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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.

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.

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 achieving ‘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 delivery of, and satisfaction with, LISTEN that will be tested in a hybrid type 1 effectiveness-implementation trial.

There is limited evidence supporting the recommendation that drivers with insulin-treated diabetes need to start journeys with glucose90 mg/dL. Glucose levels of drivers with type 1 diabetes were monitored for 3 weeks using masked continuous glucose monitoring (CGM). Eighteen drivers (median [IQR] age 40 [35, 51] years; 11 men) undertook 475 trips (duration 15 [13, 21] min). Hypoglycemia did not occur in any trip starting with glucose90 mg/dL (92%

There has been little recognition that people with type 2 diabetes are vulnerable to weight stigma and diabetes stigma and almost no research examining the implications of these forms of stigma for their health and well-being. This study examined health behavior correlates of weight stigma and diabetes stigma in 1,227 adults with type 2 diabetes. Results showed that experiencing weight stigma in health care, experiencing differential treatment from others because of their diabetes, and engaging in self-stigma for diabetes and body weight were each significantly associated with increased frequency of binge eating and eating as a coping strategy to deal with negative feelings. Internalizing weight stigma was also significantly associated with lower levels of physical activity and worse self-rated health. These findings suggest that initiatives to improve the health and well-being of people with type 2 diabetes must consider the potentially harmful roles of weight stigma and diabetes stigma.

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.

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.

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

Objective: An emerging group of people with type 1 diabetes are building and using their own artificial pancreas systems (APS). Currently, these “user-led,” open-source systems are not endorsed by ...

Background: This prerandomization analysis from the Australian HCL-Adult trial (registration number: ACTRN12617000520336) compared masked continuous glucose monitoring (CGM) metrics among adults using insulin pumps versus multiple daily injections (MDIs), who were all self-monitoring blood glucose (SMBG). Methods: Adults with type 1 diabetes, using an insulin pump or MDIs without real-time CGM (and entering a trial of closed-loop technology), were eligible. MDI users were given an insulin dosage calculator. All participants received diabetes and carbohydrate-counting education, then wore masked CGM sensors for 3 weeks. Ethics Approval: HREC-D 088/16 Results: Adults using MDIs (n = 61) versus pump (n = 59) did not differ by age, sex, diabetes duration, insulin total daily dose, or HbA1c at baseline. After education, median (interquartile range) CGM time in range (TIR) 70-180 mg/dL (3.9-10.0 mmol/L) was 54% (47, 62) for those using MDIs and 56% (48, 66) for those using pump (P = 0.40). All CGM metrics were equivalent for 24 h/day for MDI and pump users. Overnight, those using MDIs (vs. pump) spent more time with glucose

Aim: To examine how hypoglycemia while asleep impacts self-reported daily functioning among adults with type 1 diabetes (T1D) . Methods: On 70 consecutive mornings, 250 people with T1D wearing a continuous glucose monitor reported sleep quality, mood, and alertness via the Hypo-METRICS smartphone app. Each night was categorized based on presence (+) or absence (-) of person-reported hypoglycemia (PRH) and sensor-detected hypoglycemia (SDH) into one of four types (see Figure 1, Type A-D) . Multilevel regression assessed associations between hypoglycemia and daily functioning (unstandardized coefficients (β) on original 0-scale) , adjusted for baseline demographic, clinical and psychological factors. Results: In the first 54 adults (52% women, age[M±SD]: 45±15 years) , nighttime PRH (Type C & D, Figure 1) was associated with reduced subjective sleep quality (C: β=-0.67; D: β=-0.58) , mood (C: β=-0.43; D: β=-0.58) and alertness (C: β=-0.34, p=0.015; D: β=-0.46) (all p0.05) . Conclusion: These novel data show the potentially pivotal role of the subjective experience of hypoglycemia for sleep quality, mood and alertness. Disclosure U.Soeholm: Research Support; Novo Nordisk A/S. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. E.J.Abbink: None. P.M.Baumann: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. D.Pollard: Other Relationship; Novo Nordisk. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. M.M.Broadley: None. C.Hendrieckx: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. N.Zaremba: None. P.Divilly: None. G.Martine-edith: Other Relationship; Novo Nordisk. G.Nefs: None. Z.Mahmoudi: Employee; Novo Nordisk A/S. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. M.Cigler: None. Funding This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement 777460

