are constantly being updated and customized, so a well-controlled study is essentially impossible. The same is true, however, or many medical treatments, and we often have to be content with lesser standards of clinical evidence, such as open-label treatment (you can’t double-blind surgery, for example).
These DIY systems are also not a panacea. While they make closed-loop systems more available, specifically to those who cannot afford commercial systems, they are still highly selective in who benefits. Adopters need to have a certain level of technical savvy. They will have to do all updates and customization themselves, and there is no centralized support structure. There is a DIY community of support, however.
Essentially, the recommendation of the international panel of experts authoring this paper is that physicians should not work against the DIY community, but rather work with and support them. In this specific context the recommendation makes sense, but it definitely had me thinking about the broader implications for the practice of SBM in an increasingly digital and DIY world. This is also an extension of a broader discussion we have had within SBM about the following dilemma – when it comes to paraprofessional or non-professional medical interventions that are clearly not science-based, do we push for full regulation and banning, or emphasize reform and collaboration? We have not arrived at any consensus on this question, because I don’t think it has one clear answer. It is very context-dependent, with strengths and weaknesses in each approach.
Ultimately the question may be taken out of our (meaning the medical community’s) hands. Perhaps this is part of the evolution away from the old paternalism model of health care. I was educated within the paradigm of the cooperative model, where patients are given fully informed consent and are partners in the clinical decision-making. The role of the physician is not so much to make decisions as to provide information and offer options. In practice this also varies considerably depending on the situation. For chronic medical conditions, however, the cooperative model is not only preferred – it is essential. Patients need to become partners in their own care.
This is hugely complicated, however, by the existence of unregulated over-the-counter snake oil, and unscientific pseudoprofessionals and gurus whose practice seems to be based on giving the worst and most unscientific advice possible. Further, there is a wealth of health misinformation on social media, and entire ecosystems built on conspiracy theories and antiscientific notions. This makes helping patients treat themselves feel more like throwing them to the sharks. But like it or not, this is the world in which we are now practicing.
Which brings us back to this core dilemma. I think the only answer is to take an individualized hybrid approach. Some practices and products just need to be regulated. There is no legitimate role, for example, for homeopathy, which is 100% magical snake oil. There is no way to work with a patient to manage their illness with homeopathy, and the only advice a science-based practitioner can give is that it is worthless and not recommended at all.
At the other end of the spectrum are over-the-counter products and lifestyle choices that are highly evidence-based. The role of the practitioner here is to educate their patients about these options and their optimal use, to monitor outcomes, and help their patients manage their own illness with these options, along with those requiring prescriptions or procedures.
In between there is a vast gray-zone. There are products like CBD and Kratom that are drugs, even powerful drugs, with all the risks and benefits that implies. Kratom is essentially an addictive opioid-like drug that is available over-the-counter. There are many practices like intermittent fasting, ketogenic diets, deep-tissue massage, even hot-yoga that have some rationale, but often come with claims that go way beyond the evidence and have some safety concerns.
The modern physician needs to be aware of all these things, and be able to work with their patients to help them navigate these options, while minimizing risk. It would be simpler and easier if all medical interventions were regulated and controlled, but that world never existed and is getting farther away, if anything. We essentially have no choice but to collaborate with the DIY medicine model to some extent. In this way we may be able to make it a bit more science-based, and at least have more of an open discussion with our patients so that they can make better decisions. We also need to better study these options, not to promote them but to understand their risks and benefits better. Meanwhile we need to push for better regulations, to at least reduce the extent to which the market is flooded with fraudulent, harmful, and useless products and services.
The DIY AID treatments are a good example of when this model can work. In fact, it shows how we can leverage the open-source community to improve the care of our patients and bring cutting edge technology to those who would otherwise not be able to access it.