Towards standardization of person-reported outcomes (PROs) in pediatric diabetes research: A consensus report.

Background: Diabetes ranks among the most common chronic conditions in childhood and adolescence. It is unique among chronic conditions, in that clinical outcomes are intimately tied to how the child or adolescent living with diabetes and their parents or carers react to and implement good clinical practice guidance. It is widely recognized that the individual's perspective about the impact of trying to manage the disease together with the burden of self-management should be addressed to achieve optimal health outcomes.

Coping strategies for managing diabetes distress in adults with type 1 and type 2 diabetes: a cross-sectional study on use and perceived usefulness.

Purpose: The purpose of this study is to identify the use of coping strategies employed by adults with type 1 and type 2 diabetes to manage diabetes distress, using data provided by persons with lived experiences.

Methods: Adults with diabetes completed an anonymous online survey on Diabetes.co.

Effectiveness of the MyDiaMate application in reducing diabetes distress in adults with type 1 diabetes: Study protocol of the multi-national, randomised-controlled MyREMEDY trial.

Aims: Diabetes distress is common among people with type 1 diabetes (T1D), negatively affecting quality of life, self management, and diabetes outcomes. E-health-based interventions could be an effective and low-cost way to improve the psychological care for people with T1D experiencing diabetes distress. The MyREMEDY study aims to test the effectiveness of the online unguided self-help intervention MyDiaMate in decreasing diabetes distress in adults with T1D.

Person-reported outcomes in registered randomised diabetes trials: A mapping review of constructs.

Aim: Recently, efforts have been made to use and report person-reported outcomes (PROs) in randomised clinical trials (RCTs). Here, we aim to (1) assess the status of inclusion of PROs in registered RCTs over 5 years in people with type 1 or 2 diabetes, and (2) map the PRO measures (PROMs) onto predefined domains.

Methods: The largest trial registries (Clinicatrials.

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.

The diabetes body project: Study protocol of a multi-site trial of a virtually delivered eating disorder prevention program for young women with type 1 diabetes.

Aim: Young women with type 1 diabetes are a high-risk population for eating disorders (ED). Prevention programs are lacking. In young women without diabetes, the Body Project has produced reductions in ED risk factors, ED symptoms and future ED onset.

A Self-Guided Web-Based App (MyDiaMate) for Enhancing Mental Health in Adults With Type 1 Diabetes: Insights From a Real-World Study in the Netherlands.

Background: MyDiaMate is a web-based intervention specifically designed for adults with type 1 diabetes (T1D) that aims to help them improve and maintain their mental health. Prior pilot-testing of MyDiaMate verified its acceptability, feasibility, and usability.

Objective: This study aimed to investigate the real-world uptake and usage of MyDiaMate in the Netherlands.

Psychometric properties of the Diabetes Eating Problem Survey-Revised among Dutch adults with type 1 diabetes and implications for clinical use.

Aims: Disordered eating behaviour (DEB) in people with type 1 diabetes (T1D) can be screened with the Diabetes Eating Problem Survey-Revised (DEPS-R). This study aimed to investigate the psychometric properties of the DEPS-R among Dutch adults with T1D and to explore the individual items alongside the standard cut-off score of ≥20 for clinical use.

Methods: The construct validity of the DEPS-R was assessed with an exploratory factor analysis, through principal axis factoring and with Spearman correlations between clinical variables and the DEPS-R.

Bringing an end to diabetes stigma and discrimination: an international consensus statement on evidence and recommendations.

People with diabetes often encounter stigma (ie, negative social judgments, stereotypes, prejudice), which can adversely affect emotional, mental, and physical health; self-care, access to optimal health care; and social and professional opportunities. To accelerate an end to diabetes stigma and discrimination, an international multidisciplinary expert panel (n=51 members, from 18 countries) conducted rapid reviews and participated in a three-round Delphi survey process. We achieved consensus on 25 statements of evidence and 24 statements of recommendations.

The relationship between emotional self-awareness, emotion regulation, and diabetes distress among Italian and Dutch adults with type 1 diabetes.

Objective: Evidence suggests that many adults with type 1 diabetes (T1D) experience clinically relevant levels of diabetes distress, indicating coping difficulties. Studies have primarily focused on emotion regulation as a possible construct to be addressed in psychological interventions to alleviate diabetes distress. This study extends the literature by investigating the cross-sectional association between emotion regulation, diabetes distress and the construct of emotional self-awareness as an additional variable to be considered in potentially reducing diabetes distress.

Glucose variability and mood in people with type 1 diabetes using ecological momentary assessment.

Objective: Mood fluctuations related to blood glucose excursions are a commonly reported source of diabetes-distress, but research is scarce. We aimed to assess the relationship between real-time glucose variability and mood in adults with type 1 diabetes (T1D) using ecological momentary assessments.

Methods: In this prospective observational study, participants wore a masked continuous glucose monitor and received prompts on their smartphone 6 times a day to answer questions about their current mood (Profile Of Mood States (POMS)-SF (dimensions: Anxiety, Depressive symptoms, Anger, Fatigue, Vigor)) for 14 days.

Observing, 'doing' and 'making' gender in Dutch paediatric type 1 diabetes care, at home and in the clinic: Multiple-stakeholder perspectives.

