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Contains fulltext : 305057.pdf (Publisher’s version ) (Closed access), 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.

Item does not contain fulltext, BACKGROUND: Assessment of patient-reported outcome measures (PROMs), including quality of life (QoL), is essential in diabetes research and care. However, a recent review concluded that current hypoglycaemia-specific PROMs have limited evidence of validity, reliability and responsiveness for assessing the impact of hypoglycaemia on QoL in people living with diabetes. None of the PROMs identified could be used directly to inform the cost-effectiveness of treatments and interventions. There is a need for a new hypoglycaemia-specific QoL PROM, which can be used directly to inform economic evaluations. AIMS: This project has three aims: (a) To develop draft PROM content for measuring the impact of hypoglycaemia on QoL in adults with diabetes. (b) To refine the draft content using cognitive debriefing interviews and psychometrics. This will result in a condition-specific PROM that can be used to quantify the impact of hypoglycaemia upon QoL. (c) To generate a preference-based measure (PBM) that will enable utility values to be calculated for economic evaluation. METHODS: A mixed-methods, three-stage design is used: (a) Qualitative interviews will inform the draft PROM content. (b) Cognitive debriefing interview data will be used to refine the draft PROM content. The PROM will be administered in a large-scale survey to enable psychometric validation. Final item selection for the PROM will be informed by psychometric performance, translatability assessment and input from stakeholder groups. (c) A classification system will be generated, comprising a reduced number of items from the PROM. A valuation survey will be conducted to derive a value set for the PBM.

Item does not contain fulltext, AIMS: To summarize and critically appraise evidence regarding the effectiveness of educational and/or behavioural interventions in reducing fear of hypoglycaemia among adults with type 1 diabetes. METHODS: Systematic searches of medical and psychology databases were conducted. Risk-of-bias was assessed using the Joanna Briggs Institute Critical Appraisal Tools. Data were synthesized using random-effects meta-analyses for randomized controlled trials (RCTs) and narrative synthesis for observational studies. RESULTS: Five RCTs (N = 682) and seven observational studies (N = 1519) met the inclusion criteria, reporting on behavioural, structured education and cognitive-behavioural therapy (CBT) interventions. Most studies assessed fear of hypoglycaemia using the Hypoglycaemia Fear Survey Worry (HFS-W) and Behaviour (HFS-B) subscales. Mean fear of hypoglycaemia at baseline was relatively low across studies. Meta-analyses showed a significant effect of interventions on HFS-W (SMD = -0.17, p = 0.032) but not on HFS-B scores (SMD = -0.34, p = 0.113). Across RCTs, Blood Glucose Awareness Training (BGAT) had the largest effect on HFS-W and HFS-B scores, and one CBT-based program was as effective as BGAT in reducing HFS-B scores. Observational studies showed that Dose Adjustment for Normal Eating (DAFNE) was associated with significant fear of hypoglycaemia reductions. CONCLUSIONS: Current evidence suggests that educational and behavioural interventions can reduce fear of hypoglycaemia. However, no study to date has examined these interventions among people with high fear of hypoglycaemia.

AIMS: To explore the association between the use of glycaemic technologies and person-reported outcomes (PROs) in adults with type 1 diabetes (T1D). METHODS: We included T1D and technology publications reporting on PROs since 2014. Only randomised controlled trials and cohort studies that used validated PRO measures (PROMs) were considered. RESULTS: T1D studies reported on a broad range of validated PROMs, mainly as secondary outcome measures. Most studies examined continuous glucose monitoring (CGM), intermittently scanned CGM (isCGM), and the role of continuous subcutaneous insulin infusion (CSII), including sensor-augmented CSII and closed loop systems. Generally, studies demonstrated a positive impact of technology on hypoglycaemia-specific and diabetes-specific PROs, including reduced fear of hypoglycaemia and diabetes distress, and greater satisfaction with diabetes treatment. In contrast, generic PROMs (including measures of health/functional status, emotional well-being, depressive symptoms, and sleep quality) were less likely to demonstrate improvements associated with the use of glycaemic technologies. Several studies showed contradictory findings, which may relate to study design, population and length of follow-up. Differences in PRO findings were apparent between randomised controlled trials and cohort studies, which may be due to different populations studied and/or disparity between trial and real-world conditions. CONCLUSIONS: PROs are usually assessed as secondary outcomes in glycaemic technology studies. Hypoglycaemia-specific and diabetes-specific, but not generic, PROs show the benefits of glycaemic technologies, and deserve a more central role in future studies as well as routine clinical care.

Contains fulltext : 300138.pdf (Publisher’s version ) (Open Access), AIMS: Research on hypoglycaemia and quality of life (QoL) has focused mostly on severe hypoglycaemia and psychological outcomes, with less known about other aspects of hypoglycaemia (e.g., self-treated episodes) and impacts on other QoL domains (e.g., relationships). Therefore, we examined the impact of all aspects of hypoglycaemia on QoL in adults with type 1 diabetes (T1DM). METHODS: Participants completed an online survey, including assessment of hypoglycaemia-specific QoL (using the 12-item Hypoglycaemia Impact Profile). Mann-Whitney U tests examined differences in hypoglycaemia-specific QoL by hypoglycaemia frequency, severity, and awareness. Hierarchical linear regression examined associations with QoL. RESULTS: Participants were 1028 adults with T1DM (M ± SD age: 47 ± 15 years; diabetes duration: 27 ± 16 years). Severe and self-treated hypoglycaemia and impaired awareness negatively impacted on overall QoL and several QoL domains, including leisure activities, physical health, ability to keep fit/be active, sleep, emotional well-being, spontaneity, independence, work/studies, and dietary freedom. Diabetes distress was most strongly associated with hypoglycaemia-specific QoL, followed by generic emotional well-being, fear of hypoglycaemia, and confidence in managing hypoglycaemia. Hypoglycaemia frequency and awareness were no longer significantly associated with QoL once psychological factors were considered. CONCLUSIONS: Hypoglycaemia negatively impacts on several QoL domains. Psychological factors supersede the effect of hypoglycaemia frequency and awareness in accounting for this negative impact., 01 november 2023

Contains fulltext : 296933.pdf (Publisher’s version ) (Open Access), BACKGROUND: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. OBJECTIVE: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. METHODS: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. RESULTS: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were d

BACKGROUND: There is increasing recognition of the substantial burden of mental health disorders at an individual and population level, including consequent demand on mental health services. Lifestyle-based mental healthcare offers an additional approach to existing services with potential to help alleviate system burden. Despite the latest Royal Australian New Zealand College of Psychiatrists guidelines recommending that lifestyle is a 'first-line', 'non-negotiable' treatment for mood disorders, few such programs exist within clinical practice. Additionally, there are limited data to determine whether lifestyle approaches are equivalent to established treatments. Using an individually randomised group treatment design, we aim to address this gap by evaluating an integrated lifestyle program (CALM) compared to an established therapy (psychotherapy), both delivered via telehealth. It is hypothesised that the CALM program will not be inferior to psychotherapy with respect to depressive symptoms at 8 weeks. METHODS: The study is being conducted in partnership with Barwon Health's Mental Health, Drugs & Alcohol Service (Geelong, Victoria), from which 184 participants from its service and surrounding regions are being recruited. Eligible participants with elevated psychological distress are being randomised to CALM or psychotherapy. Each takes a trans-diagnostic approach, and comprises four weekly (weeks 1-4) and two fortnightly (weeks 6 and 8) 90-min, group-based sessions delivered via Zoom (digital video conferencing platform). CALM focuses on enhancing knowledge, behavioural skills and support for improving dietary and physical activity behaviours, delivered by an Accredited Exercise Physiologist and Accredited Practising Dietitian. Psychotherapy uses cognitive behavioural therapy (CBT) delivered by a Psychologist or Clinical Psychologist, and Provisional Psychologist. Data collection occurs at baseline and 8 weeks. The primary outcome is depressive symptoms (assessed

