Protocol for the Australian Type 1 Diabetes National Screening Pilot: Assessing the feasibility and acceptability of three general population screening models in children.

AIM: One third of Australian children diagnosed with type 1 diabetes present with life-threatening diabetic ketoacidosis (DKA) at diagnosis. Screening for early-stage, presymptomatic type 1 diabetes, with ongoing follow-up, can substantially reduce this risk (<5% risk). Several screening models are being trialled internationally, without consensus on the optimal approach. This pilot study aims to assess three models for a routine, population-wide screening programme in Australia. METHODS: An implementation science-guided pilot study to evaluate the feasibility, acceptability and costs of three screening models in children will be conducted between July 2022 and June 2024. These models are as follows: (1) Genetic risk-stratified screening using newborn heel prick dried bloodspots, followed by autoantibody testing from 11 months of age; (2) genetic risk-stratified screening of infant (6-12 months) saliva followed by autoantibody testing from 10 months of age; and (3) autoantibody screening using capillary dried bloodspots collected from children aged 2, 6 or 10 years. Cohorts for each model will be recruited from targeted geographic areas across Australia involving ≥2 states per cohort, with a recruitment target of up to 3000 children per cohort (total up to 9000 children). The primary outcome is screening uptake for each cohort. Secondary outcomes include programme feasibility, costs, parental anxiety, risk perception, satisfaction, well-being and quality of life, and health professional attitudes and satisfaction. CONCLUSIONS: This pilot is the first direct comparison of three screening implementation models for general population screening. Findings will provide evidence to inform a potential national screening programme for Australian children. TRIAL REGISTRATION: ACTRN12622000381785.

The impact of hypoglycaemia on daily functioning among adults with diabetes: a prospective observational study using the Hypo-METRICS app.

AIMS/HYPOTHESIS: The aim of this work was to examine the impact of hypoglycaemia on daily functioning among adults with type 1 diabetes or insulin-treated type 2 diabetes, using the novel Hypo-METRICS app. METHODS: For 70 consecutive days, 594 adults (type 1 diabetes, n=274; type 2 diabetes, n=320) completed brief morning and evening Hypo-METRICS 'check-ins' about their experienced hypoglycaemia and daily functioning. Participants wore a blinded glucose sensor (i.e. data unavailable to the participants) for the study duration. Days and nights with or without person-reported hypoglycaemia (PRH) and/or sensor-detected hypoglycaemia (SDH) were compared using multilevel regression models. RESULTS: Participants submitted a mean ± SD of 86.3±12.5% morning and 90.8±10.7% evening check-ins. For both types of diabetes, SDH alone had no significant associations with the changes in daily functioning scores. However, daytime and night-time PRH (with or without SDH) were significantly associated with worsening of energy levels, mood, cognitive functioning, negative affect and fear of hypoglycaemia later that day or while asleep. In addition, night-time PRH (with or without SDH) was significantly associated with worsening of sleep quality (type 1 and type 2 diabetes) and memory (type 2 diabetes). Further, daytime PRH (with or without SDH), was associated with worsening of fear of hyperglycaemia while asleep (type 1 diabetes), memory (type 1 and type 2 diabetes) and social functioning (type 2 diabetes). CONCLUSIONS/INTERPRETATION: This prospective, real-world study reveals impact on several domains of daily functioning following PRH but not following SDH alone. These data suggest that the observed negative impact is mainly driven by subjective awareness of hypoglycaemia (i.e. PRH), through either symptoms or sensor alerts/readings and/or the need to take action to prevent or treat episodes.

Perceived comfort with weight, body shape and eating pattern of young adults with type 1 diabetes and associations with clinical and psychological parameters in a clinical setting.

