O'Donnell Shane, Lewis Dana, Marchante Fernández María, Wäldchen Mandy, Cleal Bryan, Skinner Timothy, Raile Klemens, Tappe Adrian, Ubben Tebbe, Willaing Ingrid, Hauck Bastian, Wolf Saskia, Braune Katarina
School of Sociology, University College Dublin, Belfield, Ireland.
OpenAPS, Seattle, WA, United States.
JMIR Res Protoc. 2019 Nov 19;8(11):e15368. doi: 10.2196/15368.
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).
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.
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.
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.
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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15368.
医疗保健领域的数字创新传统上遵循自上而下的路径，制造商主导技术支持解决方案的设计和生产，慢性病患者仅作为最终产品的被动接受者参与其中。然而，医疗保健领域由用户驱动的开源倡议正变得越来越受欢迎。一个例子是糖尿病患者日益壮大的运动，他们创建了自己的“自制人工胰腺系统”（DIYAPS）。
本研究的总体目标是为DIYAPS的临床有效性和生活质量益处建立实证证据基础，并确定实现其更广泛传播的挑战和可能的解决方案。
一个由5个工作包组成的研究项目将研究DIYAPS解决方案的成果和扩大规模的潜力。将使用定量和定性方法来检查DIYAPS用户的临床和自我报告的结果指标。研究团队的大多数成员患有1型糖尿病，并且是活跃的DIYAPS用户，这使得“新型自制人工胰腺技术患者证据结果”（OPEN）成为一个独特的、由用户驱动的研究项目。
该项目已获得欧盟委员会“地平线2020研究与创新计划”的资助，属于玛丽·斯克沃多夫斯卡-居里行动研究与创新人员交流项目。已招募具有学术和非学术背景的研究人员来制定研究问题、推动研究过程，并将正在进行的研究结果传播回DIYAPS社区和其他利益相关者。
OPEN项目的独特之处在于它是一个真正由患者和用户主导的研究项目，汇集了一个国际、跨学科和跨部门的研究团队，成员包括医疗保健专业人员、技术开发人员、生物医学和社会科学家，其中大多数人也患有糖尿病。因此，它直接解决了DIYAPS运动的核心研究和用户需求。作为一种新的合作模式，它将突出学术界、工业界和患者社区的研究人员如何能够共同创造以患者为中心的创新并减轻疾病负担。
国际注册报告识别号（IRRID）：PRR1-10.2196/15368
