A European regulatory pathway for Tidepool loop following clearance in the United States?

The recent clearance by the United States Food and Drug Administration of Tidepool Loop sets an important precedent within the medical device landscape. For the first time, an automated insulin delivery mobile application-based on an algorithm initially designed and developed by users -has been recognised as safe and effective by a regulatory body. The aim of this paper is twofold: firstly, we map out the regulatory pathways and processes that were navigated by Tidepool, the non-profit behind Tidepool Loop, in order to make this landmark moment possible. Secondly, we set out potential approvals processes in the European Union and United Kingdom with a view to examining the challenges to obtaining regulatory clearance for Tidepool Loop in these jurisdictions. In so doing, we highlight the significant differences, not only between the United States and European systems but also between the European Union and Great Britain systems. We conclude by arguing that the complexity encountered when seeking to introduce an innovative solution in different regulatory systems has the potential to act as a disincentive to open source developers from seeking regulatory approvals for such technologies in the future.

Prevalence and associated risk factors for suicidal ideation, non-suicidal self-injury and suicide attempt among male construction workers in Ireland.

BACKGROUND: Suicide among male construction workers are reported to be disproportionally high compared to the working age population. However, there is minimal understanding of the prevalence and associated factors for suicidal ideation, non-suicidal self-injury, and suicide attempt among this occupational group globally. METHODS: A cross-sectional study was conducted on a large sample of male construction workers in Ireland (n = 1,585). We investigated the prevalence of suicidal ideation, non-suicidal self-injury and suicide attempts and sociodemographic, occupational, and mental health factors associated with these three outcomes. Multivariable Poisson regression was performed to estimate the prevalence rate ratio of suicidal ideation (model 1 primary outcome), while multivariable logistic regression was used to estimate the odds ratio of non-suicidal self-injury (model 2 primary outcome), and suicide attempt (model 3 primary outcome). RESULTS: The lifetime prevalence rate for suicidal ideation was 22%, 6% for non-suicidal self-injury, and 6% for suicide attempt. In univariate modelling, socio-demographic and occupation-specific factors associated with the three outcomes included younger age (suicidal ideation and non-suicidal self-injury), not being in a relationship (suicide attempt) and working 35-44 h per week (suicidal ideation and suicide attempt). The mental health factors generalized anxiety disorder, depression, and suicide bereavement were significantly associated with increased risk of the three outcomes. In fully adjusted multivariable models, increasing severity of generalized anxiety disorder and depression were associated with an increased prevalence rate ratio of suicidal ideation, and a higher odds ratio of non-suicidal self-injury and suicide attempt. CONCLUSION: Suicidal ideation, non-suicidal self-injury and suicide attempt are significant issues for male construction workers that require specific attention. Findings highlight a need to support younger male construction workers and those bereaved by suicide. They also highlight the need for the early detection and treatment of generalized anxiety disorder and depression in order to intervene in, and potentially prevent, suicidality among male construction workers.

Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes.

BACKGROUND: Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity. OBJECTIVE: This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study. METHODS: Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID. RESULTS: In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics. CONCLUSIONS: Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items.

Men's mental health and the arts: perceived benefits and dynamics of engagement.

Arts engagement is gaining recognition as a non-clinical approach to promote mental health and well-being. However, the perceived utility of the arts to promote mental health among men with low socioeconomic status (SES) and how to best engage them is underexplored. This study explores the lived experiences of men with low SES who engage with the arts in Northern Ireland (n = 41). Data collected via focus groups (n = 5) and interviews (n = 11) were analysed using reflexive thematic analysis to inductively derive four themes. Theme 1 highlights how the arts facilitated friendship, a collective identity, peer support and a reason to socialize. Themes 2 and 3 explore how the arts enhanced self-esteem and emotional regulation by developing a routine, purpose, sense of mastery, a sense of catharsis through immersion in a soothing endeavour and an alternative outlet for self-expression. Theme 4 covers strategies that facilitate male engagement in the arts such as using a familiar space, delivering to an existing male group, framing the programme around male interests not health or creativity, building on existing strengths and capacities, enabling ownership, using tangible action-orientated activities, and being non-authoritative and flexible with delivery. This is one of the first studies to highlight the gendered dimensions in which men with low SES engage with and experience mental health benefits through arts engagement. This study points towards relevant theories to further understand the pathways between the arts and improved mental health among men which can inform development of tailored arts programmes for men.