BACKGROUND: Higher prevalence of disordered eating in young adults with type 1 diabetes (T1D) culminates in higher levels of morbidity and mortality. In addition to validated questionnaires for diabetes distress, depression/anxiety symptoms and emotional well-being, the Diabetes Psychosocial Assessment Tool (DPAT) includes three questions about comfort with weight, body shape and eating pattern (WSE), which were derived from literature and multidisciplinary team consensus. Recognising individuals with low comfort with WSE, is the first step towards identifying those who may be at risk of developing eating disorders. AIMS: Observe comfort with WSE, in young adults with T1D, and its associations with demographic/clinical characteristics and psychological parameters. METHODS: 276 young adults, aged 15-26, who attended routine clinical care at a Young Adult Diabetes Clinic, completed the DPAT. The WSE questions were scored on a 5-point Likert scale (1 indicating lowest comfort). Linear regression analysed differences in comfort with weight and eating pattern by demographic and psychological parameters. RESULTS: 1 in 3 young adults (29%) reported low comfort with WSE (scores 1 or 2). In females, 40%, 41% and 35% had low comfort with weight, shape and eating patterns respectively, in comparison to males in whom it was 18.5%, 16% and 21.5%. Females reported lower comfort with weight and eating pattern (mean 2.9 and 3.0 respectively) than Males (mean 3.7 and 3.6 respectively), each p < 0.001. Lower comfort with weight (p < 0.001) and eating pattern (p = 0.001) was associated with higher body mass index (BMI). Young adults with low comfort with weight and eating pattern experienced elevated diabetes distress and depressive/anxiety symptoms (each p < 0.001), also when adjusted for sex and BMI. CONCLUSIONS: The study has shown that low comfort with WSE is common among young adults with T1D. Adding these questions into routine care, can allow for easy and early identification of low comfort, initiation of a therapeutic dialogue and implementation of focused management strategies.

There is a higher rate of disordered eating (DE) in young adults with type 1 diabetes (T1D) compared to their peers without diabetes. DE occurs on a spectrum from mildly distorted thoughts and behaviours regarding weight, shape and eating to thoughts and behaviours with medical and mental health consequences that do not meet formal diagnostic criteria for an eating disorder. Early screening for DE in T1D is not routinely performed and therefore often remains undetected. Due to the seriousness of the conditions, identification is key. The Diabetes Psychosocial Assessment Tool was developed to annually assess psychosocial well-being of young adults (≥ 16 years) with T1D and includes three questions about comfort with weight, shape and eating pattern (WSE). 1 in 3 young adults with T1D reported low comfort with WSE. Lower comfort with weight and eating pattern was associated with females and with higher body mass index. There was a strong relationship between low comfort with weight and eating pattern and diabetes distress and depressive/anxiety symptoms, after adjusting for sex and body mass index. Hence, inclusion of the WSE questions is valuable for early identification of young adults with T1D who may be at risk for an eating disorder.

Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes.

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programs are being increasingly emphasized. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk for (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in nonspecialized settings. To inform this monitoring, JDRF, in conjunction with international experts and societies, developed consensus guidance. Broad advice from this guidance includes the following: 1) partnerships should be fostered between endocrinologists and primary care providers to care for people who are IAb+; 2) when people who are IAb+ are initially identified, there is a need for confirmation using a second sample; 3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; 4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; 5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and 6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasizes significant unmet needs for further research on early-stage type 1 diabetes to increase the rigor of future recommendations and inform clinical care.

Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes.

Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programmes are being increasingly emphasised. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk of (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in non-specialised settings. To inform this monitoring, JDRF in conjunction with international experts and societies developed consensus guidance. Broad advice from this guidance includes the following: (1) partnerships should be fostered between endocrinologists and primary-care providers to care for people who are IAb+; (2) when people who are IAb+ are initially identified there is a need for confirmation using a second sample; (3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; (4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; (5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and (6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasises significant unmet needs for further research on early-stage type 1 diabetes to increase the rigour of future recommendations and inform clinical care.

Hybrid Closed Loop in Adults With Type 1 Diabetes and Severely Impaired Hypoglycemia Awareness.