AIMS: To explore the preferences of adults with type 2 diabetes regarding the approach to weight management discussions in clinical care. METHODS: Online survey of Australian adults with type 2 diabetes, recruited via a national diabetes registry. Three open-ended questions explored participants' experiences and ideal approach to discussing weight management with health professionals. Data subjected to inductive thematic template analysis. RESULTS: Participants were 254 adults, 58% aged 60+ years, 52% women and 35% insulin-treated. Five themes were developed to categorise participants' preferences for, as well as differing experiences of, weight management discussions: (1) collaborative, person-centred care: working together to make decisions and achieve outcomes, taking personal context into consideration; (2) balanced communication: open, clear messages encouraging action, empathy and kindness; (3) quality advice: knowledgeable health professionals, providing specific details or instructions; (4) weight management intervention: suitable modalities to address weight management and (5) system-wide support: referral and access to appropriate multi-disciplinary care. CONCLUSIONS: Participants expressed preferences for discussing weight management in collaborative, person-centred consultations, with quality advice and personalised interventions across the health system, delivered with empathy. By adopting these recommendations, health professionals may build constructive partnerships with adults with type 2 diabetes and foster weight management.

OBJECTIVES: This study examined the effect of using patient-reported outcome measures (PROMs) routinely to assess and address depressive symptoms and diabetes distress among adults with type 2 diabetes. DESIGN: A systematic review of published peer-reviewed studies. DATA SOURCES: Medline, Embase, CINAHL Complete, PsycINFO, The Cochrane Library and Cochrane Central Register of Controlled Trials were searched. ELIGIBILITY CRITERIA: Studies including adults with type 2 diabetes, published in English, from the inception of the databases to 24 February 2022 inclusive; and where the intervention included completion of a PROM of depressive symptoms and/or diabetes distress, with feedback of the responses to a healthcare professional. DATA EXTRACTION AND SYNTHESIS: Using Covidence software, screening and risk of bias assessment were conducted by two reviewers independently with any disagreements resolved by a third reviewer. RESULTS: The search identified 4512 citations, of which 163 full-text citations were assessed for eligibility, and nine studies met the inclusion criteria. Five studies involved assessment of depressive symptoms only, two studies assessed diabetes distress only, and two studies assessed both. All studies had an associated cointervention. When depressive symptoms were assessed (n=7), a statistically significant between-group difference in depressive symptoms was observed in five studies; with a clinically significant (>0.5%) between-group difference in HbA1c in two studies. When diabetes distress was assessed (n=4), one study demonstrated statistically significant difference in depressive symptoms and diabetes distress; with a clinically significant between-group difference in HbA1c observed in two studies. CONCLUSION: Studies are sparse in which PROMs are used to assess and address depressive symptoms or diabetes distress during routine clinical care of adults with type 2 diabetes. Further research is warranted to understand how to integrate PROMs into

INTRODUCTION: Hypoglycaemia is a frequent adverse event and major barrier for achieving optimal blood glucose levels in people with type 1 or type 2 diabetes using insulin. The Hypo-RESOLVE (Hypoglycaemia-Redefining SOLutions for better liVEs) consortium aims to further our understanding of the day-to-day impact of hypoglycaemia. The Hypo-METRICS (Hypoglycaemia-MEasurement, ThResholds and ImpaCtS) application (app) is a novel app for smartphones. This app is developed as part of the Hypo-RESOLVE project, using ecological momentary assessment methods that will minimise recall bias and allow for robust investigation of the day-to-day impact of hypoglycaemia. In this paper, the development and planned psychometric analyses of the app are described. METHODS AND ANALYSIS: The three phases of development of the Hypo-METRICS app are: (1) establish a working group-comprising diabetologists, psychologists and people with diabetes-to define the problem and identify relevant areas of daily functioning; (2) develop app items, with user-testing, and implement into the app platform; and (3) plan a large-scale, multicountry study including interviews with users and psychometric validation. The app includes 7 modules (29 unique items) assessing: self-report of hypoglycaemic episodes (during the day and night, respectively), sleep quality, well-being/cognitive function, social interactions, fear of hypoglycaemia/hyperglycaemia and work/productivity. The app is designed for use within three fixed time intervals per day (morning, afternoon and evening). The first version was released mid-2020 for use (in conjunction with continuous glucose monitoring and activity tracking) in the Hypo-METRICS study; an international observational longitudinal study. As part of this study, semistructured user-experience interviews and psychometric analyses will be conducted. ETHICS AND DISSEMINATION: Use of the novel Hypo-METRICS app in a multicountry clinical study has received ethical approval in eac

INTRODUCTION: Psychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these barriers. We describe the protocol for a randomised controlled trial (RCT) examining the efficacy of a novel, theoretically grounded, psychoeducational, web-based resource designed to reduce psychological barriers to insulin among adults with non-insulin treated T2D: 'Is insulin right for me?'. METHODS AND ANALYSIS: Double-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to 'Is insulin right for me?' (intervention) or widely available online resources (control). Eligible participants include adults (18-75 years), residing in Australia, currently taking oral hypoglycaemic agents to manage T2D. They will be primarily recruited via invitations and reminders from the national diabetes registry (from a purposefully selected sample of N≥12 000). EXCLUSION CRITERIA: experience of self-administered injectable; previously enrolled in pilot RCT; 'very willing' to start insulin as baseline. Outcomes will be assessed via online survey at 2 weeks and 6 months. Primary outcome between-group: difference in mean negative Insulin Treatment Appraisal Scores (ITAS negative) at 2-week and 6-month follow-up. SECONDARY OUTCOMES: between-group differences in mean positive insulin appraisals (ITAS positive) and percentage difference in intention to commence insulin at follow-up time points. All data analyses will be conducted according to the intention-to-treat principle. ETHICS AND DISSEMINATION: Deakin University Human Research Ethics Committee (2020-073). Dissemination via peer-reviewed journals, conferences and a plain-language summary. TRIAL REGISTRATION NUMBER: ACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.

