Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Nondisclosure of Type 1 Diabetes in Adolescence: A Single-Center Experience.

Objective: The aim of this study was to assess the extent of nondisclosure of type 1 diabetes in adolescents and investigate its association with several psychosocial parameters and clinical outcomes. Research design and methods: This was a cross-sectional study based on data collected from 69 adolescents with type 1 diabetes who were 12-18 years of age and followed at our diabetes clinic. The degree of disclosure, demographics, diabetes management, and psychosocial issues were assessed via questionnaires. Clinical parameters were derived from medical records. Associations between nondisclosure status and clinical and psychosocial study variables were assessed. Results: Fifty-three participants (77%) reported some extent of nondisclosure. Nondisclosure was associated with low self-esteem, reduced friend support, and increased diabetes-related worries. Nondisclosure was also found to be associated with diminished self-care behaviors related to insulin administration and with elevated A1C. Conclusion: Our results demonstrate that nondisclosure of type 1 diabetes in adolescents may be more common than initially recognized and is likely associated with unfavorable psychological outcomes and reduced self-care and diabetes management. Our results emphasize the importance of social interactions and disclosure in adolescents and may serve as a potential stepping stone to address other social barriers hindering diabetes management.

Disordered Eating Behaviors Among Adolescents and Young Adults with Type 1 Diabetes Treated with Insulin Pumps and Hybrid Closed-Loop Systems.

Background and Aims: Disordered eating behaviors (DEB) are more common among individuals with type 1 diabetes (T1D) compared to those without, and for insulin pump users may be associated with higher hemoglobin A1c (HbA1c). We investigated DEB risk factors among insulin pump-treated individuals with T1D and clinical characteristics of hybrid closed-loop (HCL) systems' users by DEB level. Methods: An observational, cross-sectional study of 167 insulin pump-treated individuals with T1D, 13-21 years of age. Data were obtained from patients' medical charts with additional self-reported questionnaires, including assessment of DEB. Results: DEB were found in 71 (42.5%) individuals, and positively associated with female sex (ß = 2.98 [standard error (SE) = 1.31], P = 0.025), body mass index (BMI)-Z-score (ß = 2.12 [SE = 0.64], P = 0.001), HbA1c (ß = 1.40 [SE = 0.45], P = 0.02), and higher rate of pump discontinuation (ß = 4.48 [SE = 1.99], P = 0.026). The use of HCL systems compared to insulin pumps was associated with higher BMI-Z-score (odds ratio [OR]: 3.46 [95% confidence interval, CI: 1.52-7.87], P = 0.003) and tendency to lower HbA1c level (OR: 0.44 [95% CI: 0.18-1.09], P = 0.078) among individuals without DEB, and with lower HbA1c level (OR: 0.29 [95% CI: 0.10-0.83], P = 0.022) and higher socioeconomic status (OR: 1.73 [95% CI: 1.09-2.74], P = 0.020) among individuals with DEB. Conclusions: DEB are common among individuals with T1D treated with insulin pumps and are associated with higher HbA1c levels. Among T1D individuals with DEB, HCL system use is associated with lower HbA1c compared to insulin pump treatment. Our findings highlight the importance of regular screening for DEB and its risk factors to improve pump treatment and diabetes management. Moreover, individuals with DEB using HCL systems may benefit from reduced HbA1c levels.

Disordered eating behaviours in adolescents with type 1 diabetes can be influenced by their weight at diagnosis and rapid weight gain subsequently.

AIMS: To assess the prevalence and disease-related risk factors for disordered eating behaviours among adolescents with type 1 diabetes and also to search for risk factors at disease diagnosis that can predict the development of disordered eating behaviours. METHODS: A retrospective observational study of 291 adolescents aged 15-19 years with type 1 diabetes who completed the Diabetes Eating Problem Survey-Revised (DEPS-R) as is routine in our diabetes clinic. The prevalence of disordered eating behaviours and risk factors for their development was assessed. RESULTS: In 84 (28.9%) adolescents, disordered eating behaviours were found. Disordered eating behaviours were positively associated with female sex (ß = 3.01 [SE = 0.97], p = 0.002), higher BMI-Z score (ß = 2.08 [SE = 0.49], p < 0.001), higher HbA1c (ß = 0.19 [SE = 0.03], p < 0.001) and treatment with multiple daily injections of insulin (ß = 2.19 [SE = 1.02], p = 0.032). At type 1 diabetes diagnosis, higher BMI-Z score (ß = 1.54 [SE = 0.63], p = 0.016) for those diagnosed before age 13 years and increased weight gain at 3 months post-diagnosis (ß = 0.88 [SE = 0.25], p = 0.001) in females diagnosed at age 13 years or older were found to be risk factors for disordered eating behaviours. CONCLUSIONS: Disordered eating behaviours are common among adolescents with type 1 diabetes and are associated with various parameters, including BMI at diagnosis and the rate of weight gain at 3 months post-diagnosis in females. Our findings highlight the need for early preventive efforts for disordered eating behaviours and interventions to avoid late diabetes complications.

Fear of hyperglycaemia in parents of children with type 1 diabetes mellitus - A multi-centre multinational study.

