Consensus statement on open-source closed-looping published
medwireNews: A consensus statement published in The Lancet Diabetes & Endocrinology offers information and guidance for healthcare practitioners faced with a person using DIY closed-loop insulin delivery.
The authors however state a preference for the term “open-source” closed-looping, “given the collaborative effort.”
Such systems were in existence well before the first commercial system, from Medtronic, was approved in 2016, and the consensus authors estimate that more than 10,000 people worldwide are currently using them.
They point out that, despite the increasing availability of commercial systems, these open-source algorithms still offer specific benefits to their users, including a greater degree of control over operating parameters, a wider range of devices with which the algorithm will work, including smartwatches, and worldwide availability.
Open-source closed-loop algorithms are now supported by some published evidence from real-world users, suggesting improvements in glycemic control and in parameters such as sleep quality and fear of hypoglycemia, albeit in a highly selected population with no control group.
Given the difficulties inherent in testing open-source systems in randomized trials and “the value of true user experience,” the statement authors believe that “real-world evidence should also be considered in regulatory decisions and assessing effectiveness and safety of diabetes technologies.”
Addressing safety issues, the team stresses that open-source algorithms, like commercial ones, are designed to prioritize hypoglycemia avoidance, and that significant updates to the code are tested by developers, followed by a select group of users, before being made generally available. Although there is no support helpline as would be available with a commercial system, there are many online resources and an active support community of knowledge users and developers.
“However, searching for the correct resources and support online can be a daunting task for some users,” note the statement authors.
Considering the evidence on open-source systems alongside the four principles of biomedical ethics – autonomy, beneficence, non-maleficence, and justice – the team believes it is imperative that healthcare professionals be ready and willing to support people who wish to use these systems, and even, “given the ethical implications of withholding information on effective treatment options,” to mention them as an option to people who might benefit.
Clinicians should therefore familiarize themselves with the systems on offer, say the statement authors, or consider referring to other healthcare professionals with the required expertise.
But they acknowledge the dilemma for clinicians, given the often unclear legal situation and lack of precedents, and they warn against acting contrary to local laws, while stating that these should be challenged if they go against the best interests of people with diabetes.
The statement offers best-practice advice for healthcare professionals, divided into discussing, supporting, documenting, and reporting; and gives a glossary of terms specific to automated insulin delivery.
The initiative was organized by the three lead authors – Katarina Braune (Charité—Universitätsmedizin Berlin, Germany), Rayhan Lal (Stanford University, California, USA), and Sufyan Hussain (Guy’s and St Thomas’ NHS Trust, London). They also involved healthcare professionals with expertise in multiple relevant areas including endocrinology, sports physiology, and psychology, in the writing and steering committee, and took advice from additional healthcare professionals as well as legal professionals and professional diabetes organizations.
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