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.

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.

Direct Costs of Healthcare for Children with Type 1 Diabetes Using a CGM System: A Health Economic Analysis of the VIDIKI Telemedicine Study in a German Setting.

AIMS: The Virtual Diabetes Outpatient Clinic for Children and Adolescents (VIDIKI) study was a 6-month quasi-randomized, multicentre study followed by an extension phase to evaluate the effects of monthly video consultations in addition to regular care. A health economic analysis was conducted to assess the direct costs. METHODS: The cost data of 240 study participants (1-16 years of age) with type 1 diabetes who were already using a continuous glucose monitoring system were collected in the first 6 months of the study. The intervention group (IG) received monthly video consultations plus regular care, and the waiting control group (WG) received only regular care. Cost data were collected for a comparable anonymized group of children from the participating health insurance companies during the 6-month period before the study started (aggregated data group [AG]). RESULTS: Cost data were analysed for the AG (N=840) 6 months before study initiation and those for the study participants (N=225/240). Hospital treatment was the highest cost category in the AG. There was a cost shift and cost increase in the IG and WG, whereby diabetes supplies were the highest cost category. The mean direct diabetes-associated 6-month costs were € 4,702 (IG) and € 4,936 (WG). CONCLUSION: The cost development within the cost collection period over two years possibly reflects the switch to higher-priced medical supplies. Video consultation as an add-on service resulted in a small but nonsignificant reduction in the overall costs.

Three-variate trajectories of metabolic control, body mass index, and insulin dose: Heterogeneous response to initiation of pump therapy in youth with type 1 diabetes.

OBJECTIVE: Continuous subcutaneous insulin infusion (CSII) in youths with type 1 diabetes (T1D) is often associated with lower HbA1c, lower total daily insulin dose (TDD), and lower body mass index (BMI) compared with multiple daily injections (MDI). Individual responses to CSII are diverse. The aim was to identify unique three-variate patterns of HbA1c, BMI standard deviation score (SDS), and TDD after switching to CSII. METHODS: Five thousand one hundred and thirty-three youths (≤20 years; 48% boys; median age at pump start 12.5 years) with T1D duration ≥3 years at CSII initiation were selected from the multicenter DPV registry. We applied group-based multitrajectory modeling to identify groups of individuals following similar trajectories. Measurements were aggregated quarterly during a 3-year follow-up period. Trajectory variables were changes of HbA1c, BMI-SDS, and TDD from baseline (delta = quarterly aggregated values at each time point [i] minus the respective baseline value). RESULTS: Four groups of diverging Delta-HbA1c, Delta-BMI-SDS, and Delta-TDD patterns were identified. All showed improvements in HbA1c during the first 3 months. Group 1 (12%) was characterized by modest HbA1c increase thereafter, TDD reduction, and stable BMI-SDS. In Group 2 (39%), increasing HbA1c, decreasing BMI-SDS, and stable TDD were found. By contrast, sustainably improved HbA1c, increasing BMI-SDS, and stable TDD were observed in Group 3 (32%). Group 4 (17%) was characterized by increasing levels for HbA1c, BMI-SDS, and TDD. Between-group differences in baseline HbA1c, BMI-SDS, TDD as well as in sex ratio, age at diabetes onset and at pump start were observed. CONCLUSIONS: Definite trajectories of glycemic control, BMI, and TDD over 3 years after CSII initiation were identified in youths with T1D allowing a more personalized treatment recommendation.

Video Consultation for Parents with a Child Newly Diagnosed with Type 1 Diabetes: A Qualitative Study.

