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.

Somatic and mental symptoms associated with dysglycaemia, diabetes-related complications and mental conditions in people with diabetes: Assessments in daily life using continuous glucose monitoring and ecological momentary assessment.

Aim: To analyse the potential drivers (glucose level, complications, diabetes type, gender, age and mental health) of diabetes symptoms using continuous glucose monitoring (CGM) and ecological momentary assessment.

Materials And Methods: Participants used a smartphone application to rate 25 diabetes symptoms in their daily lives over 8 days. These symptoms were grouped into four blocks so that each symptom was rated six times on 2 days (noon, afternoon and evening).

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.

Person-reported outcomes in diabetes care: What are they and why are they so important?

In this review, we aim to show how person-reported outcomes (PROs) and person-reported experiences (PREs) can significantly contribute to the way diabetes care is delivered, the involvement of people with diabetes in diabetes care, and the collaboration between health care professionals and people with diabetes. This review focuses on the definition and measurement of PROs and PREs, the importance of PROs and PREs for person-centred diabetes care, and integrating the perspectives of people with diabetes in the evaluation of medical, psychological and technological interventions. PROs have been increasingly accepted by Health Technology Assessment bodies and are therefore valued in the context of reimbursement decisions and consequently by regulators and other health care stakeholders for the allocation of health care resources.

Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomised controlled trial.

Background: The majority of people with type 2 diabetes who require insulin therapy use only basal insulin in combination with other anti-diabetic agents. We tested whether using a smartphone application to titrate insulin could improve glycaemic control in people with type 2 diabetes who use basal insulin.

Methods: This was a 12-week, multicentre, open-label, parallel, randomised controlled trial conducted in 36 diabetes practices in Germany.

More Frequent Use of Glucose Alarms Is Associated with Continuous Glucose Monitoring-Specific Diabetes Education: Findings from the Dia·Link Diabetes Panel.

The associations of continuous glucose monitoring (CGM)-specific diabetes education with real-world utilization of glucose alerts and alarms were assessed in current CGM-users with type 1 or type 2 diabetes. A cross-sectional online survey was conducted in Germany assessing utilization (use and responses) of different alerts and alarms. Ordinal logistic regression analyses were conducted to analyze associations between utilization and participation in CGM-specific education.

Explaining improvement in diabetes distress: a longitudinal analysis of the predictive relevance of resilience and acceptance in people with type 1 diabetes.

Aims: To analyze if midterm improvement in diabetes distress can be explained by resilience, diabetes acceptance, and patient characteristics.

Methods: N = 179 adults with type 1 diabetes were enrolled during their stay at a tertiary diabetes center (monocentric enrolment) and followed up over three months in a prospective, observational study ('DIA-LINK1'). Improvement in diabetes distress was assessed as reduction in the Problem Areas in Diabetes Scale score from baseline to follow-up.

Assessing attitudes towards insulin pump therapy in adults with type 1 diabetes: Italian validation of the Insulin Pump Attitudes Questionnaire (IT-IPA questionnaire).

Aims: The aim of the study was to adapt the German version of the insulin pump therapy (IPA) questionnaire to Italian (IT-IPA) and to evaluate its psychometric properties in adults with type 1 diabetes.

Methods: We conducted a cross-sectional study, data were collected through an online survey. In addition to IT-IPA, questionnaires evaluating depression, anxiety, diabetes distress, self-efficacy, and treatment satisfaction were administered.

Posttraumatic stress disorder and diabetes-related outcomes in patients with type 1 diabetes.

Mental comorbidities in patients with type 1 diabetes mellitus (T1D) are common, and can have a negative impact on acute blood glucose levels and long-term metabolic control. Information on the association of T1D and comorbid posttraumatic stress disorder (PTSD) with diabetes-related outcomes is limited. The aim was to examine the associations between a clinical diagnosis of PTSD and diabetes-related outcomes in patients with T1D.

An Integrated Psychosomatic Treatment Program for People with Diabetes (psy-PAD).

Background: Many people with diabetes have permanently elevated blood sugar concentrations and a high level of diabetes-related psychological stress, also called "diabetes distress." In clinical practice, diabetes distress is often an impediment to successful self-management. psy-PAD is a psychodynamically oriented short-term therapy program whose goal is to reduce diabetes distress and improve glycemic control.

A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies.

Aims: Measurement tools to evaluate self-management behavior are useful for diabetes research and clinical practice. The Diabetes Self-Management Questionnaire (DSMQ) was introduced in 2013 and has become a widely used tool. This article presents a revised and updated version, DSMQ-R, and evaluates its properties in assessing self-management practices in type 1 diabetes (T1D) and type 2 diabetes (T2D).

The bidirectional longitudinal association between depressive symptoms and HbA : A systematic review and meta-analysis.

Aim: To investigate whether there is a bidirectional longitudinal association of depression with HbA .

Methods: We conducted a systematic literature search in PubMed, PsycINFO, CINAHL and EMBASE for observational, longitudinal studies published from January 2000 to September 2020, assessing the association between depression and HbA in adults. We assessed study quality with the Newcastle-Ottawa-Scale.

