The Influence of Age, Sex, and Socioeconomic Status on Glycemic Control Among People With Type 1 and Type 2 Diabetes in Canada: Patient-Led Longitudinal Retrospective Cross-sectional Study With Multiple Time Points of Measurement.

BACKGROUND: Clinical guidelines for most adults with diabetes recommend maintaining hemoglobin A1c (HbA1c) levels ≤7% (≤53 mmol/mol) to avoid microvascular and macrovascular complications. People with diabetes of different ages, sexes, and socioeconomic statuses may differ in their ease of attaining this goal. OBJECTIVE: As a team of people with diabetes, researchers, and health professionals, we aimed to explore patterns in HbA1c results among people with type 1 or type 2 diabetes in Canada. Our research question was identified by people living with diabetes. METHODS: In this patient-led retrospective cross-sectional study with multiple time points of measurement, we used generalized estimating equations to analyze the associations of age, sex, and socioeconomic status with 947,543 HbA1c results collected from 2010 to 2019 among 90,770 people living with type 1 or type 2 diabetes in Canada and housed in the Canadian National Diabetes Repository. People living with diabetes reviewed and interpreted the results. RESULTS: HbA1c results ≤7.0% represented 30.5% (male people living with type 1 diabetes), 21% (female people living with type 1 diabetes), 55% (male people living with type 2 diabetes) and 59% (female people living with type 2 diabetes) of results in each subcategory. We observed higher HbA1c values during adolescence, and for people living with type 2 diabetes, among people living in lower income areas. Among those with type 1 diabetes, female people tended to have lower HbA1c levels than male people during childbearing years but higher HbA1c levels than male people during menopausal years. Team members living with diabetes confirmed that the patterns we observed reflected their own life courses and suggested that these results be communicated to health professionals and other stakeholders to improve the treatment for people living with diabetes. CONCLUSIONS: A substantial proportion of people with diabetes in Canada may need additional support to reach or maintain the guideline-recommended glycemic control goals. Blood sugar management goals may be particularly challenging for people going through adolescence or menopause or those living with fewer financial resources. Health professionals should be aware of the challenging nature of glycemic management, and policy makers in Canada should provide more support for people with diabetes to live healthy lives.

Recent Developments in Islet Biology: A Review With Patient Perspectives.

Navigating the coronavirus disease-2019 (COVID-19, now COVID) pandemic has required resilience and creativity worldwide. Despite early challenges to productivity, more than 2,000 peer-reviewed articles on islet biology were published in 2021. Herein, we highlight noteworthy advances in islet research between January 2021 and April 2022, focussing on 5 areas. First, we discuss new insights into the role of glucokinase, mitogen-activated protein kinase-kinase/extracellular signal-regulated kinase and mitochondrial function on insulin secretion from the pancreatic ß cell, provided by new genetically modified mouse models and live imaging. We then discuss a new connection between lipid handling and improved insulin secretion in the context of glucotoxicity, focussing on fatty acid-binding protein 4 and fetuin-A. Advances in high-throughput "omic" analysis evolved to where one can generate more finely tuned genetic and molecular profiles within broad classifications of type 1 diabetes and type 2 diabetes. Next, we highlight breakthroughs in diabetes treatment using stem cell-derived ß cells and innovative strategies to improve islet survival posttransplantation. Last, we update our understanding of the impact of severe acute respiratory syndrome-coronavirus-2 infection on pancreatic islet function and discuss current evidence regarding proposed links between COVID and new-onset diabetes. We address these breakthroughs in 2 settings: one for a scientific audience and the other for the public, particularly those living with or affected by diabetes. Bridging biomedical research in diabetes to the community living with or affected by diabetes, our partners living with type 1 diabetes or type 2 diabetes also provide their perspectives on these latest advances in islet biology.

Building Capacity for Patient-Oriented Research: Utilizing Decision Aids to Translate Evidence into Practice, Policy and Outcomes.

BACKGROUND: The aim of this project was to engage with patient partners to translate knowledge about the decision aids and develop a scaling-up strategy for wider effects and reach. METHOD: This project was guided by the World Health Organization and IDEAS (Integrate, Design, Assess and Share) frameworks for design thinking (e.g., ideating creative strategies), dissemination (e.g., sharing locally and widely) and scalability. RESULTS: We engaged 132 stakeholders in six webinars, had 321 total page views of the decision aids and conducted 16 interviews to determine revisions to the design of the decision aids before scalability. CONCLUSION: Patient-partner collaborations assisted with design thinking, dissemination and scalability.

Patient engagement partnerships in clinical trials (PEP-CT): protocol for the systematic development and testing of patient partner and investigator decision aids.

INTRODUCTION: Building capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials requires training and support. The overall goal of this 2-year project is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials. METHODS AND ANALYSIS: Two decision aids were designed in Phase 1 of this programme of research and this protocol describes a subsequent sequential phased approach to refine/translate (Phase 2A) and conduct alpha/usability (Phase 2B) and beta/field (Phase 3) testing. Decision aid development is guided by the International Patient Decision Aid Standards, User-Centred Design, Ottawa Decision-Support Framework and the Ottawa Model of Research Use. We have integrated patient-oriented research methods by engaging patient partners across all phases of our programme of research. Decision aids will first be refined and then translated to French (Phase 2A). Eight iterative cycles of semistructured interviews with 40 participants (20 patient partners and 20 investigators) will be conducted to determine usability (Phase 2B). A pragmatic pre/post pilot study design will then be implemented for field/beta testing using another purposive sample of 80 English-speaking and French-speaking participants (40 patients and 40 investigators). The samples are purposive to ensure an equal representation of English-speaking and French-speaking participants and an equal representation of men and women. Since sex and/or gender differences in utilisation and effectiveness of decision aids have not been previously reported, Phase 3 outcomes will be reported for the total sample and separately for men and women. ETHICS AND DISSEMINATION: Ethics approval has been granted from the University of Toronto (41109, 28 September 2021). Informed consent will be obtained from participants. Dissemination will include co-authored publications, conference presentations, educational national public forums, fact sheets/newsletters, social media sharing and videos/webinars.

Patient Engagement Partnerships in Clinical Trials: Development of Patient Partner and Investigator Decision Aids.

BACKGROUND: A 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research. OBJECTIVES: The overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR). METHODS: We used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature. RESULTS: A total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation. CONCLUSION: Our digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.

The goal of this project was to improve sex/gender knowledge and help patients and investigators work together as partners in clinical trials. There were three phases to this project: Phase 1, search the literature to see what others had done; Phase 2, share the results of Phase 1 with key stakeholders to determine gaps, and develop tools to fill the gaps; and Phase 3, share the tools developed in Phase 2 with others to get feedback. We worked with Clinical Trials Ontario and other key stakeholders to make two decision aids­one for patients and one for investigators. The decision aids share sex/gender knowledge and information about patient-oriented research. Each decision aid has five parts: (1) Introduction (get the facts); (2) My Priorities (patient partner and investigator priorities); (3) Learn More (information on sex/gender and other resources to help patients and investigators work together); (4) My Readiness (comparing priorities with benefits and risks); and (5) My Decision (decision and next steps). Patients, investigators, and other key stakeholders really liked the decision aids and found them easy to move through, they had useful information, and they looked good. Comments included "I enjoyed that the decision aids were separated for patients and investigators"; "I liked it, it was user-friendly and easy to navigate"; and "there could be more interaction and aimed more for mobile devices". These decision aids are the first to provide knowledge and support beyond the standard decision aids used for health decisions. Next steps include getting more feedback and using the decision aids in a laboratory and then in a real-life setting and see if people still like them.