AIMS: Study aims: (1) developing and validating a novel questionnaire for measuring fear of hyperglycaemia among parents of children with type 1 diabetes (T1D) - the Hyperglycaemia Fear Survey - Parent version (FoHyper-P); (2) investigating correlations between parental fear of hyperglycaemia and objective measures of glycaemic control. METHODS: A multi-centre, multinational study of 152 parents of children with T1D was conducted in three large diabetes clinics from Israel, Poland, and Greece. Inclusion criteria were parents of children aged 6-16 years, at least 6 months from diagnosis, at least 3 months of CGM use and parental involvement in care. Parents filled the FoHyper-P and the Hypoglycaemia Fear Survey - Parent Version (HFS-P). Patient data were obtained via electronic medical records and informative questionnaires. Bonferroni correction was performed to counteract multiple comparisons. RESULTS: Significant strong-moderate correlations were found between FoHyper-P and HFS-P including total questionnaires scoring (r = 0.747, pBonf < 0.001), worries subscales (r = 0.735, pBonf <0.001), and behaviour subscales (r = 0.532, pBonf <0.001). Using linear regression models, we found a positive association between the worry subscale and HbA1C. Weak correlations (p < 0.05, not significant after Bonferroni correction) were found between time in range, time above range and parental fear of hyperglycaemia as well as between worry subscales and a higher HbA1C in the past year, percent of hyperglycaemia and lower TIR. CONCLUSIONS: The FoHyper-P is a novel, validated tool for assessing parental fear of hyperglycaemia. Integrating it into clinical practice addresses an underestimated aspect of parental diabetes management, enabling better care for children with T1D.

SO(5) Non-Fermi Liquid in a Coulomb Box Device.

Non-Fermi liquid (NFL) physics can be realized in quantum dot devices where competing interactions frustrate the exact screening of dot spin or charge degrees of freedom. We show that a standard nanodevice architecture, involving a dot coupled to both a quantum box and metallic leads, can host an exotic SO(5) symmetry Kondo effect, with entangled dot and box charge and spin. This NFL state is surprisingly robust to breaking channel and spin symmetry, but destabilized by particle-hole asymmetry. By tuning gate voltages, the SO(5) state evolves continuously to a spin and then "flavor" two-channel Kondo state. The expected experimental conductance signatures are highlighted.

Executive Functions and Adherence to Continuous Glucose Monitoring in Children and Adolescents with Type 1 Diabetes.

Background: Continuous glucose monitoring (CGM) has a beneficial impact on diabetes control; however, its utilization within people with diabetes remains low. The success of CGM requires cluster of cognitive skills and executive functions (EF). We speculated that participants with high EF would be more adherent to CGM use. Materials and Methods: The study population included 85 children and adolescents between 5 and 18 years old being followed for type 1 diabetes. Participants and their parents completed three questionnaires-"Behavior Rating Inventory of Executive Function" (BRIEF), CGM satisfaction, and a questionnaire assessing reasons for discontinuing CGM use. Results: Sixty-one participants used CGM on a regular basis and 24 discontinued use. Adherent participants were significantly younger than participants with nonadherence to CGM (P = 0.011). No significant differences were found between gender, diabetes duration, or HbA1c. Females adhering to CGM had a significantly higher "organization of environment" skill than those with nonadherence to CGM (P = 0.023). Also, adherent participants older than 14 years had a higher "organization of environment" skill than participants with nonadherence to CGM (P = 0.032). No difference was found between the groups in other EF domains. Alarm fatigue was found to be the main reason for discontinuing CGM. Conclusions: Given the interplay between CGM adherence and EF, it is recommended that people with diabetes should receive training by a multidisciplinary team, including psychological counseling, before CGM use and thus preparing them to cope with the demands of CGM and to avoid false expectations.

Reduced Worries of Hypoglycaemia, High Satisfaction, and Increased Perceived Ease of Use after Experiencing Four Nights of MD-Logic Artificial Pancreas at Home (DREAM4).

AIMS: This study assesses the impact of using an AP-system at home on fear of hypoglycaemia. In addition, satisfaction and acceptance of the new technology are evaluated. METHODS: In a multicentre, multinational study of 75 patients using the MD-Logic AP during four consecutive nights in home setting 59 of them (aged 10-54 years, 54% male, HbA1c 7.89 ± 0.69% [62.72 ± 7.51 mmol/mol], diabetes duration 11.6 ± 8.4 yrs) answered standardized questionnaires (HFS, adapted TAM, and AP satisfaction) before and after using the AP. RESULTS: After experiencing the AP in home setting worries of hypoglycaemia were significantly reduced (before 1.04 ± 0.53 versus after 0.90 ± 0.63; P = 0.017). Perceived ease of use as a measure of acceptance with the AP significantly increased after personal experience (before 4.64 ± 0.94 versus after 5.06 ± 1.09; P = 0.002). The overall satisfaction mean score after using the AP was 3.02 ± 0.54 (range 0-4), demonstrating a high level of satisfaction with this technology. CONCLUSIONS: The four-night home-based experience of using MD Logic AP was associated with reduced worries of hypoglycaemia, high level of satisfaction, and increased perceived ease of use of the new technology in children, adolescents, and adults.