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Item does not contain fulltext, AIM: To conduct a systematic review of published studies reporting on the longitudinal impacts of hypoglycaemia on quality of life (QoL) in adults with type 2 diabetes. METHOD: Database searches with no restrictions by language or date were conducted in MEDLINE, Cochrane Library, CINAHL and PsycINFO. Studies were included for review if they used a longitudinal design (e.g. cohort studies, randomised controlled trials) and reported on the association between hypoglycaemia and changes over time in patient-reported outcomes related to QoL. RESULTS: In all, 20 longitudinal studies published between 1998 and 2020, representing 50,429 adults with type 2 diabetes, were selected for review. A descriptive synthesis following Synthesis Without Meta-analysis guidelines indicated that self-treated symptomatic hypoglycaemia was followed by impairments in daily functioning along with elevated symptoms of generalised anxiety, diabetes distress and fear of hypoglycaemia. Severe hypoglycaemic events were associated with reduced confidence in diabetes self-management and lower ratings of perceived health over time. Frequent hypoglycaemia was followed by reduced energy levels and diminished emotional well-being. There was insufficient evidence, however, to conclude that hypoglycaemia impacted sleep quality, depressive symptoms, general mood, social support or overall diabetes-specific QoL. CONCLUSIONS: Longitudinal evidence in this review suggests hypoglycaemia is a common occurrence among adults with type 2 diabetes that impacts key facets in the physical and psychological domains of QoL. Nonetheless, additional longitudinal research is needed-in particular, studies targeting diverse forms of hypoglycaemia, more varied facets of QoL and outcomes assessed using hypoglycaemia-specific measures.

Item does not contain fulltext, This systematic review aims to summarize and critically evaluate the current evidence regarding the impact of hypoglycaemia in children and adolescents with type 1 diabetes on parental quality of life. MEDLINE, PsycINFO, CINAHL, and the Cochrane Library were searched. Inclusion criteria were: 1) quantitative design, 2) included parents of children or adolescents with type 1 diabetes, 3) assessment of hypoglycemia in children/adolescents with type 1 diabetes, 4) assessment of parent quality of life (or related domains of life), and 5) analysis of the relationship(s) between the child's hypoglycaemia and parents' quality of life. The data were summarised in accordance with Synthesis Without Meta-Analysis Guidelines. Twelve studies were included, reporting data from 1895 parents across six countries. Ten studies were cross-sectional; two included prospective data. Evidence suggested that greater frequency and severity of hypoglycemia was associated with greater parental fear of hypoglycemia, emotional distress and family burden. Children's hypoglycaemia has a negative impact on the well-being of parents, but there is an absence of evidence regarding the impact on their overall quality of life. Research into the hypoglycaemia-specific quality of life of parents is needed to explore the impact on various areas, such as social and physical dimensions.

Item does not contain fulltext, INTRODUCTION: Hypoglycaemia is a significant burden to people living with diabetes and an impediment to achieving optimal glycaemic outcomes. The use of continuous glucose monitoring (CGM) has improved the capacity to assess duration and level of hypoglycaemia. The personal impact of sensor-detected hypoglycaemia (SDH) is unclear. Hypo-METRICS is an observational study designed to define the threshold and duration of sensor glucose that provides the optimal sensitivity and specificity for events that people living with diabetes experience as hypoglycaemia. METHODS: We will recruit 600 participants: 350 with insulin-treated type 2 diabetes, 200 with type 1 diabetes and awareness of hypoglycaemia and 50 with type 1 diabetes and impaired awareness of hypoglycaemia who have recent experience of hypoglycaemia. Participants will wear a blinded CGM device and an actigraphy monitor to differentiate awake and sleep times for 10 weeks. Participants will be asked to complete three short surveys each day using a bespoke mobile phone app, a technique known as ecological momentary assessment. Participants will also record all episodes of self-detected hypoglycaemia on the mobile app. We will use particle Markov chain Monte Carlo optimization to identify the optimal threshold and duration of SDH that have optimum sensitivity and specificity for detecting patient-reported hypoglycaemia. Key secondary objectives include measuring the impact of symptomatic and asymptomatic SDH on daily functioning and health economic outcomes. ETHICS AND DISSEMINATION: The protocol was approved by local ethical boards in all participating centres. Study results will be shared with participants, in peer-reviewed journal publications and conference presentations.

Item does not contain fulltext, OBJECTIVE: Hypoglycaemic episodes and fear of hypoglycaemia can be burdensome for adults with type 1 diabetes. This study explored support needs relating to hypoglycaemia among adults with type 1 diabetes living in Denmark, Germany, the Netherlands and the United Kingdom. RESEARCH DESIGN AND METHODS: Respondents participated in a web-based qualitative study involving four open-ended questions that asked what they wished other people understood about hypoglycaemia and what other people could do differently to support them with hypoglycaemia. Responses were analyzed using reflexive thematic analysis. RESULTS: Participants were 219 adults with type 1 diabetes (mean ± SD age 39 ± 13 years; mean ± SD diabetes duration 20 ± 14 years). They described unmet needs relating to: (1) Clinical support, involving access to new diabetes technologies, training on hypoglycaemia prevention, personalised care and psychological support; (2) Practical support, involving family and friends better supporting them with hypoglycaemia management and prevention; (3) Education for other people, involving others becoming more informed about hypoglycaemia; and (4) An appreciation of the burden, involving others recognizing the experience and impact of episodes, and the burden of living with the risk of hypoglycaemia. CONCLUSIONS: Adults with type 1 diabetes report several unmet support needs relating to hypoglycaemia. Service delivery should be person-centred and prioritise the individual's support needs. Clinical conversations are needed to identify the individual's support needs and develop tailored support plans. People with diabetes and their family members should be offered hypoglycaemia-specific education and training.

AIM: Diabetes distress is experienced by up to 36% of adults with type 2 diabetes. Australian type 2 diabetes guidelines recommend annual assessment of diabetes distress in general practice. This study explores general practitioners' knowledge, current practice, and factors influencing implementation of guidelines, including Person Reported Outcome Measure (PROM) use. METHODS: A cross-sectional online survey was disseminated via e-mail to 4776 Australian general practitioners listed on the Australasian Medical Publishing Company database. RESULTS: 264 (5%) surveys were returned. 75% indicated that general practitioners were the most appropriate professionals to assess diabetes distress. Sixteen percent reported asking about diabetes distress during type 2 diabetes consultations more than half the time, with 13% using a PROM more than half the time: 64% use the Kessler-10, and 1.9% use the Problem Areas in Diabetes (PAID) scale. While general practitioners had positive beliefs about the consequences of assessing and addressing diabetes distress, they also reported barriers in motivation, environment, and knowledge of guidelines. CONCLUSION: Most respondents endorsed general practitioners' role in assessing diabetes distress, but few ask about or assess diabetes distress in routine consultations. To support uptake of guideline recommendations for diabetes-specific PROM use, environmental factors, specifically time, need to be addressed.

AIMS: Racial and ethnic disparities exist in gestational diabetes prevalence and risk of subsequent type 2 diabetes mellitus (T2DM). Postpartum engagement in healthy behaviours is recommended for prevention and early detection of T2DM, yet uptake is low among women from diverse cultural backgrounds. Greater understanding of factors impacting postpartum health behaviours is needed. Applying the Theoretical Domains Framework (TDF) and Capability, Opportunity, Motivation-Behaviour (COM-B) model, our aim was to synthesise barriers to and enablers of postpartum health behaviours among women from diverse cultural backgrounds with prior GDM and identify relevant intervention components. METHODS: Databases, reference lists and grey literature were searched from September 2017 to April 2021. Two reviewers screened articles independently against inclusion criteria and extracted data. Using an inductive-deductive model, themes were mapped to the TDF and COM-B model. RESULTS: After screening 5148 citations and 139 full texts, we included 35 studies (N = 787 participants). The main ethnicities included Asian (43%), Indigenous (15%) and African (11%). Barriers and enablers focused on Capability (e.g. knowledge), Opportunity (e.g. competing demands, social support from family, friends and healthcare professionals, culturally appropriate education and resources) and Motivation (e.g. negative emotions, perceived consequences and necessity of health behaviours, social/cultural identity). Five relevant intervention functions are identified to link the barriers and enablers to evidence-based recommendations for communications to support behaviour change. CONCLUSIONS: We provide a conceptual model to inform recommendations regarding the development of messaging and interventions to support women from diverse cultural backgrounds in engaging in healthy behaviours to reduce risk of T2DM.