Aim: To investigate the perspectives of Dutch care professionals, parents and experts by experience on gender dynamics in paediatric type 1 diabetes care.

Design: Qualitative research design.

Methods: Fifteen semi-structured interviews were held with care professionals, supplemented by two focus groups with parents of children with diabetes (n = 12 parents) and three semi-structured interviews with two experts by experience and a mother.

Associations between disordered eating behaviour, diabetes distress and emotion regulation strategies in adults with type 1 diabetes: Results from a Dutch-Italian cross-sectional study.

Aims: Disordered eating behaviour (DEB) and diabetes distress are prevalent in adults with type 1 diabetes (T1D). Emotion regulation strategies, such as cognitive reappraisal and expressive suppression, are associated with DEB and managing stress in general. Here we examine the associations between DEB, diabetes distress, and emotion regulation strategies in the context of T1D.

Improved Effectiveness of Immediate Continuous Glucose Monitoring in Hypoglycemia-Prone People with Type 1 Diabetes Compared with Hypoglycemia-Focused Psychoeducation Following a Previous Structured Education: A Randomized Controlled Trial.

Stepped-care has been suggested in the management of patients with problematic hypoglycemia and impaired awareness of hypoglycemia (IAH), initially with psychoeducational programs based on blood glucose awareness training, progressing to diabetes technology in those with persisting need. We examined the clinical effectiveness of stepped-care starting with HypoAware and adding continuous glucose monitoring (CGM) as needed, versus immediate CGM in type 1 diabetes patients with problematic hypoglycemia despite previous structured education in insulin adjustment. A randomized controlled trial ( = 52, mean age 53, 56% females).

The handling of missing data in trial-based economic evaluations: should data be multiply imputed prior to longitudinal linear mixed-model analyses?

Introduction: For the analysis of clinical effects, multiple imputation (MI) of missing data were shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to trial-based economic evaluations. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost and effect data.

A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial.

Background: Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes have been reported. A potential explanation for this inconsistency is a 'one size fits all' approach, with interventions not tailored to the needs and preferences of individuals.

Content Validity of Patient-Reported Outcome Measures Developed for Assessing Health-Related Quality of Life in People with Type 2 Diabetes Mellitus: a Systematic Review.

Purpose Of Review: We aimed to systematically evaluate the content validity of patient-reported outcome measures (PROMs) specifically developed to measure (aspects of) health-related quality of life (HRQOL) in people with type 2 diabetes. A systematic review was performed in PubMed and Embase of PROMs measuring perceived symptoms, physical function, mental function, social function/participation, and general health perceptions, and that were validated to at least some extent. Content validity (relevance, comprehensiveness, and comprehensibility) was evaluated using COSMIN methodology.

The role of mental disorders in precision medicine for diabetes: a narrative review.

This narrative review aims to examine the value of addressing mental disorders as part of the care of people with type 1 and type 2 diabetes in terms of four components of precision medicine. First, we review the empirical literature on the role of common mental disorders in the development and outcomes of diabetes (precision prevention and prognostics). We then review interventions that can address mental disorders in individuals with diabetes or at risk of diabetes (precision treatment) and highlight recent studies that have used novel methods to individualise interventions, in person and through applications, based on mental disorders.

Feasibility and user experience of the unguided web-based self-help app 'MyDiaMate' aimed to prevent and reduce psychological distress and fatigue in adults with diabetes.

Introduction: Psychological distress and fatigue are common in persons with diabetes, adversely affecting quality of life and complicating diabetes self-management. Offering diabetes-specific self-guided cognitive behavioral therapy (CBT) may be helpful for persons with diabetes and mild symptoms of psychological distress and fatigue. We are the first to test the feasibility and user experiences of a web-based self-help app called 'MyDiaMate' in adults with type 1 and type 2 diabetes.

All together: Integrated care for youth with type 1 diabetes.

Objective: We describe the implementation and evaluation of an integrated, stepped care model aimed to identify and address the concerns of adolescents with type 1 diabetes (T1D) associated with diabetes-related quality of life (DRQoL), emotional well-being, and depression.

Research Design And Methods: The care model with 4 steps: (1) Systematic identification and discussion of concerns salient to adolescents; (2) Secondary screening for depressive symptoms when indicated; (3) Developing collaborative treatment plans with joint physical and mental health goals; and (4) Psychiatric assessment and embedded mental health treatment; was implemented into an ambulatory pediatric diabetes clinic and evaluated using quantitative and qualitative methods.

Results: There were 236 adolescents (aged 13-18 years) with T1D that were enrolled in the care model.

Health-related quality of life in parents and partners of people with type 1 diabetes: Development and validation of type 1 diabetes and life (T1DAL) measures.

Introduction: Despite the significant impact of type 1 diabetes (T1D) on family, few instruments are available to assess health-related quality of life (HRQOL) among family members of people with T1D. This study aimed to develop and evaluate the psychometric properties of new measures of diabetes-specific HRQOL for parents and partners of people with T1D. We report on the multistep development and validation process for the self-report Type 1 Diabetes and Life (T1DAL) measures, with versions for parents of youth age <8, 8-11, 12-17, and 18-25 years, and for partners of people age ≥18 years with T1D.