Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial.

BACKGROUND: Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs). METHODS: A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN-a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes. DISCUSSION: It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required. TRIAL REGISTRATION: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022.

Producing a preference-based quality of LIFE measure to quantify the impact of HYPOGLYCAEMIA on people living with diabetes: A mixed-methods research protocol.

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.

Type 2 Diabetes Stigma Assessment Scale (DSAS-2): Cultural and linguistic adaptation and psychometric assessment of the Arabic version.

AIMS: To culturally and linguistically adapt the Type 2 Diabetes Stigma Assessment Scale (DSAS-2) into Arabic and assess its psychometric properties. METHODS: Following forward-backward translation of the DSAS-2, the Content Validity Index (CVI) was assessed. Cognitive debriefing and pilot testing were conducted with adults with T2DM. The Arabic DSAS-2 was included in a multi-center, cross-sectional study (N = 327) Arabic-speaking adults with type 2 diabetes. Psychometric analyses included exploratory and confirmatory factor analysis (EFA/CFA), internal consistency reliability, and convergent validity. RESULTS: The Arabic DSAS-2 was considered appropriate, with an excellent CVI (0.98). Unforced EFA revealed a satisfactory three-factor structure, indicating the same subscales as the original instrument ('Treated differently', 'Blame and judgment', 'Self-stigma'). EFA for three factors showed good indicators (KMO=0.924; Bartlett's test of sphericity χ2 = 4063.709, df=171, p < 0.001). Internal consistency was satisfactory for both the three-factor structure (α = 0.91, α = 0.88, and α = 0.88, respectively) and the single factor (α = 0.94). CFA results were inconclusive. Although fit indices improved for the single-factor model, compared to the three-factor, they remained inadequate. The total scale demonstrated satisfactory convergent validity with self-esteem. CONCLUSIONS: The Arabic DSAS-2 has excellent reliability and acceptable validity, supporting a three-factor structure as well as the use of a total score.

Hypo-METRICS: Hypoglycaemia-MEasurement, ThResholds and ImpaCtS-A multi-country clinical study to define the optimal threshold and duration of sensor-detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol.

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.

Cost-effectiveness of professional-mode flash glucose monitoring in general practice among adults with type 2 diabetes: Evidence from the GP-OSMOTIC trial.

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.

A Spanish-language translation for the U.S. of the type 2 diabetes stigma assessment scale (DSAS-2 Spa-US).

Background: Diabetes stigma is recognized to negatively impact health-related outcomes for people living with type 2 diabetes (T2D), but there is a dearth of evidence among U.S. Latino adults with T2D. Our aim was to develop a Spanish-language translation of the Type 2 Diabetes Stigma Assessment Scale (DSAS-2) and examine its psychometric properties among U.S. Latino adults with T2D. Methods: The translation was developed through a multi-step process, including a focus group with community health workers (n=5) and cognitive debriefing interviews with Latino adults with T2D (n=8). It was field-tested in an online survey of U.S. Latino adults with T2D, recruited via Facebook (October 2018 to June 2019). Exploratory factor analysis examined structural validity. Convergent and divergent validity were assessed by testing hypothesized correlations with measures of general chronic illness stigma, diabetes distress, depressive and anxiety symptoms, loneliness, and self-esteem. Results: Among 817 U.S. Latino adults with T2D who participated in the online survey, 517 completed the Spanish-language DSAS-2 (DSAS Spa-US) and were eligible for the study (mean age 54 ± 10 years, and 72% female). Exploratory factor analysis supported a single-factor solution (eigenvalue=8.20), accounting for 82% of shared variance among the 19 items, all loading ≥ 0.5. Internal consistency reliability was high (α=0.93). As expected, strong, positive correlations were observed between diabetes stigma and general chronic illness stigma (rs=0.65) and diabetes distress (rs=0.57); medium, positive correlations, between diabetes stigma and depressive (rs=0.45) and anxiety (rs=0.43) symptoms, and loneliness (rs=0.41); and a moderate negative correlation between diabetes stigma and self-esteem (rs=-0.50). There was no relationship between diabetes stigma and diabetes duration (rs=0.07, ns). Conclusion: The DSAS-2 Spa-US is a version of the DSAS-2, translated into Spanish, that has good psychometric properties for assessing diabetes stigma in U.S. Latino adults with T2D.

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

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.

Characterization of pre-transplant psychosocial burden in an integrated national islet transplant program.

