Growing Use of DIY Artificial Pancreas Among Patients With Type 1 Diabetes Requires Clearer Guidelines for Benefit

Data have demonstrated that some patients with type 1 diabetes have resorted to unregulated do-it-yourself (DIY) systems for disease management due to frustrations with slow progress made by health care providers in the management of their disease.

For this reason, investigators at the University of Birmingham published an article in Medical Law International explaining that greater trust and transparency between patients and their providers is required in order to facilitate open discussions regarding the potential benefits and risks of patients using DIY artificial pancreas systems (APS).

In the DIY APS systems created by some patients, there is a smartphone or mini-computer that links their continuous glucose monitor and insulin pump, which allows them to frequently adjust and maintain their glucose levels in real-time.

Many health care professionals have remained cautious about discussing DIY APS with patients due to the almost complete lack of guidance around their use globally. However, this avoidance has not helped to support or deter their use by patients.

"Clinicians are encountering more patients considering using DIY systems,” said Muireann Quigley, PhD, professor of law, medicine, and technology at the University of Birmingham, in a press release. “However, lack of clear guidance means even specialist doctors are not starting conversations with their patients for fear of potential regulatory and legal ramifications. This approach undoubtedly threatens to undermine trust and transparency, making the goal of shared decision-making harder to achieve. Analyzing professional guidance from the UK regulator—the General Medical Council [(GMC)]—nothing within it should be interpreted as preventing clinicians from starting discussions about these systems."

The investigators explain that a cautious approach by providers toward DIY APS hinders not only an open, honest conversation between patients and clinicians, but also has the potential to damage the relationship and diminish trust.

Additionally, although the GMC has advised that providers act with caution before prescribing unapproved medical devices, they are not precluded from doing so. However, making such a decision to prescribe a patient a DIY APS requires that the provider determine that the system is necessary with sufficient evidence demonstrating its efficacy in order to justify their decision.

"If doctors are to take shared decision-making seriously, then, at the very least, they ought to be free to initiate conversations with their patients about DIY APS,” said Joseph Roberts, PhD, research fellow in law and philosophy at the University of Birmingham, in a press release. “For them to be able to do this, and given the increasing use of DIY APS technology, guidance on clinicians' ethical and professional obligations has become an imperative—something which is needed sooner rather than later."

REFERENCE

'DIY' type one diabetes treatment demands clearer guidelines for patient benefit. Birmingham, UK: University of Birmingham; March 29, 2021. https://www.eurekalert.org/pub_releases/2021-03/uob-to032621.php. Accessed April 2, 2021.