INTRODUCTION: Globally, Indigenous people have a greater incidence and earlier onset of diabetes than the general population and have higher documented rates of emotional distress and mental illness. This systematic review will provide a synthesis and critical appraisal of the evidence focused on the social and emotional well-being of Indigenous peoples living with diabetes, including prevalence, impact, moderators, and the efficacy of interventions. METHODS: We will search MEDLINE Complete, EMBASE, APA PsycINFO, and CINAHL Complete from inception until late April 2021. Search strategies will include keywords related to Indigenous peoples, diabetes, and social and emotional well-being. All abstracts will be rated independently by two researchers against specified inclusion criteria. Eligible studies will report social and emotional well-being data for Indigenous people with diabetes, and/or report on the efficacy of interventions designed to address social and emotional well-being in this population. For each eligible study, quality will be rated using standard checklists to appraise each study's internal validity, to be determined based on study type. Any discrepancies will be resolved through discussions and consultation with other investigators as needed. We expect to present a narrative synthesis of the evidence. DISCUSSION: The findings of the systematic review will enable greater understanding of the impact of relationships between diabetes and emotional well-being among Indigenous peoples to inform research, policy and practice. The findings will be accessible to Indigenous people affected by diabetes through a summary published in plain language on our research centre's website. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number: CRD42021246560.

BACKGROUND: Diabetes distress is a commonly experienced negative emotional response to the ongoing burden of diabetes. Holistic diabetes care, including attention to diabetes distress, is recommended in clinical guidelines, yet not routinely implemented. Diabetes health professionals have highlighted lack of training as a barrier to implementation of psychological care. Therefore, we developed an e-learning: 'Diabetes distress e-learning: A course for diabetes educators' to address this need. This pilot study aimed to examine the feasibility of evaluating the e-learning in a randomised controlled trial study, the acceptability of the e-learning to credentialled diabetes educators (CDEs); and preliminary evidence of its effect upon CDEs' diabetes distress-related knowledge, motivation, confidence, behavioural skills, and barriers to implementation. METHODS: A pilot, unblinded, 2-armed, parallel group randomised controlled trial. Participants were recruited during a 4-month timeframe. Eligible participants were CDEs for ≥ 1 year providing care to ≥ 10 adults with type 1 or type 2 diabetes per week. Participants were randomly allocated (1:1 computer automated) to 1 of 2 learning activities: diabetes distress e-learning (intervention) or diabetes distress chapter (active control). They had 4 weeks to access the activity. They completed online surveys at baseline, 2-week and 12-week follow-up. RESULTS: Seventy-four eligible CDEs (36 intervention, 38 active control) participated. At baseline, recognition of the clinical importance of diabetes distress was high but knowledge and confidence to provide support were low-to-moderate. Engagement with learning activities was high (intervention: 83%; active control: 92%). Fifty-five percent returned at least 1 follow-up survey. All 30 intervention participants who returned the 2-week follow-up survey deemed the e-learning high quality and relevant. Systemic barriers (e.g., financial limitations and access to mental health profess

INTRODUCTION: Hypoglycaemia is a significant burden to people living with diabetes and an impediment to achieving optimal glycaemic outcomes. The use of continuous glucose monitoring (CGM) has improved the capacity to assess duration and level of hypoglycaemia. The personal impact of sensor-detected hypoglycaemia (SDH) is unclear. Hypo-METRICS is an observational study designed to define the threshold and duration of sensor glucose that provides the optimal sensitivity and specificity for events that people living with diabetes experience as hypoglycaemia. METHODS: We will recruit 600 participants: 350 with insulin-treated type 2 diabetes, 200 with type 1 diabetes and awareness of hypoglycaemia and 50 with type 1 diabetes and impaired awareness of hypoglycaemia who have recent experience of hypoglycaemia. Participants will wear a blinded CGM device and an actigraphy monitor to differentiate awake and sleep times for 10 weeks. Participants will be asked to complete three short surveys each day using a bespoke mobile phone app, a technique known as ecological momentary assessment. Participants will also record all episodes of self-detected hypoglycaemia on the mobile app. We will use particle Markov chain Monte Carlo optimization to identify the optimal threshold and duration of SDH that have optimum sensitivity and specificity for detecting patient-reported hypoglycaemia. Key secondary objectives include measuring the impact of symptomatic and asymptomatic SDH on daily functioning and health economic outcomes. ETHICS AND DISSEMINATION: The protocol was approved by local ethical boards in all participating centres. Study results will be shared with participants, in peer-reviewed journal publications and conference presentations.

AIMS: Managing weight in the context of type 2 diabetes presents unique hormonal, medicinal, behavioural and psychological challenges. The relationship between weight management and personality has previously been reviewed for general and cardiovascular disease populations but is less well understood in diabetes. This systematic review investigated the relationship between personality constructs and weight management outcomes and behaviours among adults with type 2 diabetes. METHODS: Medline, PubMed, Embase, PsycINFO and SPORTDiscus databases were searched to July 2021. Eligibility: empirical quantitative studies; English language; adults with type 2 diabetes; investigation of personality-weight management association. Search terms included variants of: diabetes, physical activity, diet, body mass index (BMI), adiposity, personality constructs and validated scales. A narrative synthesis, with quality assessment, was conducted. RESULTS: Seventeen studies were identified: nine cross-sectional, six cohort and two randomised controlled trials (N=6,672 participants, range: 30-1,553). Three studies had a low risk of bias. Personality measurement varied. The Big Five and Type D personality constructs were the most common measures. Higher emotional instability (neuroticism, negative affect, anxiety, unmitigated communion and external locus of control) was negatively associated with healthy diet and physical activity, and positively associated with BMI. Conscientiousness had positive associations with healthy diet and physical activity and negative associations with BMI and anthropometric indices. CONCLUSIONS: Among adults with type 2 diabetes, evidence exists of a relationship between weight management and personality, specifically, negative emotionality and conscientiousness. Consideration of personality may be important for optimising weight management and further research is warranted. SYSTEMATIC REVIEW REGISTRATION: www.crd.york.ac.uk/prospero/, identifier CRD4201911100

Contains fulltext : 245723.pdf (Publisher’s version ) (Open Access), OBJECTIVE: To conduct a systematic review to examine associations between hypoglycemia and quality of life (QoL) in children and adolescents with type 1 diabetes. METHODS: Four databases (Medline, Cochrane Library, CINAHL, PsycINFO) were searched systematically in November 2019 and searches were updated in September 2021. Studies were eligible if they included children and/or adolescents with type 1 diabetes, reported on the association between hypoglycemia and QoL (or related outcomes), had a quantitative design, and were published in a peer-reviewed journal after 2000. A protocol was registered the International Prospective Register of Systematic Reviews (PROSPERO; CRD42020154023). Studies were evaluated using the Joanna Briggs Institute's critical appraisal tool. A narrative synthesis was conducted by outcome and hypoglycemia severity. RESULTS: In total, 27 studies met inclusion criteria. No hypoglycemia-specific measures of QoL were identified. Evidence for an association between SH and (domains) of generic and diabetes-specific QoL was too limited to draw conclusions, due to heterogenous definitions and operationalizations of hypoglycemia and outcomes across studies. SH was associated with greater worry about hypoglycemia, but was not clearly associated with diabetes distress, depression, anxiety, disordered eating or posttraumatic stress disorder. Although limited, some evidence suggests that more recent, more frequent, or more severe episodes of hypoglycemia may be associated with adverse outcomes and that the context in which hypoglycemia takes places might be important in relation to its impact. CONCLUSIONS: There is insufficient evidence regarding the impact of hypoglycemia on QoL in children and adolescents with type 1 diabetes at this stage. There is a need for further research to examine this relationship, ideally using hypoglycemia-specific QoL measures.

