TY - JOUR

T1 - Evidence on user-led innovation in diabetes technology (The OPEN project)

T2 - Protocol for a mixed methods study

AU - O'Donnell, Shane

AU - Lewis, Dana

AU - Fernández, María Marchante

AU - Wäldchen, Mandy

AU - Cleal, Bryan

AU - Skinner, Timothy

AU - Raile, Klemens

AU - Tappe, Adrian

AU - Ubben, Tebbe

AU - Willaing, Ingrid

AU - Hauck, Bastian

AU - Wolf, Saskia

AU - Braune, Katarina

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Digital 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). Objective: The 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. Methods: A 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. Results: This 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. Conclusions: The 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.

AB - Background: Digital 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). Objective: The 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. Methods: A 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. Results: This 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. Conclusions: The 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.

KW - #WeAreNotWaiting

KW - Automated insulin delivery systems

KW - Closed-loop insulin delivery systems

KW - Diabetes

KW - Digital health

KW - Open source

U2 - 10.2196/15368

DO - 10.2196/15368

M3 - Journal article

C2 - 31742563

AN - SCOPUS:85076104601

VL - 8

JO - Journal of Medical Internet Research

JF - Journal of Medical Internet Research

SN - 1439-4456

IS - 11

M1 - e15368

ER -