Real-World Use of Do-It-Yourself Artificial Pancreas Systems in Children and Adolescents With Type 1 Diabetes: Online Survey and Analysis of Self-Reported Clinical Outcomes

BACKGROUND: Patient-driven initiatives have made uptake of Do-it-Yourself Artificial Pancreas Systems (DIYAPS) increasingly popular among people with diabetes of all ages. Observational studies have shown improvements in glycemic control and quality of life among adults with diabetes. However, there is a lack of research examining outcomes of children and adolescents with DIYAPS in everyday life and their social context. OBJECTIVE: This survey assesses the self-reported clinical outcomes of a pediatric population using DIYAPS in the real world. METHODS: An online survey was distributed to caregivers to assess the hemoglobin A1c levels and time in range (TIR) before and after DIYAPS initiation and problems during DIYAPS use. RESULTS: A total of 209 caregivers of children from 21 countries responded to the survey. Of the children, 47.4% were female, with a median age of 10 years, and 99.4% had type 1 diabetes, with a median duration of 4.3 years (SD 3.9). The median duration of DIYAPS use was 7.5 (SD 10.0) months. Clinical outcomes improved significantly, including the hemoglobin A1c levels (from 6.91% [SD 0.88%] to 6.27% [SD 0.67]; P<.001) and TIR (from 64.2% [SD 15.94] to 80.68% [SD 9.26]; P<.001). CONCLUSIONS: Improved glycemic outcomes were found across all pediatric age groups, including adolescents and very young children. These findings are in line with clinical trial results from commercially developed closed-loop systems

Comment on Young-Hyman et al. Psychosocial care for people with diabetes: A position statement of the American Diabetes Association. Diabetes Care 2016;39:2126–2140

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Higher health literacy is associated with better glycemic control in adults with type 1 diabetes:a cohort study among 1399 Danes

Aim: Self-management of diabetes is influenced by a range of factors including the ability to access, understand, appraise, and use of health information in everyday life, which can collectively be called health literacy. We investigated associations between nine domains of health literacy and HbA1c level in people with type 1 diabetes.Methods: A cross-sectional study was conducted with 1399 people with type 1 diabetes attending a Danish specialist diabetes clinic. Health literacy was assessed using the nine-domain Health Literacy Questionnaire. The association between health literacy and HbA1c was analyzed using linear regression with adjustment for age, sex, educational attainment and diabetes duration. Results: Of the 1399 participants, 50% were women, mean age was 54 years, and mean HbA1c was 61&thinsp;mmol/mol (7.8%). Higher health literacy scores were associated with lower HbA1c levels across eight of nine health literacy domains. This association remained significant after adjusting for educational attainment. Among the domains, \u27Actively managing my health\u27 had the strongest impact on HbA1c. This was in turn predicted by \u27Appraising health information\u27, \u27Having sufficient information to manage health\u27, and \u27Social support for health\u27. Conclusions: Higher health literacy levels are associated with lower HbA1c regardless of educational background. This study highlights the importance of healthcare provision to respond to the health literacy levels of people with diabetes and to the possible need to provide program designed to enhance health literacy

Evidence on user-led innovation in diabetes technology (The OPEN project):Protocol for a mixed methods study

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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15368

A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study

BACKGROUND: Achieving consensus from a range of relevant stakeholders about an agreed set of core outcomes to be measured and reported as a minimum in clinical trials has the potential to enhance evidence synthesis and make findings more relevant and applicable. Intervention research to improve outcomes for young adults with type 1 diabetes (T1DM) is hampered by inconsistent use of outcome measures. This population frequently struggles to manage their condition and reports suboptimal clinical outcomes. Our aim was to conduct an international, e-Delphi consensus study to identify a core outcome set (COS) that key stakeholders (young adults with T1DM, diabetes health professionals, diabetes researchers and diabetes policy makers) consider as essential outcomes for future intervention research. METHODS: Using a list of 87 outcomes generated from a published systematic review, we administered two online surveys to a sample of international key stakeholders. Participants in the first survey (survey 1; n&thinsp;=&thinsp;132) and the second survey (survey 2; n&thinsp;=&thinsp;81) rated the importance of the outcomes. Survey 2 participants received information on total mean rating for each outcome and a reminder of their personal outcome ratings from Survey 1. Survey 2 results were discussed at a consensus meeting and participants (n&thinsp;=&thinsp;12: three young adults with T1DM, four diabetes health professionals, four diabetes researchers and one diabetes policy maker) voted on outcomes. Final core outcomes were included provided that 70% of consensus group participants voted for their inclusion. RESULTS: Eight core outcomes were agreed for inclusion in the final COS: measures of diabetes-related stress; diabetes-related quality of life; number of severe hypoglycaemic events; self-management behaviour; number of instances of diabetic ketoacidosis (DKA); objectively measured glycated haemoglobin (HbA1C); level of clinic engagement; and perceived level of control over diabetes. CONCLUSIONS: This study is the first to identify a COS for inclusion in future intervention trials to improve outcomes for young adults with T1DM. Use of this COS will improve the quality of future research and increase opportunities for evidence synthesis. Future research is necessary to identify the most robust outcome measure instruments