Item does not contain fulltext, Hypoglycaemia is a common barrier to optimal glycaemic management and often feared among adults with type 1 diabetes. The aim of this systematic review was to summarize current evidence regarding the impact of hypoglycaemia on quality of life (QoL) and related outcomes. Electronic searches of MEDLINE, PsycINFO, CINAHL, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials were conducted. Peer-reviewed empirical studies investigating the relationship between hypoglycaemia and QoL were eligible for inclusion. Thirty studies met the inclusion criteria. Extracted data was summarized in a narrative synthesis according to Synthesis Without Meta-Analysis guidelines. None of the studies examined the impact of hypoglycaemia on general QoL. There was no association between hypoglycaemia and diabetes-specific QoL in four of the 30 studies. Severe hypoglycaemia was associated with greater fear of hypoglycaemia and diabetes distress, and lower general emotional well-being, but not with depression, anxiety, or health status. Self-treated hypoglycaemia was associated with greater fear of hypoglycaemia. With the exception of fear of hypoglycaemia, this review shows mixed associations between hypoglycaemia and psychological outcomes. Further research is needed to investigate the impact of hypoglycaemia on other domains of QoL.

Contains fulltext : 236713.pdf (Publisher’s version ) (Open Access)

Contains fulltext : 237446.pdf (Publisher’s version ) (Open Access), Objectives: The objectives of this study were to investigate the associations of dispositional mindfulness and its facets with diet quality in Dutch adults with type 1 diabetes and type 2 diabetes and to evaluate the potential mediating role of emotional distress in these associations. Methods: This was a cross-sectional study using data from the Diabetes MILES-The Netherlands. In total, 296 adults with type 1 diabetes and 364 with type 2 diabetes completed questionnaires. We assessed dispositional mindfulness by the Five Facet Mindfulness Questionnaire-Short Form, including total mindfulness and five facets: observing, describing, acting with awareness, being non-judgmental, and being non-reactive, and diet quality by the Dutch Healthy Diet 2015-index. Linear regression models were used to estimate the association. Mediation effects of depressive symptoms, anxiety symptoms, and diabetes-related distress were evaluated using the PROCESS macro with bias-corrected bootstrapped confidence intervals. Results: Higher scores on the total mindfulness (ß = 0.14, p = 0.02) and the observing facet (ß = 0.15, p = 0.01) were significantly associated with higher diet quality in people with type 1 diabetes only, after adjustment for demographic factors. These associations were not mediated by depressive symptoms, anxiety symptoms, or diabetes-related distress. In adults with type 1 diabetes (but not type 2), higher dispositional mindfulness levels were associated with more optimal diet quality. Conclusions: Higher mindfulness in general and observing in particular were related to a healthier diet with higher quality in Dutch adults with type 1 diabetes. Further longitudinal studies are warranted to understand the temporal relationship between mindfulness and diet quality.

Item does not contain fulltext, AIM: To summarize and critically appraise the recent qualitative evidence regarding the impact of hypoglycaemia on the quality of life of family members of adults with type 1 or type 2 diabetes. METHODS: Four databases were searched systematically (MEDLINE, PsycINFO, CINAHL and Cochrane Library), and results were screened for eligibility. Article quality was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research. Data were extracted, coded and analysed using thematic analysis. The systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Enhancing transparency in reporting of qualitative research (ENTREQ) guidelines. RESULTS: Eight qualitative studies were included in the final review. The majority of participants were partners or spouses of adults with type 1 diabetes. Thematic synthesis resulted in six analytical themes: 'Hypoglycaemia alters everyday life, reducing freedoms and increasing disruptions', 'Hypoglycaemia has an adverse impact on sleep', 'Hypoglycaemia negatively changes the relationship with the person with diabetes', 'Hypoglycaemia negatively impacts emotional well-being', 'The detection, prevention, and treatment of hypoglycaemia consumes time and energy' and 'Family members have unmet needs for informational and emotional support regarding hypoglycaemia'. Across the six analytical themes, family members described how hypoglycaemia has a severe negative impact on different aspects of their lives, including daily living, personal relationships and emotional well-being. CONCLUSIONS: Family members experience the impact of hypoglycaemia as a major recurrent challenge in their lives. The unmet needs of family members need further attention in research and clinical practice.

Aim: To examine psychosocial and behavioural impacts of the novel coronavirus disease 2019 (COVID-19) pandemic and lockdown restrictions among adults with type 2 diabetes. Methods: Participants enrolled in the PRogrEssion of DIabetic ComplicaTions (PREDICT) cohort study in Melbourne, Australia (n = 489 with a baseline assessment pre-2020) were invited to complete a phone/online follow-up assessment in mid-2020 (i.e., amidst COVID-19 lockdown restrictions). Repeated assessments that were compared with pre-COVID-19 baseline levels included anxiety symptoms (7-item Generalised Anxiety Disorder scale [GAD-7]), depressive symptoms (8-item Patient Health Questionnaire [PHQ-8]), diabetes distress (Problem Areas in Diabetes scale [PAID]), physical activity/sedentary behaviour, alcohol consumption and diabetes self-management behaviours. Additional once-off measures at follow-up included COVID-19-specific worry, quality of life (QoL), and healthcare appointment changes (telehealth engagement and appointment cancellations/avoidance). Results: Among 470 respondents (96%; aged 66 ± 9 years, 69% men), at least ‘moderate’ worry about COVID-19 infection was reported by 31%, and 29%–73% reported negative impacts on QoL dimensions (greatest for: leisure activities, feelings about the future, emotional well-being). Younger participants reported more negative impacts (p < 0.05). Overall, anxiety/depressive symptoms were similar at follow-up compared with pre-COVID-19, but diabetes distress reduced (p < 0.001). Worse trajectories of anxiety/depressive symptoms were observed among those who reported COVID-19-specific worry or negative QoL impacts (p < 0.05). Physical activity trended lower (~10%), but sitting time, alcohol consumption and glucose-monitoring frequency remained unchanged. 73% of participants used telehealth, but 43% cancelled a healthcare appointment and 39% avoided new appointments despite perceived need. Conclusions: COVID-19 lockdown restrictions negatively impacted Qo

