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Abstract Background Management of type 1 diabetes (T1D) requires the use of insulin, which can cause hypoglycaemia (low blood glucose levels). While most hypoglycaemic episodes can be self-treated, all episodes can be sudden, inconvenient, challenging to prevent or manage, unpleasant and/or cause unwanted attention or embarrassment. Severe hypoglycaemic episodes, requiring assistance from others for recovery, are rare but potentially dangerous. Repeated exposure to hypoglycaemia can reduce classic warning symptoms (‘awareness’), thereby increasing risk of severe episodes. Thus, fear of hypoglycaemia is common among adults with T1D and can have a negative impact on how they manage their diabetes, as well as on daily functioning, well-being and quality of life. While advances in glycaemic technologies and group-based psycho-educational programmes can reduce fear, frequency and impact of hypoglycaemia, they are not universally or freely available, nor do they fully resolve problematic hypoglycaemia or associated worries. This study aims to determine the effectiveness of a fully online, self-directed, scalable, psycho-educational intervention for reducing fear of hypoglycaemia: the Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) programme. Methods A 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial, conducted remotely (online and telephone). Australian adults (≥ 18 years) with self-reported T1D and fear of hypoglycaemia will be recruited, and allocated at random (1:1) to HypoPAST or control (usual care). The primary outcome is the between-group difference in fear of hypoglycaemia (assessed using HFS-II Worry score) at 24 weeks. A sample size of N = 196 is required to detect a 9-point difference, with 90% power and allowing for 30% attrition. Multiple secondary outcomes include self-reported psychological, behavioural, biomedical, health economic, and process evaluation data. Data will be collected at baseline, 12 and 24 weeks using online surveys, 2-week ecological momentary assessments, website analytics and semi-structured interviews. Discussion This study will provide evidence regarding the effectiveness, cost-effectiveness and acceptability of a novel, online psycho-educational programme: HypoPAST. Due to the fully online format, HypoPAST is expected to provide an inexpensive, convenient, accessible and scalable solution for reducing fear of hypoglycaemia among adults with T1D. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023).

Abstract Background Diabetes-specific quality of life (QoL) questionnaires are commonly used to assess the impact of diabetes and its management on an individual’s quality of life. While several valid and reliable measures of diabetes-specific QoL exist, there is no consensus on which to use and in what setting. Furthermore, there is limited evidence of their acceptability to people with diabetes. Our aim was to explore perceptions of adults with type 1 diabetes (T1D) toward five diabetes-specific QoL measures. Methods Adults (aged 18 + years) with T1D living in Australia or the United Kingdom (UK) were eligible to take part in ‘YourSAY: QoL’, an online cross-sectional survey. Recruitment involved study promotion on diabetes-related websites and social media, as well as direct invitation of people with T1D via a hospital client list (UK only). In random order, participants completed five diabetes-specific QoL measures: Audit of Diabetes-Dependent Quality of Life (ADDQoL-19); Diabetes Care Profile: Social and Personal Factors subscale (DCP); DAWN Impact of Diabetes Profile (DIDP); Diabetes-Specific Quality of Life Scale: Burden Subscale (DSQoLS); Diabetes Quality of Life Questionnaire (Diabetes QOL-Q). They were invited to provide feedback on each questionnaire in the form of a brief free-text response. Responses were analysed using inductive, thematic template analysis. Results Of the N = 1,946 adults with T1D who completed the survey, 20% (UK: n = 216, Australia: n = 168) provided qualitative responses about ≥ 1 measure. All measures received both positive and negative feedback, across four themes: (1) clarity and ease of completion, e.g., difficulty isolating impact of diabetes, dislike of hypothetical questions, and preference for ‘not applicable’ response options; (2) relevance and comprehensiveness, e.g., inclusion of a wide range of aspects of life to improve personal relevance; (3) length and repetition, e.g., length to be balanced against respondent burden; (4) framing and tone, e.g., preference for respectful language and avoidance of extremes. Conclusions These findings suggest opportunities to improve the relevance and acceptability of existing diabetes-specific QoL measures, and offer considerations for developing new measures, which need to be better informed by the preferences of people living with diabetes.

