[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] 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.
[2][8] As of July 2022[update] 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.
[11] 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.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.