The psychological burden experienced by people with diabetes prior to islet transplantation is recognized but has not been studied comprehensively, especially in relation to glycemia. Therefore, we conducted a rigorous pre-operative psychosocial profile of UK islet transplant recipients, and compared groups with higher/lower HbA1 c to test the null hypothesis that pre-transplant hypoglycemia awareness and psychosocial burden would not be related to baseline HbA1 c in this high-risk cohort. Pre-transplant, recipients (n = 44) completed validated hypoglycemia awareness questionnaires and generic/diabetes-specific measures of psychological traits and states. Scores were compared in groups, dichotomized by HbA1 c (≤8% versus >8%). Participants were aged (mean±SD) 53 ± 10 years; 64% were women; with HbA1 c 8.3 ± 1.7%. Median rate of severe hypoglycemia over the preceding 12 months was 13 events/person-year and 90% had impaired awareness of hypoglycemia (Gold/Clarke score ≥4). Participants had elevated fear of hypoglycemia (HFS-II Worry), impaired diabetes-specific quality of life (DQoL) and low generic health status (SF-36; EQ-5D). One quarter reported scores indicating likely anxiety/depression (HAD). Dispositional optimism (LOT-R) and generalized self-efficacy (GSE) were within published 'norms.' Despite negative perceptions of diabetes (including low personal control), participants were confident that islet transplantation would help (BIPQ). Hypoglycemia awareness and psychosocial profile were comparable in lower (n = 24) and higher (n = 20) HbA1 c groups. Islet transplant candidates report sub-optimal generic psychological states (anxiety/depressive symptoms), health status and diabetes-specific psychological states (fear of hypoglycemia, diabetes-specific quality of life). While their generic psychological traits (optimism, self-efficacy) are comparable with the general population, they are highly optimistic about forthcoming transplant. HbA1 c is not a proxy measure of psychosocial burden, which requires the use of validated questionnaires to systematically identify those who may benefit most from psychological assessment and support.

Screening, assessment and management of type 2 diabetes mellitus in children and adolescents: Australasian Paediatric Endocrine Group guidelines.

INTRODUCTION: The incidence of type 2 diabetes mellitus has increased in children and adolescents due largely to the obesity epidemic, particularly in high risk ethnic groups. ß-Cell function declines faster and diabetes complications develop earlier in paediatric type 2 diabetes compared with adult-onset type 2 diabetes. There are no consensus guidelines in Australasia for assessment and management of type 2 diabetes in paediatric populations and health professionals have had to refer to adult guidelines. Recent international paediatric guidelines did not address adaptations to care for patients from Indigenous backgrounds. MAIN RECOMMENDATIONS: This guideline provides advice on paediatric type 2 diabetes in relation to screening, diagnosis, diabetes education, monitoring including targets, multicomponent healthy lifestyle, pharmacotherapy, assessment and management of complications and comorbidities, and transition. There is also a dedicated section on considerations of care for children and adolescents from Indigenous background in Australia and New Zealand. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINES: Published international guidelines currently exist, but the challenges and specifics to care for children and adolescents with type 2 diabetes which should apply to Australasia have not been addressed to date. These include: recommendations regarding care of children and adolescents from Indigenous backgrounds in Australia and New Zealand including screening and management; tighter diabetes targets (glycated haemoglobin, ≤ 48 mmol/mol [≤ 6.5%]) for all children and adolescents; considering the use of newer medications approved for adults with type 2 diabetes under the guidance of a paediatric endocrinologist; and the need to transition adolescents with type 2 diabetes to a diabetes multidisciplinary care team including an adult endocrinologist for their ongoing care.

Effect of a tailored leaflet to promote diabetic retinopathy screening among young adults with type 2 diabetes: a randomised controlled trial.