Abstract Background Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. Methods Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. ‘Embedders’ supported practices and self-management programme providers to embed programme referral into routine practice, and an online ‘toolkit’ contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months − 3–0), step one (months 1–9), step 2 (months 10–18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. Results No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p

Abstract Background This study examined the feasibility and acceptability of the low-intensity mental health support via telehealth-enabled network (LISTEN) intervention, for adults with diabetes, facilitated by diabetes health professionals (HPs). Methods LISTEN training. Three HPs participated in three half-day online workshops and applied their learnings during training cases (maximum four). Competency was assessed with a validated tool and achieved ‘satisfactory’ ratings for three consecutive sessions. LISTEN pilot. A single-group, pre-post study (up to four LISTEN sessions) with online assessments at baseline, post-intervention, and 4-week follow-up. Eligible participants were adults with type 1 or type 2 diabetes, with diabetes distress, but excluded if they had moderate/severe depressive and/or anxiety symptoms. Feasibility was assessed via recruitment and session completion rates. Acceptability was assessed with post-intervention self-report data. Changes in diabetes distress and general emotional well-being from baseline (T1) were explored at post-intervention (T2) and at 4-week follow-up (T3). Results Two HPs achieved competency (median training case sessions required: 7) and progressed to deliver LISTEN in the pilot study. In the pilot, N = 16 adults (Med [IQR] age: 60 [37–73] years; 13 women) with diabetes participated (median sessions per participant: 2). Twelve participants (75%) completed the post-intervention assessment (T2): 92% endorsed the number of sessions offered as ‘just right’, 75% felt comfortable talking with the HP, and 67% were satisfied with LISTEN. Perceived limitations were the structured format and narrow scope of problems addressed. Diabetes distress scores were lower post-intervention. Conclusions This pilot demonstrates the feasibility of training HPs to deliver LISTEN, and the acceptability and potential benefits of LISTEN for adults with diabetes. The findings highlight adaptations that may enhance the delivery of, and satisfaction with, LISTEN that will be tested in a hybrid type 1 effectiveness-implementation trial.

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

Abstract 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.

Associations between islet graft function and well-being in islet transplant recipients requiring exogenous insulin remain unclear. This cross-sectional analysis compared person-reported outcome measures in 15 adults with type 1 diabetes whose islet transplants were classified according to Igls criteria as “Good” (n = 5), “Marginal” (n = 4) and “Failed” (n = 6) graft function. At a mean of 6.2 years post-first islet transplant, 90% reduction in severe hypoglycaemia was maintained in all groups, with HbA1c (mean ± SD mmol/mol) 49 ± 4 in recipients with “Good” function; 56 ± 5 (“Marginal”); and 69 ± 25 (“Failed”). Self-reported impaired awareness of hypoglycaemia persisted in all groups but those with “Good” function were more likely to experience symptoms during hypoglycaemia. “Marginal” function was associated with greater fear of hypoglycaemia (HFS-II score: “Marginal”: 113 [95, 119]; “Failed”: 63 [42, 93] (p = 0.082); “Good”: 33 [29, 61]) and severe anxiety (GAD7: “Marginal”): 21 [17, 21]; “Failed”: 6 [6, 6] “Good”: 6 [3, 11]; (p = 0.079)), diabetes distress and low mood. Despite clear evidence of ongoing clinical benefit, Igls criteria ‘Marginal’ function is associated with sub-optimal well-being, including greater fear of hypoglycaemia and severe anxiety. This study provides person-reported validation that “Good” and “Marginal” graft function are differentiated by general and diabetes-specific subjective well-being, suggesting those with “Marginal” function may benefit from further intervention, including re-transplantation.

BackgroundThe 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. ObjectiveThe 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. MethodsParticipants 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. ResultsA 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 derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. ConclusionsThe Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual’s daily functioning. Despite suggested improvements, participants’ responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact.

Abstract 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 professionals) to supporting people with diabetes distress were common at baseline and follow-up. Conclusions The e-learning was acceptable to CDEs. The study design was feasible but needs modification to improve follow-up survey return. The e-learning showed potential for improving diabetes distress-related knowledge, confidence and asking behaviours, but systemic barriers to implementation remained. Systemic barriers need to be addressed to facilitate implementation of support for diabetes distress in clinical practice. Future larger-scale evaluation of the e-learning is warranted.