Background: Use of open-source automated insulin delivery (AID) is associated with improved psychosocial outcomes among people with type 1 diabetes (T1D) . However, research to date has been qualitative or used study-specific single items. There is a need for quantitative research using validated measures in larger samples. Method: We conducted an international online survey to examine the psychosocial outcomes of open-source AID users and non-users. Validated questionnaires assessed diabetes-specific quality of life (QoL) , impact of the COVID-pandemic on diabetes-specific QoL, diabetes specific-positive well-being, diabetes treatment satisfaction, diabetes distress, fear of hypoglycaemia, general emotional well-being, and subjective sleep quality. Results: 587 participants completed at least one questionnaire, including 447 adults using open-source AID (mean age 43, 42% women) and 140 non-users (mean age 40, 64% women) . Table 1 shows significant between-group differences for all questionnaire scores. Discussion: Adults with T1D using open-source AID report significantly better psychosocial outcomes than non-users. Due to the cross-sectional design of this study, we cannot make any causal inferences about the use of these devices. Further research is needed to examine the reasons for these differences. Disclosure J.Schipp: None. T.C.Skinner: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. C.Hendrieckx: None. K.Braune: None. S.O'donnell: None. H.Ballhausen: None. B.Cleal: None. M.Wäldchen: None. C.Knoll: None. K.A.Gajewska: None. Funding European Commission Horizon 2020 (823902)

Acute hypoglycemia impacts negatively on cognitive function. However, it remains unclear which specific domains of cognitive function are affected, and the extent to which level of hypoglycemia modifies this relationship. We conducted a systematic review and meta-analysis to investigate the impact of controlled hyperinsulinaemic hypoglycemia on cognitive function in adults with type 1 diabetes, following PRISMA guidelines. Experimental studies comparing cognitive function task performance during euglycemia and hypoglycemia were eligible for inclusion. Preliminary analyses were conducted on 38 studies, involving 54 cognitive task outcomes across three domains of cognitive function of varying complexity: attention/information processing speed (simplest) , working memory, and complex reasoning (most complex) . Three-level meta-analyses of the standardized mean differences (SMD) in performance during euglycemia and hypoglycemia, moderated by hypoglycemia level (Mdn=2.51; range=1.98-3.5 mmol/l) were conducted for each domain, with study and task as random effects to allow inclusion of multiple effect sizes per study. Hypoglycemia significantly impaired performance on all domains, with large effect sizes for attention/information processing speed (SMD=-1.17, 95% CI:-1.60 to -0.74) and working memory (SMD=-0.84, CI:-1.to -0.63) , and a medium effect size for complex reasoning (SMD=-0.61, CI:-0.99 to -0.23) . The degree of hypoglycemia significantly moderated this relationship for working memory only, such that for every 1mmol/l decrease in glucose level, performance was reduced by SMD=0.84 (CI:0.2 to 1.49) . These findings suggest that the impact of hypoglycemia on cognitive function is related to the cognitive domain complexity, with more impaired performance on simpler relative to more complex tasks. Further, degree of hypoglycemia may be differentially related to performance depending on the domain of cognitive function. Disclosure M.M.Broadley: None. C.Hendrieckx: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. G.Nefs: None. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. C.E.Verhulst: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. The hypo-resolve consortium: n/a. H.Chatwin: None. U.Soeholm: Research Support; Novo Nordisk A/S. J.Axelsen: None. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. B.E.De galan: Research Support; Novo Nordisk. T.W.Fabricius: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)