AIMS/HYPOTHESIS: It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties. METHODS: Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM's content validity included reviewer ratings (N = 16) of relevance, comprehensiveness and comprehensibility: by researchers (n = 6); clinicians (n = 6); and adults with diabetes (n = 4). RESULTS: Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), seven hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; and the QoLHYPO questionnaire. Content validity was rated as 'inconsistent', with most a

INTRODUCTION: Achieving glycemic targets and optimizing quality of life (QoL) are important goals of type 1 diabetes care. Hypoglycemia is a common barrier to achieving targets and can be associated with significant distress. However, the impact of hypoglycemia on QoL is not fully understood. The aim of this study was to explore how adults with type 1 diabetes are impacted by hypoglycemia in areas of life that are important to their overall QoL. RESEARCH DESIGN AND METHODS: Participants responded to a web-based qualitative survey involving a novel 'Wheel of Life' activity. Responses were analyzed using reflexive thematic analysis. RESULTS: The final sample included 219 adults with type 1 diabetes from Denmark, Germany, the Netherlands, and the UK. They had a mean±SD age of 39±13 years and diabetes duration of 20±14 years. Participants identified eight areas of life important to their overall QoL, including relationships and social life, work and studies, leisure and physical activity, everyday life, sleep, sex life, physical health, and mental health. Participants reported emotional, behavioral, cognitive, and social impacts of hypoglycemia within domains. Across domains, participants described interruptions, limited participation in activities, exhaustion, fear of hypoglycemia, compensatory strategies to prevent hypoglycemia, and reduced spontaneity. CONCLUSIONS: The findings emphasize the profound impact of hypoglycemia on QoL and diabetes self-care behaviors. Diabetes services should be aware of and address the burden of hypoglycemia to provide person-centered care. Clinicians could ask individuals how hypoglycemia affects important areas of their lives to better understand the personal impact and develop tailored management plans.

OBJECTIVE: To conduct a systematic review to examine associations between hypoglycemia and quality of life (QoL) in children and adolescents with type 1 diabetes. METHODS: Four databases (Medline, Cochrane Library, CINAHL, PsycINFO) were searched systematically in November 2019 and searches were updated in September 2021. Studies were eligible if they included children and/or adolescents with type 1 diabetes, reported on the association between hypoglycemia and QoL (or related outcomes), had a quantitative design, and were published in a peer-reviewed journal after 2000. A protocol was registered the International Prospective Register of Systematic Reviews (PROSPERO; CRD42020154023). Studies were evaluated using the Joanna Briggs Institute's critical appraisal tool. A narrative synthesis was conducted by outcome and hypoglycemia severity. RESULTS: In total, 27 studies met inclusion criteria. No hypoglycemia-specific measures of QoL were identified. Evidence for an association between SH and (domains) of generic and diabetes-specific QoL was too limited to draw conclusions, due to heterogenous definitions and operationalizations of hypoglycemia and outcomes across studies. SH was associated with greater worry about hypoglycemia, but was not clearly associated with diabetes distress, depression, anxiety, disordered eating or posttraumatic stress disorder. Although limited, some evidence suggests that more recent, more frequent, or more severe episodes of hypoglycemia may be associated with adverse outcomes and that the context in which hypoglycemia takes places might be important in relation to its impact. CONCLUSIONS: There is insufficient evidence regarding the impact of hypoglycemia on QoL in children and adolescents with type 1 diabetes at this stage. There is a need for further research to examine this relationship, ideally using hypoglycemia-specific QoL measures.

Purpose The purpose of this study is to investigate medication intake, perceived barriers and their correlates in adults with type 1 or type 2 diabetes. Methods In this cross-sectional study, 3,383 Dutch adults with diabetes (42% type 1; 58% type 2) completed the 12-item ‘Adherence Starts with Knowledge’ questionnaire (ASK-12; total score range: 12-60) and reported socio-demographics, clinical and psychological characteristics and health behaviors. Univariable and multivariable logistic regression analyses were used. Results Adults with type 1 diabetes had a slightly lower mean ASK-12 score (i.e. more optimal medication intake and fewer perceived barriers) than adults with non-insulin-treated type 2 diabetes. After adjustment for covariates, correlates with suboptimal intake and barriers were fewer severe hypoglycemic events and more depressive symptoms and diabetes-specific distress. In type 2 diabetes, correlates were longer diabetes duration, more depressive symptoms and diabetes-specific distress. Conclusions Adults with type 1 diabetes showed slightly more optimal medication intake and fewer perceived barriers than adults with non-insulin treated type 2 diabetes. Correlates differed only slightly between diabetes types. The strong association with depressive symptoms and diabetes-specific distress in both diabetes types warrants attention, as improving these outcomes in some people with diabetes might indirectly improve medication intake.

AIMS: An emerging group of people with type 1 diabetes are not waiting for commercial solutions, choosing to manage their condition with open-source artificial pancreas systems (APS). Our aim was to explore their perspectives on the future of APS. METHODS: Semi-structured telephone interviews were conducted (in Australia, October 2018 to January 2019) with 23 adults with type 1 diabetes currently using open-source APS. Interviews were recorded, transcribed and analysed thematically. RESULTS: Participants described five key features of open-source APS they value: compatibility, user-led design, customisability, ability to evolve faster and community-driven. They attributed the success of the open-source APS movement to benefits they derive from these features: choice, solutions that meet their needs, ownership, staying one step ahead and real-time support. They expressed hope that future commercial products and healthcare would benefit from their learnings and from collaboration with the open-source APS community. CONCLUSIONS: Participants believed that there will always be a place for the open-source community. It will continue to build on and advance commercial products, respond to user needs, offering a higher degree of control and customisation than afforded by commercial products and generating optimism for the future. Participants desired that future commercial diabetes technologies would be inspired by the open-source community and developed collaboratively with people with diabetes.

Hypoglycaemia is a common barrier to optimal glycaemic management and often feared among adults with type 1 diabetes. The aim of this systematic review was to summarize current evidence regarding the impact of hypoglycaemia on quality of life (QoL) and related outcomes. Electronic searches of MEDLINE, PsycINFO, CINAHL, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials were conducted. Peer-reviewed empirical studies investigating the relationship between hypoglycaemia and QoL were eligible for inclusion. Thirty studies met the inclusion criteria. Extracted data was summarized in a narrative synthesis according to Synthesis Without Meta-Analysis guidelines. None of the studies examined the impact of hypoglycaemia on general QoL. There was no association between hypoglycaemia and diabetes-specific QoL in four of the 30 studies. Severe hypoglycaemia was associated with greater fear of hypoglycaemia and diabetes distress, and lower general emotional well-being, but not with depression, anxiety, or health status. Self-treated hypoglycaemia was associated with greater fear of hypoglycaemia. With the exception of fear of hypoglycaemia, this review shows mixed associations between hypoglycaemia and psychological outcomes. Further research is needed to investigate the impact of hypoglycaemia on other domains of QoL.