Emotional and Physical Health Impact in Children and Adolescents and Their Caregivers Using Open-source Automated Insulin Delivery: Qualitative Analysis of Lived Experiences.

BACKGROUND: Given the limitations in the access and license status of commercially developed automated insulin delivery (AID) systems, open-source AID systems are becoming increasingly popular among people with diabetes, including children and adolescents. OBJECTIVE: This study aimed to investigate the lived experiences and physical and emotional health implications of children and their caregivers following the initiation of open-source AID, their perceived challenges, and sources of support, which have not been explored in the existing literature. METHODS: Data were collected through 2 sets of open-ended questions from a web-based multinational survey of 60 families from 16 countries. The narratives were thematically analyzed, and a coding framework was identified through iterative alignment. RESULTS: A range of emotions and improvements in quality of life and physical health were reported, as open-source AID enabled families to shift their focus away from diabetes therapy. Caregivers were less worried about hypoglycemia at night and outside their family homes, leading to increased autonomy for the child. Simultaneously, the glycemic outcomes and sleep quality of both the children and caregivers improved. Nonetheless, the acquisition of suitable hardware and technical setup could be challenging. The #WeAreNotWaiting community was the primary source of practical and emotional support. CONCLUSIONS: Our findings show the benefits and transformative impact of open-source AID and peer support on children with diabetes and their caregivers and families, where commercial AID systems are not available or suitable. Further efforts are required to improve the effectiveness and usability and facilitate access for children with diabetes, worldwide, to benefit from this innovative treatment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/15368.

Why #WeAreNotWaiting-Motivations and Self-Reported Outcomes Among Users of Open-source Automated Insulin Delivery Systems: Multinational Survey.

BACKGROUND: Automated insulin delivery (AID) systems have been shown to be safe and effective in reducing hyperglycemia and hypoglycemia but are not universally available, accessible, or affordable. Therefore, user-driven open-source AID systems are becoming increasingly popular. OBJECTIVE: This study aims to investigate the motivations for which people with diabetes (types 1, 2, and other) or their caregivers decide to build and use a personalized open-source AID. METHODS: A cross-sectional web-based survey was conducted to assess personal motivations and associated self-reported clinical outcomes. RESULTS: Of 897 participants from 35 countries, 80.5% (722) were adults with diabetes and 19.5% (175) were caregivers of children with diabetes. Primary motivations to commence open-source AID included improving glycemic outcomes (476/509 adults, 93.5%, and 95/100 caregivers, 95%), reducing acute (443/508 adults, 87.2%, and 96/100 caregivers, 96%) and long-term (421/505 adults, 83.3%, and 91/100 caregivers, 91%) complication risk, interacting less frequently with diabetes technology (413/509 adults, 81.1%; 86/100 caregivers, 86%), improving their or child's sleep quality (364/508 adults, 71.6%, and 80/100 caregivers, 80%), increasing their or child's life expectancy (381/507 adults, 75.1%, and 84/100 caregivers, 84%), lack of commercially available AID systems (359/507 adults, 70.8%, and 79/99 caregivers, 80%), and unachieved therapy goals with available therapy options (348/509 adults, 68.4%, and 69/100 caregivers, 69%). Improving their own sleep quality was an almost universal motivator for caregivers (94/100, 94%). Significant improvements, independent of age and gender, were observed in self-reported glycated hemoglobin (HbA1c), 7.14% (SD 1.13%; 54.5 mmol/mol, SD 12.4) to 6.24% (SD 0.64%; 44.7 mmol/mol, SD 7.0; P<.001), and time in range (62.96%, SD 16.18%, to 80.34%, SD 9.41%; P<.001). CONCLUSIONS: These results highlight the unmet needs of people with diabetes, provide new insights into the evolving phenomenon of open-source AID technology, and indicate improved clinical outcomes. This study may inform health care professionals and policy makers about the opportunities provided by open-source AID systems. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/15368.

Establishing consensus on key public health indicators for the monitoring and evaluating childhood obesity interventions: a Delphi panel study.