Objective: To examine whether symptoms of depression or anxiety predict glycaemia and incident diabetes complications four years later, and whether diabetes self-care behaviours mediate these associations, in adults with type 1 diabetes (T1DM). Methods: Data of 205 adults with T1DM from the 2011 and 2015 Diabetes MILES–Australia surveys were analysed. Variables of interest were: baseline depression and anxiety (PHQ-8 and GAD-7, respectively) symptoms; HbA1c and incident complications at four-year follow-up; and self-care behaviours at both time points. Longitudinal associations were analysed using structural equation modelling. Results: Forty-two participants (20.6%) reported incident complications. Baseline depressive symptoms predicted higher HbA1c at follow-up indirectly via less optimal self-care at follow-up (β = 0.19, P = 0.011). Baseline anxiety was not independently associated with HbA1c or self-care at follow-up (P ≥ 0.64). Neither depressive nor anxiety symptoms predicted incident complications, although depressive symptoms were associated with less optimal self-care at baseline (β = -0.67, P < 0.001), and this predicted microvascular complications (β = -0.38, P = 0.044); however, the indirect association via self-care was not significant (β = 0.25, P = 0.067). Limitations: Participants were self-selected; all study variables were assessed using self-report measures; and adjusting for baseline HbA1c was not possible. Conclusions: Depressive symptoms predicted suboptimal self-care behaviour and glycaemic outcome four years later, while anxiety symptoms did not. The findings suggest that tailored diabetes care should take the potential impact of comorbid depression into consideration to help people improve their diabetes self-care and achieve best possible health outcomes.

The aims of this study were to assess cognitions relating to hypoglycaemia in adults with type 1 diabetes and impaired awareness of hypoglycaemia before and after the multimodal HypoCOMPaSS intervention, and to determine cognitive predictors of incomplete response (one or more severe hypoglycaemic episodes over 24 months).This analysis included 91 adults with type 1 diabetes and impaired awareness of hypoglycaemia who completed the Attitudes to Awareness of Hypoglycaemia (A2A) questionnaire before, 24 weeks and 24 months after the intervention, which comprised a short psycho-educational programme with optimisation of insulin therapy and glucose monitoring.The age and diabetes duration of the participants were 48±12 and 29±12 years, respectively (mean±SD). At baseline, 91% reported one or more severe hypoglycaemic episodes over the preceding 12 months; this decreased to20% at 24 weeks and after 24 months (p=0.001). The attitudinal barrier 'hyperglycaemia avoidance prioritised' (ηParticipation in the HypoCOMPaSS RCT was associated with improvements in hypoglycaemia-associated cognitions, with 'hyperglycaemia avoidance prioritised' most prevalent. Incomplete prevention of subsequent severe hypoglycaemia episodes was associated with persistence of the cognition 'asymptomatic hypoglycaemia normalised'. Understanding and addressing cognitive barriers to hypoglycaemia avoidance is important in individuals prone to severe hypoglycaemia episodes.www.isrctn.org : ISRCTN52164803 and https://eudract.ema.europa.eu : EudraCT2009-015396-27.

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.

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

Psychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these barriers. We describe the protocol for a randomised controlled trial (RCT) examining the efficacy of a novel, theoretically grounded, psychoeducational, web-based resource designed to reduce psychological barriers to insulin among adults with non-insulin treated T2D: 'Double-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to 'experience of self-administered injectable; previously enrolled in pilot RCT; 'very willing' to start insulin as baseline. Outcomes will be assessed via online survey at 2 weeks and 6 months. Primary outcome between-group: difference in mean negative Insulin Treatment Appraisal Scores (ITAS negative) at 2-week and 6-month follow-up.between-group differences in mean positive insulin appraisals (ITAS positive) and percentage difference in intention to commence insulin at follow-up time points. All data analyses will be conducted according to the intention-to-treat principle.Deakin University Human Research Ethics Committee (2020-073). Dissemination via peer-reviewed journals, conferences and a plain-language summary.ACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.

