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.

Using person reported outcomes: Psychometric properties of the German diabetes treatment satisfaction questionnaire (DTSQ) for teens and parents.

Aims: To examine psychometric properties including the factor structure of the German versions of the Diabetes Treatment Satisfaction Questionnaire for teens and parents (DTSQ-T/-P). Methods: Linguistically validated questionnaires were completed by 363 adolescents with type 1 diabetes and 655 parent-caregivers in a multicenter study. Confirmatory factor analysis (CFA), reliability, and correlations were examined. Results: CFA confirmed the 2-factor model of treatment satisfaction (TS) & perceived diabetes control (PDC) with an adjustment of removing the "medical support" item from the TS and examining it as a single item in this study. Cronbach's α of TS for DTSQ-T/-P was 0.82 & 0.83, respectively, and α of the two-item PDC factor was 0.70 & 0.60, respectively. The DTSQ scale scores positively correlated with time in range and inversely correlated with HbA1c. Scale scores of DTSQ-T/-P showed significantly positive relations to the KIDSCREEN-10 Index and negative associations with the Problem Areas in Diabetes (PAID). The TS of the parents was correlated with depressive symptoms measured in the Patient Health Questionnaire-9. Conclusions: The DTSQ-T/-P produced psychometrically sound scores in measuring diabetes treatment satisfaction in German teens with type 1 diabetes and their parents. German DTSQ versions for teens and parents are recommended in research and clinical practice.

Health-related quality of life among adolescents with type 1 diabetes since the second wave of the COVID-19 pandemic in Germany.

OBJECTIVE: The COVID-19 pandemic had an impact on everyday life and in general, reduced the health-related quality of life (HRQoL) of adolescents. In this study, we assess the HRQoL of adolescents with type 1 diabetes (T1D) in Germany since the second wave of the COVID-19 pandemic by using self-report and parent-proxy reports, to identify risk factors, to compare to peers and to examine the agreement of HRQoL between parents and their children. METHODS: A total of 445 adolescents (12-18 years) and 413 parents participated in an anonymous cross-sectional survey conducted at three German diabetes centres from January 2021 to June 2022. Inclusion criteria were diabetes duration ≥1 year and German-speaking. Teen HRQoL was assessed by using self-report and parent-proxy report versions of the KIDSCREEN-10 index. RESULTS: The majority of adolescents reported average (75.5%) HRQoL. Approximately 11.3% of teens reported high and 13.2% low HRQoL. Teen's female gender, older age, higher diabetes burden and parental depression symptoms contributed to lower self-reported HRQoL among teens. For parent-proxy reports, increasing diabetes burdens, parental depression symptoms, non-migrant status, high education and ketoacidosis contributed to lower scores on teen HRQoL. The mean scores of the KIDSCREEN-10 index for adolescents did not differ from the German norm. In comparison to healthy peers during the first wave of the pandemic, adolescents in the current study reported higher HRQoL. The overall teen-parent agreement was fair although parents reported significantly lower teen HRQoL than adolescents did. CONCLUSIONS: HRQoL of most adolescents with T1D during the COVID-19 pandemic was average with parents reporting significantly lower scores. Self-reported and parent-proxy-reported HRQoL and the level of agreement due to different perspectives can provide important information for clinical care and intervention planning.

Socioeconomic inequalities in type 2 diabetes comorbidities in different population subgroups: trend analyses using German health insurance data.