BACKGROUND: Childhood obesity is influenced by myriad individual, societal and environmental factors that are not typically reflected in current interventions. Socio-ecological conditions evolve and require ongoing monitoring in terms of assessing their influence on child health. The aim of this study was to identify and prioritise indicators deemed relevant by public health authorities for monitoring and evaluating childhood obesity interventions. METHOD: A three-round Delphi Panel composed of experts from regions across Europe, with a remit in childhood obesity intervention, were asked to identify indicators that were a priority in their efforts to address childhood obesity in their respective jurisdictions. In Round 1, 16 panellists answered a series of open-ended questions to identify the most relevant indicators concerning the evaluation and subsequent monitoring of interventions addressing childhood obesity, focusing on three main domains: built environments, dietary environments, and health inequalities. In Rounds 2 and 3, panellists rated the importance of each of the identified indicators within these domains, and the responses were then analysed quantitatively. RESULTS: Twenty-seven expert panellists were invited to participate in the study. Of these, 16/27 completed round 1 (5 9% response rate), 14/16 completed round 2 (87.5% response rate), and 8/14 completed the third and final round (57% response rate). Consensus (defined as > 70% agreement) was reached on a total of 45 of the 87 indicators (49%) across three primary domains (built and dietary environments and health inequalities), with 100% consensus reached for 5 of these indicators (6%). CONCLUSION: Forty-five potential indicators were identified, pertaining primarily to the dietary environment, built environment and health inequalities. These results have important implications more widely for evaluating interventions aimed at childhood obesity reduction and prevention.

'Your wealth is your health': the fundamental causes of inequalities in diabetes management outcomes: a qualitative analysis.

Fundamental Cause Theory (FCT) is among the most influential explanations for health inequalities. The theory posits that the social gradient in health persists because higher-socioeconomic status (SES) groups are systematically more able to take advantage of new medical innovations and health-enhancing knowledge due to their greater access to resources. Taking the life histories of people with diabetes (PwD) (N = 17) in the Republic of Ireland as a case study, this paper aims to elucidate the behaviours and agencies underlying 'fundamental causality' through examining how PwD of contrasting SES respond to disease management information. Findings highlight how the most common barriers to effective diabetes control were chronic psychological distress, combined with the cultural significance of alcohol consumption, which was central to both the social and economic subsistence of male participants in particular. However, higher-SES groups were more likely to experience a 'turnabout' in their life, whereby they could remove themselves from the conditions giving rise to their distress and move into a social space where more health-enhancing behaviours were possible. It concludes with a discussion of potential mechanisms that may explain why such turnabouts were more likely to occur in the case of higher-SES groups and the implications for FCT.

Changing social and scientific discourses on type 2 diabetes between 1800 and 1950: a socio-historical analysis.

Since the emergence of type 2 diabetes as a public health threat around the middle of the 20(th) century, accounts of disease causation have focused predominately on lifestyle or genetics, or both, while the role of broader structural issues such as psychosocial distress has been downplayed. Yet in the years prior to this emergence, when diabetes remained the preserve of the upper classes, medical experts drew upon multiple narratives when considering the condition, the most popular of which being the role of social organisation and the interplay between mind, body and environment. This article is based on a discourse analysis of the writings of the most prominent diabetes experts between 1800 and 1950 about both the causes and management of the illness. It highlights how, although the connection between lifestyle and diabetes was well established among physicians, individual-level explanations only fully supplanted the emphasis on social organisation as diabetes began to make the transition from being a disease of the rich to one of the poor. It argues that this discursive shift was shaped by the dynamics of class relations rather than any new forms of scientific evidence developed at the time.

Workplace Interventions Targeting Mental Health Literacy, Stigma, Help-Seeking, and Help-Offering in Male-Dominated Industries: A Systematic Review.

Mental ill-health and suicide represent a significant proportion of the burden of global disease among men. Connell's relational theory of masculinities provides a useful framework to explore how mental health literacy, mental health stigma, and delayed help-seeking and help-offering behaviors are associated with mental ill-health among men, particularly within male-dominated industries. To address the high incidences of mental ill-health in male-dominated industries, several workplace interventions targeting these outcomes have been implemented. No review to date has examined the current state of evidence for these interventions or identified the behavior change techniques used. This review was restricted to empirical, quantitative research reporting on psychosocial interventions targeting mental health literacy, stigma, and help-seeking and help-offering behaviors in male-dominated industries. Quality appraisal was completed using the Effective Public Health Practice Project and a narrative synthesis was conducted. Twelve articles were included for review which reported on four distinct interventions. The methodological quality of two articles was strong, three moderate and seven weak. The strongest evidence of intervention effects related to mental health literacy and help-seeking intentions. There was less evidence relating to help-offering and help-seeking behaviors and mental health stigma. Sixteen behavior change techniques were identified across interventions that are discussed in relation to the wider men's health literature. The evidence on psychosocial interventions in male-dominated industries is limited due to methodological and conceptual issues. Recommendations for future research include standardized reporting of intervention descriptions, the use of theory to guide intervention development, and utilizing validated and reliable outcome measures.