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

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

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

Contains fulltext : 286827.pdf (Publisher’s version ) (Open Access) AIM: To conduct a systematic review of published studies reporting on the longitudinal impacts of hypoglycaemia on quality of life (QoL) in adults with type 2 diabetes. METHOD: Database searches with no restrictions by language or date were conducted in MEDLINE, Cochrane Library, CINAHL and PsycINFO. Studies were included for review if they used a longitudinal design (e.g. cohort studies, randomised controlled trials) and reported on the association between hypoglycaemia and changes over time in patient-reported outcomes related to QoL. RESULTS: In all, 20 longitudinal studies published between 1998 and 2020, representing 50,429 adults with type 2 diabetes, were selected for review. A descriptive synthesis following Synthesis Without Meta-analysis guidelines indicated that self-treated symptomatic hypoglycaemia was followed by impairments in daily functioning along with elevated symptoms of generalised anxiety, diabetes distress and fear of hypoglycaemia. Severe hypoglycaemic events were associated with reduced confidence in diabetes self-management and lower ratings of perceived health over time. Frequent hypoglycaemia was followed by reduced energy levels and diminished emotional well-being. There was insufficient evidence, however, to conclude that hypoglycaemia impacted sleep quality, depressive symptoms, general mood, social support or overall diabetes-specific QoL. CONCLUSIONS: Longitudinal evidence in this review suggests hypoglycaemia is a common occurrence among adults with type 2 diabetes that impacts key facets in the physical and psychological domains of QoL. Nonetheless, additional longitudinal research is needed-in particular, studies targeting diverse forms of hypoglycaemia, more varied facets of QoL and outcomes assessed using hypoglycaemia-specific measures.

A response to the ADA/EASD consensus report on the definition of "remission" of type 2 diabetes.

Background: Glucose monitoring is an essential aspect of self-care for people with type 1 diabetes. With technologies developing rapidly, valid assessment of user experiences and satisfaction is needed. Our aim was to develop a novel measure: the Glucose Monitoring Experiences Questionnaire (GME-Q). Methods: Questionnaire design was informed by exploratory and cognitive debriefing interviews. The GME-Q was included in a large online survey enabling psychometric validation. Results: The interview sample included 17 adults (aged [mean ± SD] 46 ± 11 years, 53% women) with type 1 diabetes duration of 26 ± 14 years. The proposed conceptual framework included three domains: "Effectiveness", "Intrusiveness", and "Convenience", assessed with 25 items plus a single, overview item. The validation sample included 589 adults (aged 44 ± 15 years; 64% women) with type 1 diabetes (duration: 22 ± 14 years, self-monitoring blood glucose [SMBG] using finger-prick devices: median [IQR] 6 [4-7] daily checks). Questionnaire acceptability was indicated: 98% (n = 578) completion rate. After deleting 3 redundant items, principal components analysis supported a 22-item questionnaire with 3 domains ("Effectiveness" [9 items]; "Intrusiveness" [6 items]; "Convenience" [7 items]), accounting for 55% of variance, with good internal consistency reliability (α = 0.83-0.88). Subscales correlated significantly (rs = ±0.44-0.66, P

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$3,807 (95% CI: 3,604, 4,007)) 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 three 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.

