Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals

Affiliations

¹ Department of Paediatric Endocrinology and Diabetes, Charité-Universitätsmedizin Berlin, Berlin, Germany; Institute of Medical Informatics, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.
² Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA. Electronic address: inforay@stanford.edu.
³ Department of Pediatrics, University Hospital Motol, Prague, Czech Republic.
⁴ Integrated Diabetes Services, Wynnewood, PA, USA.
⁵ Diabeter, Center for Pediatric and Adult Diabetes Care and Research, Rotterdam, Netherlands.
⁶ Steno Diabetes Center Copenhagen, Gentofte, Denmark.
⁷ Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA.
⁸ Muscle Health Research Centre, York University, Toronto, ON, Canada.
⁹ Department of Psychology, University of Copenhagen, Copenhagen, Denmark; La Trobe Rural Health School, La Trobe University, Bendigo, VIC, Australia.
¹⁰ Department of Paediatric Endocrinology and Diabetes, Charité-Universitätsmedizin Berlin, Berlin, Germany.
¹¹ Department of Diabetes and Endocrinology, Guy's and St Thomas' Hospital NHS Trust, London, UK; Department of Diabetes, King's College London, London, UK; Institute of Diabetes, Endocrinology and Obesity, King's Health Partners, London, UK. Electronic address: sufyan.hussain@kcl.ac.uk.

PMID: 34785000
PMCID: PMC8720075
DOI: 10.1016/S2213-8587(21)00267-9

Review

Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals

Katarina Braune et al. Lancet Diabetes Endocrinol. 2022 Jan.

. 2022 Jan;10(1):58-74.

doi: 10.1016/S2213-8587(21)00267-9. Epub 2021 Nov 13.

Affiliations

¹ Department of Paediatric Endocrinology and Diabetes, Charité-Universitätsmedizin Berlin, Berlin, Germany; Institute of Medical Informatics, Charité-Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.
² Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA. Electronic address: inforay@stanford.edu.
³ Department of Pediatrics, University Hospital Motol, Prague, Czech Republic.
⁴ Integrated Diabetes Services, Wynnewood, PA, USA.
⁵ Diabeter, Center for Pediatric and Adult Diabetes Care and Research, Rotterdam, Netherlands.
⁶ Steno Diabetes Center Copenhagen, Gentofte, Denmark.
⁷ Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA.
⁸ Muscle Health Research Centre, York University, Toronto, ON, Canada.
⁹ Department of Psychology, University of Copenhagen, Copenhagen, Denmark; La Trobe Rural Health School, La Trobe University, Bendigo, VIC, Australia.
¹⁰ Department of Paediatric Endocrinology and Diabetes, Charité-Universitätsmedizin Berlin, Berlin, Germany.
¹¹ Department of Diabetes and Endocrinology, Guy's and St Thomas' Hospital NHS Trust, London, UK; Department of Diabetes, King's College London, London, UK; Institute of Diabetes, Endocrinology and Obesity, King's Health Partners, London, UK. Electronic address: sufyan.hussain@kcl.ac.uk.

PMID: 34785000
PMCID: PMC8720075
DOI: 10.1016/S2213-8587(21)00267-9

Erratum in

Correction to Lancet Diabetes Endocrinol 2022; 10: 58-74.
[No authors listed] [No authors listed] Lancet Diabetes Endocrinol. 2022 Jan;10(1):e1. doi: 10.1016/S2213-8587(21)00324-7. Lancet Diabetes Endocrinol. 2022. PMID: 34919870 No abstract available.

Abstract

Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

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Conflict of interest statement

Declaration of interests In addition to their professional roles, KB, RAL, PW, MCR, KR, GS, KKH, and SH have personal experience of using open-source AID systems. KB received research grants from the European Commission's Horizon 2020 Research and Innovation programme, the Berlin Institute of Health Digital Clinician Scientist programme, and SPOKES Wellcome Trust; and has received grants from the Berlin Institute of Health Junior Clinician Scientist programme, Stiftung Charité, and the German Diabetes Association. KB received fees for medical consulting and public speaking from Roche Diabetes Care, Dexcom, Medtronic Diabetes, Diabeloop, and Bertelsmann Stiftung. RAL has consulted for GlySens, Abbott Diabetes Care, Biolinq, Capillary Biomedical, Morgan Stanley, and Tidepool. RAL is supported by a Diabetes, Endocrinology and Metabolism Training Grant (1K12DK122550, 1K23DK122017) from the National Institute of Diabetes and Digestive and Kidney Diseases and has additional research support from the Stanford Maternal and Child Health Research Institute. GS serves on the clinical advisory boards for Capillary Biomedical and Companion Medical. GS serves as a consultant to Adocia, Ascensia, Modular Medical, Triple Jump, and Ypsomed. GS is a paid speaker for Dexcom, Eli Lilly, and Xeris Pharmaceuticals. GS is a paid certified trainer for Insulet, Medtronic, and Tandem Diabetes. LP has received a research grant from the Technical Agency of the Czech Republic (TJ02000342) for a pilot study of open-source hybrid closed loop–Good News–Pancreas4All projects. LP has served as a speaker for Medtronic Diabetes, Aimport-Dexcom, and Abbott Diabetes Care. MCR has received lecture fees Medtronic Diabetes, Insulet, Novo Nordisk, and Sanofi Diabetes and consulting fees for Xerus Pharmaceuticals, Zealand Pharma, and Zucara Therapeutics. SH reports personal fees from Abbott Diabetes Care and Roche Diabetes care. SS reports Medtronic Diabetes advisory board attendance, and is employed at Steno Diabetes Center Copenhagen, a public hospital and research institution under the Capital Region of Denmark, which is partly funded by a grant from the Novo Nordisk Foundation. LR has served as speaker for Abbott Diabetes Care. LR works at Steno Diabetes Center Copenhagen, a public hospital and research institution under the Capital Region of Denmark, which is partly funded by a grant from the Novo Nordisk Foundation. KR received research money from the European Commission's Horizon 2020 Research and Innovation programme and received fees for medical consulting and public speaking from Dexcom, Abbott (Germany), Lilly diabetes care (Germany), Novo Nordisk (Germany), and Springer Healthcare UK. All other authors declare no competing interests.

References

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Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals

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Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals

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