BACKGROUND: Benefits of hybrid closed-loop (HCL) systems in a high-risk group with type 1 diabetes and impaired awareness of hypoglycemia (IAH) have not been well-explored. METHODS: Adults with Edmonton HYPO scores ≥1047 were randomized to 26-weeks HCL (MiniMed™ 670G) vs standard therapy (multiple daily injections or insulin pump) without continuous glucose monitoring (CGM) (control). Primary outcome was percentage CGM time-in-range (TIR; 70-180 mg/dL) at 23 to 26 weeks post-randomization. Major secondary endpoints included magnitude of change in counter-regulatory hormones and autonomic symptom responses to hypoglycemia at 26-weeks post-randomization. A post hoc analysis evaluated glycemia risk index (GRI) comparing HCL with control groups at 26 weeks post-randomization. RESULTS: Nine participants (median [interquartile range (IQR)] age 51 [41, 59] years; 44% male; enrolment HYPO score 1183 [1058, 1308]; Clarke score 6 [6, 6]; n = 5 [HCL]; n = 4 [control]) completed the study. Time-in-range was higher using HCL vs control (70% [68, 74%] vs 48% [44, 50%], P = .014). Time <70 mg/dL did not differ (HCL 3.8% [2.7, 3.9] vs control 6.5% [4.3, 8.6], P = .14) although hypoglycemia episode duration was shorter (30 vs 50 minutes, P < .001) with HCL. Glycemia risk index was lower with HCL vs control (38.1 [30.0, 39.2] vs 70.8 [58.5, 72.4], P = .014). Following 6 months of HCL use, greater dopamine (24.0 [12.3, 27.6] vs -18.5 [-36.5, -4.8], P = .014), and growth hormone (6.3 [4.6, 16.8] vs 0.5 [-0.8, 3.0], P = .050) responses to hypoglycemia were observed. CONCLUSIONS: Six months of HCL use in high-risk adults with severe IAH increased glucose TIR and improved GRI without increased hypoglycemia, and partially restored counter-regulatory responses. CLINICAL TRIAL REGISTRATION: ACTRN12617000520336.

Diabetes Research Matters: A Three-Round Priority-Setting Survey Consultation with Adults Living with Diabetes and Family Members in Australia.

OBJECTIVE: We aimed to identify the health and quality-of-life research priorities of Australians with diabetes or family members. METHODS: Through an iterative, three-step, online survey process we (1) qualitatively generated research topics (long list) in response to one question "What research is needed to support people with diabetes to live a better life?"; (2) determined the most important research questions (short list); and (3) ranked research questions in order of importance (priorities). We aimed to recruit N = 800 participants, with approximate equal representation of diabetes type and family members. RESULTS: Participants (N = 661) were adults (aged 18+ years) in Australia with a self-reporting diagnosis of diabetes (type 1, n = 302; type 2, n = 204; prior/current gestational, n = 58; less common types, n = 22, or a family member, n = 75). Retention rates for Surveys 2 and 3 were 47% (n = 295) and 50% (n = 316), respectively. From 1549 open-text responses, 25 topics and 125 research questions were identified thematically. Research priorities differed by cohort, resulting in specific lists developed and ranked by each cohort. The top-ranked research question for the type 1 diabetes cohort was "How can diabetes technology be improved …?" and for the type 2 diabetes cohort: "How can insulin resistance be reversed …?". One question was common to the final lists of all cohorts: "What are the causes or triggers of diabetes?" Within cohorts, the top priorities were perceived as being of similar importance. CONCLUSIONS: The research priorities differ substantially by diabetes type and for family members. These findings should inform funding bodies and researchers, to align future research and its communication with community needs.

Roles and competencies of the clinical psychologist in adult diabetes care-A consensus report.

AIMS: Psychological care is recognised as an integral part of quality diabetes care. We set out to describe the roles and competencies of the clinical psychologist as a member of the multidisciplinary adult diabetes care team, focused on secondary care. METHODS: The authors are clinically experienced psychologists involved in adult diabetes care, from Australia, Europe and North America, and active members of the international psychosocial aspects of diabetes study group. Consensus was reached as a group on the roles and competencies of the clinical psychologist working in adult diabetes secondary care, building both on expert opinion and a selective review and discussion of the literature on psychological care in diabetes, clinical guidelines and competency frameworks. RESULTS: The clinical psychologist fulfils multiple roles: (1) as a clinician (psychological assessment and therapy), (2) as advisor to the healthcare team (training, consulting), (3) as a communicator and promotor of person-centred care initiatives and (4) as a researcher. Four competencies that are key to successfully fulfilling the above-mentioned roles in a diabetes setting are as follows: (a) specialised knowledge, (b) teamwork and advice, (c) assessment, (d) psychotherapy (referred to as STAP framework). CONCLUSIONS: The roles and competencies of clinical psychologists working in diabetes extend beyond the requirements of most university and post-graduate curricula. There is a need for a comprehensive, accredited specialist post-graduate training for clinical psychologists working in diabetes care, building on the proposed STAP framework. This calls for a collaborative effort involving diabetes organisations, clinical psychology societies and diabetes psychology interest groups.

