OpenAPS explained

OpenAPS
Author:Dana Lewis, Scott Leibrand, Ben West
Latest Release Version:0.7.0
Latest Preview Version:0.7.1
Operating System:Cross platform
Language:JavaScript, Python
Genre:Medical software
License:MIT License

The Open Artificial Pancreas System (OpenAPS) project is a free and open-source project that aims to make basic artificial pancreas system (APS) technology available to everyone.[1] The OpenAPS project was designed with the idea of quickly getting the APS technology to more people using a direct approach, rather than waiting for clinical trials to be completed and regulatory approval to be granted.[1]

History

OpenAPS traces its origin to 2013, when Dana M. Lewis and Scott Leibrand became aware of privately shared software created by John Costik. This software (which also led to development of the Nightscout project) enabled access and transfer of continuous glucose monitor (CGM) data to cloud computing infrastructure. Lewis, a Type 1 Diabetes patient, was dissatisfied with her commercial device: the device's alarm for hypoglycemic status (which can be life-threatening, if untreated) was too quiet to wake Dana up while sleeping. To address this, Lewis and Leibrand extended the CGM-in-the-cloud software to create a custom high volume alarm. After this initial project, they then used the same CGM-in-the-cloud software to create the Do-It-Yourself Pancreas System (DIYPS) software, which provided a decision assist system for insulin delivery.

This decision automation was able to become a "closed loop" with the help of an open source decoding-carelink project created by Ben West to communicate with Medtronic insulin pumps, enabling data retrieval and issuance of insulin-dosing commands to pumps that support it. With this update, the DIYPS system became "OpenAPS".

Lewis has since presented the OpenAPS at conferences,[2] and has been profiled in various news articles.[3] [4]

Software

The OpenAPS software can run on a small computer such as a Raspberry Pi or Intel Edison and automates an insulin pump's insulin delivery to keep blood glucose in a target range.[5] It does this by monitoring CGM data, algorithmically determining when insulin doses should occur, and issuing commands to the insulin pump to deliver these doses. OpenAPS is a subset of a broader "CGM in the Cloud" social movement; this includes the Nightscout project, which allows CGM users access to their blood sugar data in real time by putting the data in the cloud.[6] the OpenAPS project knew of over 2,720 people worldwide with various types of DIY closed loop implementations, for over 62 million real-world testing hours.[7]

Regulatory concerns

As with the Nightscout project more generally and as a non-commercial open source project, OpenAPS has not been subject to regulation; this has raised some regulatory concerns, particularly since each user builds their own implementation of the system.[1] [8]

This has also raised some ethical concerns by regulators and researchers.[9] The OpenAPS project emphasizes a "use at your own risk" approach, with the following disclaimer:

Commercial alternatives

In September 2016, subsequent to the development of OpenAPS, the US FDA released its first approval for an automated insulin delivery device for type 1 diabetes, for Medtronic's MiniMed 670G hybrid closed-loop system.[10]

See also

Notes and References

  1. Web site: Home page - What is OpenAPS - FAQ. OpenAPS. openaps.org. 23 July 2017.
  2. Web site: Dana Lewis.
  3. Web site: This Woman Designed - And Texts - Her Own Pancreas . Rebecca Heilweil . Forbes . June 15, 2017 . 2017-07-25 .
  4. Web site: Alabamian with diabetes built her own artificial pancreas, gives away plan for free . Lee Roop . AL.com . May 23, 2017 . 2017-07-25 .
  5. Web site: OpenAPS Offers Open Source Tools for Diabetes Management. Martin. Lisa. Make: DIY Projects and Ideas for Makers. 31 March 2017.
  6. Web site: CGM in the Cloud: The How, Why, and Why Not of Remote CGM Watching. Kerri. Sparling. diaTribe. 14 August 2021. first published 12 September 2014.
  7. Web site: Outcomes. OpenAPS. 5 July 2022.
  8. Lee . Joyce M. . Hirschfield . Emily . Wedding . James . 2016-04-12 . A Patient-Designed Do-It-Yourself Mobile Technology System for Diabetes: Promise and Challenges for a New Era in Medicine . JAMA . 315 . 14 . 10.1001/jama.2016.1903 . 2017-05-05 . 27115262 . 1447–8 .
  9. Farrington. Conor. Hacking diabetes: DIY artificial pancreas systems. The Lancet Diabetes & Endocrinology. May 2017. 5. 5. 332. 10.1016/S2213-8587(16)30397-7. 27913173. the danger with OpenAPS is that some despairing parent with limited technical knowledge will build things incorrectly, with untoward consequences for their offspring..
  10. Web site: FDA approves first automated insulin delivery device for type 1 diabetes FDA. FDA. 26 July 2017. en. 28 September 2016.