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DIY Artificial Pancreas Systems – self-developed technology for more safety and health?

DIY Artificial Pancreas Systems – self-developed technology for more safety and health?
Project team:

Woll, Silvia (Dissertation)

Start date:

2018

End date:

2021

Research group:

Life, Innovation, Health, and Technology

Project description

Type 1 diabetes (T1D) is a severe chronic disease with potentially serious acute and long-term consequences. Achieving the desired blood levels is extremely difficult. Being affected by T1D means lifelong constant self-control that rarely leads to stable levels. The vital insulin must be externally administered after calculating the respective requirement. At the worst, a wrong dosage can be fatal. Some people with T1D use an insulin pump which allows a more accurate dosing. However, a technology to replace the pancreatic function adequately is not yet available.

A community of privat persons, mainly people with T1D, uses the hashtag #WeAreNotWaiting to express their conviction that they can develop better solutions for their specific problems than those offered by the conventional health system. DIY Artificial Pancreas Systems (DIY-APS) automatically adjust insulin delivery through the insulin pump to keep blood glucose levels in a safe range.

The systems are automated and supposed to be precise in their measurements. DIY-APS are “far safer than standard pump” therapy and lead to “remarkable improvements in quality of life due to increased time in range, uninterrupted sleep, and peace of mind” (Lewis et al. 2016). Currently (December 2018), approximately 1015 people worldwide use DIY-APS and the number of users is steadily increasing.

This visionary technology comes with many promises, but also raises questions. DIY-APS are not officially tested and approved systems and therefore in a legal grey area – the use for oneself is permitted, but since commercial distribution would be just as illegal as the free provision of the software or setting up the app for others, prospective users have to compile the code themselves. Instructions and a supporting community can be found online. Despite the technological hurdle and the lack of a registration as medical device, more and more people use DIY-APS.

As part of a technology assessment, the dissertation project deals with technologies for handling T1D which can be divided into three categories:

  1. officially approved and tested technologies, the costs of which are covered by the statutory health insurances if certain conditions are met,
  2. technologies manufactured and legally distributed by companies, but not approved as medical devices, and
  3. technologies neither approved as medical devices nor commercially manufactured and distributed as their distribution would violate applicable law.

The dissertation focuses on DIY-APS and the growing and convinced DIY movement behind it. A vision assessment method is used to investigate why DIY-APS users trust in an unauthorized technology that has massive impact on the therapy of their T1D. What are the hopes and fears associated with DIY-APS? Do DIY-APS lead to a significant improvement in metabolic control, and do they affect the users’ quality of life? What areas of life are affected and to what extent?

Another question deals with potential changes in health technology and the conventional health system landscape resulting from approaches such as DIY-APS. Is the community interested in exchanging information with conventional manufacturers and/or researchers? Would people with T1D wish for (more) institutional research into DIY-APS or should everything remain in the hands of the DIY movement and thus remain freely accessible and open? Is the resulting independence from the medical device industry desired and what is perceived as advantageous or disadvantageous?

References

  • Lewis, D.; Leibrand, S.; #OpenAPS Community. (2016). Real-World Use of Open Source Artificial Pancreas Systems. Journal of Diabetes Science and Technology 10(6), p. 1411. http://doi.org/10.1177/1932296816665635
  • https://openaps.org/
  • https://openaps.org/outcomes/

Administrative data

Supervisor: Prof. Dr. Armin Grunwald
Advisor: Prof. Dr. Klaus Wiegerling
Doctoral students at ITAS: See Doctoral studies at ITAS

Contact

Silvia Woll, M.A.
Karlsruhe Institute of Technology (KIT)
Institute for Technology Assessment and Systems Analysis (ITAS)
P.O. Box 3640
76021 Karlsruhe
Germany

Tel.: +49 721 608-28331
E-Mail