Hypoglycaemia symptom frequency, severity, burden, and utility among adults with type 1 diabetes and impaired awareness of hypoglycaemia: Baseline and 24-week findings from the HypoCOMPaSS study.

AIMS: To determine the frequency, severity, burden, and utility of hypoglycaemia symptoms among adults with type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) at baseline and week 24 following the HypoCOMPaSS awareness restoration intervention. METHODS: Adults (N = 96) with T1D (duration: 29 ± 12 years; 64% women) and IAH completed the Hypoglycaemia Burden Questionnaire (HypoB-Q), assessing experience of 20 pre-specified hypoglycaemia symptoms, at baseline and week 24. RESULTS: At baseline, 93 (97%) participants experienced at least one symptom (mean ± SD 10.6 ± 4.6 symptoms). The proportion recognising each specific symptom ranged from 15% to 83%. At 24 weeks, symptom severity and burden appear reduced, and utility increased. CONCLUSIONS: Adults with T1D and IAH experience a range of hypoglycaemia symptoms. Perceptions of symptom burden or utility are malleable. Although larger scale studies are needed to confirm, these findings suggest that changing the salience of the symptomatic response may be more important in recovering protection from hypoglycaemia through regained awareness than intensifying symptom frequency or severity.

Associations of clinical, psychological, and sociodemographic characteristics and ecological momentary assessment completion in the 10-week Hypo-METRICS study: Hypoglycaemia MEasurements ThResholds and ImpaCtS.

INTRODUCTION: Reporting of hypoglycaemia and its impact in clinical studies is often retrospective and subject to recall bias. We developed the Hypo-METRICS app to measure the daily physical, psychological, and social impact of hypoglycaemia in adults with type 1 and insulin-treated type 2 diabetes in real-time using ecological momentary assessment (EMA). To help assess its utility, we aimed to determine Hypo-METRICS app completion rates and factors associated with completion. METHODS: Adults with diabetes recruited into the Hypo-METRICS study were given validated patient-reported outcome measures (PROMs) at baseline. Over 10 weeks, they wore a blinded continuous glucose monitor (CGM), and were asked to complete three daily EMAs about hypoglycaemia and aspects of daily functioning, and two weekly sleep and productivity PROMs on the bespoke Hypo-METRICS app. We conducted linear regression to determine factors associated with app engagement, assessed by EMA and PROM completion rates and CGM metrics. RESULTS: In 602 participants (55% men; 54% type 2 diabetes; median(IQR) age 56 (45-66) years; diabetes duration 19 (11-27) years; HbA1c 57 (51-65) mmol/mol), median(IQR) overall app completion rate was 91 (84-96)%, ranging from 90 (81-96)%, 89 (80-94)% and 94(87-97)% for morning, afternoon and evening check-ins, respectively. Older age, routine CGM use, greater time below 3.0 mmol/L, and active sensor time were positively associated with app completion. DISCUSSION: High app completion across all app domains and participant characteristics indicates the Hypo-METRICS app is an acceptable research tool for collecting detailed data on hypoglycaemia frequency and impact in real-time.

The diabetes management experiences questionnaire: Psychometric validation among adults with type 1 diabetes.

AIMS: To examine the psychometric properties of the Diabetes Management Experiences Questionnaire (DME-Q). Adapted from the validated Glucose Monitoring Experiences Questionnaire, the DME-Q captures satisfaction with diabetes management irrespective of treatment modalities. METHODS: The DME-Q was completed by adults with type 1 diabetes as part of a randomized controlled trial comparing hybrid closed loop (HCL) to standard therapy. Most psychometric properties were examined with pre-randomization data (n = 149); responsiveness was examined using baseline and 26-week follow-up data (n = 120). RESULTS: Pre-randomization, participants' mean age was 44 ± 12 years, 52% were women. HbA1c was 61 ± 11 mmol/mol (7.8 ± 1.0%), diabetes duration was 24 ± 12 years and 47% used an insulin pump prior to the trial. A forced three-factor analysis revealed three expected domains, that is, 'Convenience', 'Effectiveness' and 'Intrusiveness', and a forced one-factor solution was also satisfactory. Internal consistency reliability was strong for the three subscales ( α range = 0.74-0.84) and 'Total satisfaction' ( α = 0.85). Convergent validity was demonstrated with moderate correlations between DME-Q 'Total satisfaction' and diabetes distress (PAID: rs = -0.57) and treatment satisfaction (DTSQ; rs = 0.58). Divergent validity was demonstrated with a weak correlation with prospective/retrospective memory (PRMQ: rs = -0.16 and - 0.13 respectively). Responsiveness was demonstrated, as participants randomized to HCL had higher 'Effectiveness' and 'Total satisfaction' scores than those randomized to standard therapy. CONCLUSIONS: The 22-item DME-Q is a brief, acceptable, reliable measure with satisfactory structural and construct validity, which is responsive to intervention. The DME-Q is likely to be useful for evaluation of new pharmaceutical agents and technologies in research and clinical settings.

