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- W3008860276 abstract "Type 1 diabetes is one of the most challenging long-term medical conditions to manage. Over the past five years, technologically skilled people with type 1 diabetes have developed communication systems and algorithms that allow insulin delivery from insulin pumps to be automatically controlled. These systems combine glucose data from a continuous glucose monitor with an original algorithm that communicates with an insulin pump to sustain, reduce, or increase insulin delivery to maintain glucose levels within a target range. Use of such systems is increasing, with OpenAPS reporting more than 1500 users worldwide.1OpenAPSOpenAPS Ouctomes.https://openaps.org/outcomes/Date accessed: January 27, 2020Google Scholar Users perceive the system as safe, and self-reported improvements have been seen in HbA1c, time in target glucose range, and quality of life.2Lewis D Leibrand S Open APSC Real-world use of open source artificial pancreas systems.J Diabetes Sci Technol. 2016; 101411Crossref PubMed Scopus (87) Google Scholar, 3Litchman ML Lewis D Kelly LA Gee PM Twitter analysis of #OpenAPS DIY artificial pancreas technology use suggests improved A1C and quality of life.J Diabetes Sci Technol. 2019; 13: 164-170Crossref PubMed Scopus (42) Google Scholar However, the algorithms and the systems used, unlike commercially available closed-loop systems (eg, Medtronic MiniMed 670G), have not been through the rigorous safety testing required by regulators such as the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency. As such, they do not have regulatory approval, and the use of such do-it-yourself (DIY) systems raises many medicolegal and ethical concerns.4Crabtree TSJ McLay A Wilmot EG DIY artificial pancreas systems: here to stay?.Pract Diabetes. 2019; 36: 63-68Crossref Scopus (11) Google Scholar, 5Wilmot EG Danne T DIY artificial pancreas systems: the clinician perspective.Lancet Diabetes Endocrinol. 2020; 8: 175-184Google Scholar This situation has generated uncertainty among health-care professionals about what their approach should be to these systems. The Diabetes Technology Network UK sought to gain an understanding of professional health-care attitudes and clinical practice with respect to DIY artificial pancreas systems. We created a survey (in SurveyMonkey) and distributed it via the Association of British Clinical Diabetologists–Diabetes Technology Network UK and the Association of Children's Diabetes Clinicians, targeting predominantly health-care professionals working in pump multidisciplinary teams in the UK. The survey took place from Feb 22 to April 29, 2019. Of 317 responses, 146 (46%) were from consultants, 24 (8%) were from registrars specialising in diabetes, 122 (38%) were from diabetes-specialist nurses or dietitians, and the remaining 25 (8%) were from other health professionals. Almost a third of responses (85 [27%]) were from health-care professionals working in paediatrics. Most respondents (289 [91%]) said that they would not initiate conversations about DIY artificial pancreas systems as a treatment option; 212 (67%) indicated that a reason for this position was because these systems are “not regulated/approved”, 200 (63%) indicated “limited knowledge of the system”, and 101 (32%) indicated “fears around indemnity”. Respondents were cautious of potential risk, perceiving DIY systems as “risky in the wrong hands” (136 [43%]) or “slightly riskier than approved options” (76 [24%]). However, only 2% (seven respondents) perceived DIY systems as “dangerous”. More than half (174 [55%]) expressed a willingness to support users in some way, whereas a minority (41 [13%]) said that they would refuse to supply devices if the patient wanted to use a DIY artificial pancreas system; 25 (8%) said that they would actively warn against use. More than half (187 [59%]) did not feel comfortable providing clinical support, but only 12 (4%) felt unable to provide ongoing care. There was a shared belief that health-care professionals should learn more about DIY artificial pancreas systems to support users (308 [97%]). Notably, when asked if they would they use a DIY artificial pancreas system themselves if they had type 1 diabetes, almost half (149 [47%]) of respondents said yes. To our knowledge, this survey is the first to explore health-care professionals’ attitudes to DIY artificial pancreas systems. Health-care professionals are generally supportive of users but remain cautious regarding the unlicensed