OBJECTIVE: Hypoglycaemic episodes and fear of hypoglycaemia can be burdensome for adults with type 1 diabetes. This study explored support needs relating to hypoglycaemia among adults with type 1 diabetes living in Denmark, Germany, the Netherlands and the United Kingdom. RESEARCH DESIGN AND METHODS: Respondents participated in a web-based qualitative study involving four open-ended questions that asked what they wished other people understood about hypoglycaemia and what other people could do differently to support them with hypoglycaemia. Responses were analyzed using reflexive thematic analysis. RESULTS: Participants were 219 adults with type 1 diabetes (mean ± SD age 39 ± 13 years; mean ± SD diabetes duration 20 ± 14 years). They described unmet needs relating to: (1) Clinical support, involving access to new diabetes technologies, training on hypoglycaemia prevention, personalised care and psychological support; (2) Practical support, involving family and friends better supporting them with hypoglycaemia management and prevention; (3) Education for other people, involving others becoming more informed about hypoglycaemia; and (4) An appreciation of the burden, involving others recognizing the experience and impact of episodes, and the burden of living with the risk of hypoglycaemia. CONCLUSIONS: Adults with type 1 diabetes report several unmet support needs relating to hypoglycaemia. Service delivery should be person-centred and prioritise the individual's support needs. Clinical conversations are needed to identify the individual's support needs and develop tailored support plans. People with diabetes and their family members should be offered hypoglycaemia-specific education and training.

INTRODUCTION: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs). METHODS AND ANALYSIS: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals. TRIAL REGISTRATION NUMBER: ISRCTN42908016.

AIM: To summarize and critically appraise the recent qualitative evidence regarding the impact of hypoglycaemia on the quality of life of family members of adults with type 1 or type 2 diabetes. METHODS: Four databases were searched systematically (MEDLINE, PsycINFO, CINAHL and Cochrane Library), and results were screened for eligibility. Article quality was assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research. Data were extracted, coded and analysed using thematic analysis. The systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Enhancing transparency in reporting of qualitative research (ENTREQ) guidelines. RESULTS: Eight qualitative studies were included in the final review. The majority of participants were partners or spouses of adults with type 1 diabetes. Thematic synthesis resulted in six analytical themes: 'Hypoglycaemia alters everyday life, reducing freedoms and increasing disruptions', 'Hypoglycaemia has an adverse impact on sleep', 'Hypoglycaemia negatively changes the relationship with the person with diabetes', 'Hypoglycaemia negatively impacts emotional well-being', 'The detection, prevention, and treatment of hypoglycaemia consumes time and energy' and 'Family members have unmet needs for informational and emotional support regarding hypoglycaemia'. Across the six analytical themes, family members described how hypoglycaemia has a severe negative impact on different aspects of their lives, including daily living, personal relationships and emotional well-being. CONCLUSIONS: Family members experience the impact of hypoglycaemia as a major recurrent challenge in their lives. The unmet needs of family members need further attention in research and clinical practice.

AIMS: To compare the acceptability, reliability and validity of five contemporary diabetes-specific quality of life (QoL) scales among adults with type 1 diabetes in the United Kingdom and Australia. METHODS: Adults with type 1 diabetes (UK = 1139, Australia = 439) completed a cross-sectional, online survey including ADDQoL-19, DCP, DIDP, DSQOLS and Diabetes QoL-Q, presented in randomised order. After completing each scale, participants rated it for clarity, relevance, ease of completion, length and comprehensiveness. We examined scale acceptability (scale completion and user ratings), response patterns, structure (exploratory and confirmatory factor analyses) and validity (convergent, concurrent, divergent and known groups). To assess cross-country reproducibility, analyses conducted on the UK dataset were replicated in the Australian dataset. RESULTS: Findings were largely consistent between countries. All scales were acceptable to participants: ≥90% completing all items, and ≥80% positive user ratings, except for DSQOLS' length. Scale structure was not supported for the DCP. Overall, in terms of acceptability and psychometric evaluation, the DIDP was the strongest performing scale while the ADDQoL-19 and Diabetes QoL-Q scales also performed well. CONCLUSIONS: These findings suggest that the recently developed brief (7 items), neutrally worded DIDP scale is acceptable to adults with type 1 diabetes and has the strongest psychometric performance. However, questionnaire selection should always be considered in the context of the research aims, study design and population, as well as the wider published evidence regarding both the development and responsiveness of the scales.

The aim of this study was to take ‘snapshots’ of how people with diabetes are feeling emotionally during the coronavirus disease 2019 (COVID-19) pandemic. Three ‘snapshot’ surveys were conducted during May 2020, August 2020 and April 2021, each over a two-week period. Adults (≥18 years) with diabetes calling the Australian Government’s National Diabetes Services Scheme Helpline (NDSS) were invited to participate. Those who accepted were asked three questions sourced/adapted from the Problem Areas in Diabetes scale. Responses were recorded on a 5-point scale (0=’not a problem’, 4=’serious problem’). Of interest were scores ≥2, indicating this was at least a ‘moderate problem’. The survey was administered by NDSS Helpline staff via telephone. Basic demographic and clinical data were collected. In total, 1,278 surveys were completed over the three ‘snapshots’ (1st N=449; 2nd N=414; 3rd N=415). Participants were aged (median[IQR]) 62[47,72] years, 56% were women, and 57% had type 2 diabetes. At the 3rd ‘snapshot’, 21% had received a COVID-19 vaccine. Our findings show that feeling at least moderately ‘burned out’ by the constant effort needed to manage diabetes is salient, and consistently experienced by adults with diabetes calling the NDSS Helpline at three timepoints during the coronavirus pandemic. Those who participated in the 3rd ‘snapshot’ survey were less likely to report that feeling ‘alone with their diabetes’ or ‘worrying about their diabetes because of the COVID-19 pandemic’ were moderate or serious problems for them. Except for younger adults, findings indicate that the easing of restrictions may mitigate some of the effects of the pandemic on diabetes-specific emotional problems, including feeling ‘burned out’, ‘alone’ with diabetes, and/or worried about diabetes due to COVID-19. Prospective data are needed to improve our understanding of the emotional impact of COVID-19 on people with diabetes and to inform when and how to target support for those who nee

AIM: To conduct a systematic review of published studies reporting on the longitudinal impacts of hypoglycaemia on quality of life (QoL) in adults with type 2 diabetes. METHOD: Database searches with no restrictions by language or date were conducted in MEDLINE, Cochrane Library, CINAHL and PsycINFO. Studies were included for review if they used a longitudinal design (e.g. cohort studies, randomised controlled trials) and reported on the association between hypoglycaemia and changes over time in patient-reported outcomes related to QoL. RESULTS: In all, 20 longitudinal studies published between 1998 and 2020, representing 50,429 adults with type 2 diabetes, were selected for review. A descriptive synthesis following Synthesis Without Meta-analysis guidelines indicated that self-treated symptomatic hypoglycaemia was followed by impairments in daily functioning along with elevated symptoms of generalised anxiety, diabetes distress and fear of hypoglycaemia. Severe hypoglycaemic events were associated with reduced confidence in diabetes self-management and lower ratings of perceived health over time. Frequent hypoglycaemia was followed by reduced energy levels and diminished emotional well-being. There was insufficient evidence, however, to conclude that hypoglycaemia impacted sleep quality, depressive symptoms, general mood, social support or overall diabetes-specific QoL. CONCLUSIONS: Longitudinal evidence in this review suggests hypoglycaemia is a common occurrence among adults with type 2 diabetes that impacts key facets in the physical and psychological domains of QoL. Nonetheless, additional longitudinal research is needed-in particular, studies targeting diverse forms of hypoglycaemia, more varied facets of QoL and outcomes assessed using hypoglycaemia-specific measures.

