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

被引：91

作者：

Braune, Katarina ^{[1
,2
,3
]}

Lal, Rayhan A. ^{[4
]}

Petruzelkova, Lenka ^{[5
]}

Scheiner, Gary ^{[6
]}

Winterdijk, Per ^{[7
]}

Schmidt, Signe ^{[8
]}

Raimond, Linda ^{[8
]}

Hood, Korey K. ^{[4
]}

Riddell, Michael C. ^{[9
]}

Skinner, Timothy C. ^{[10
,11
]}

Raile, Klemens ^{[1
]}

Hussain, Sufyan ^{[12
,13
,14
]}

机构：

[1] Charite Univ Med Berlin, Dept Paediat Endocrinol & Diabet, Berlin, Germany

[2] Charite Univ Med Berlin, Inst Med Informat, Berlin, Germany

[3] Berlin Inst Hlth, Berlin, Germany

[4] Stanford Univ, Sch Med, Stanford Diabet Res Ctr, Stanford, CA 94305 USA

[5] Univ Hosp Motol, Dept Pediat, Prague, Czech Republic

[6] Integrated Diabet Serv, Wynnewood, PA USA

[7] Ctr Pediat & Adult Diabet Care & Res, Diabeter, Rotterdam, Netherlands

[8] Steno Diabet Ctr Copenhagen, Gentofte, Denmark

[9] York Univ, Muscle Hlth Res Ctr, Toronto, ON, Canada

[10] Univ Copenhagen, Dept Psychol, Copenhagen, Denmark

[11] La Trobe Univ, La Trobe Rural Hlth Sch, Bendigo, Vic, Australia

[12] Guys & St Thomas Hosp NHS Trust, Dept Diabet & Endocrinol, London SE1 7EH, England

[13] Kings Coll London, Dept Diabet, London, England

[14] Kings Hlth Partners, Inst Diabet Endocrinol & Obes, London, England

来源：

LANCET DIABETES & ENDOCRINOLOGY | 2022年 / 10卷 / 01期

基金：

英国惠康基金;

关键词：

ARTIFICIAL PANCREAS SYSTEMS; POSITION STATEMENT; GLYCEMIC CONTROL; HOME USE; LOOP; ADULTS; INDIVIDUALS; EXPERIENCES; TECHNOLOGY; MANAGEMENT;

D O I：

10.1016/S2213-8587(21)00267-9

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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, induding developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

引用

页码：58 / 74

页数：17

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