Traditionally, patients have been regarded as passive recipients of healthcare interventions. However, the growing demand for inclusion and representation of patients as stakeholders has led to a paradigm shift. The mantra "Nothing About Us Without Us" emphasizes the need for people living with chronic conditions to be involved in the development of services, products, policies, and educational resources.
A primary example of patient-led innovation democratization in healthcare is the #WeAreNotWaiting movement, spearheaded by people with diabetes and their loved ones who transform their existing medical devices into "do-it-yourself" or "open-source" artificial pancreas systems. These systems enable automated, closed-loop insulin delivery based on available medical devices. Unlike commercially developed systems, code and documentation needed to create open-source systems are freely and openly shared by the #WeAreNotWaiting community and used at the user's own risk. Leveraging predictive control algorithms, these systems adjust insulin dosing based on predicted glycemic trends. Despite lacking regulatory approval, open-source automated insulin delivery systems have gained widespread popularity and are being used by thousands of individuals worldwide.
This thesis provides a comprehensive overview of open-source automated insulin delivery systems, elucidating their clinical and quality of life benefits for users. It presents novel evidence of the real-world effectiveness of these systems, offering insights into the lived experiences of users and their families. Moreover, the feasibility of implementing open-science infrastructures for sharing real-world data is explored. An international consensus statement is also provided, offering guidance to healthcare professionals and other key stakeholders. Additionally, this thesis addresses the issues of health disparities and barriers to access related to diabetes treatments and technology, both on a global scale and within specific countries. Further, the ethical and legal dilemmas associated with open-source automated insulin delivery systems and the significance of addressing the digital divide in access to modern treatments are being discussed, as well as potential advancements in artificial intelligence and diabetes technology.
User-led initiatives such as #WeAreNotWaiting and the technological innovations emerging from them hold promise for enhancing healthcare. However, concerted efforts are necessary to ensure universal accessibility and suitability for all patients.