AIMS: With the exception of the coronavirus pandemic, video consultations have not been a part of the standard care for children with diabetes in Germany. The "Virtual Diabetes Outpatient Clinic for Children and Adolescents 2.0" (VIDIKI 2.0) study investigated the effect of monthly and supplementary video consultations on standard care over one year. The qualitative substudy investigated the experiences of families with a child newly diagnosed with type 1 diabetes mellitus (T1DM) who received at least four weekly supplementary video consultations. METHODS: Guideline-based qualitative interviews were conducted with seven families with children under the age of eight and T1DM onset shortly before study entry. The answers were analyzed using a qualitative content analysis approach, particularly inductive category formation. RESULTS: Families of patients with T1DM onset have questions, almost daily, concerning various aspects of insulin therapy. The offer of high-frequency video consultations can reduce the number of trips to the diabetes team, facilitate the organization of daily life and increase the sense of security. CONCLUSION: Video consultations as a supplementary offer of health care, especially after diabetes onset, were considered very helpful by the affected families. High-frequency video consultations may provide a tool to overcome existing deficiencies in specialized diabetes care.

Heterogeneity of Access to Diabetes Technology Depending on Area Deprivation and Demographics Between 2016 and 2019 in Germany.

BACKGROUND: Despite increasing use of technology in type 1 diabetes, persistent ethnic and socio-economic disparities have been reported. We analyzed how the use of insulin pump therapy and continuous glucose monitoring (CGM) evolved over the years in Germany depending on demographics and area deprivation. METHOD: We investigated the use of insulin pump and CGM between 2016 and 2019 in 37,798 patients with type 1 diabetes aged < 26 years from the German Prospective Follow-up Registry (DPV). Associations with federal state, area-deprivation quintile (German Index of Multiple Deprivation 2010 on district level), gender, and migration background were investigated over time using multiple logistic regression. RESULTS: Between 2016 and 2019, the regional distribution of insulin pump use did not change substantially and the association with area deprivation remained non-linear and statistically non-significant. The effect of area deprivation on CGM use decreased continuously and disappeared in 2019 (OR [95%-CI] Q1 vs Q5: 1.85 [1.63-2.10] in 2016; 0.97 [0.88-1.08] in 2019). The effect of migration background on the use of either technology decreased over the years but remained significant in 2019. Girls had constantly higher odds of using an insulin pump than boys (OR: 1.25 [1.18-1.31] in 2019), whereas no gender difference was identified for CGM use. CONCLUSIONS: Although disparities decreased in Germany, access to diabetes technology still depends on migration background in 2019, and gender differences in pump use persist. As technological advances are made, further research is needed to understand the reasons for these persistent disparities.

Assessing the benefits and challenges of video consultations for the treatment of children with type 1 diabetes - A qualitative study among diabetes professionals.

BACKGROUND: Video consultations are promoted as a tool to effectively supplement paediatric diabetes outpatient care. However, knowledge about attitudes of diabetes professionals towards this new technology is lagging behind. Diabetologists and diabetes nurses participating in a controlled study (the VIDIKI study) with monthly video consultations for children with type 1 diabetes were interviewed about their experience with this type of communication. RESEARCH DESIGN AND METHODS: Guideline-based qualitative interviews with 9 telemedicine experts (7 paediatric diabetologists and 2 diabetes nurses) and 7 paediatric diabetologists who agreed to the telemedical co-treatment of their patients were analysed using qualitative content analysis, in particular inductive category formation. RESULTS: Diabetes experts reported generally positive attitudes towards video consultations. They identified a number of unique benefits of telemedical interventions, including higher frequency of contacts, greater sense of patient´s safety, ability to interact with patients in their own homes, more timely and accurate medical monitoring, and improved data management. Additionally, it was important to the experts to maintain regular face-to-face consultations and to ensure close communication between telemedicine and outpatient clinical experts. CONCLUSIONS: Prerequisites for successful video consultations include a comprehensive initial technical training and an agreement on treatment responsibilities of all health care professionals involved in the patient's care. Under these conditions, the experts reported significant advantages of video consultation in the treatment of children with type 1 diabetes.

Outcomes of monthly video consultations as an add-on to regular care for children with type 1 diabetes: A 6-month quasi-randomized clinical trial followed by an extension phase.

