DIY Diabetes, Misuse and Ethics. A painful mishmash for healthcare

DIY Diabetes, Misuse and Ethics. A painful mishmash for healthcare
DIY Diabetes, Misuse and Ethics. A painful mishmash for healthcare

While giving a presentation on diabetes technology to healthcare professionals at a day conference recently, the usual question of what can be said to patients in clinic and what can be prescribed came up. A question that was asked related to whether a clinician should prescribe something that would be knowingly misused, given what DIY APS systems do and how they work.

It raises an interesting point that leads on to some difficult ethical questions. 

Addressing this question first:

Misuse

The dictionary.com definition of misuse is:

wrong or improper usemisapplication.

The question then arises that if you are controlling an insulin pump using a piece of software instead of your brain, because it can be controlled like that, are you using it improperly?

If I was to change the basal rate 4 times an hour and bolus small amounts 6 times an hour in order to optimise glucose level management manually, instead of having an automatic mechanism for doing this, would I be misusing it?

Given that the aim of the pump is to deliver insulin in a more optimal fashion, no-one would argue that doing this manually is misuse.

Whether I do this manually or electronically shouldn’t be at question, and let’s be honest here, an algorithm written to do diabetes maths will have a much better handle on what’s going on than a human brain that has a million other tasks to do.  

But let’s take that question and broaden it more widely. The entire aim of diabetes management is to try and encourage the person with diabetes to take responsibility for their own condition, which includes managing the amount of insulin delivered at each and every point throughout the day. Indeed, as the picture below shows, clinicians see very little of a person’s diabetes management:

If a person presents at a clinic and admits to the clinician that they deliberately, systematically give themselves more insulin than has been agreed at a previous clinic appointment, or gives themselves less than has previously been agreed, and as a result has experienced either severe hypoglycaemia or DKA, potentially on more than one occasion, does the clinician then refuse to prescribe insulin due to clear and admitted misuse of it? No, they don’t.

So if a person presents at a clinic and says they have decided to use a DIY system, which is keeping their Time-in-Range at a whole new level of high, with reduced hypo- and hyperglycaemic episodes, and they ask for assistance with CGM or a pump, is it right to deny them this on the basis of misuse?

Is using a CGM and Pump in line with recommendations (i.e. to obtain data and deliver insulin) and then automating that process yourself, a misuse?

Is undertaking an activity that enable tools that have sound evidence for and the intention of improvements in glucose management and enabling to do this even more effectively, a misuse?

Especially where there is peer reviewed observational data that shows that DIY systems improve a range of factors compared to sensor augmented pumps, as per the data from ADA Scientific Sessions that was presented from the OpenAPS commons, a brief glimpse of which is below:

You can clearly see where my views on this lie, and I think you’d be hard pressed to argue against much of this.

Not having regulatory approval is not the same as misuse!

Are there ethical considerations?

Given that all healthcare professionals belong to a professional body, let’s start with one of these to get a view on ethics. now it’s worth stating that I’m not a medical lawyer, nor a lawyer of any type, so the following purely represents my opinions and has no case law review to back this up.

As I’m based in the UK, we’ll look at the General Medical Council, who have the following view relating to medical ethics. We’ll take the summary from their Ethical Guidance tome, “Good Medical Practice” as our starting point:

Good medical practice describes what it means to be a good doctor.

It says that as a good doctor you will:

  • make the care of your patient your first concern
  • be competent and keep your professional knowledge and skills up to date
  • take prompt action if you think patient safety is being compromised
  • establish and maintain good partnerships with your patients and colleagues
  • maintain trust in you and the profession by being open, honest and acting with integrity.

This presents an interesting viewpoint in relation to DIY (and in fact, other aspects of care). From an ethical perspective, the first point on this list is to “make the care of your patient your first concern”.

If we dig further into the guidance for this, the section on “Applying knowledge and experience to practice” seems to take this further. In article 15 it dictates that:

You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must: 

  1. adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient
  2. promptly provide or arrange suitable advice, investigations or treatment where necessary
  3. refer a patient to another practitioner when this serves the patient’s needs.8 
And then in article 16 it provides for the following:

In providing clinical care you must: 

  1. prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs9 
  2. provide effective treatments based on the best available evidence
  3. take all possible steps to alleviate pain and distress whether or not a cure may be possible

Footnote 9 is of particular interest in this article, as it relates to the document “Prescribing and managing medicines and devices“. There is, in particular, a section on prescribing unlicensed medicines. This states that:

Prescribing unlicensed medicines may be necessary where:

  1. There is no suitably licensed medicine that will meet the patient’s need.

And in addition:

When prescribing an unlicensed medicine you must:

  1. be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy
  2. take responsibility for prescribing the medicine and for overseeing the patient’s care, monitoring, and any follow up treatment, or ensure that arrangements are made for another suitable doctor to do so
  3. make a clear, accurate and legible record of all medicines prescribed and, where you are not following common practice, your reasons for prescribing an unlicensed medicine.