and unregulated nature of the systems and the potential risks (panel). Most of the survey respondents do not discuss DIY systems as a treatment option but will continue to support those who choose to use such systems. This survey provides unique insight into standard UK clinical care of users of DIY artificial pancreas system and has informed the development of the Diabetes UK joint societies national consensus statement on DIY closed-loop systems.6Diabetes UK Royal College of NursingDo it yourself (DIY) closed loop for people living with type 1 diabetes.https://www.diabetes.org.uk/professionals/position-statements-reports/do-it-yourself-closed-loopDate accessed: January 27, 2020Google ScholarPanelKey messages from the 2019 Diabetes Technology Network UK survey of health-care professional perspectives on DIY artificial pancreas systems•Most respondents were keen to support users of DIY artificial pancreas systems; few actively warned against the use of DIY systems•Most respondents did not initiate discussions about DIY artificial pancreas systems in clinic because of concerns that the systems are not regulated or approved, insufficient knowledge of the systems, and fears of indemnity•Almost all respondents had been able to provide ongoing care for users of DIY artificial pancreas systems, although more than half did not feel comfortable providing clinical support•Most respondents were not comfortable describing the risks and benefits of DIY artificial pancreas systems; many agreed that DIY systems could be “risky in the wrong hands” or were “riskier than approved systems”•Almost all respondents were keen to learn more about DIY artificial pancreas systems•Almost half of respondents indicated that they would opt to use a DIY artificial pancreas system if they had type 1 diabetes themselvesDIY=do-it-yourself. •Most respondents were keen to support users of DIY artificial pancreas systems; few actively warned against the use of DIY systems•Most respondents did not initiate discussions about DIY artificial pancreas systems in clinic because of concerns that the systems are not regulated or approved, insufficient knowledge of the systems, and fears of indemnity•Almost all respondents had been able to provide ongoing care for users of DIY artificial pancreas systems, although more than half did not feel comfortable providing clinical support•Most respondents were not comfortable describing the risks and benefits of DIY artificial pancreas systems; many agreed that DIY systems could be “risky in the wrong hands” or were “riskier than approved systems”•Almost all respondents were keen to learn more about DIY artificial pancreas systems•Almost half of respondents indicated that they would opt to use a DIY artificial pancreas system if they had type 1 diabetes themselves DIY=do-it-yourself. EGW reports personal fees and previous writing support from Abbott Diabetes Care, Sanofi Aventis, and Novo Nordisk, and personal fees from Eli Lilly, Dexcom, Medtronic, and Insulet. PC has received personal fees from Abbott Diabetes Care, Medtronic, Dexcom, Insulet, Roche, Novo Nordisk, Sanofi Aventis, Lilly Diabetes, and Novartis. PH has received personal fees from Medtronic, Insulet, Abbott Diabetes Care, Novo Nordisk, Lilly Diabetes, Sanofi Aventis, and Roche. AL has received personal fees from Dexcom, Insulet, Abbott Diabetes Care, and Novo Nordisk. AM is a user of artificial pancreas systems and has received personal fees from Eli Lilly and Novo Nordisk. TSJC declares no competing interests. DIY artificial pancreas systems: the clinician perspectiveWe are witnessing a technological revolution in type 1 diabetes, with a race to bring commercial closed-loop (artificial pancreas) systems to market. However, only one automated insulin-delivery system, the Medtronic MiniMed 670G, has received both US Food and Drug Administration (FDA) and European CE mark approval and is commercially available in several countries. The French Diabeloop system, designed to work with several continuous glucose monitors and insulin pumps, has received a CE mark, and the FDA have awarded the Tandem Diabetes Care t:slim X2 the status of an alternate controller enabled interoperable pump, facilitating efficient premarket review; however, neither are commercially available yet. Full-Text PDF" @default.
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- W3008860276 title "Health-care professional opinions of DIY artificial pancreas systems in the UK" @default.
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