OBJECTIVE: To explore the outcomes of monthly video consultations for children with diabetes. METHODS: The Virtual Outpatient Diabetes Clinic for Children and Youth (VIDIKI) was a 6-month multicenter controlled clinical trial followed by an extension phase. The 240 participants (1-16 years), all using a CGM, were quasi-randomized by residence location to the intervention group (IG) or the waitlist-control group (WG). The IG started immediately after enrollment with monthly video consultations as an add-on to regular care, while the WG received regular care for 6 months before starting the intervention. The extension phase lasted between 12 months and 2 years, depending on the enrollment date. Linear regression was applied to model the primary outcome of HbA1c after 6 months and other metabolic and psychosocial outcomes. RESULTS: After covariate adjustments, the HbA1c at 6 months-corresponding to the controlled treatment phase-was 0.11% lower in the IG than that in the WG (95% CI -0.31 to 0.09, P = .277). For the total study sample, a significant HbA1c improvement was found after 12 months of video consultations, which increased further until month 15. The diabetes burden of the main caregivers was lower, and parental treatment satisfaction was significantly higher in the IG than that in the WG. CONCLUSIONS: The VIDIKI study found no significant HbA1c difference between IG and WG after 6 months in the controlled phase, but there was a decreased diabetes burden and increased treatment satisfaction for the parents. In the longitudinal perspective, a significant HbA1c improvement was found after 12 and 15 months.

Monthly Video-Consultation for Children With Type 1 Diabetes Using a Continuous Glucose Monitoring System: Design of ViDiKi, a Multimethod Intervention Study to Evaluate the Benefit of Telemedicine.

BACKGROUND: The introduction of continuous glucose monitoring (CGM) implies new challenges for diabetes care. As CGM systems are often directly linked to a web-based software solution, structured telemedicine care using a video-consultation may be a new option for families who care for children with type 1 diabetes mellitus (T1DM). METHODS: "ViDiKi" (Virtual Diabetes Outpatient Clinic for Children and Youth) is a multicenter controlled trial carried out in Northern Germany. ViDiKi will examine if monthly telemedical consultations, in addition to regular care, will improve glycemic control and psychosocial outcomes. The primary outcome is glycemic control as measured by a change in glycated hemoglobin (HbA1c). A total of 240 participants aged between one year and 16 years using a CGM with multiple daily injections (MDI) or insulin pump therapy were recruited and assigned to a starter group or a six-month waiting control group. The sample size is designed to detect a between-group difference of 0.5% in HbA1c change at six months. Secondary outcomes are variability of blood glucose, health-related quality of life, self-efficacy, and satisfaction with telemedicine. To gain deeper insight into the experience of using telemedicine, qualitative interviews will be conducted. In a health-economic analysis, the costs of telemedicine and a cost-of-care analysis will be calculated. CONCLUSIONS: The results from the ViDiKi study shall give important information on the feasibility and putative benefits of telemedicine in children with T1DM and their caregivers. GERMAN CLINICAL TRAILS REGISTER (DRKS): DRKS00012645.

Temporal Trends and Contemporary Use of Insulin Pump Therapy and Glucose Monitoring Among Children, Adolescents, and Adults With Type 1 Diabetes Between 1995 and 2017.

OBJECTIVE: To investigate temporal trends and contemporary use of insulin pump therapy and glucose monitoring in type 1 diabetes. RESEARCH DESIGN AND METHODS: In a population-based study, we analyzed the use of insulin pump therapy, continuous glucose monitoring (CGM), and self-monitoring of blood glucose (SMBG) from 1995 to 2017 in patients with type 1 diabetes identified from the Diabetes Prospective Follow-up (DPV) database in Germany and Austria. Patients were stratified by age, sex, migration background, and country. RESULTS: Among 96,547 patients with type 1 diabetes (median age 17.9 years, 53% males), the percentage using insulin pump therapy increased from 1% in 1995 to 53% in 2017, with the highest rates in the youngest patients (92% in preschoolers, 74% in children, 56% in adolescents aged <15 years, 46% in adolescents aged ≥15 years, 37% in adults). The percentage of patients using CGM increased from 3% in 2006 to 38% in 2017, with the highest rates in the youngest patients (58%, 52%, 45%, 33%, and 15% of respective age-groups). Daily SMBG frequencies increased from 1995 to 2016 and decreased afterward, most prominently in the youngest patients. Between 2015 and 2017, pump therapy was more frequently used in female versus male adolescents and adults (all P < 0.001), while no sex differences were observed for pump use in children <10 years (all P = 1.0) and for CGM use in all age-groups (all P = 1.0). CONCLUSIONS: Since 1995, insulin pump use has continuously increased, and insulin pump therapy is now standard in patients aged <15 years. CGM use sharply rose in recent years, particularly in young children.