AIMS: This qualitative study aims to explore beliefs, attitudes and experiences of injectable glucagon-like-peptide-1 receptor agonists (GLP-1RAs) use and discontinuation, as well as attitudes to further injectable treatment intensification, among adults with type 2 diabetes (T2D). METHODS: Nineteen in-depth semi-structured interviews lasting (mean ± standard deviation) 45 ± 18 min were conducted, face-to-face (n = 14) or via telephone (n = 5). Transcripts were analysed using inductive template analyses. Eligible participants were English-speaking adults with T2D who had recently initiated (≤3 years) GLP-1RA treatment. RESULTS: Participants were aged 28-72 years, who predominantly lived in metropolitan areas (n = 15), and had an experience of daily (n = 11) and/or once-weekly (n = 13) GLP-1RA formulations. Six participants had discontinued treatment and seven had trialled two or more formulations. Expectations and experiences of GLP-1RA were related to the perceived: (1) symbolism and stigma of injectable diabetes treatment; (2) ease of injectable administration and device preferences; (3) treatment convenience and social impact; (4) treatment efficacy and benefits, and; (5) negative treatment side effects. Some participants reported increased receptiveness to insulin therapy following their GLP-1RA experience, others emphasised unique concerns about insulin beyond injectable administration. CONCLUSIONS: This study provides a novel understanding of expectations and experience of non-insulin injectables among Australian adults with T2D. Our data suggest expectations may be informed by attitudes to insulin therapy, while perceived treatment benefits (e.g. weight-related benefits, administration frequency) may motivate uptake and ongoing use despite concerns. Experience of GLP-1RA injections may impact receptiveness to future insulin use.

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, pro

OBJECTIVE: To develop a theory and evidence-based web intervention to reduce psychological barriers towards insulin therapy among adults with non-insulin-treated type 2 diabetes (T2D). METHODS: Salient psychological barriers towards insulin were identified from the literature and classified using the Theoretical Domains Framework (TDF). Relevant TDF domains were mapped to evidence-based behaviour change techniques (BCTs), which informed the content for each barrier. Acceptability was explored using cognitive debriefing interviews (n=6 adults with T2D). RESULTS: 'Is Insulin Right for Me' addresses eight barriers, phrased as common questions: Does insulin mean my diabetes is more serious? Do insulin injections cause complications? Is it my fault I need to inject insulin? Will I gain weight? Will injecting hurt? What about hypos? Will injecting insulin be a burden? What will others think of me? BCTs, including persuasive communication and modelling/demonstration, were delivered using appropriate methods (eg, demonstration of the injection process). Participant suggestions for improvement included clear and direct messages, normalising insulin and avoiding confronting images. CONCLUSIONS: 'Is Insulin Right for Me' is the first theory and evidence-based, web intervention designed to reduce psychological barriers towards insulin therapy for adults with T2D. Evaluation is needed to determine its impact on negative appraisals and receptiveness towards insulin.

AIMS: Acceptable and accessible interventions are needed to address 'psychological insulin resistance', which is a common barrier to insulin uptake among adults with type 2 diabetes (T2D). Our aim was to test the feasibility of a randomised controlled trial (RCT) study design and acceptability of a theoretically grounded, psycho-educational, web-based resource to reduce negative insulin appraisals among adults with T2D. METHODS: A double-blinded, parallel group, two-arm pilot RCT (1:1), comparing intervention with active control (existing online information about insulin). Eligible participants were Australian adults with T2D, taking oral diabetes medications. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Primary outcomes: study feasibility (recruitment ease, protocol fulfilment, attrition, data completeness); secondary outcomes: intervention acceptability (intervention engagement, user feedback) and likely efficacy (negative Insulin Treatment Appraisal Scale [ITAS] scores at follow-up). Online surveys completed at baseline and 2 weeks. RESULTS: During 4-week recruitment, 76 people expressed interest: 51 eligible and 35 enrolled (intervention = 17, control = 18; median[interquartile range] age = 62[53, 69] years; 17 women). Protocol fulfilment achieved by 26 (74%) participants (n = 13 per arm), with low participant attrition (n = 6, 17%). Intervention acceptability was high (>80% endorsement, except format preference = 60%). ITAS negative scores differed between-groups at follow-up (M diff = -6.5, 95% confidence interval: -10.7 to -2.4), favouring the intervention. CONCLUSIONS: This novel web-based resource ("Is insulin right for me?") is acceptable and associated with a likely reduction in negative insulin appraisals, relative to existing resources. This pilot shows the study design is feasible and supports conduct of a fully powered RCT.

AIM: To assess the cost-effectiveness of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice compared with usual clinical care. METHODS: An economic evaluation was conducted as a component of the GP-OSMOTIC trial, a pragmatic multicentre 12-month randomised controlled trial enrolling 299 adults with type 2 diabetes in Victoria, Australia. The economic evaluation was conducted from an Australian healthcare sector perspective with a lifetime horizon. Health-related quality of life (EQ-5D) and total healthcare costs were compared between the intervention and the usual care group within the trial period. The 'UKPDS Outcomes Model 2' was used to simulate post-trial lifetime costs, life expectancy and quality-adjusted life years (QALYs). RESULTS: No significant difference in health-related quality of life and costs was found between the two groups within the trial period. Professional-mode flash glucose monitoring yielded greater QALYs (0.03 [95% CI: 0.02, 0.04]) and a higher cost (A$3807 [95% CI: 3604, 4007]) compared with usual clinical care using a lifetime horizon under the trial-based monitoring frequency, considered not cost-effective (incremental cost-effectiveness ratio = A$120,228). The intervention becomes cost-effective if sensor price is reduced to lower than 50%, or monitoring frequency is decreased to once per year while maintaining the same treatment effect on HbA1c . CONCLUSIONS: Including professional-mode flash glucose monitoring every 3 months as part of a management plan for people with type 2 diabetes in general practice is not cost-effective, but could be if the sensor price or monitoring frequency can be reduced.

INTRODUCTION: Type 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes. METHODS AND ANALYSIS: MEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case-control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate. ETHICS AND DISSEMINATION: Ethics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42020200246.

The words used about diabetes affect the physical and emotional health of people living with diabetes. They also affect how individuals and society view people living with, or at risk of, diabetes. People with diabetes, their families, and people at risk of diabetes, need and deserve communications that are clear and accurate, respectful and inclusive, and free from judgement and bias. The aim of this position statement is to help bring about positive change in the language used about diabetes. It is based on 30+ years of research into the experiences of people with diabetes. Changing the language of diabetes can make a powerful and positive difference to the emotional well-being, self-care and health outcomes of people affected by diabetes. It also affects community and government support for funding diabetes care, prevention and research. Diabetes Australia encourages everyone communicating about diabetes, or about people affected by diabetes, to choose and use their words carefully to support all people affected by diabetes. This position statement is intended as a guide for people working in healthcare, the media, government and policy, academia, industry, as well as employers and the community. It may also be helpful for the family and friends of people with diabetes.

Contains fulltext : 221451.pdf (Publisher’s version ) (Closed access)

Contains fulltext : 220541.pdf (Publisher’s version ) (Open Access), BACKGROUND: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of 'non-severe' hypoglycaemia and the glucose level below which hypoglycaemia causes harm. AIM: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. METHODS: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems. RESULTS: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement. CONCLUSION: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.