BackgroundSelf-monitoring of blood glucose (SMBG) is considered of little clinical benefit for adults with non-insulin-treated type 2 diabetes, but no comprehensive review of a structured approach to SMBG has been published to date.PurposeTo conduct a systematic review and meta-analysis of the impact of sSMBG on HbA1c, treatment modifications, behavioral and psychosocial outcomes, and; examine the moderating effects of sSMBG protocol characteristics on HbA1c.Data sourcesFour databases searched (November 2020; updated: February 2022).Study selectionInclusion criteria: non-randomized and randomized controlled trials (RCTs) and prospective observational studies; reporting effect of sSMBG on stated outcomes; among adults (≥18 years) with non-insulin-treated type 2 diabetes. Studies excluded if involving children or people with insulin-treated or other forms of diabetes.Data extraction and analysisOutcome data extracted, and risk of bias/quality assessed independently by two researchers. Meta-analysis was conducted for RCTs, and moderators explored (HbA1c only).Data synthesisFrom 2,078 abstracts, k=23 studies were included (N=5,372). Risk of bias was evident and study quality was low. Outcomes assessed included: HbA1c (k=23), treatment modification (k=16), psychosocial/behavioral outcomes (k=12). Meta-analysis revealed a significant mean difference favoring sSMBG in HbA1c (-0·29%, 95% CI: -0·46 to -0·11, k=13) and diabetes self-efficacy (0.17%, 95% CI: 0.01 to 0.33, k=2). Meta-analysis revealed no significant moderating effects by protocol characteristics.LimitationsFindings limited by heterogeneity in study designs, intervention characteristics, and psychosocial assessments.ConclusionA small positive effect of sSMBG on HbA1c and diabetes self-efficacy was observed. Narrative synthesis of sSMBG intervention characteristics may guide future implementation.PROSPERO registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020208857, identifier CRD42020208857.

Abstract 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 via the Patient Health Questionnaire-9) at 8 weeks. Societal and healthcare costs will be estimated to determine the cost-effectiveness of the CALM program. A process evaluation will determine its reach, adoption, implementation and maintenance. Discussion If the CALM program is non-inferior to psychotherapy, this study will provide the first evidence to support lifestyle-based mental healthcare as an additional care model to support individuals experiencing psychological distress. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12621000387820 , Registered 8 April 2021.

IntroductionWomen with previous gestational diabetes mellitus (GDM) are at increased risk of type 2 diabetes (T2D). Guidelines recommend postnatal diabetes screening (oral glucose tolerance test or HbA1c) typically 6-12 weeks after birth, with screening maintained at regular intervals thereafter. Despite this, around half of women are not screened, representing a critical missed opportunity for early identification of prediabetes or type 2 diabetes. While policy and practice-level recommendations are comprehensive, those at the personal-level primarily focus on increasing screening knowledge and risk perception, potentially missing other influential behavioral determinants. We aimed to identify modifiable, personal-level factors impacting postpartum type 2 diabetes screening among Australian women with prior gestational diabetes and recommend intervention functions and behavior change techniques to underpin intervention content.Research design and methodsSemi-structured interviews with participants recruited via Australia’s National Gestational Diabetes Register, using a guide based on the Theoretical Domains Framework (TDF). Using an inductive-deductive approach, we coded data to TDF domains. We used established criteria to identify ‘important’ domains which we then mapped to the Capability, Opportunity, Motivation–Behavior (COM-B) model.ResultsNineteen women participated: 34 ± 4 years, 19 ± 4 months postpartum, 63% Australian-born, 90% metropolitan, 58% screened for T2D according to guidelines. Eight TDF domains were identified: ‘knowledge’, ‘memory, attention, and decision-making processes’, ‘environmental context and resources’, ‘social influences’, ‘emotion’, ‘beliefs about consequences’, ‘social role and identity’, and ‘beliefs about capabilities’. Study strengths include a methodologically rigorous design; limitations include low recruitment and homogenous sample.ConclusionsThis study identified numerous modifiable barriers and enablers to postpartum T2D screening for women with prior GDM. By mapping to the COM-B, we identified intervention functions and behavior change techniques to underpin intervention content. These findings provide a valuable evidence base for developing messaging and interventions that target the behavioral determinants most likely to optimize T2D screening uptake among women with prior GDM.