Now this is not to suggest that healthcare professionals should “prescribe” the use of unlicensed DIY hybrid closed loops, but it demonstrates that the GMC has clearly thought about the use of drugs and devices that do not have licenses in the UK and that there is guidance related to it. 

It’s worth mentioning that the same document also includes, in section 51, commentary about monitoring, which would need to be taken into account:

Whether you prescribe with repeats or on a one-off basis, you must make sure that suitable arrangements are in place for monitoring, follow-up and review, taking account of the patients’ needs and any risks arising from the medicines.

But lets be clear here. All of this relates to prescribing and suggesting to people what they should do. Nothing within this guidance clearly says that, if you know your patient, you shouldn’t mention DIY closed loop system. Indeed, if we look at the following points,

  1. adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient
  2. promptly provide or arrange suitable advice, investigations or treatment where necessary

it’s possible to argue that were the GMC to suggest to their members that they shouldn’t be giving advice about these tools, they could be acting contrary to their own ethical guidance. Especially if we take the view of article 16 into account, where:

In providing clinical care you must: 

  1. prescribe drugs or treatment, including repeat prescriptions, only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs9 
  2. provide effective treatments based on the best available evidence

No-one can argue that there is no evidence that DIY systems have improved patient outcomes, as alongside the studies documented at openaps.org and diyps.org , there are also peer reviewed reports in journals and a variety of other materials available, including the snippet of the presentation I have included above from ADA Scientific Sessions 2019.

So it’s clear that the GMC’s Good Medical Practice could be interpreted to potentially encourage the use of DIY systems. Even then, the ethical guidance only goes as far as what is being prescribed. Going a step further, there is nothing in the guidance that states that it would be wrong to mention tools and treatments that a person could go and investigate in their own time, under their own guidance. 

In terms of communication, in the section of Good Medical Practice on “Communication partnership and teamwork“, there is very clear guidance on working in partnership with patients. It states that:

You must work in partnership with patients, sharing with them the information they will need to make decisions about their care,21 including:

  1. their condition, its likely progression and the options for treatment, including associated risks and uncertainties

Paragraph one talks about sharing the options for treatment, of which DIY systems is one, especially if the associated risks and uncertainties are also discussed.

Footnote 21 takes you to another area: Consent: patients and doctors making decisions together

Once again, as we dig through the detail of this section, we encounter some interesting articles, including the following in article 2:

If patients have capacity to make decisions for themselves, a basic model applies:

  1. The doctor and patient make an assessment of the patient’s condition, taking into account the patient’s medical history, views, experience and knowledge.
  2. The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatments are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice.
  3. The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one. They also have the right to accept or refuse an option for a reason that may seem irrational to the doctor, or for no reason at all.2 
  4. If the patient asks for a treatment that the doctor considers would not be of overall benefit to them, the doctor should discuss the issues with the patient and explore the reasons for their request. If, after discussion, the doctor still considers that the treatment would not be of overall benefit to the patient, they do not have to provide the treatment. But they should explain their reasons to the patient, and explain any other options that are available, including the option to seek a second opinion.
Given paragraph 2 of this article, it would seem to be amiss that a doctor was not able to include in discussing options that of DIY systems where it appeared to be appropriate for the patient. 
 
I could go on, however, at this point, it seems that the GMC’s Good Medical Practice ethical guidance taken on its own, give clear opportunities for doctors to both talk about and recommend the use of DIY systems, even if the most senior members of the organisation (a registered charity) were to opine otherwise. 
 
It presents an interesting view into the world of regulation of medicine that a body responsible for upholding the best ethical and physical principles, has within its own guidance, clear scope for allowing the discussion of, and potentially recommendations for, the use of DIY systems in diabetes care.
 
Once again, unlicensed does not mean untouchable.

Where does this leave healthcare professionals?

My initial reaction to this question is, “In a sticky situation”. While the Good Medical Practice ethical guide clearly presents all the arguments that should make a doctor comfortable with discussing DIY systems with patients, even if not recommending them, they face a difficult dilemma, given the history of the GMC in relation to the people that it represents. I suspect that there is a similar dilemma in other parts of the world given the regulatory bodies that are in place.

Overall then, whilst I would like to see the GMC and other regulatory bodies live up to their own ethical guidance, I don’t see them doing so, and I believe it would be a brave doctor who would use the guidance presented here in an argument with the GMC or other body, given the risks that it would present to their livelihood and life. 

It raises the very ugly question. Whilst regulatory bodies exist to ensure that there is no malpractice in the profession in which they operate, do they always have the best interests of the affected individuals in their sights?

Or to put it more bluntly, are they acting ethically?

 

1 Comment

  1. Very interesting and well-written. I am in the USA, but there seem to be many parallels with your healthcare system..

    I assume you are aware of the DIY scare among some here in the US because of what I consider an irresponsible “warning” from the FDA. My own endocrinologist, a very competent and caring doctor, is confused by the FDA letter.

    Hopefully, thoughtful assessments such as yours will result in conversations that lead to patient-first healthcare.

    Best regards,

    Mike

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