Changes in cardiovascular risk factors among children and young adults with type 1 diabetes during the COVID-19 pandemic compared to previous years-Results from the German DPV registry.

BACKGROUND: The diverse stages of the COVID-19 pandemic led to several social circumstances that influenced daily life and health behavior. PURPOSE: To evaluate changes in cardiovascular risk factors and physical activity among children and young adults with type 1 diabetes (T1D) during the COVID-19 pandemic in Germany compared to previous years. METHODS: A total of 32 785 individuals aged 6-21 years at baseline with T1D from the German diabetes patient follow-up (DPV) registry contributed data on 101 484 person-years between 2016 and 2021. The first treatment year of each individual within this period was considered as baseline. Based on trends from 2016 to 2019, we estimated differences in body mass index-SD score (BMI-SDS), blood pressure (BP-SDS), and lipid levels (non-high-density lipoprotein [non-HDL]) between observed and predicted estimates for the years 2020 and 2021 using linear regression analysis standardized for age, diabetes duration, sex, and migratory background. The proportion doing organized sports and smoking cigarettes was analyzed using multivariable logistic regression models. RESULTS: BMI-SDS increased constantly from 2016 to 2021 without a significant increase above expected values for 2020/2021. Systolic BP-SDS (difference observed vs. expected with 95% confidence interval, 2020: 0.10 [0.07-0.14], 2021: 0.17 [0.14-0.20]) and non-HDL (2020: 2.7 [1.3-4.1] mg/dl, 2021: 4.1 [2.7-5.5] mg/dl) were significantly increased (all p < .001) in both pandemic years. The proportion of subjects participating in organized sports was reduced from over 70% in prepandemic years to 35%-65% in diverse stages/waves of the COVID-19 pandemic. The percentage smoking cigarettes did not change. CONCLUSIONS: We describe an increase in BP and atherogenic lipid levels coinciding with a reduction in physical activity but no acceleration of the prepandemic increases in BMI-SDS among young people with T1D during the COVID-19 pandemic.

Psychosocial Outcomes among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Findings from an International Survey of Adults with Type 1 Diabetes

Background: Use of open-source automated insulin delivery (AID) is associated with improved psychosocial outcomes among people with type 1 diabetes (T1D) . However, research to date has been qualitative or used study-specific single items. There is a need for quantitative research using validated measures in larger samples. Method: We conducted an international online survey to examine the psychosocial outcomes of open-source AID users and non-users. Validated questionnaires assessed diabetes-specific quality of life (QoL) , impact of the COVID-pandemic on diabetes-specific QoL, diabetes specific-positive well-being, diabetes treatment satisfaction, diabetes distress, fear of hypoglycaemia, general emotional well-being, and subjective sleep quality. Results: 587 participants completed at least one questionnaire, including 447 adults using open-source AID (mean age 43, 42% women) and 140 non-users (mean age 40, 64% women) . Table 1 shows significant between-group differences for all questionnaire scores. Discussion: Adults with T1D using open-source AID report significantly better psychosocial outcomes than non-users. Due to the cross-sectional design of this study, we cannot make any causal inferences about the use of these devices. Further research is needed to examine the reasons for these differences.

Open-source Web Portal for Managing Self-reported Data and Real-world Data Donation in Diabetes Research: Platform Feasibility Study.

BACKGROUND: People with diabetes and their support networks have developed open-source automated insulin delivery systems to help manage their diabetes therapy, as well as to improve their quality of life and glycemic outcomes. Under the hashtag #WeAreNotWaiting, a wealth of knowledge and real-world data have been generated by users of these systems but have been left largely untapped by research; opportunities for such multimodal studies remain open. OBJECTIVE: We aimed to evaluate the feasibility of several aspects of open-source automated insulin delivery systems including challenges related to data management and security across multiple disparate web-based platforms and challenges related to implementing follow-up studies. METHODS: We developed a mixed methods study to collect questionnaire responses and anonymized diabetes data donated by participants-which included adults and children with diabetes and their partners or caregivers recruited through multiple diabetes online communities. We managed both front-end participant interactions and back-end data management with our web portal (called the Gateway). Participant questionnaire data from electronic data capture (REDCap) and personal device data aggregation (Open Humans) platforms were pseudonymously and securely linked and stored within a custom-built database that used both open-source and commercial software. Participants were later given the option to include their health care providers in the study to validate their questionnaire responses; the database architecture was designed specifically with this kind of extensibility in mind. RESULTS: Of 1052 visitors to the study landing page, 930 participated and completed at least one questionnaire. After the implementation of health care professional validation of self-reported clinical outcomes to the study, an additional 164 individuals visited the landing page, with 142 completing at least one questionnaire. Of the optional study elements, 7 participant-health care professional dyads participated in the survey, and 97 participants who completed the survey donated their anonymized medical device data. CONCLUSIONS: The platform was accessible to participants while maintaining compliance with data regulations. The Gateway formalized a system of automated data matching between multiple data sets, which was a major benefit to researchers. Scalability of the platform was demonstrated with the later addition of self-reported data validation. This study demonstrated the feasibility of custom software solutions in addressing complex study designs. The Gateway portal code has been made available open-source and can be leveraged by other research groups.