BACKGROUND: Young adults with type 2 diabetes (aged 18-39 years) are at risk of early onset and rapid progression of diabetic retinopathy, the leading cause of blindness and vision loss in working age adults. Early detection via retinal screening can prevent most vision loss, yet screening rates are consistently lower among this priority population than the general diabetes population. We aimed to test the effect of a tailored, evidence-based brief health behaviour change intervention (leaflet) on self-reported screening uptake, and previously identified social cognitive determinants of retinal screening. METHODS: A pragmatic, two-arm randomised controlled trial was conducted from September 2014 to April 2015. Participants were stratified by prior screening uptake (Yes/No) and randomly allocated to intervention (leaflet) or 'usual care' control (no leaflet). Primary outcome was self-reported screening uptake four weeks post-intervention for 'No' participants who had not previously screened for diabetic retinopathy. Secondary outcome variables were changes in knowledge, attitudes, normative beliefs, intention and behavioural skills for all participants, irrespective of prior screening behaviour. To assess intervention effects on secondary outcome variables, we conducted independent samples t-tests (two-tailed) on pre-post change scores. RESULTS: 129 young adults (26% no prior retinal screen) completed baseline; 101 completed post-intervention. Power to determine effect on the primary outcome was curtailed by low recruitment of individuals with no prior retinal screen and loss to follow-up. Attrition was associated significantly with country of birth, language spoken at home, and marital status. Significant intervention effect was observed for one secondary outcome variable: knowledge of diabetic retinopathy (p = .03) with moderate effect (partial eta squared η2 = .05); no adverse effects were reported. Control group participants received the leaflet at study completion. CONCLUSIONS: This study confirms that a well-designed eye health and retinal screening promotion leaflet can increase knowledge of diabetic retinopathy, an important screening predictor. The study highlights the challenges of conducting 'real-world' health behaviour change research with this priority population, providing insights for clinicians and researchers. Strategies to recruit, engage and retain hard-to-reach populations are discussed including nonconventional alternatives to randomised controlled trial designs. TRIAL REGISTRATION: ACTRN12614001110673, UTN No.: U1111-1161-9803. Registered 20 October 2014 - retrospectively registered https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367127.

What Do Adults with Type 2 Diabetes Want from the "Perfect" App? Results from the Second Diabetes MILES: Australia (MILES-2) Study.

Background: We investigated what Australian adults with type 2 diabetes (T2D) want from the "perfect" diabetes self-management application. Methods: Adults with T2D completed a national online survey including an open-ended question: "If you were describing the perfect app to help you manage your diabetes, what would it do?" Qualitative responses were subjected to thematic analysis. Results: Of the 339 participants who provided usable responses, 153 (45%) were women, the mean age was 58 ± 10 years, and 139 participants (41%) managed their diabetes with insulin. Two primary themes emerged. First, participants expressed a desire for assistance with practical aspects of diabetes self-management to improve, and reduce the cognitive burden of, self-management; this included tracking and visualizing multiple sources of data, using data to inform automated, personalized coaching, reminders, and alarms, and automating upload and linking of data through connected devices. Second, they desired assistance with psychological and emotional aspects of diabetes self-management; this included ongoing encouragement and motivation, help with stress management or negative emotions, and complementing existing health care by facilitating interconnectivity with health professionals. Conclusions: Our findings suggest that the clear desire of people with type 2 diabetes is for the "perfect app" to reduce not only the practical, but also the cognitive and emotional burden of diabetes self-management. They provide further evidence that understanding the desires of people living with diabetes needs to be the first step in app development to ensure that apps provide features, support, and benefits that people with diabetes value.

Modeling Interactions Between Latent Variables in Research on Type D Personality: A Monte Carlo Simulation and Clinical Study of Depression and Anxiety.

Several approaches exist to model interactions between latent variables. However, it is unclear how these perform when item scores are skewed and ordinal. Research on Type D personality serves as a good case study for that matter. In Study 1, we fitted a multivariate interaction model to predict depression and anxiety with Type D personality, operationalized as an interaction between its two subcomponents negative affectivity (NA) and social inhibition (SI). We constructed this interaction according to four approaches: (1) sum score product; (2) single product indicator; (3) matched product indicators; and (4) latent moderated structural equations (LMS). In Study 2, we compared these interaction models in a simulation study by assessing for each method the bias and precision of the estimated interaction effect under varying conditions. In Study 1, all methods showed a significant Type D effect on both depression and anxiety, although this effect diminished after including the NA and SI quadratic effects. Study 2 showed that the LMS approach performed best with respect to minimizing bias and maximizing power, even when item scores were ordinal and skewed. However, when latent traits were skewed LMS resulted in more false-positive conclusions, while the Matched PI approach adequately controlled the false-positive rate.

GP-OSMOTIC trial protocol: an individually randomised controlled trial to determine the effect of retrospective continuous glucose monitoring (r-CGM) on HbA1c in adults with type 2 diabetes in general practice.

