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

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 glob...

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Published inThe lancet. Diabetes & endocrinology Vol. 10; no. 1; pp. 58 - 74
Main Authors Braune, Katarina, Lal, Rayhan A, Petruželková, Lenka, Scheiner, Gary, Winterdijk, Per, Schmidt, Signe, Raimond, Linda, Hood, Korey K, Riddell, Michael C, Skinner, Timothy C, Raile, Klemens, Hussain, Sufyan
Format Journal Article
LanguageEnglish
Published England Elsevier Ltd 01.01.2022
Subjects
Diabetes Mellitus, Type 1 - drug therapy
Health Personnel
Humans
Hypoglycemic Agents - therapeutic use
Insulin - therapeutic use
Insulin Infusion Systems
Online AccessGet full text
ISSN2213-8587
2213-8595
2213-8595
DOI10.1016/S2213-8587(21)00267-9

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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.
AbstractList 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.
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.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.
Author Raile, Klemens
Schmidt, Signe
Petruželková, Lenka
Scheiner, Gary
Hussain, Sufyan
Braune, Katarina
Raimond, Linda
Lal, Rayhan A
Hood, Korey K
Riddell, Michael C
Skinner, Timothy C
Winterdijk, Per
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  surname: Lal
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  organization: Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
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  organization: Integrated Diabetes Services, Wynnewood, PA, USA
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  organization: Diabeter, Center for Pediatric and Adult Diabetes Care and Research, Rotterdam, Netherlands
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  fullname: Schmidt, Signe
  organization: Steno Diabetes Center Copenhagen, Gentofte, Denmark
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  surname: Raimond
  fullname: Raimond, Linda
  organization: Steno Diabetes Center Copenhagen, Gentofte, Denmark
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  surname: Hood
  fullname: Hood, Korey K
  organization: Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA
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  givenname: Michael C
  surname: Riddell
  fullname: Riddell, Michael C
  organization: Muscle Health Research Centre, York University, Toronto, ON, Canada
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  givenname: Sufyan
  surname: Hussain
  fullname: Hussain, Sufyan
  email: sufyan.hussain@kcl.ac.uk
  organization: Department of Diabetes and Endocrinology, Guy's and St Thomas' Hospital NHS Trust, London, UK
BackLink https://www.ncbi.nlm.nih.gov/pubmed/34785000$$D View this record in MEDLINE/PubMed
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KB, RAL, and SH led the consensus authorship group. All authors formed the steering committee and equally contributed to the manuscript draft. All contributors (ie, Outcomes of Patients’ Evidence with Novel, Do-it-yourself Artificial Pancreas Technology [OPEN] International Healthcare Professional Network and OPEN Legal Advisory Group) critically reviewed the manuscript and provided comments to the authors. All authors reviewed and approved the final version of the manuscript.
Members are listed in the appendix
Contributors
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Snippet Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven...
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SubjectTerms Diabetes Mellitus, Type 1 - drug therapy
Health Personnel
Humans
Hypoglycemic Agents - therapeutic use
Insulin - therapeutic use
Insulin Infusion Systems
Title Open-source automated insulin delivery: international consensus statement and practical guidance for health-care professionals
URI https://www.clinicalkey.com/#!/content/1-s2.0-S2213858721002679
https://dx.doi.org/10.1016/S2213-8587(21)00267-9
https://www.ncbi.nlm.nih.gov/pubmed/34785000
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