The first regulatory clearance of an open-source automated insulin delivery algorithm
Open accessAbstract
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.
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Prospective real-world data from 558 adults and children with type 1 diabetes on Loop was used to support FDA clearance of Tidepool Loop.
“Prospective realworld data from 558 adults and children with type 1 diabetes on this system (255) was used to support the FDA clearance of a variant called Tidepool Loop (259).”
From 7. Diabetes Technology: Standards of Care in Diabetes—2025 (2025) · cites this paper as [259]
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Cites
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- Authors
- Braune, K., Hussain, S., & Lal, R.
- Affiliations
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin (DE)
- King's College London (GB)
- Stanford Medicine (US)
- Corresponding author
- Lal, Rayhan
- Venue
- Journal of Diabetes Science and Technology
- Publisher
- SAGE Publications
- Published
- 2023-04-13
- Volume
- 17
- Issue
- 5
- Pages
- 1139-1141
- ISSN
- 1932-2968 (ISSN-L)
- PMC
- PMC10563523
- OpenAlex
- W4365444122
- Cited by
- 23
- References
- 8
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 10 · 2023: 2
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Diabetes Science and Technology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- national institute of diabetes and digestive and kidney diseases (1K23DK122017)
- Bioengineering and Behavioral Sciences working group for the Stanford Diabetes Research Center (P30 DK116074)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- artificial pancreas, open source software, type 1 diabetes, FDA approval, interoperability, real-world evidence
- MeSH terms
- Algorithms, Blood Glucose, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Insulin, Regular, Human
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