While socioeconomic inequalities in the prevalence and management of type 2 diabetes (T2D) are well established, little is known about whether inequalities exist in the prevalence and the temporal development of T2D comorbidities. Previous research points towards expansion of morbidity in T2D as depicted mainly by a rising trend of T2D comorbidities. Against this background, and using German claims data, this study aims to examine whether socioeconomic status (SES) inequalities exist in the rates and the temporal development of T2D comorbidities. Since previous research indicates varying risk levels for T2D prevalence in the population subgroups: working individuals, nonworking spouses and pensioners, the analyses are stratified by these three population subgroups. The study is done on a large population of statutory insured individuals with T2D in three time-periods between 2005 and 2017. Predicted probabilities of three comorbidity groups and the number of comorbidities were estimated using logistic and ordinal regression analyses among different income, education and occupation groups. Interaction analyses were applied to examine whether potential SES inequalities changed over time. The study showed that neither the cross-sectional existence, nor the temporal development of T2D comorbidities differed significantly among SES groups, ruling out SES inequalities in the prevalence and the temporal development of T2D comorbidities in Germany. In men and women of all examined population subgroups, predicted probabilities for less severe cardiovascular (CVD) comorbidities, other vascular diseases and the number of comorbidities per individual rose significantly over time regardless of SES, but little if any change took place for more severe CVD comorbidities. Another important finding is that the population subgroup of nonworking spouses had markedly higher predicted probabilities for most of the examined outcomes compared to working individuals. The study indicates that the expansion of morbidity in T2D in Germany does not appear to be SES-dependent, and applies equally to different population subgroups. Yet, the study highlights that nonworking spouses are a susceptible population subgroup that needs to be focused upon when planning and implementing T2D management interventions.

Alterations in Dietary Behavior, Appetite Regulation, and Health-Related Quality of Life in Youth with Obesity in Germany during the COVID-19 Pandemic.

BACKGROUND: This study aimed to evaluate the impact of the COVID-19 pandemic on the nutritional patterns, eating behavior, dietary content, and health-related quality of life (HrQoL) of adolescents with preexisting obesity. METHODS: Anthropometric and metabolic parameters were measured, and validated questionnaires on eating habits, nutritional content, and HrQoL were administered to 264 adolescents with obesity during the COVID-19 pandemic (June 2020-June 2022) and 265 adolescents with obesity before the pandemic (from June 2017 to June 2019). RESULTS: Both study cohorts were comparable in age and sex distribution. Significant differences were found between the COVID-19 and pre-COVID-19 cohorts in HOMA-index (3.8 (interquartile range [IQR])): 3.3; 4.1) vs. 3.2 (IQR: 2.8; 3.5, p < 0.001), total cholesterol (208.8 mg/dL (IQR: 189.9; 214.5) vs. 198.5 mg/dL (IQR: 189.5; 207.4), p < 0.001), and GPT (93.4 (IQR 88.7; 96.5) vs. 72.8 U/L (IQR 68.9; 75.7), p < 0.001). The COVID-19 cohort reported significantly higher consumption of obesity-promoting food components, such as soft drinks, meat, sausages, fast food and delivery food, chocolate, and sweets. There was also a significant decrease in cognitive hunger control (p = 0.002) and an increase in distractibility potential (p = 0.001) while eating. HrQoL was significantly lower in the COVID-19 cohort (p = 0.001). CONCLUSIONS: This study reveals the adverse associations of exposure to the public health measures during the COVID-19 pandemic with nutrition, dietary content, and HrQoL in adolescents with preexisting obesity. These findings underscore the importance of tailored preventive and treatment strategies for addressing the specific challenges of disruptive events such as pandemics, especially in population-based context.

Prevalence of LDL-hypercholesterolemia and other cardiovascular risk factors in young people with type 1 diabetes.

