OpenAPS

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 FDA approval to be granted as is traditional.[2]

OpenAPS
Original author(s)Dana Lewis, Scott Leibrand, Ben West
Initial release2015 (2015)
Stable release
0.7.0 / 10 November 2019 (2019-11-10)
Preview release
0.7.1 / 13 May 2019 (2019-05-13)
Operating systemCross platform
Available inJavaScript, Python
TypeMedical software
LicenseMIT License
Websiteopenaps.org

History
Dana Lewis at linux.conf.au in 2019

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 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.[3] 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.[4] With this update, the DIYPS system became "OpenAPS".

Lewis has since presented the OpenAPS at conferences,[5][6] and has been profiled in various news articles.[3][7][8]

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.[3] It does this by monitoring continuous glucose monitor (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.[3][9] As of 2017, the OpenAPS project estimates that over 360 people worldwide with various OpenAPS implementations, amounting to over 1.6 million real-world testing hours.[10]

Regulatory concerns

As with the Nightscout project more generally and as a non-commercial open source project, OpenAPS has not been regulated by the FDA; this has raised some regulatory concerns, particularly since each user builds their own implementation of the system.[2][11]

This has also raised some ethical concerns.[12] The OpenAPS project emphasizes a "use at your own risk" approach, with the following disclaimer:

[T]he ultimate answer to “is it safe” will be something each individual decides for themselves.

Commercial alternatives

In September 2016, subsequent to the development of OpenAPS, the FDA released its first approval for an automated insulin delivery device for type 1 diabetes: Medtronic’s MiniMed 670G hybrid closed looped system.[13]

References
  1. "OpenAPS.org – #WeAreNotWaiting to reduce the burden of Type 1 diabetes". openaps.org. Retrieved 23 July 2017.
  2. "What is #OpenAPS? – OpenAPS.org". openaps.org. Retrieved 23 July 2017.
  3. "OpenAPS Offers Open Source Tools for Diabetes Management | Make:". Make: DIY Projects and Ideas for Makers. 31 March 2017. Retrieved 23 July 2017.
  4. www.github.com/bewest/decoding-carelink
  5. www.frontiersconference.org/speakers/dana-lewis
  6. https://medicinex.stanford.edu/medx-speakers/dana-lewis/
  7. Rebecca Heilweil (June 15, 2017). "This Woman Designed - And Texts - Her Own Pancreas". Forbes. Retrieved 2017-07-25.
  8. Lee Roop (May 23, 2017). "Alabamian with diabetes built her own artificial pancreas, gives away plan for free". AL.com. Retrieved 2017-07-25.
  9. "CGM in the Cloud: The How, Why, and Why Not of Remote CGM Watching | diaTribe". diaTribe. 12 September 2014. Retrieved 23 July 2017.
  10. "Outcomes – OpenAPS.org". openaps.org. Retrieved 23 July 2017.
  11. 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): 1447–8. doi:10.1001/jama.2016.1903. PMID 27115262. Retrieved 2017-05-05.
  12. Farrington, Conor (May 2017). "Hacking diabetes: DIY artificial pancreas systems". The Lancet Diabetes & Endocrinology. 5 (5): 332. doi:10.1016/S2213-8587(16)30397-7.
  13. "FDA approves first automated insulin delivery device for type 1 diabetes | FDA". FDA. 28 September 2016. Retrieved 26 July 2017.

See also
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