[The creation of a data protection policy: a guide to telemedicine healthcare projects]. / Die Erstellung eines Datenschutzkonzeptes: eine Anleitung für telemedizinische Versorgungsprojekte.

In Germany, an increasing number of telemedical pilot projects are in the implementation phase. All these projects have in common that they continuously produce, store, and exchange highly sensitive digital data. A basic prerequisite for projects implemented in conformity with the law is a comprehensive data protection concept, especially after the introduction of the European Data Protection Regulation (DSGVO) in May 2018.The preparation of a data protection concept for a telemedical project is illustrated in this article using the example of the care project "Virtual Diabetes Outpatient Clinic for Children and Adolescents" (ViDiKi), which started on 1 April 2017 and is funded by the Innovation Fund of the Joint Federal Committee (G-BA). Firstly, the legal basis for data protection and the related challenges in the application of new communication technologies are explained. Subsequently, the creation and structure of the data protection concept are described.The data protection concept for a project is constantly changing. It must be audited and regularly evaluated to ensure the security of patient data and to regulate data flows, data storage, and data processing. In practice, a secure and legally compliant exchange of data between study participants and physicians can thus be achieved.

Therapy Adjustments Based on Trend Arrows Using Continuous Glucose Monitoring Systems.

Continuous glucose monitoring (CGM) systems use trend arrows to accurately display the anticipated glucose curve for the user. These are used for both "real-time" glucose monitoring and for intermittent scanning glucose monitoring. Trend arrow data are used by people with diabetes to make corrections to their glucose control. It is essential that they are correctly interpreted when adjusting insulin doses and to ensure that appropriate treatment decisions are made. The aim of this article is to provide general treatment guidance for diabetes teams and for people with diabetes using CGM in the context of trend arrows. This is based on previous recommendations for interpreting trend arrows without losing sight of the need for individual therapy adjustment.

Experiences in Sensor-Augmented Pump Therapy in Families with two Children with Type 1 diabetes: A Qualitative Study.

BACKGROUND: Caring for a child with type 1 diabetes is a tremendous challenge for a family. The aim of the study was to explore the experiences of transition to sensor-augmented pump therapy (SAP) in families with 2 affected children and the internal and external conditions which potentially impede or facilitate the adjustment process. METHODS: 5 families (9 parents, 8 children and adolescents) who used the SAP technology for 6 months were interviewed to describe their experiences. The interviews were analysed using thematic content analysis. RESULTS: Qualitative analysis of the transcribed interviews revealed that the adaptation process to SAP consisted of several phases and differed among families. There were benefits as well as hassles of using SAP with regard to managing the diabetes, and psychosocial issues: school and peer relations, as well as family relations. While parents clearly regarded the improved metabolic control and hypoglycaemic safety as the most important benefits of SAP, the hassles reported as most important covered a wide range, from technical problems of the system to family conflicts. On the whole, families rated the experience of using SAP as a positive one, with most recommending SAP to other families as long as they were willing to come to terms with the technology and commit to the work and time involved. CONCLUSION: Sensor-augmented pump therapy can be extremely beneficial and a resource for families who care for more than one child with diabetes. During the adaptation process there is a great need of education and frequent follow-up e. g., by telemedical support.