Contains fulltext : 286868.pdf (Publisher’s version ) (Open Access) OBJECTIVE: Hypoglycaemic episodes and fear of hypoglycaemia can be burdensome for adults with type 1 diabetes. This study explored support needs relating to hypoglycaemia among adults with type 1 diabetes living in Denmark, Germany, the Netherlands and the United Kingdom. RESEARCH DESIGN AND METHODS: Respondents participated in a web-based qualitative study involving four open-ended questions that asked what they wished other people understood about hypoglycaemia and what other people could do differently to support them with hypoglycaemia. Responses were analyzed using reflexive thematic analysis. RESULTS: Participants were 219 adults with type 1 diabetes (mean ± SD age 39 ± 13 years; mean ± SD diabetes duration 20 ± 14 years). They described unmet needs relating to: (1) Clinical support, involving access to new diabetes technologies, training on hypoglycaemia prevention, personalised care and psychological support; (2) Practical support, involving family and friends better supporting them with hypoglycaemia management and prevention; (3) Education for other people, involving others becoming more informed about hypoglycaemia; and (4) An appreciation of the burden, involving others recognizing the experience and impact of episodes, and the burden of living with the risk of hypoglycaemia. CONCLUSIONS: Adults with type 1 diabetes report several unmet support needs relating to hypoglycaemia. Service delivery should be person-centred and prioritise the individual's support needs. Clinical conversations are needed to identify the individual's support needs and develop tailored support plans. People with diabetes and their family members should be offered hypoglycaemia-specific education and training.

To culturally and linguistically adapt the Type 2 Diabetes Stigma Assessment Scale (DSAS-2) into Arabic and assess its psychometric properties.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.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 lt; 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.The Arabic DSAS-2 has excellent reliability and acceptable validity, supporting a three-factor structure as well as the use of a total score.

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

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

Women with prior gestational diabetes have nearly 10 times the risk of developing type 2 diabetes. Postpartum screening for type 2 diabetes is recommended for early diagnosis and management, yet uptake is low. This work updates a previous systematic review and advances it through the application of the Theoretical Domains Framework (TDF) to synthesise personal-level factors impacting type 2 diabetes screening and the Capability, Opportunity, Motivation-Behaviour model (COM-B), to develop messaging recommendations for use in clinical practice and screening promotion interventions.We searched seven academic databases from September 2017 (prior review) to April 2021, reference lists and grey literature. Two reviewers independently screened articles against inclusion criteria (qualitative studies exploring factors impacting postpartum diabetes screening, any language) and extracted data. Using an inductive-deductive model, we coded determinants to the TDF and mapped onto the COM-B model.We identified 38 eligible papers from 34 studies (N = 1291 participants). Most (71%) reported sample sizes of N ≥ 16. The ratio of barriers to enablers was three to one. Eight key TDF domains were identified. Evidence-based recommendations include addressing knowledge, risk perception, fear of diabetes diagnosis, low prioritisation of personal health and fatalism. The risk of bias was low and confidence in findings was moderate to high. A limitation was conceptual overlap between TDF domains, which we addressed via the study procedure.The theoretical categorisation of determinants enables the development of messaging and interventions at the personal level, to promote women's uptake of postpartum type 2 diabetes screening.

Type 1 diabetes is a demanding, complex lifelong condition. Optimal self-care involves repetitive behavioural tasks, undertaken ‘24/7’: administering multiple daily insulin doses, adjusted for food/activity and monitoring glucose levels to avoid hyper- and hypoglycaemia. This requires a comprehensive understanding of diabetes, as well as healthy coping, resilience, problem-solving, and risk reduction skills. It is unsurprising that many experience emotional distress as a consequence of living with type 1 diabetes, which impacts not only on their well-being but also on self-management and outcomes. Clinical guidelines acknowledge that diabetes affects both physical and emotional health. However, the misguided perception persists that the psychosocial care is separate from the diabetes care, and that it requires mental health specialists to assist. A paradigm shift is needed. Diabetes health professionals need to enhance their consultation skills to identify and address psychological needs, if they are to support people to live well with this challenging condition.

