Evidence on User-Led Innovation in Diabetes Technology (The OPEN Project): Protocol for a Mixed Methods Study

Abstract

BackgroundDigital innovations in health care have traditionally followed a top-down pathway, with manufacturers leading the design and production of technology-enabled solutions and those living with chronic conditions involved only as passive recipients of the end product. However, user-driven open-source initiatives in health care are becoming increasingly popular. An example is the growing movement of people with diabetes, who create their own “Do-It-Yourself Artificial Pancreas Systems” (DIYAPS).ObjectiveThe overall aim of this study is to establish the empirical evidence base for the clinical effectiveness and quality-of-life benefits of DIYAPS and identify the challenges and possible solutions to enable their wider diffusion.MethodsA research program comprising 5 work packages will examine the outcomes and potential for scaling up DIYAPS solutions. Quantitative and qualitative methodologies will be used to examine clinical and self-reported outcome measures of DIYAPS users. The majority of members of the research team live with type 1 diabetes and are active DIYAPS users, making Outcomes of Patients’ Evidence With Novel, Do-It-Yourself Artificial Pancreas Technology (OPEN) a unique, user-driven research project.ResultsThis project has received funding from the European Commission’s Horizon 2020 Research and Innovation Program, under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange. Researchers with both academic and nonacademic backgrounds have been recruited to formulate research questions, drive the research process, and disseminate ongoing findings back to the DIYAPS community and other stakeholders.ConclusionsThe OPEN project is unique in that it is a truly patient- and user-led research project, which brings together an international, interdisciplinary, and intersectoral research group, comprising health care professionals, technical developers, biomedical and social scientists, the majority of whom are also living with diabetes. Thus, it directly addresses the core research and user needs of the DIYAPS movement. As a new model of cooperation, it will highlight how researchers in academia, industry, and the patient community can create patient-centric innovation and reduce disease burden together.International Registered Report Identifier (IRRID)PRR1-10.2196/15368

Do-It-Yourself Artificial Pancreas Systems: A Review of the Emerging Evidence and Insights for Healthcare Professionals

“…54 Future directions for DIY APS related research include a European Commission funded initiative, the OPEN Project, which provides a patient and user-led quantitative and qualitative research approach. 55 Given the lack of resources for formal trials, it is likely that such approaches will help provide further real-world evidence including QoL data. Tidepool, a non-profit software organization, has recently secured funding from partners like the Juvenile Diabetes Research Foundation and Helmsley Charitable trust to deliver an FDA-regulated version of Loop, which is currently a DIY closed loop application.…”

Open Innovation in Medical and Pharmaceutical Research: A Literature Landscape Analysis

“…Another aspect waiting to be further developed in the future is patient-centered innovation. Focus interviews have shown that stakeholders in the healthcare sector were keen on patient-centered care innovations ( Reed et al, 2012 ), and initiatives have been launched in drug development ( Hirsch, 2019 ) and diabetes therapy ( O'Donnell et al, 2019 ). More patient-centered initiatives should be encouraged, and their efficacy evaluated in the future.…”

User and Healthcare Professional Perspectives on Do-It-Yourself Artificial Pancreas Systems: A Need for Guidelines

“…Ongoing research includes the OPEN Project, which may address some of these outstanding questions. 13 Based on the workshop presentations and discussions, HCPs, including those who positively regard DIY APS, continue to have many questions related to patient safety, provider liability, official technical support, and how these systems work. A combination of liability and patient safety, particularly the possibility of an adverse event, appears to be the prominent barrier to support/recommendation of DIY APS from stakeholders, which has historically led to users assuming full liability for their own systems with HCPs and peer mentors.…”