INTRODUCTION: Optimal glycaemia can reduce type 2 diabetes (T2D) complications. Observing retrospective continuous glucose monitoring (r-CGM) patterns may prompt therapeutic changes but evidence for r-CGM use in T2D is limited. We describe the protocol for a randomised controlled trial (RCT) examining intermittent r-CGM use (up to 14 days every three months) in T2D in general practice (GP). METHODS AND ANALYSIS: General Practice Optimising Structured MOnitoring To achieve Improved Clinical Outcomes is a two-arm RCT asking 'does intermittent r-CGM in adults with T2D in primary care improve HbA1c?' PRIMARY OUTCOME: Absolute difference in mean HbA1c at 12 months follow-up between intervention and control arms. SECONDARY OUTCOMES: (a) r-CGM per cent time in target (4-10 mmol/L) range, at baseline and 12 months; (b) diabetes-specific distress (Problem Areas in Diabetes). ELIGIBILITY: Aged 18-80 years, T2D for ≥1 year, a (past month) HbA1c>5.5 mmol/mol (0.5%) above their individualised target while prescribed at least two non-insulin hypoglycaemic therapies and/or insulin (therapy stable for the last four months). Our general glycaemic target is 53 mmol/mol (7%) (patients with a history of severe hypoglycaemia or a recorded diagnosis of hypoglycaemia unawareness will have a target of 64 mmol/mol (8%)).Our trial compares r-CGM use and usual care. The r-CGM report summarising daily glucose patterns will be reviewed by GP and patient and inform treatment decisions. Participants in both arms are provided with 1 hour education by a specialist diabetes nurse.The sample (n=150/arm) has 80% power to detect a mean HbA1c difference of 5.5 mmol/mol (0.5%) with an SD of 14.2 (1.3%) and alpha of 0.05 (allowing for 10% clinic and 20% patient attrition). ETHICS AND DISSEMINATION: University of Melbourne Human Ethics Sub-Committee (ID 1647151.1). Dissemination will be in peer-reviewed journals, conferences and a plain-language summary for participants. TRIAL REGISTRATION NUMBER: >ACTRN12616001372471; Pre-results.

Stigma Perceived and Experienced by Adults with Type 1 Diabetes: Linguistic Adaptation and Psychometric Validation of the Danish Version of the Type 1 Diabetes Stigma Assessment Scale (DSAS-1 DK).

OBJECTIVES: We aimed to (a) culturally and linguistically adapt the Type 1 Diabetes Stigma Assessment Scale (DSAS-1) from English (for Australia) into Danish and (b) examine psychometric properties of the measure among Danish adults with type 1 diabetes. METHODS: We performed a forward-backward translation, face validity interviews with experts and cognitive debriefing of the Danish version (DSAS-1 DK) with ten adults from the target group. The DSAS-1 DK was then completed by 1594 adults with type 1 diabetes. Electronic clinical records provided age, diabetes duration, diabetes-related complications, and glycemic control [glycated hemoglobin (HbA1c)]. We examined internal consistency, construct validity and structural validity of the DSAS-1 DK using exploratory and confirmatory factor analysis in a cross-validation design. RESULTS: The translated measure was found acceptable by the experts and target group, with only minor adaptations required for the Danish context. The DSAS-1 DK structure was best represented by a three-factor model representing the subscales 'Treated Differently,' 'Blame and Judgement,' and 'Identity Concern' (α = 0.88-0.89). The results also provided some support for calculation of a total score (19-item scale; α = 0.75). The subscales and total scale demonstrated satisfactory convergent and discriminant validity. Good structural validity was demonstrated for the three-factor model for four out of five indices [normed χ 2 = 4.257, goodness-of-fit index (GFI) = 0.923, root mean square error of approximation (RMSEA) = 0.065, standardized root mean square residual (SRMSR) = 0.0567, comparative fit index (CFI) = 0.93]. CONCLUSION: The DSAS-1 DK has a confirmed three-factor structure, consistent with the original Australian English version. The measure is now validated and available to advance research into the stigma perceived and experienced by adults with type 1 diabetes in a Danish context.

What is diabetes distress and how can we measure it? A narrative review and conceptual model.

BACKGROUND: Diabetes distress is the negative emotional impact of living with diabetes. It has tangible clinical importance, being associated with sub-optimal self-care and glycemic control. Diabetes distress has been operationalized in various ways and several measures exist. Measurement clarity is needed for both scientific and clinical reasons. OBJECTIVES: To clarify the conceptualization and operationalization of diabetes distress, identify and distinguish relevant measures, and evaluate their appropriateness for this purpose. RESULTS: Six measures were identified: Problem Areas in Diabetes (PAID) scale, Diabetes Distress Scale (DDS); Type I Diabetes Distress Scale (T1-DDS), Diabetes-specific Quality of Life Scale-Revised (DSQoLs-R) 'Burden and Restrictions-Daily Hassles' sub-scale, Well-being Questionnaire 28 (W-BQ 28) 'Diabetes Well-being' sub-scale, and Illness Perceptions Questionnaire-Revised (IPQ-R) 'Emotional Representations' sub-scale. Across these measures a broad spectrum of diabetes distress is captured, including distress associated with treatment regimen, food/eating, future/complications, hypoglycemia, social/interpersonal relationships, and healthcare professionals. No single measure appears fully comprehensive. Limited detail of the qualitative work informing scale design is reported, raising concerns about content validity. CONCLUSIONS: Across the available measures diabetes distress is seemingly comprehensively assessed and measures should be considered in terms of their focus and scope to ensure the foci of interventions are appropriately targeted.