Type 2 diabetes is a complex condition requiring attention to blood glucose, blood pressure, cholesterol, and emotional well-being. The overall objective of diabetes self-management is to reduce these risk factors, thereby preventing, delaying, or minimizing risk of long-term complications. Typical strategies include informed dietary choices and physical activity, medication taking and monitoring glucose levels; and, for many, this will also include the challenge of sustaining some weight loss. Substantial advances in medical technologies and treatments in the past 20 years have not been matched with comparable improvements in biomedical outcomes. This chapter highlights five common facets or ‘SHADEs’ of diabetes distress: Scared, Helpless, Alone, Deprived, and Exhausted. As the role of health professionals is not to manage diabetes but rather support people to self-manage their own diabetes, this acronym can be used in clinical practice to identify constructive and creative ways to motivate and sustain effective self-management.

Aim To examine psychosocial and behavioural impacts of the novel coronavirus disease 2019 (COVID‐19) pandemic and lockdown restrictions among adults with type 2 diabetes. Methods Participants enrolled in the PRogrEssion of DIabetic ComplicaTions (PREDICT) cohort study in Melbourne, Australia (n = 489 with a baseline assessment pre‐2020) were invited to complete a phone/online follow‐up assessment in mid‐2020 (i.e., amidst COVID‐19 lockdown restrictions). Repeated assessments that were compared with pre‐COVID‐19 baseline levels included anxiety symptoms (7‐item Generalised Anxiety Disorder scale [GAD‐7]), depressive symptoms (8‐item Patient Health Questionnaire [PHQ‐8]), diabetes distress (Problem Areas in Diabetes scale [PAID]), physical activity/sedentary behaviour, alcohol consumption and diabetes self‐management behaviours. Additional once‐off measures at follow‐up included COVID‐19‐specific worry, quality of life (QoL), and healthcare appointment changes (telehealth engagement and appointment cancellations/avoidance). Results Among 470 respondents (96%; aged 66 ± 9 years, 69% men), at least ‘moderate’ worry about COVID‐19 infection was reported by 31%, and 29%–73% reported negative impacts on QoL dimensions (greatest for: leisure activities, feelings about the future, emotional well‐being). Younger participants reported more negative impacts (p

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

OBJECTIVE Impaired awareness of hypoglycemia (IAH) and recurrent severe hypoglycemia (RSH) remain problematic for people with type 1 diabetes (T1D), despite major therapeutic advances. We explored beliefs around hypo- and hyperglycemia in adults with T1D with, and without, IAH and RSH. RESEARCH DESIGN AND METHODS A cross-sectional U.S. multicenter survey included Attitudes to Awareness of Hypoglycemia (A2A; a 19-item questionnaire concerning beliefs about hypoglycemia), the Gold score (single item: awareness of hypoglycemia), and a question about severe hypoglycemia over the preceding year. The survey was emailed to 6,200 adult participants of the annual T1D Exchange clinic registry data collection. A2A data were subjected to principal component analysis with varimax rotation. RESULTS Among 1,978 respondents (response rate 32%), 61.7% were women, mean ± SD age was 39.6 ± 16.3 years, and T1D duration was 23.1 ± 13.8 years. Thirty-seven percent reported IAH, 16% RSH, and 9% both. A2A items segregated into three factors, differently distributed by hypoglycemia experience. Respondents with IAH or RSH expressed appropriate concern about hypoglycemia, but those with IAH were more likely to prioritize hyperglycemia concerns than those with intact awareness (P = 0.002). Those with RSH showed greater normalization of asymptomatic hypoglycemia than those without (P = 0.019) and trended toward prioritizing hyperglycemia concerns (P = 0.097), driven by those with both IAH and RSH. CONCLUSIONS Adults with T1D with IAH and RSH report specific cognitions about hypoglycemia and hyperglycemia, which may act as barriers to hypoglycemia avoidance and recovery of awareness. These may be modifiable and present a target for enhancing engagement of vulnerable people with strategies to avoid future hypoglycemia.

