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

Pancreatic β-cells are finely tuned to secrete insulin so that plasma glucose levels are maintained within a narrow physiological range (3.5-5.5 mmol/L). Hyperinsulinaemic hypoglycaemia (HH) is the inappropriate secretion of insulin in the presence of low plasma glucose levels and leads to severe and persistent hypoglycaemia in neonates and children. Mutations in 12 different key genes (ABCC8,

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 <italic>Outcomes of Patients’ Evidence With Novel, Do-It-Yourself Artificial Pancreas Technology</italic> (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. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15368

BACKGROUND People with diabetes and their support networks have developed open-source automated insulin delivery systems to help manage their diabetes therapy, as well as to improve their quality of life and glycemic outcomes. Under the hashtag #WeAreNotWaiting, a wealth of knowledge and real-world data has been generated by users of these systems but has been left largely untapped by research; the opportunity for multimodal studies investigating this group remains open. OBJECTIVE Developing a mixed-methods study to evaluate several aspects of open-source automated insulin delivery presents challenges relating to data management and security across multiple disparate online platforms, and implementation of follow-up studies with study participants. This research article reports on the feasibility of such a multimodal concept. METHODS A web portal was developed to manage both front-end participant interactions with study elements and back-end data management of survey responses and donated anonymized diabetes data. Participant data in REDCap and Open Humans was pseudonymously and securely linked and stored within a custom-built database using both open-source and commercial software. Participants—which included adults and children with diabetes, their partners and caregivers—were recruited through multiple online diabetes community groups. Participants were later given the option to include their healthcare providers in the study; database architecture was designed specifically with this kind of extensibility in mind. RESULTS Of 1052 visitors to the study landing page, 930 participated and completed at least one or multiple questionnaires. After the implementation of healthcare professional validation of self-reported clinical outcomes to the study, an additional 145 individuals visited the landing page, with 124 completing at least one or multiple questionnaires. Of the optional study elements, 7 participant-healthcare professional dyads participated in the survey, and 97 participants who completed the survey joined Open Humans to also donate their anonymized medical device data. CONCLUSIONS The study design proved successful in being both accessible for participants and manageable for researchers while maintaining compliance with data regulations. The gateway proved scalable when tested with the later addition of validation of self-reported data. Custom software solutions like the gateway may become increasingly common in diabetes research, especially with medical device data donation and follow-up studies. The gateway portal code has been made available open-source and can also be leveraged by other research projects.

BACKGROUND Real-time continuous glucose monitoring (rtCGM) systems have shown to be a low-pain, safe and effective method in preventing hypo- and hyperglycemia in people with diabetes of various age groups. Evidence on rtCGM use in infants, and in patients with conditions other than diabetes, remains limited. OBJECTIVE This case study describes the off-label use of rtCGM, and the use of an open-source app for glucose monitoring, in a newborn with prolonged hypoglycemia secondary to transient congenital hyperinsulinism during the perinatal period. METHODS rtCGM was introduced at 39 hours of age. CBG checks were performed regularly. In order to benefit from customizable alert settings and include hypoglycemic sensor glucose levels below 40 mg/dL, the open-source app xDrip+ was introduced at 9 days of age. RESULTS Time-in-Range (45-180 mg/dL) remained consistent above 90%, whereas Time-in-Hypoglycemia (<45 mg/dL) decreased, and mean glucose was maintained above 70 mg/dL at 72 h of life and after. Daily sensor glucose profiles showed cyclic fluctuations that were less pronounced over time. CONCLUSIONS While off-label use of medication is both common practice and a necessity in newborn infants, there are few examples for off-label uses of medical devices, rtCGM being a notable exception. Real-time information allowed us to better understand glycemic patterns and to improve the quality of glycemic control accordingly. Severe hypoglycemia was prevented, measurement of serum levels of insulin and further lab diagnostics were performed much faster, whilst the patient’s individual burden caused by invasive procedures has been reduced. A wider customizability of threshold and alert settings would be beneficial for user groups with glycemic instability other than people with diabetes, and hospitalized infants in particular. Further research in the field of personal and off-label open-source rtCGM use, differences between native and open-source algorithms in translating raw sensor data, as well as customization of commercially available rtCGM systems is needed. CLINICALTRIAL Does not apply.