BACKGROUND: Mortality and morbidity in people with Type 1 diabetes (T1D) is mainly caused by cardiovascular disease (CVD). Early treatment of cardiovascular risk factors (CVRFs) is of great importance. OBJECTIVE: To analyze the prevalence of LDL-hypercholesterolemia and other CVRFs in youth with T1D. METHODS: Clinical and laboratory parameters, and vascular thickness measurement were obtained in youth with T1D (age 6-18 years, T1D duration >1 year) attending a diabetes clinic. LDL-hypercholesterolemia, microalbuminuria and arterial hypertension were defined as CVRFs. RESULTS: A total of 333 youth (48% girls; age: 13.3 years [10.3-15.5], median [interquartile range]) participated in the study. The T1D duration was 5.9 years [3.5-9.4] with HbA1c of 7.4% [6.8-8.0]. Intima media thickness (N=223) was 538.0 µm [470.0-618.0]). LDL-hypercholesterolemia was present in 30 participants (9%; 18 girls; age: 14.3 years [11.2-15.7]). None of the participants had persistent microalbuminuria, although 59 (18.3%) had elevated albumin excretion in a random urine specimen. LDL-hypercholesterolemia was associated with increased blood pressure (p<0.05), insulin requirement (p<0.05), HbA1c (p<0.05), triglyceride (p<0.001) and total cholesterol (p<0.001), and a family history of premature CVD (p<0.001), but negatively correlated with HDL cholesterol levels (p<0.05). Sex, pubertal status, duration of diabetes, type of therapy, and physical activity did not differ between participants with and without LDL- hypercholesterolemia. Arterial hypertension was present in 11 participants (3.3%; 4 girls; age: 14.1 years [11.1-16.1]). CONCLUSION: LDL-hypercholesterolemia affected 9% of youth with T1D in this cohort and was associated with other CVRFs. A holistic therapeutic concept for these young people is essential.

Psychometric properties of the German teen and parent versions of the Problem Areas in Diabetes Scale (PAID).

The negative impact of psychosocial burden in connection with the treatment of Type 1 diabetes (T1D) indicates the need for regular screening of diabetes distress in adolescents with T1D and their parents. Psychometric properties of the German versions of Problem Areas in Diabetes scale-Teen (PAID-T) and Parent (P-PAID-T) are examined in order to provide a clinical screening tool. Linguistically translated questionnaires were used in a multicenter study with 459 families. Confirmatory factor analysis, validity, and reliability were examined. Teens (42.8% female) had a mean age of 14.7 years. Most parent-caregivers were mothers (74.4%) and were born in Germany (83.1%). Results corroborate the three-factor model for the PAID-T with acceptable model fit, and convergent and discriminant validity was observed. The four-factor model for parents was also supported but had inadequate discriminant validity in this study. Teen and parent scores showed excellent Cronbach's α = 0.91 and 0.93, respectively. The PAID-T and P-PAID-T scores were positively correlated with HbA1c (rs = .343 and .252, respectively, p < .001) and negatively correlated with treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire) and KIDSCREEN-10 index (teens: rs = -.545 and -.575; parents: rs = -.563 and -.489, respectively, all p < .001). The P-PAID-T correlated positively with depressive symptoms measured in Patient Health Questionnaire -9 (rs = .537, p < .001). The German versions of PAID-T and P-PAID-T produced scores that demonstrated good reliability and validity. Like the original English versions, the German versions are useful to detect diabetes-specific distress in families and to tailor interventions for affected teenagers and their parents. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Direct LDL-C estimation in preschoolers: Practicable first step for FH screening.

BACKGROUND: Individuals with FH develop cardiovascular disease due to lifelong cumulative exposure to elevated LDL-C. Effective screening for FH is not yet established. OBJECTIVE: To evaluate the practicability of a FH screening by measuring directly the LDL-C in preschoolers. METHODS: LDL-C measurement through capillary blood sampling during the compulsory routine check-ups by the pediatrician in children aged 2 to 6 years including information on family history as dyslipidemia and/or premature cardiovascular disease in first and second grade of pedigrees. RESULTS: 15,009 children (52.2% males, median age 3.9 years [IQR 3.0-5.1]) participated in the study. Positive family history for hyperlipidemia was stated in 40.9% cases, in 12.0% also in at least one 1st degree relative. In the total cohort, median LDL-C was 93 mg/dL [IQR 79-109 mg/dL]. Boys had significantly higher LDL-C levels than girls (p < 0.0001), whereas there was no difference regarding their age (p = 0.757). Children from families with a positive history for hypercholesterolemia/dyslipidemia had significantly higher LDL-C levels (p < 0.001) and were more frequently among those with LDL-C values above 135 mg/dL (3.5 mmol/L, 96th percentile; 53.2% vs. 40.3%, p < 0.001) and those with LDL-C levels above 160 mg/dL (4.1 mmol/L, 99th percentile; 45.3% vs. 40.7%, p < 0.001) than children without positive family history. CONCLUSIONS: Direct measurement of LDL-C levels in children at ages 2-6 years during the compulsory routine check-ups as well as at any voluntary visits to the pediatrician's office is practicable and delivers reliable information, which can be used for a FH screening strategy in the general population.