Aim Hypoglycaemia affects many people with Type 2 diabetes using insulin and other glucose-lowering therapies. This systematic review examined the impact of severe hypoglycaemia (episodes requiring external assistance) on psychological outcomes (e.g. emotional well-being, health status and quality of life) in adults with Type 2 diabetes. Methods MEDLINE Complete, PsycINFO and CINAHL databases were searched for peer-reviewed empirical studies, published in English, reporting the occurrence and severity of hypoglycaemia and its relationship with patient-reported outcomes (PROs) in adults with Type 2 diabetes. Data were extracted from published reports and analysed. Results Of 3756 potentially relevant abstracts, 29 studies met the inclusion criteria. Most reported cross-sectional data and sample sizes varied widely (N = 71 to 17 563). Although definitions of mild and severe hypoglycaemia were largely consistent between studies, additional non-standard categorizations (e.g. moderate, very severe) were apparent and recall periods varied. Overall, severe hypoglycaemia was associated with increased fear of hypoglycaemia and decreased emotional well-being, health status and diabetes-specific quality of life. Effect sizes show that the association with fear of hypoglycaemia was stronger than with general health status. Conclusions Notwithstanding the limitations of the empirical studies, these findings indicate that severe hypoglycaemia in adults with Type 2 diabetes (insulin- and non-insulin-treated) is associated with impaired psychological outcomes. Healthcare professionals should address the psychological impact of severe hypoglycaemia during clinical consultations, to support individuals to minimize exposure to, and the psychological consequences of, severe hypoglycaemia.

Aims: Prospective memory has been long considered a fundamental cognitive ability for optimal medication taking, but the role of prospective memory errors (termed ‘slips’) in diabetes self-care is unclear. Our aim was to examine associations between prospective memory and medication taking in adults with Type 1 and Type 2 diabetes mellitus. Methods: Some 901 adults with Type 1 diabetes and 927 with Type 2 diabetes completed a cross-sectional survey focused on the psychological and behavioural aspects of living with diabetes. Respondents reported whether they had forgotten to take their diabetes medication over the previous 14 days. Results: Twenty-four per cent (n = 220) of adults with Type 1 diabetes and 23% (n = 211) with Type 2 diabetes reported that they had forgotten their medication at least once over the previous 14 days. This was associated with more prospective memory slips in adults with Type 1 diabetes [odds ratio (OR) 1.09, 95% confidence interval (CI) 1.05 to 1.13; P 1c (Type 1 diabetes). Conclusions: These findings suggest that forgetting medication is relatively common among adults with Type 1 or Type 2 diabetes, and provide preliminary evidence for its relationship with self-reported prospective memory slips.

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

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.

Diabetes distress is a common negative emotional response to the ongoing burden of living with diabetes. Elevated diabetes distress is associated with impaired diabetes self-management and quality of life yet rarely identified and addressed in clinical practice. Health professionals report numerous barriers to the provision of care for diabetes distress, including lack of skills and confidence, but few diabetes distress training opportunities exist. The purpose of this paper is to describe how we utilized Intervention Mapping to plan the development, implementation, and evaluation of a novel diabetes distress e-learning program for diabetes educators, to meet a well-documented need and significant gap in diabetes care. A multidisciplinary team (combining expertise in research, health and clinical psychology, diabetes education, nursing, tertiary education, and website architecture) developed a diabetes distress e-learning program. We followed a six-step process (logic model of the problem, program outcomes and objectives, program design, program production, program implementation plan, and evaluation plan) known as Intervention Mapping. The program is underpinned by educational and psychological theory, including Bloom’s Taxonomy of Educational Objectives and social cognitive theory. We developed a short (estimated 4 h) e-learning program for diabetes educators, which draws on the content of the Diabetes and Emotional Health handbook and toolkit. It integrates a 7As model, which provides a stepwise approach to identifying and addressing diabetes distress. Our diabetes distress e-learning program has been developed systematically, guided by an Intervention Mapping approach. In the next phase of the project, we will trial the e-learning.

