The First Regulatory Clearance of an Open-Source Automated Insulin Delivery Algorithm

被引：10

作者：

Braune, Katarina ^{[1
]}

Hussain, Sufyan ^{[2
,3
]}

Lal, Rayhan ^{[4
,5
,6
,7
]}

机构：

[1] Charite Univ Med Berlin, Inst Med Informat, Berlin Inst Hlth Charite, Berlin, Germany

[2] Kings Coll London, Guys & St Thomas NHS Fdn Trust, Dept Diabet & Endocrinol, London, England

[3] Kings Coll London, Sch Cardiovasc Metab Med & Sci, Dept Diabet, London, England

[4] Stanford Univ, Dept Med, Div Endocrinol, Stanford, CA USA

[5] Stanford Univ, Dept Pediat, Div Endocrinol, Stanford, CA USA

[6] Stanford Univ, Stanford Diabet Res Ctr, Stanford, CA USA

[7] Stanford Univ, Stanford Diabet Res Ctr, 300 Pasteur Dr, Stanford, CA 94305 USA

来源：

JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY | 2023年

关键词：

automated insulin delivery; interoperability; regulatory clearance; open-source; real-world evidence;

D O I：

10.1177/19322968231164166

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Open-source Automated Insulin Dosing (OS-AID) algorithms are made publicly accessible so that every facet of their operation can be understood. Currently, commercial AID algorithms are kept proprietary trade secrets, despite the role they take in making life and death decisions for people living with type 1 diabetes. Loop was the second OS-AID algorithm, developed initially by Nate Racklyeft and Pete Schwamb. In 2018, the nonprofit organization Tidepool (Palo Alto, CA) announced the launch of the "Tidepool Loop" initiative with the aim to generate real-world evidence and obtain regulatory clearance. By the end of 2020, the U.S. Food and Drug Administration received Tidepool's application for an interoperable automated glycemic controller based on Loop. After 2 years, the FDA approved the Tidepool Loop on January 23, 2023.

引用

页码：1139 / 1141

页数：3

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