Trends of Antidiabetic and Cardiovascular Diseases Medication Prescriptions in Type 2 Diabetes between 2005 and 2017-A German Longitudinal Study Based on Claims Data.

BACKGROUND: With an attempt to understand possible mechanisms behind the severity-dependent development of type 2 diabetes (T2D) comorbidities, this study examines the trends of antidiabetic and cardiovascular diseases (CVD) medication prescriptions in individuals with T2D. METHODS: The study is based on claims data from a statutory health insurance provider in Lower Saxony, Germany. The period prevalence of antidiabetic and CVD medication prescriptions was examined for the periods 2005-2007, 2010-2012, and 2015-2017 in 240,241, 295,868, and 308,134 individuals with T2D, respectively. (Ordered) logistic regression analyses were applied to examine the effect of time period on the number and prevalence of prescribed medications. Analyses were stratified by gender and three age groups. RESULTS: The number of prescribed medications per person has increased significantly for all examined subgroups. For the two younger age groups, insulin prescriptions decreased but those of non-insulin medications increased, while both increased significantly over time for the age group of 65+ years. Except for glycosides and antiarrhythmic medications, the predicted probabilities for CVD medications increased over the examined periods, with lipid-lowering agents demonstrating the highest increase. CONCLUSIONS: Results point towards an increase in medication prescriptions in T2D, which is in line with the evidence of the increase in most comorbidities indicating morbidity expansion. The increase in CVD medication prescriptions, especially lipid-lowering agents, could explain the specific development of severe and less severe T2D comorbidities observed in this population.

Comparison of diabetes distress and depression screening results of emerging adults with type 1 diabetes onset at different ages: findings from the German early-onset T1D study and the German Diabetes Study (GDS).

BACKGROUND: Diabetes distress is increasingly considered one of the most important psychosocial issues in the care of people with type 1 diabetes (T1D). We analyse whether diabetes distress and depression screening results of emerging adults are associated with the age at T1D onset. METHODS: Data were taken from two cohort studies conducted at the German Diabetes Center, Düsseldorf, Germany. The 18-30-year-old participants had an age at onset either before the age of 5 years (childhood-onset long-term T1D study group, N = 749) or during adulthood (adult-onset short-term T1D study group from the German Diabetes Study (GDS), N = 163). Diabetes distress and depression screening were analysed by means of the 20-item Problem Areas in Diabetes (PAID-20) scale and the nine-item depression module from the Patient Health Questionnaire (PHQ-9). The average causal effect of age at onset was estimated by a doubly robust causal inference method. RESULTS: The PAID-20 total scores were increased in the adult-onset study group [potential outcome mean (POM) 32.1 (95% confidence interval 28.0; 36.1) points] compared to the childhood-onset study group [POM 21.0 (19.6; 22.4) points, difference 11.1 (6.9; 15.3) points, p<0.001] adjusted for age, sex and haemoglobin A1c (HbA1c) levels. Moreover, more participants in the adult-onset group [POM 34.5 (24.9; 44.2) %] than in the childhood-onset group [POM 16.3 (13.3; 19.2) %] screened positive for diabetes distress [adjusted difference 18.3 (8.3; 28.2) %, p<0.001]. The PHQ-9 total score [difference 0.3 (-1.1; 1.7) points, p=0.660] and the proportion of participants with a positive screening result for depression [difference 0.0 (-12.7; 12.8) %, p=0.994] did not differ between the groups in the adjusted analyses. CONCLUSIONS: Emerging adults with short-term type 1 diabetes screened positive for diabetes distress more often than adults with type 1 diabetes onset during early childhood when age, sex and HbA1c values were considered confounding factors. Accounting for age at onset or the duration of diabetes may help explain the heterogeneity in the data when psychological factors are examined.

