Forthcoming consensus statement offers guidance on DIY closed-looping
medwireNews: A consensus statement covering the practical, ethical, and legal aspects of the use of open-source closed-loop insulin delivery algorithms is soon to be published, the authors reported at the virtual ATTD 2021 conference.
Addressing delegates, Sufyan Hussain (Guy’s and St Thomas’ NHS Foundation, London, UK) said: “What we’ve detailed is an example of how citizen science and do-it-yourself technologies, which have been developed and used over years, have received professional endorsement with a consensus statement, helping healthcare professionals [HCPs] to use them in practical settings.”
He noted that there are an estimated 8–10,000 people worldwide using these open-source algorithms: Loop, OpenAPS, and AndroidAPS, which work with a variety of system components.
To date, there is no professional guidance for HCPs faced with patients who opt to use these systems, and the legal and ethical situation is unclear, yet there is an increasing amount of real-world evidence supporting their use, said Hussain.
This consensus statement aimed to address that, he said, by collating the scientific evidence, detailing the systems currently in use, addressing safety issues, advising on legal and ethical considerations, and providing best practice recommendations, including use of the systems during exercise and pregnancy.
It was put together by the International OPEN HCP network and legal advisory group, which was created specifically for this project and included 44 adult and pediatric endocrinologists, diabetes educators, nurses, and psychologists from 25 countries, along with four legal experts with knowledge of diabetes technologies.
Hussain noted that they do not advise HCPs to go against local law when assisting users of DIY automated insulin-delivery systems, but they do urge them to push for clarification if such laws are a barrier to “ethical and effective treatment.”
He said that the document, which is currently undergoing peer review, is endorsed by organizations including ISPAD and the IDF, and is under consideration by other professional bodies.
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