The objective of this study was to examine the associations between personality, general and diabetes-specific well-being and self-efficacy, and weight management indicators, among adults with type 2 diabetes. In addition, to examine whether personality provides incremental explanation of variance in weight management indicators. Australian adults with type 2 diabetes (N = 270; 56% women; age: 61±12 years) were recruited via the national diabetes registry. An online survey included measures of: personality (HEXACO-PI-R), weight management indicators (physical activity, healthy diet, body mass index [BMI]), general well-being (WHO-5), general self-efficacy (GSE), diabetes distress (DDS) and diabetes self-efficacy (DMSES). Analyses included bivariate correlations and linear regression, adjusted for demographic, clinical, and psychological variables. All six personality domains showed significant correlation with at least one weight management indicator: physical activity with extraversion (r = .28), conscientiousness (r = .18) and openness (r = .19); healthy diet with honesty-humility (r = .19), extraversion (r = .24), and agreeableness (r = .14); and BMI with emotionality (r = .20) and extraversion (r = -.20). The strongest associations with general and diabetes-specific well-being and self-efficacy were apparent for extraversion, emotionality and conscientiousness (range: r = -.47-.66). Beyond covariates, personality domains explained additional variance for physical activity (Adjusted R2 = .31, R2 difference = .03, p = .03; openness: β = .16, p = .02, emotionality: β = .15, p = .04) and healthy diet (Adjusted R2 = .19, R2 difference = .03, p = .02; honesty-humility: β = .20, p = .002, extraversion: β = .19, p = .04) but not BMI. This study shows that personality is associated with weight management indicators and psychological factors among adults with type 2 diabetes. Further research is needed, including objective measurement of weight management indictors, to examine how personality influences the experience of type 2 diabetes.

IntroductionThe aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes.Materials and methods100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rsResultsParticipants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation ConclusionHigh completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

BackgroundDiabetes 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.MethodsThe 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.ResultsAmong 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).ConclusionThe 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.

AimsManaging 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.MethodsMedline, 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.ResultsSeventeen 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.ConclusionsAmong 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 registrationwww.crd.york.ac.uk/prospero/, identifier CRD42019111002.

Introduction The aim of this study was to determine the psychometric properties of the 12-Item Hypoglycemia Impact Profile (HIP12), a brief measure of the impact of hypoglycemia on quality of life (QoL) among adults with type 1 (T1D) or type 2 diabetes (T2D).Research design and methods Adults with T1D (n=1071) or T2D (n=194) participating in the multicountry, online study, ‘Your SAY: Hypoglycemia’, completed the HIP12. Psychometric analyses were undertaken to determine acceptability, structural validity, internal consistency, convergent/divergent validity, and known-groups validity.Results Most (98%) participants completed all items on the HIP12. The expected one-factor solution was supported for T1D, T2D, native English speaker, and non-native English speaker groups. Internal consistency was high across all groups (ω=0.91–0.93). Convergent and divergent validity were satisfactory. Known-groups validity was demonstrated for both diabetes types, by frequency of severe hypoglycemia (0 vs ≥1 episode in the past 12 months) and self-treated episodes (

IntroductionGlobally, 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.MethodsWe 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.DiscussionThe 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 RegistrationPROSPERO registration number: CRD42021246560.

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 clinical care efficiently and determine appropriate interventions to manage identified problem areas.PROSPERO registration number CRD42020200246.

Abstract 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 η 2 = .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 .

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 need it most.

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.

