The First Regulatory Clearance of an Open-Source Automated Insulin Delivery Algorithm-Reference-Cited by-同舟云学术

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

Published:2023-04-13 Issue:5 Volume:17 Page:1139-1141
ISSN:1932-2968
Container-title:Journal of Diabetes Science and Technology
language:en
Short-container-title:J Diabetes Sci Technol

Author:

Braune Katarina¹^ORCID,Hussain Sufyan²³^ORCID,Lal Rayhan⁴⁵⁶^ORCID

Affiliation:

1. Institute of Medical Informatics, Berlin Institute of Health at Charité, Charité – Universitätsmedizin Berlin, Berlin, Germany

2. Department of Diabetes and Endocrinology Guy’s and St Thomas’ NHS Foundation Trust, King’s College London, London, UK

3. Department of Diabetes, School of Cardiovascular, Metabolic Medicine and Sciences, King’s College London, London, UK

4. Department of Medicine, Divisions of Endocrinology, Stanford University, Stanford, CA, USA

5. Department of Pediatrics, Divisions of Endocrinology, Stanford University, Stanford, CA, USA

6. Stanford Diabetes Research Center, Stanford University, Stanford, CA, USA

Abstract

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.

Funder

national institute of diabetes and digestive and kidney diseases

Bioengineering and Behavioral Sciences working group for the Stanford Diabetes Research Center

Publisher

SAGE Publications

Subject

Biomedical Engineering,Bioengineering,Endocrinology, Diabetes and Metabolism,Internal Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/19322968231164166

Reference10 articles.

1. Tidepool. https://www.tidepool.org/tidepool-loop. Accessed February 15, 2023.

2. Tidepool. Tidepool announces FDA clearance of Tidepool loop. https://www.tidepool.org/blog/tidepool-loop-has-received-fda-clearance. Published January 24, 2023. Accessed March 16, 2023.

3. In Silico Trials of an Open-Source Android-Based Artificial Pancreas: A New Paradigm to Test Safety and Efficacy of Do-It-Yourself Systems

4. Full closed loop open‐source algorithm performance comparison in pigs with diabetes

5. Why #WeAreNotWaiting—Motivations and Self-Reported Outcomes Among Users of Open-source Automated Insulin Delivery Systems: Multinational Survey

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