A Review of Safety and Design Requirements of the Artificial Pancreas
As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an a...
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| Format: | Online |
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Springer US
2016
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| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5093196/ |
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pubmed-5093196 |
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pubmed-50931962016-11-17 A Review of Safety and Design Requirements of the Artificial Pancreas Blauw, Helga Keith-Hynes, Patrick Koops, Robin DeVries, J. Hans Article As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components—type 1 diabetes, artificial pancreas, and safety or design—and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential. Springer US 2016-06-28 2016 /pmc/articles/PMC5093196/ /pubmed/27352278 http://dx.doi.org/10.1007/s10439-016-1679-2 Text en © The Author(s) 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
| repository_type |
Open Access Journal |
| institution_category |
Foreign Institution |
| institution |
US National Center for Biotechnology Information |
| building |
NCBI PubMed |
| collection |
Online Access |
| language |
English |
| format |
Online |
| author |
Blauw, Helga Keith-Hynes, Patrick Koops, Robin DeVries, J. Hans |
| spellingShingle |
Blauw, Helga Keith-Hynes, Patrick Koops, Robin DeVries, J. Hans A Review of Safety and Design Requirements of the Artificial Pancreas |
| author_facet |
Blauw, Helga Keith-Hynes, Patrick Koops, Robin DeVries, J. Hans |
| author_sort |
Blauw, Helga |
| title |
A Review of Safety and Design Requirements of the Artificial Pancreas |
| title_short |
A Review of Safety and Design Requirements of the Artificial Pancreas |
| title_full |
A Review of Safety and Design Requirements of the Artificial Pancreas |
| title_fullStr |
A Review of Safety and Design Requirements of the Artificial Pancreas |
| title_full_unstemmed |
A Review of Safety and Design Requirements of the Artificial Pancreas |
| title_sort |
review of safety and design requirements of the artificial pancreas |
| description |
As clinical studies with artificial pancreas systems for automated blood glucose control in patients with type 1 diabetes move to unsupervised real-life settings, product development will be a focus of companies over the coming years. Directions or requirements regarding safety in the design of an artificial pancreas are, however, lacking. This review aims to provide an overview and discussion of safety and design requirements of the artificial pancreas. We performed a structured literature search based on three search components—type 1 diabetes, artificial pancreas, and safety or design—and extended the discussion with our own experiences in developing artificial pancreas systems. The main hazards of the artificial pancreas are over- and under-dosing of insulin and, in case of a bi-hormonal system, of glucagon or other hormones. For each component of an artificial pancreas and for the complete system we identified safety issues related to these hazards and proposed control measures. Prerequisites that enable the control algorithms to provide safe closed-loop control are accurate and reliable input of glucose values, assured hormone delivery and an efficient user interface. In addition, the system configuration has important implications for safety, as close cooperation and data exchange between the different components is essential. |
| publisher |
Springer US |
| publishDate |
2016 |
| url |
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5093196/ |
| _version_ |
1613710548887666688 |