Psychological Distress Among Parents of Children With Chronic Health Conditions and Its Association With Unmet Supportive Care Needs and Children's Quality of Life.

OBJECTIVE: To assess parent psychological distress in families of children with common chronic health conditions (CHC) and to explore relationships between parent psychological distress, unmet supportive care needs and children's quality of life (QoL). METHOD: Cross-sectional study involving parents of children diagnosed with a common CHC between 0 and 12 years of age and who had received treatment within the last 5 years. Eligible parents completed an online survey, that included the Depression Anxiety Stress Scale (DASS-21) assessing distress in parents and a 34-item assessment of unmet supportive care needs across 6 domains. Parents completed ratings of their child's current functioning (QoL) using the 23-item PedsQL. Multivariable regression models examined the relative association between unmet needs, children's QoL and parents' depression, anxiety, and stress. RESULTS: The sample consisted of 194 parents of children with congenital heart disease (n=97; 50%), diabetes (n=50; 26%), cancer (n=39; 20%), and asthma (n=8; 4%). A significant proportion of parents had moderate-severe symptoms of depression (26%), anxiety (38%), and stress (40%). Of the PedsQL scales, the poorest outcomes were found for emotional and school functioning. Multivariable analyses showed that both higher unmet needs and poorer child emotional functioning were associated with parent depression, anxiety, and stress symptoms. CONCLUSION: Evidence linking parent distress symptoms to higher unmet needs and poorer child emotional functioning suggests these factors may be targets for interventions to alleviate parent distress. Longitudinal research using larger samples is required to replicate findings, and clarify the magnitude and direction of associations.

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.

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.

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.

Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App: Survey and Interview Study.

BACKGROUND: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. OBJECTIVE: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. METHODS: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. RESULTS: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. CONCLUSIONS: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual's daily functioning. Despite suggested improvements, participants' responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact.

Feasibility and acceptability of 'low-intensity mental health support via a telehealth-enabled network' for adults with type 1 and type 2 diabetes: the LISTEN pilot study.

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

Unmet supportive care needs of families of children with chronic illness: A systematic review.

BACKGROUND AND AIMS: Unmet supportive care needs (SCN) refer to perceived gaps in the support parents want to manage caregiving activities for children with chronic health conditions (CHC) and the support received. This review aims to systematically identify the unmet SCN of families with children living with five common paediatric CHC and characterise the assessment tools used to measure SCN. DESIGN: Systematic review methodology with narrative synthesis of data. Reporting followed the PRISMA statement guidelines. METHOD: Literature searches were conducted in electronic databases Medline complete, PsycINFO, CINHAL and EMBASE to retrieve relevant articles published between 1990 and July 2022. Eligible studies involved (i) children aged 0-18 years diagnosed with either of cancer, congenital heart disease (CHD), diabetes, asthma, renal disease and (ii) assessment of unmet SCN. Studies involving children with genetic or developmental conditions were excluded. The methodological quality of studies was assessed using JBI assessment tool. RESULTS: Of 6223 articles screened, 34 papers were included (25 quantitative, 5 qualitative and 4 mixed design). Most papers explored unmet needs of families with cancer (n = 26). The remaining articles concerned CHD (n = 5), asthma (n = 2) and mixed CHC (n = 1, renal failure, and diabetes). Information (e.g. treatment, lifestyle, etc.) and health care (e.g. emotional support, practical services, etc.) were the most common unmet need domains across health conditions. A variety of methods and need assessments hampered comparisons between studies both across and within CHC. CONCLUSION: Irrespective of illness, addressing unmet informational or health care needs may help to optimise outcomes and care for children and families living with common CHC. There was considerable variation in reporting styles, study design and need assessments both within and across conditions. RELEVANCE TO CLINICAL PRACTICE: Health care professionals must routinely evaluate the type, quality and quantity of psychoeducation and support that families of children with CHC want and receive. Providing nurses with more effective strategies to assess child and family needs across a broad range of domains may help to increase understanding of where further support for families is required. PATIENT OR PUBLIC CONTRIBUTION: There was no patient or public contribution to this study as it involved a systematic review of existing literature.