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

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

© Breanne E Kunstler, John Furler, Elizabeth Holmes-Truscott, Hamish McLachlan, Douglas Boyle, Sean Lo, Jane Speight, David O'Neal, Ralph Audehm, Gary Kilov, Jo-Anne Manski-Nankervis. Originally published in JMIR Formative Research (http://formative.jmir.org), 02.09.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Formative Research, is properly cited. The complete bibliographic information, a link to the original publication on http://formative.jmir.org, as well as this copyright and license information must be included. Background: Managing type 2 diabetes (T2D) requires progressive lifestyle changes and, sometimes, pharmacological treatment intensification. General practitioners (GPs) are integral to this process but can find pharmacological treatment intensification challenging because of the complexity of continually emerging treatment options. Objective: This study aimed to use a co-design method to develop and pretest a clinical decision support (CDS) tool prototype (GlycASSIST) embedded within an electronic medical record, which uses evidence-based guidelines to provide GPs and people with T2D with recommendations for setting glycated hemoglobin (HbA1c) targets and intensifying treatment together in real time in consultations. Methods: The literature on T2D-related CDS tools informed the initial GlycASSIST design. A two-part co-design method was then used. Initial feedback was sought via interviews and focus groups with clinicians (4 GPs, 5 endocrinologists, and 3 diabetes educators) and 6 people with T2D. Following refinements, 8 GPs participated in mock consultations in which they had access to GlycASSIST. Six people with T2D viewed a similar mock consultation. Participants provided feedback on the functionality of GlycASSIST and its role in supporting shared decision making (SDM) and treatment intensification. Results: Clinicians and people with T2D believed that GlycASSIST could support SDM (although this was not always observed in the mock consultations) and individualized treatment intensification. They recommended that GlycASSIST includes less information while maintaining relevance and credibility and using graphs and colors to enhance visual appeal. Maintaining clinical autonomy was important to GPs, as they wanted the capacity to override GlycASSIST's recommendations when appropriate. Clinicians requested easier screen navigation and greater prescribing guidance and capabilities. Conclusions: GlycASSIST was perceived to achieve its purpose of facilitating treatment intensification and was acceptable to people with T2D and GPs. The GlycASSIST prototype is being refined based on these findings to prepare for quantitative evaluation.

Contains fulltext : 235355.pdf (Publisher’s version ) (Closed access) Hypoglycaemia is a common barrier to optimal glycaemic management and often feared among adults with type 1 diabetes. The aim of this systematic review was to summarize current evidence regarding the impact of hypoglycaemia on quality of life (QoL) and related outcomes. Electronic searches of MEDLINE, PsycINFO, CINAHL, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials were conducted. Peer-reviewed empirical studies investigating the relationship between hypoglycaemia and QoL were eligible for inclusion. Thirty studies met the inclusion criteria. Extracted data was summarized in a narrative synthesis according to Synthesis Without Meta-Analysis guidelines. None of the studies examined the impact of hypoglycaemia on general QoL. There was no association between hypoglycaemia and diabetes-specific QoL in four of the 30 studies. Severe hypoglycaemia was associated with greater fear of hypoglycaemia and diabetes distress, and lower general emotional well-being, but not with depression, anxiety, or health status. Self-treated hypoglycaemia was associated with greater fear of hypoglycaemia. With the exception of fear of hypoglycaemia, this review shows mixed associations between hypoglycaemia and psychological outcomes. Further research is needed to investigate the impact of hypoglycaemia on other domains of QoL.

ObjectivesThis 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.DesignA systematic review of published peer-reviewed studies.Data sourcesMedline, Embase, CINAHL Complete, PsycINFO, The Cochrane Library and Cochrane Central Register of Controlled Trials were searched.Eligibility criteriaStudies 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 synthesisUsing Covidence software, screening and risk of bias assessment were conducted by two reviewers independently with any disagreements resolved by a third reviewer.ResultsThe 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.ConclusionStudies 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 numberCRD42020200246.