'Are you sure you're going to have another one of those?': A qualitative analysis of the social control and social support models in type 2 diabetes.

While there is evidence that spouses can impact the self-management of adults with type 2 diabetes mellitus, less is known about the influence of the wider social network. This qualitative study explored the perceived impact of the family as well as friends and work colleagues on type 2 diabetes mellitus self-management. A total of 25 adults with type 2 diabetes mellitus participated in semi-structured interviews regarding their social experiences of living with diabetes. Deductive thematic analysis was applied to the data. Pre-existing themes of health-related social control and social support were identified in the wider social network, with additional themes of non-involvement and unintentional undermining also emerging.

Measuring the Stigma Surrounding Type 2 Diabetes: Development and Validation of the Type 2 Diabetes Stigma Assessment Scale (DSAS-2).

OBJECTIVE: To develop and validate a self-report measure of perceived and experienced stigma for use with adults with type 2 diabetes: the Type 2 Diabetes Stigma Assessment Scale (DSAS-2). RESEARCH DESIGN AND METHODS: An item pool was drafted based on qualitative data from 25 adults with type 2 diabetes and content from other health-related stigma questionnaires. Thirteen adults with type 2 diabetes completed 57 draft diabetes stigma items and participated in cognitive debriefing interviews. Based on participant feedback, the pool was reduced to 48 items with a 5-point Likert scale (strongly disagree to strongly agree). A total of 1,064 adults with type 2 diabetes completed a survey including these 48 items and other validated measures. Data were subject to principal components analysis and Spearman ρ correlations. RESULTS: The scale was reduced to 19 items, with an unforced three-factor solution indicative of three subscales: Treated Differently (6 items, α = 0.88), Blame and Judgment (7 items, α = 0.90), and Self-stigma (6 items, α = 0.90). A forced one-factor solution supported the calculation of a total score (α = 0.95). Satisfactory concurrent, convergent, and discriminant validity were demonstrated. CONCLUSIONS: The 19-item DSAS-2 is a reliable and valid measure of type 2 diabetes stigma. A rigorous design and validation process has resulted in a relatively brief measure of perceived and experienced stigma in type 2 diabetes. The novel scale has satisfactory psychometric properties and is now available to facilitate much-needed research in this field.

Diabetes MILES Youth-Australia: methods and sample characteristics of a national survey of the psychological aspects of living with type 1 diabetes in Australian youth and their parents.

BACKGROUND: Type 1 diabetes is a complex and demanding condition, which places a substantial behavioural and psychological burden on young people and their families. Around one-third of adolescents with type 1 diabetes need mental health support. Parents of a child with type 1 diabetes are also at increased risk of psychological distress. A better understanding of the motivators, behaviours and psychological well-being of young people with diabetes and their parents will inform improvement of resources for supporting self-management and reducing the burden of diabetes. The Diabetes MILES (Management and Impact for Long-term Empowerment and Success) Youth-Australia Study is the first large-scale, national survey of the impact of diabetes on the psychosocial outcomes of Australian adolescents with type 1 diabetes and their parents. METHODS/DESIGN: The survey was web-based to enable a large-scale, national survey to be undertaken. Recruitment involved multiple strategies: postal invitations; articles in consumer magazines; advertising in diabetes clinics; social media (e.g. Facebook, Twitter). Recruitment began in August 2014 and the survey was available online for approximately 8 weeks. A total of 781 young people (aged 10-19 years) with type 1 diabetes and 826 parents completed the survey. Both genders, all ages within the relevant range, and all Australian states and territories were represented, although compared to the general Australian population of youth with type 1 diabetes, respondents were from a relatively advantaged socioeconomic background. DISCUSSION: The online survey format was a successful and economical approach for engaging young people with type 1 diabetes and their parents. This rich quantitative and qualitative dataset focuses not only on diabetes management and healthcare access but also on important psychosocial factors (e.g. social support, general emotional well-being, and diabetes distress). Analysis of the Diabetes MILES Youth-Australia Study data is ongoing, and will provide further insights into the psychosocial problems facing young people with type 1 diabetes and their parents. These will inform future research and support services to meet the needs of young Australians with type 1 diabetes and their families.