Abstract Background General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) is a multicentre, individually randomised controlled trial aiming to compare the use of intermittent retrospective continuous glucose monitoring (r-CGM) to usual care in patients with type 2 diabetes attending general practice. The study protocol was published in the British Medical Journal Open and described the principal features of the statistical methods that will be used to analyse the trial data. This paper provides greater detail on the statistical analysis plan, including background and justification for the statistical methods chosen, in accordance with SPIRIT guidelines. Objective To describe in detail the data management process and statistical methods that will be used to analyse the trial data. Methods An overview of the trial design and primary and secondary research questions are provided. Sample size assumptions and calculations are explained, and randomisation and data management processes are described in detail. The planned statistical analyses for primary and secondary outcomes and sub-group analyses are specified along with the intended table layouts for presentation of the results. Conclusion In accordance with best practice, all analyses outlined in the document are based on the aims of the study and have been pre-specified prior to the completion of data collection and outcome analyses. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12616001372471. Registered on 3 August 2016.

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.

ObjectiveTo conduct a systematic review to examine associations between hypoglycemia and quality of life (QoL) in children and adolescents with type 1 diabetes.MethodsFour 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.ResultsIn 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.ConclusionsThere 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.

Abstract Background Young adults (18–39 years) with type 2 diabetes are at risk of early development and rapid progression of diabetic retinopathy, a leading cause of vision loss and blindness in working-age adults. Retinal screening is key to the early detection of diabetic retinopathy, with risk of vision loss significantly reduced by timely treatment thereafter. Despite this, retinal screening rates are low among this at-risk group. The objective of this study was to develop a theoretically-grounded, evidence-based retinal screening promotion leaflet, tailored to young adults with type 2 diabetes. Methods Utilising the six steps of Intervention Mapping, our multidisciplinary planning team conducted a mixed-methods needs assessment (Step 1); identified modifiable behavioural determinants of screening behaviour and constructed a matrix of change objectives (Step 2); designed, reviewed and debriefed leaflet content with stakeholders (Steps 3 and 4); and developed program implementation and evaluation plans (Steps 5 and 6). Results Step 1 included in-depth qualitative interviews (N = 10) and an online survey that recruited a nationally-representative sample (N = 227), both informed by literature review. The needs assessment highlighted the crucial roles of knowledge (about diabetic retinopathy and screening), perception of personal risk, awareness of the approval of significant others and engagement with healthcare team, on retinal screening intentions and uptake. In Step 2, we selected five modifiable behavioural determinants to be targeted: knowledge, attitudes, normative beliefs, intention, and behavioural skills. In Steps 3 and 4, the “Who is looking after your eyes?” leaflet was developed, containing persuasive messages targeting each determinant and utilising engaging, cohort-appropriate imagery. In Steps 5 and 6, we planned Statewide implementation and designed a randomised controlled trial to evaluate the leaflet. Conclusions This research provides an example of a systematic, evidence-based approach to the development of a simple health intervention designed to promote uptake of screening in accordance with national guidelines. The methods and findings illustrate how Intervention Mapping can be employed to develop tailored retinal screening promotion materials for specific priority populations. This paper has implications for future program planners and is intended to assist those wishing to use Intervention Mapping to create similar theoretically-driven, tailored resources.

Abstract Objective: A socioeconomic gradient exists in Australia for type 2 diabetes mellitus (T2DM). It remains unclear whether economic hardship is associated with T2DM self–management behaviours. Methods: Cross‐sectional data from a subset of the Diabetes MILES – Australia study were used (n=915). The Economic Hardship Questionnaire was used to assess hardship. Outcomes included: healthy eating and physical activity (Diabetes Self‐Care Inventory – Revised), medication‐taking behaviour (Medication Adherence Rating Scales) and frequency of self‐monitoring of blood glucose (SMBG). Regression modelling was used to explore the respective relationships. Results: Greater economic hardship was significantly associated with sub‐optimal medication‐taking (Coefficient: −0.86, 95%CI −1.54, −0.18), and decreased likelihood of regular physical activity (Odds Ratio: 0.47, 0.29, 0.77). However, after adjustments for a range of variables, these relationships did not hold. Being employed and higher depression levels were significantly associated with less‐frequent SMBG, sub‐optimal medication‐taking and less‐regular healthy eating. Engaging in physical activity was strongly associated with healthy eating. Conclusions: Employment, older age and depressive symptoms, not economic hardship, were commonly associated with diabetes self‐management. Implications: Work‐based interventions that promote T2DM self‐management in younger, working populations that focus on negative emotions may be beneficial.