Perceived Benefits and Barriers Regarding CSII Treatment: Development and Psychometric Evaluation of the Insulin Pump Attitudes Questionnaire (IPA-Questionnaire).

Background: Continuous subcutaneous insulin infusion is the most advanced and demanding form of insulin therapy. Various positive and negative expectations, attitudes and experiences can occur, influencing adherence to and efficacy of continuous subcutaneous insulin infusion therapy. A new questionnaire was developed to systematically assess perceived benefits, perceived barriers and handling of continuous subcutaneous insulin infusion therapy.

Overestimation of Risk and Increased Fear of Long-term Complications of Diabetes in People with Type 1 and 2 Diabetes.

Objective: The quality report of the disease management programmes of North Rhine Westphalia 2016 showed prevalences for long-term complications (neuropathy, nephropathy, retinopathy) of less than 30% for people with diabetes type 1 (DM1) and type 2 (DM2). The aim of this study was to assess risk expectations and fear regarding long-term complications of diabetes in people with DM1 and DM2.

Methods: We assessed risk expectations and fear regarding diabetes complications in people with DM1 (n=110) and DM2 (n=143 without insulin, n=249 with insulin) visiting an University outpatient department of metabolic diseases.

Subclinical inflammation and depressive symptoms in patients with type 1 and type 2 diabetes.

Depression is a frequent comorbidity of type 1 diabetes (T1D) and type 2 diabetes (T2D). Depression and diabetes are linked by a bidirectional relationship, but the underlying mechanisms are still incompletely understood. Experimental, observational and intervention studies showed that inflammatory processes contribute to the development of depression in animal models and humans.

The Effects and Effect Sizes of Real-Time Continuous Glucose Monitoring on Patient-Reported Outcomes: A Secondary Analysis of the HypoDE Study.

Background: While real-time continuous glucose monitoring (rtCGM) has proven its efficacy for glycemic control and avoidance of hypoglycemia, evidence on its effects on patient-reported outcomes is still inconclusive. This secondary analysis of the HypoDE study analyzed effect sizes of rtCGM on patient-reported outcomes and compared them with the effect sizes for glycemic outcomes.

Materials And Methods: The intervention group using rtCGM (n = 75) and the control group using self-monitored blood glucose measurements (n = 66) in the HypoDE study were compared.

Longitudinal associations between biomarkers of inflammation and changes in depressive symptoms in patients with type 1 and type 2 diabetes.

Background: Depressive disorders represent a frequent comorbidity of type 1 diabetes (T1D) and type 2 diabetes (T2D). Subclinical inflammation increases the risk of depressive symptoms in the general population, but the relationship appears complex and bidirectional, and longitudinal data from patients with diabetes are lacking. Therefore, this study aimed to analyse associations between changes in depressive symptoms and changes in biomarkers of inflammation in patients with T1D and T2D and to investigate the hypothesis that higher baseline levels of biomarkers of inflammation are related to a less pronounced reduction of depressive symptoms over time.

Association between pro- and anti-inflammatory cytokines and depressive symptoms in patients with diabetes-potential differences by diabetes type and depression scores.

Subclinical inflammation has been implicated in the development of depression, a common comorbidity of type 1 diabetes (T1D) and type 2 diabetes (T2D). This study aimed to characterise the relationships between biomarkers of inflammation and depressive symptoms in T1D and T2D. Biomarkers of inflammation were measured in serum of participants with elevated depressive symptoms and T1D (n = 389, mean age 38 years, diabetes duration 15 ± 11 years) or T2D (n = 204, mean age 56 years, diabetes duration 13 ± 8 years).

Measurement of psychological adjustment to diabetes with the diabetes acceptance scale.

Aims: To develop a psychometric measure of diabetes acceptance.

Methods: An item pool was developed and pilot-tested using a sample of 220 people with diabetes; item selection resulted in the 20-item 'Diabetes Acceptance Scale (DAS)'. 606 people with diabetes were then cross-sectionally assessed with the DAS to evaluate its reliability, validity and clinical utility; concurrent measurements included diabetes-related coping (FQCI), diabetes distress (PAID-5), depressive symptoms (PHQ-9), quality of life (EQ-5D), self-management (DSMQ), glycaemic control (HbA) and complications.

Adherence Over Time: The Course of Adherence to Customized Diabetic Insoles as Objectively Assessed by a Temperature Sensor.

Background: Temperature sensors are an objective way to assess adherence to diabetic footwear. Good adherence is essential for the prevention of diabetic foot problems. Little is known about the long-term course of adherence in patients at risk for diabetic foot problems.

Psychometric properties of the Diabetes Self-Management Questionnaire (DSMQ) in Urdu.

Background: Numerous study tools on diabetes self-care have been introduced; however, most existing tools do not show expectable and meaningful correlations with patients' glycaemic control. The Diabetes Self-Management Questionnaire (DSMQ) was designed to appraise self-care activities which can predict glycaemic control outcomes. However, this tool has not been validated in Pakistan.