"We're seen as part of the supply chain of medicines rather than as the professionals that we are": The wellbeing of community pharmacists during the COVID response.

INTRODUCTION: Challenges facing community pharmacists in delivering and adapting services during the COVID-19 response have been reported. However, few qualitative studies have examined the impact of these experiences on their wellbeing, and what supports the profession requires in the future. AIM(S): To examine the work-related experiences and psychosocial needs of community pharmacists situated in the Republic of Ireland arising from the COVID-19 response. METHOD: 11 pharmacists and 1 representative were interviewed and data analysed through inductive thematic analysis. RESULTS: Work experiences were characterised by increased workload linked to multiple roles pharmacists played during the pandemic. Remaining open, meeting the social and medical needs of patients unable to easily access other primary services exerted its toll on pharmacists while at the same time providing a sense of professional fulfilment. Participants felt contributions made to the community during COVID-19 went largely unrecognised by the wider healthcare structure. This added to a prior sense of professional disenchantment arising from long-standing under-resourcing, lack of clinical autonomy and high administrative burden eroding their sense of purpose and meaning. Informal, peer-support networks were preferred over formal psychological support initiatives. CONCLUSIONS: The post-pandemic environment is an opportune time for policy makers to reconsider the role of community pharmacists. Greater clinical autonomy beyond dispensing of medicines, for example, for example, would also serve to enhance the sense of purpose and meaning of pharmacists as healthcare professionals. The longer-term well-being of community pharmacists is contingent on recognition of the value that community pharmacy bring both to the healthcare system and wider society as a whole.

Out-of-pocket expenses and rationing of insulin and diabetes supplies: findings from the 2022 T1International cross-sectional web-based survey.

Introduction: Continue investigating Out-of-Pocket Expenses (OoPEs) and rationing of insulin and diabetes supplies, including impacts of the COVID-19 pandemic, for people with type 1 diabetes (T1D). Methods: A cross-sectional web-based survey was conducted in English and advertised by T1International's global network of patient advocates from May through September 2022. Participants provided monthly OoPEs and rationing frequency for insulin and supplies, impacts of the COVID-19 pandemic, and open-ended comments. Results: In the seven most represented countries, mean monthly OoPEs were highest in the United States, followed by Panama, Canada, and India, and were much lower in the United Kingdom, Germany, and Sweden. OoPEs were highest for participants with partial healthcare coverage, followed by those with no healthcare coverage. The COVID-19 pandemic negatively impacted access and/or affordability of insulin and/or supplies for over half of participants. Globally, 19.5% reported insulin rationing and 36.6% reported rationing glucose testing supplies. Qualitative analysis of open-ended responses identified themes such as 'mental health impacts' and 'limits to life choices.' Discussion: High OoPEs lead to rationing of insulin and supplies for many people with T1D globally. Healthcare systems improvements and price reductions of insulin and supplies are needed to ensure adequate, equitable access for all.

Usability of the BigO system in pediatric obesity treatment: A mixed-methods evaluation of clinical end-users.

Objective: To assess technical usability of the BigO app and clinical portal among diverse participants and explore the overall user experiences of both. Methods: Methods included technical usability testing by measuring the relative user efficiency score (RUS) for the app and measuring Relative User Efficiency (RUE) using the 'think aloud' method with the clinical portal. Qualitative approaches involved focus groups with adolescent app users and semi-structured one-to-one interviews with clinician participants. Thematic analysis was applied to analyze qualitative data. Participants: Clinical participants consisted of adolescents seeking treatment for severe obesity and were invited via telephone/face to face to attend technical usability testing and a focus group. Healthcare professionals (HCPs) and researchers using the BigO clinical portal interface were invited to participate in usability testing and semi-structured interviews. Results: From 14 families invited to attend, seven consented to join the study and four adolescents (mean age=13.8 (SD 0.8) years) participated. Additionally, six HCPs and one pediatric obesity researcher took part. RUS for adolescents indicated that the tasks required of them via myBigO app were feasible, and technically efficient. No user-related errors were observed during tasks. Technical barriers reported by adolescents included notifications of battery optimization, misunderstanding image annotation language, and compatibility challenges with certain phone models. RUS for the HCPs and researcher indicated that basic technical skills are a potential barrier for clinical portal use and qualitative findings revealed that clinical users wanted a logging option for monitoring goals and providing feedback on the portal. Conclusion: Our study provided valuable formative findings from clinical end-users in Ireland indicating that adolescents being treated for obesity rated myBigO app as usable, acceptable and that it may assist other key stakeholders to understand food marketing and to monitor dietary and physical activity behaviors. Several key suggestions for future iterations of the clinical portal were provided to enhance its value in pediatric obesity treatment.

Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations.

People with diabetes often encounter stigma (ie, negative social judgments, stereotypes, prejudice), which can adversely affect emotional, mental, and physical health; self-care, access to optimal health care; and social and professional opportunities. To accelerate an end to diabetes stigma and discrimination, an international multidisciplinary expert panel (n=51 members, from 18 countries) conducted rapid reviews and participated in a three-round Delphi survey process. We achieved consensus on 25 statements of evidence and 24 statements of recommendations. The consensus is that diabetes stigma is driven primarily by blame, perceptions of burden or sickness, invisibility, and fear or disgust. On average, four in five adults with diabetes experience diabetes stigma and one in five experience discrimination (ie, unfair and prejudicial treatment) due to diabetes, such as in health care, education, and employment. Diabetes stigma and discrimination are harmful, unacceptable, unethical, and counterproductive. Collective leadership is needed to proactively challenge, and bring an end to, diabetes stigma and discrimination. Consequently, we achieved unanimous consensus on a pledge to end diabetes stigma and discrimination.

Using an Intersectional Approach to Explore the Lived Mental Health Experiences of Traveller Men Affected by Suicide in Ireland.

Rates of suicide are seven times higher among Traveller men, an Indigenous ethnic minority group in Ireland, compared with non-Traveller men. Several factors are implicated, including racism, social exclusion, discrimination, inadequate accommodation, unemployment, and lower educational attainment. Systemic and cultural barriers inhibit Traveller men from seeking support. This study addresses a gap in the literature by exploring the lived mental health experiences of Traveller men affected by suicide. Semi-structured interviews (n = 13; aged 19-50) were conducted with Traveller men affected by suicide. Interviews were recorded and transcribed verbatim. Thematic content analysis was used to analyze the data, which yielded three broad themes. Theme 1, "key determinants of Traveller men's mental health," describes the impact on Traveller men of issues relating to accommodation/homelessness, education, and unemployment, as well as frequent exposure to prejudice, discrimination, and racism. Theme 2, "contemporary Traveller masculinities," considers how Traveller masculinities were shaped by a patrilineal tradition and by historical/ongoing tensions related to their ethnicity. Theme 3, "navigating support seeking and coping with distress," encapsulates both resistant and proactive approaches used by participants to manage their mental health. The intersection of structural inequalities, internalized racism, Traveller masculinities, and strong historical associations between stigma and mental health/suicide within the Traveller community lies at the heart of the heavy burden of suicide carried by Traveller men. Findings provide a deeper understanding of the sources of distress and pathways to resilience/recovery among Traveller men affected by suicide and can inform the development of more gender- and culturally appropriate suicide prevention interventions.

Open-source automated insulin delivery systems and formal healthcare: A qualitative study of challenges in the interaction between service-users with type 1 diabetes and healthcare professionals.

OBJECTIVES: To explore the challenges that open-source automated insulin delivery systems pose to the encounter between service-users and healthcare professionals and how these challenges might be addressed in the future. METHODS: Five adult service-users and six healthcare professionals participated in semi-structured interviews. A six-step thematic analysis was conducted, the focus being on challenges and needs for improvement of the interactions. RESULTS: The analysis revealed three overarching challenges and wishes: (1) Lack of exchange of experiences. Service-users are reticent about disclosing their use of the systems to healthcare professionals. (2) Unclear ethical responsibility. Service-users are aware of their responsibility and guidelines can help to alleviate healthcare professional's legal responsibility; however, ambiguities around ethical responsibility for healthcare professionals remain an impediment to meaningful clinical interactions. (3) Unresolved individual and mutual expectations. Service-users expect better access to technology and focus on psychosocial aspects. In contrast, healthcare professionals fear the burden associated with the rising technical expectations. CONCLUSION: Transparency and openness towards open-source systems need to be part of service-user and healthcare professionals interaction. Requirements for future care include improved knowledge about the systems, an openminded approach towards user-driven initiatives among healthcare professionals, and a focus on psychosocial aspects in the interaction.