Real-World Use of Continuous Glucose Monitoring Systems Among Adolescents and Young Adults With Type 1 Diabetes: Reduced Burden, but Little Interest in Data Analysis.

BACKGROUND: Since 2016, German health insurance companies reimburse continuous glucose monitoring (CGM) systems for persons with insulin-dependent diabetes, leading to a tremendous increase of CGM use. This study assessed the use of CGM, the satisfaction with, and the data analysis behavior among young people. METHODS: During a diabetes camp for young people from all over Germany, participants anonymously answered a questionnaire on their method of glucose monitoring, satisfaction and quality of CGM use, HbA1c, and diabetes distress (Problem Areas in Diabetes Scale [PAID]-5). RESULTS: A total of 308 participants (age 21.4 ± 3.5 years; 73% female; diabetes duration 10.1 ± 5.9 years) completed the questionnaire. Approximately, 25% used self-monitoring of blood glucose (SMBG), 46% intermittent-scanning continuous glucose monitoring (iscCGM), and 30% real-time continuous glucose monitoring (rtCGM). Mean HbA1c was slightly, but not significantly, higher among SMBG users compared with CGM users (8.0% ± 1.9% vs. 7.7% ± 1.4%; P = .791). Diabetes distress was not associated with the method of glucose monitoring (SMBG 5.6 vs. iscCGM 6.2 vs. rtCGM 6.5; P = .386). Overall, satisfaction with CGM use was very high; 98% of the CGM users reported better well-being with CGM compared with previous SMBG use. Only 19% of CGM users reported regular data analyses; their HbA1c was lower compared with other CGM users (7.2% ± 1.2% vs. 7.7% ± 1.4%; P = .039). CONCLUSIONS: In this large sample of young people, 75% were using a CGM system. Treatment satisfaction was very high, but CGM use was not associated with reduced diabetes distress or better glycemic control. However, young people who regularly analyzed their CGM data reported lower HbA1c levels.

Understanding Daily, Emotional, and Physical Burdens and Needs of Parents Caring for Children with Type 1 Diabetes.

Aims: To investigate (1) daily, emotional, and physical caregiving burdens in parents of children with type 1 diabetes, (2) the sociodemographic and clinical predictors of three burdens, and (3) support measures that parents wish to receive. Methods: The study was a multicenter cross-sectional survey conducted in nine German pediatric diabetes centers. A questionnaire assessing three types of burdens and wishes for support was distributed to parents with a child with type 1 diabetes visiting one of the pediatric centers for a routine check-up. Results: Data from 1,107 parents (83% mothers) were analyzed. Parents reported significantly higher emotional burdens compared to daily and physical burdens (p < 0.0001). Mothers felt more burdened than fathers did. Parents of younger children reported higher daily and physical burdens compared to the parents of older children, and similarly, parents of technology users reported higher daily and physical burdens compared to the parents of nontechnology users. However, emotional burdens did not differ in both comparisons. Other demographic factors (i.e., parent's age, migration status, and single-parent family status) predicted high levels of daily or physical burdens, but only HbA1c level and the parent's gender (mother) predicted a high emotional burden. Independent of the level of burden, 78% of parents wanted additional diabetes training. Conclusion: Despite parents reporting high emotional burdens in connection with diabetes care, HbA1c and the gender of the reporting parent were the only risk factors. As the child gets older, parents' daily and physical distress decrease but not the emotional burden. Diabetes training including regularly offered booster sessions as well as low-threshold interventions for mental health issues and practical self-care skills is recommended to provide continuous support for parents.

Monthly video consultation for children and adolescents with type 1 diabetes mellitus during the COVID-19 pandemic.