Changes in attitudes to awareness of hypoglycaemia during a hypoglycaemia awareness restoration programme are associated with avoidance of further severe hypoglycaemia episodes within 24 months: the A2A in HypoCOMPaSS study.

AIMS/HYPOTHESIS: 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). METHODS: 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. RESULTS: 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 to <20% at 24 weeks and after 24 months (p=0.001). The attitudinal barrier 'hyperglycaemia avoidance prioritised' (η2p=0.250, p=0.001) decreased from baseline to 24 weeks, and this decrease was maintained at 24 months (mean±SD=5.3±0.3 vs 4.3±0.3 vs 4.0±0.3). The decrease in 'asymptomatic hypoglycaemia normalised' from baseline (η2p=0.113, p=0.045) was significant at 24 weeks (1.5±0.3 vs 0.8±0.2). Predictors of incomplete hypoglycaemia response (one or more further episodes of severe hypoglycaemia) were higher baseline rates of severe hypoglycaemia, higher baseline scores for 'asymptomatic hypoglycaemia normalised', reduced change in 'asymptomatic hypoglycaemia normalised' scores at 24 weeks, and lower baseline 'hypoglycaemia concern minimised' scores (all p<0.05). CONCLUSIONS/INTERPRETATION: Participation 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. CLINICAL TRIALS REGISTRATION: www.isrctn.org : ISRCTN52164803 and https://eudract.ema.europa.eu : EudraCT2009-015396-27.

Impact of diabetes stigma in diabetes distress and diabetes self-care: The moderating role of diabetes social support and general self-esteem in Arabic-speaking adults with type 2 diabetes.

AIMS: There is increasing evidence that diabetes stigma has negative impacts on behavioural and psychological outcomes among people with type 2 diabetes (T2D). However, research has focused largely on Caucasian and certain Asian groups. The aim of this study was to examine associations of diabetes stigma with diabetes distress and self-care, and investigate the moderating effects of self-esteem and social support, in Arabic-speaking communities. METHODS: A cross-sectional study was conducted at 21 outpatient clinics and diabetes-specialist centres in the United Arab Emirates. Besides the Arabic Type-2 Diabetes Stigma Assessment Scale, participants completed other validated questionnaires assessing distress, self-care, social support, and self-esteem. General linear models were used to estimate the mean difference in diabetes-specific distress and self-care for every 1-point increase in diabetes stigma total score. RESULTS: Among 327 adults with T2D, the mean total score of diabetes stigma was 43.55 ± 13.95. Every 1-point increase in diabetes stigma was associated with significantly increased diabetes distress (ß = 0.113, 95% CI: 0.078 to 0.147; p = 0.003) and decreased self-care behaviours: diet (ß = -0.029, 95% CI: -0.048 to -0.009; p = 0.008), physical activity (ß = -0.022, 95% CI: -0.038 to -0.006; p = 0.013) and foot care (ß = -0.043, 95% CI: -0.059 to -0.026; p < 0.001). Self-esteem mitigated the effect of diabetes stigma on diabetes distress. CONCLUSIONS: Perceived and experienced diabetes stigma was independently associated with increased diabetes distress and decreased engagement in diabetes self-care among Arabic-speaking adults with T2D. These findings are crucial to help clinicians provide more effective assessment and counselling and guide public health interventions to decrease diabetes stigma in these communities.

Effectiveness of educational and behavioural interventions for reducing fear of hypoglycaemia among adults with type 1 diabetes: Systematic review and meta-analyses.

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

'Is Insulin Right for Me?': Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes-A randomised controlled trial.