Work-related experiences of consultant psychiatrists during the COVID-19 response: qualitative analysis.

BACKGROUND: Research has begun to draw attention to the challenges mental health professionals faced in delivering services during the COVID-19 pandemic response. However, few studies have examined the specific experiences of consultant psychiatrists. AIMS: To examine the work-related experiences and psychosocial needs of consultant psychiatrists situated in the Republic of Ireland arising from the COVID-19 response. METHOD: We interviewed 18 consultant psychiatrists and analysed data using inductive thematic analysis. RESULTS: Work-related experience of participants was characterised by increased workload associated with assumption of guardianship of physical and mental health of vulnerable patients. Unintended consequences of public health restrictions increased case complexity, limited availability of alternative supports and hindered the practice of psychiatry, including inhibiting peer support systems for psychiatrists. Participants perceived available psychological supports as generally unsuitable for their needs given their specialty. Long-standing under-resourcing, mistrust in management and high levels of burnout exacerbated the psychological burden of the COVID-19 response. CONCLUSIONS: The challenges of leading mental health services were evident in the increased complexity involved in caring for vulnerable patients during the pandemic, contributing to uncertainty, loss of control and moral distress among participants. These dynamics worked synergistically with pre-existing system-level failures, eroding capacity to mount an effective response. The longer-term psychological well-being of consultant psychiatrists - as well as the pandemic preparedness of healthcare systems - is contingent on implementation of policies addressing long-standing under-investment in the services vulnerable populations rely on, not least community mental health services.

Quality of life and psychological well-being among children and adolescents with diabetes and their caregivers using open-source automated insulin delivery systems: Findings from a multinational survey.

BACKGROUND: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in children and adolescents with type 1 diabetes (T1D) in real-world studies. However, there is a lack of evidence on the effect on their caregivers' quality-of-life (QoL) and well-being. The aim of this study was to assess the QoL of caregivers and children and adolescents using open-source AID systems using validated measures. METHODS: In this cross-sectional online survey we examined the caregiver-reported QoL and well-being of users and non-users. Validated questionnaires assessed general well-being (WHO-5), diabetes-specific QoL (PAID, PedsQL) and sleep quality (PSQI). RESULTS: 168 caregivers from 27 countries completed at least one questionnaire, including 119 caregivers of children using open-source AID and 49 not using them. After inclusion of covariates, all measures but the PAID and one subscale of the PedsQL showed significant between-group differences with AID users reporting higher general (WHO-5: p = 0.003), sleep-related (PSQI: p = 0.001) and diabetes-related QoL (PedsQL: p < 0.05). CONCLUSIONS: The results show the potential impact of open-source AID on QoL and psychological well-being of caregivers and children and adolescents with T1D, and can therefore help to inform academia, regulators, and policymakers about the psychosocial health implications of open-source AID.

Barriers to uptake of Open-Source automated insulin delivery Systems: Analysis of socioeconomic factors and perceived challenges of adults with type 1 diabetes from the OPEN survey.

AIMS: Social and technical trends are empowering people with diabetes to co-create or self-develop medical devices and treatments to address their unmet healthcare needs, for example, open-source automated insulin delivery (AID) systems. This study aims to investigate the perceived barriers towards adoption and maintaining of open-source AID systems. METHODS: This is a multinational study based on a cross-sectional, retrospective web-based survey of non-users of open-source AID. Participants (n = 129) with type 1 diabetes from 31 countries were recruited online to elicit their perceived barriers towards building and maintaining of an open-source AID system. RESULTS: Sourcing the necessary components, lack of confidence in one's own technology knowledge and skills, perceived time and energy required to build a system, and fear of losing healthcare provider support appear to be major barriers towards the uptake of open-source AID. CONCLUSIONS: This study identified a range of structural and individual-level barriers to uptake of open-source AID. Some of these individual-level barriers may be overcome over time through the peer support of the DIY online community as well as greater acceptance of open-source innovation among healthcare professionals. The findings have important implications for understanding the possible wider diffusion of open-source diabetes technology solutions in the future.