AIMS: To explore the impact of primarily telemedical care for children and adolescents with type 1 diabetes by monthly video consultations on metabolic control and parents' treatment satisfaction and disease-specific burden during the COVID-19 pandemic. METHODS: In this 12-month multicenter observational follow-up VIDIKI 2.0 study, 100 participants (3-18 years) received monthly video consultations, which partially replaced quarterly outpatient clinic appointments during the pandemic. The children's metabolic parameters as well as the parents' treatment satisfaction and diabetes specific burden were assessed at study entry and 12 months later. RESULTS: During the study, 912 video consultations took place (mean 0.84 ±â€¯0.23 / patient/month). The children's HbA1c remained stable, while mean sensor glucose level and glucose management indicator decreased. Simultaneously, parents' treatment satisfaction significantly increased, and their diabetes-specific burden and distress decreased. CONCLUSIONS: Primarily telemedical care of children and adolescents with type 1 diabetes during the COVID-19 pandemic via monthly video consultations resulted in a significant improvement in parents' treatment satisfaction and their diabetes-specific burden and distress. It was associated with a slight improvement in mean sensor glucose and glucose management indicator, while HbA1c remained stable. Thus, video consultations offer great potential to enhance standard care for children and adolescents with diabetes.

The emotional well-being of parents with children at genetic risk for type 1 diabetes before and during participation in the POInT-study.

INTRODUCTION: This study examined the emotional impact that parents experience when confronted with an increased genetic risk of type 1 diabetes (T1D) in their child. Population-based screening of neonates for genetic risk of chronic disease carries the risk of increased emotional burden for parents. METHODS: Information was collected using a well-being questionnaire for parents of infants identified as having an increased risk for T1D in a multinational research study. Parents were asked to complete this questionnaire after they were told their child had an increased risk for T1D (Freder1k-study) and at several time points during an intervention study (POInT-study), where oral insulin was administered daily. RESULTS: Data were collected from 2595 parents of 1371 children across five countries. Panic-related anxiety symptoms were reported by only 4.9% after hearing about their child having an increased risk. Symptoms of depression were limited to 19.4% of the parents at the result-communication visit and declined over time during the intervention study. When thinking about their child's risk for developing T1D (disease-specific anxiety), 47.2% worried, felt nervous and tense. Mothers and parents with a first-degree relative (FDR) with T1D reported more symptoms of depression and disease-specific anxiety (p < 0.001) than fathers and parents without a FDR. CONCLUSION: Overall, symptoms of depression and panic-related anxiety are comparable with the German population. When asked about their child's risk for T1D during the intervention study, some parents reported disease-specific anxiety, which should be kept in mind when considering population-based screening. As certain subgroups are more prone, it will be important to continue psychological screening and, when necessary, to provide support by an experienced, multidisciplinary team.

Expert guidance on the multidisciplinary management of cystinosis in adolescent and adult patients.

Cystinosis, a rare autosomal recessive lysosomal storage disorder, results in an abnormal accumulation of the amino acid cystine in multiple organs and tissues of the body. Renal symptoms typically develop in the first few months of life, with extra-renal manifestations becoming apparent over the next 10-20 years, which require coordinated multidisciplinary care. Here, we describe a consensus-based guidance to support the management of adolescents and adults living with cystinosis. The programme was led by a Steering Committee (SC) of six experts in the management of patients with cystinosis, who identified a list of 15 key questions reflecting the multi-organ effects of cystinosis. An Extended Faculty (EF) of eight additional specialists was invited to answer the questions via an online digital platform using a quasi-Delphi approach. The consolidated answers were summarized into recommendations. Where evidence was lacking, recommendations were developed using collective expert consensus. The EF was asked to agree/disagree with the clinical recommendations. The expert-agreed clinical recommendations provide guidance that considers both renal and extra-renal systems. The topics covered are advice on fertility and family planning, consideration of the nervous, muscular, ophthalmic, cardio-respiratory, endocrine, dermatological and gastrointestinal systems, as well as guidance on dental care, diet, lifestyle, and improving quality of life and psychological well-being. In summary, this work outlines recommendations and a checklist for clinicians with a vision for improving and standardizing the multidisciplinary care for patients with cystinosis.