Unmet supportive care needs in families of children with chronic health conditions: an Australian cross-sectional study.

BACKGROUND: The aim of this study was to identify similarities and differences in the unmet supportive care needs (USCN) of families of children with major chronic health conditions (CHCs) using a universal need assessment tool. METHODS: A cross-sectional online survey involving parents of children with congenital heart disease (CHD), type 1 diabetes mellitus (T1D), cancer, and asthma diagnosed within the last 5 years recruited via social media and support organizations. Thirty-four items assessing the USCN across six domains (care needs, physical and social needs, informational needs, support needs, financial needs, child-related emotional needs) were responded to on a 4-point Likert scale [no need (1) to high need (4)]. Descriptive statistics identified the level of need, and linear regressions identified factors associated with higher need domain scores. Due to small numbers, the asthma group was excluded from comparisons across CHCs. RESULTS: One hundred and ninety-four parents completed the survey (CHD: n = 97, T1D: n = 50, cancer: n = 39, and asthma: n = 8). Parents of children with cancer were most likely to report at least one USCN (92%), followed by parents of children with T1D (62%). The five most commonly reported USCN across CHCs were drawn from four domains: child-related emotional, support, care, and financial. Three need items were included in the top five needs for all conditions. A higher USCN was associated with a greater frequency of hospital visits and the absence of parental support. CONCLUSIONS: Using a universal need assessment tool, this is one of the first studies to characterize USCN in families of children diagnosed with common CHCs. While proportions endorsing different needs varied across conditions, the most endorsed needs were similar across the illness groups. This suggests that support programs or services could be shared across different CHCs. Video Abstract.

Emotional well-being and HbA1c following the implementation of the Diabetes Psychosocial Assessment Tool (DPAT) in young adults with type 1 diabetes (T1DM): An observational study.

AIMS: This observational study evaluated the implementation of the Diabetes Psychosocial Assessment Tool (DPAT), assessing emotional well-being of young adults with type 1 diabetes (T1DM) and the clinical congruency between DPAT-recommended and specialist-led referrals. METHODS: Young adults with T1DM attending the clinic completed the DPAT on two occasions. The DPAT includes the PAID (diabetes distress), PHQ-4 (depression/anxiety) and WHO-5 (general well-being), a diabetes health audit and a referral pathway to (allied) health professionals. Demographic and clinical information was retrieved from medical records. Data was analyzed using descriptive statistics and generalized estimating equations. RESULTS: 115 people with T1DM, aged 16-25 years, were included in the analysis. Symptoms of moderate-severe diabetes distress were present in 29 (25%) participants, symptoms of depression/anxiety and impaired well-being in 21 (19%) and 26 (23%) participants, respectively. The odds of depression/anxiety symptoms was lower at the second timepoint compared to the first timepoint (OR 0.55, 95% CI 0.32-0.96, p = 0.03). The odds of moderate-severe diabetes distress tended to be lower. No change was observed in general well-being or HbA1c. There was moderate concordance between DPAT and clinician referrals to psychologists (81%) and dieticians (70%). CONCLUSIONS: Using the DPAT facilitates the conversation about emotional well-being during routine consultation and follow-up.

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

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

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app.

INTRODUCTION: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes. MATERIALS AND METHODS: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity. RESULTS: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales. CONCLUSION: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

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

Introduction: Women 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 methods: Semi-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. Results: Nineteen 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. Conclusions: This 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. .