AIMS: To test 'Is Insulin Right for Me?', a theory-informed, self-directed, web-based intervention designed to reduce psychological barriers to insulin therapy among adults with type 2 diabetes. Further, to examine resource engagement and associations between minimum engagement and outcomes. METHODS: Double-blind, two-arm randomised controlled trial (1:1), comparing the intervention with freely available online information (control). Eligible participants were Australian adults with type 2 diabetes, taking oral diabetes medications, recruited primarily via national diabetes registry. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Data collections were completed online at baseline, 2-week and 6-month follow-up. PRIMARY OUTCOME: negative insulin treatment appraisal scale (ITAS) scores; secondary outcomes: positive ITAS scores and hypothetical willingness to start insulin. ANALYSES: intention-to-treat (ITT); per-protocol (PP) examination of outcomes by engagement. TRIAL REGISTRATION: ACTRN12621000191897. RESULTS: No significant ITT between-arm (intervention: n = 233; control: n = 243) differences were observed in primary (2 weeks: Mdiff [95% CI]: -1.0 [-2.9 to 0.9]; 6 months: -0.01 [-1.9 to 1.9]), or secondary outcomes at either follow-up. There was evidence of lower Negative ITAS scores at 2-week, but not 6-month, follow-up among those with minimum intervention engagement (achieved by 44%) compared to no engagement (-2.7 [-5.1 to -0.3]). CONCLUSIONS: Compared to existing information, 'Is insulin right for me?' did not improve outcomes at either timepoint. Small intervention engagement effects suggest it has potential. Further research is warranted to examine whether effectiveness would be greater in a clinical setting, following timely referral among those for whom insulin is clinically indicated.

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

BACKGROUND: Assessment of patient-reported outcome measures (PROMs), including quality of life (QoL), is essential in diabetes research and care. However, a recent review concluded that current hypoglycaemia-specific PROMs have limited evidence of validity, reliability and responsiveness for assessing the impact of hypoglycaemia on QoL in people living with diabetes. None of the PROMs identified could be used directly to inform the cost-effectiveness of treatments and interventions. There is a need for a new hypoglycaemia-specific QoL PROM, which can be used directly to inform economic evaluations. AIMS: This project has three aims: (a) To develop draft PROM content for measuring the impact of hypoglycaemia on QoL in adults with diabetes. (b) To refine the draft content using cognitive debriefing interviews and psychometrics. This will result in a condition-specific PROM that can be used to quantify the impact of hypoglycaemia upon QoL. (c) To generate a preference-based measure (PBM) that will enable utility values to be calculated for economic evaluation. METHODS: A mixed-methods, three-stage design is used: (a) Qualitative interviews will inform the draft PROM content. (b) Cognitive debriefing interview data will be used to refine the draft PROM content. The PROM will be administered in a large-scale survey to enable psychometric validation. Final item selection for the PROM will be informed by psychometric performance, translatability assessment and input from stakeholder groups. (c) A classification system will be generated, comprising a reduced number of items from the PROM. A valuation survey will be conducted to derive a value set for the PBM.

Impact of glycaemic technologies on quality of life and related outcomes in adults with type 1 diabetes: A narrative review.

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

Validation of Igls Criteria for Islet Transplant Functional Status Using Person-Reported Outcome Measures in a Cross-Sectional Study.

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.

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

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

'I need someone to believe in me and walk the journey with me': A qualitative analysis of preferred approaches to weight management discussions in clinical care among adults with type 2 diabetes.

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

'We're all on the same team'. Perspectives on the future of artificial pancreas systems by adults in Australia with type 1 diabetes using open-source technologies: A qualitative study.

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

'Is insulin right for me?': Feasibility of a pilot randomised controlled trial and acceptability of a web-based intervention to reduce psychological barriers to insulin therapy among adults with type 2 diabetes.

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

Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: A systematic review of longitudinal studies.

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.

Unmet support needs relating to hypoglycaemia among adults with type 1 diabetes: Results of a multi-country web-based qualitative study.

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.

'For me, it didn't seem as drastic a step as being controlled by insulin': A qualitative investigation of expectations and experiences of non-insulin injectable therapy among adults with type 2 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.

Barriers to and enablers of type 2 diabetes screening among women with prior gestational diabetes: A systematic review update and qualitative synthesis applying the Theoretical Domains Framework.

AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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

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

Barriers to and enablers of postpartum health behaviours among women from diverse cultural backgrounds with prior gestational diabetes: A systematic review and qualitative synthesis applying the theoretical domains framework.

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