The Open Artificial Pancreas System (OpenAPS) project is a

free and open-source Free and open-source software (FOSS) is a term used to refer to groups of software consisting of both free software and open-source software where anyone is freely licensed to use, copy, study, and change the software in any way, and the source ...

project that aims to make basic

artificial pancreas Automated insulin delivery systems are automated (or semi-automated) systems designed to assist people with diabetes, primarily type 1, by automatically adjusting insulin delivery to help them control their blood glucose levels. Currently availabl ...

system (APS) technology available to everyone. 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 Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

to be completed and

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

approval to be granted as is traditional.

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 Nightscout is a free and open-source software, free and open-source project, and associated social movement, that enables accessing and working with blood glucose monitoring#Continuous glucose monitoring, continuous glucose monitor (CGM) data. ...

project) enabled access and transfer of

continuous glucose monitor A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis by insulin-requiring people with diabetes, e.g. people with type I, type II diabetes or other types of diabetes (e.g. gestational diabetes). A ...

(CGM) data to cloud computing infrastructure. Lewis, a

Type 1 Diabetes Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin (beta cells) are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar ...

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, and has been profiled in various news articles.

Software

The OpenAPS software can run on a small computer such as a

Raspberry Pi Raspberry Pi () is a series of small single-board computers (SBCs) developed in the United Kingdom by the Raspberry Pi Foundation in association with Broadcom. The Raspberry Pi project originally leaned towards the promotion of teaching basic ...

Intel Edison The Intel Edison is a computer-on-module that was offered by Intel as a development system for wearable devices and Internet of Things devices. The system was initially announced to be the same size and shape as an SD card and containing a dua ...

and automates an insulin pump's insulin delivery to keep blood glucose in a target range. 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

project, which allows CGM users access to their blood sugar data in real time by putting the data in the cloud. , the OpenAPS project estimates that over 360 people worldwide with various OpenAPS implementations, amounting to over 1.6 million real-world testing hours.

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. This has also raised some ethical concerns. 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 FDA released its first approval for an automated insulin delivery device for type 1 diabetes: Medtronic’s MiniMed 670G hybrid closed looped system.

History

Software

Regulatory concerns

Commercial alternatives

References

See also