Interdisciplinary Online Hackathons as an Approach to Combat the COVID-19 Pandemic: Case Study.

BACKGROUND: The COVID-19 outbreak has affected the lives of millions of people by causing a dramatic impact on many health care systems and the global economy. This devastating pandemic has brought together communities across the globe to work on this issue in an unprecedented manner. OBJECTIVE: This case study describes the steps and methods employed in the conduction of a remote online health hackathon centered on challenges posed by the COVID-19 pandemic. It aims to deliver a clear implementation road map for other organizations to follow. METHODS: This 4-day hackathon was conducted in April 2020, based on six COVID-19-related challenges defined by frontline clinicians and researchers from various disciplines. An online survey was structured to assess: (1) individual experience satisfaction, (2) level of interprofessional skills exchange, (3) maturity of the projects realized, and (4) overall quality of the event. At the end of the event, participants were invited to take part in an online survey with 17 (+5 optional) items, including multiple-choice and open-ended questions that assessed their experience regarding the remote nature of the event and their individual project, interprofessional skills exchange, and their confidence in working on a digital health project before and after the hackathon. Mentors, who guided the participants through the event, also provided feedback to the organizers through an online survey. RESULTS: A total of 48 participants and 52 mentors based in 8 different countries participated and developed 14 projects. A total of 75 mentorship video sessions were held. Participants reported increased confidence in starting a digital health venture or a research project after successfully participating in the hackathon, and stated that they were likely to continue working on their projects. Of the participants who provided feedback, 60% (n=18) would not have started their project without this particular hackathon and indicated that the hackathon encouraged and enabled them to progress faster, for example, by building interdisciplinary teams, gaining new insights and feedback provided by their mentors, and creating a functional prototype. CONCLUSIONS: This study provides insights into how online hackathons can contribute to solving the challenges and effects of a pandemic in several regions of the world. The online format fosters team diversity, increases cross-regional collaboration, and can be executed much faster and at lower costs compared to in-person events. Results on preparation, organization, and evaluation of this online hackathon are useful for other institutions and initiatives that are willing to introduce similar event formats in the fight against COVID-19.

Telemedicine and COVID-19 pandemic: The perfect storm to mark a change in diabetes care. Results from a world-wide cross-sectional web-based survey.

BACKGROUND: Telemedicine for routine care of people with diabetes (PwD) during the COVID-19 pandemic rapidly increased in many countries, helping to address the several barriers usually seen. OBJECTIVE: This study aimed to describe healthcare professionals' (HCPs) experience on telemedicine use in diabetes care and investigate the changes and challenges associated with its implementation. METHODS: A cross-sectional electronic survey was distributed through the global network of JENIOUS members of ISPAD. Respondents' professional and practice profiles, clinic sizes, their country of practice, and data regarding local telemedicine practices during COVID-19 pandemic were investigated. RESULTS: Answers from 209 HCPs from 33 countries were analyzed. During the pandemic, the proportion of PwD receiving telemedicine visits increased from <10% (65.1% of responders) to >50% (66.5%). There was an increase in specific privacy requirements for remote visits (37.3% to 75.6%), data protection policies (42.6% to 74.2%) and reimbursement for remote care (from 41.1% to 76.6%). Overall, 83.3% HCPs reported to be satisfied with the use of telemedicine. Some concerns (17.5%) about the complexity and heterogeneity of the digital platforms to be managed in everyday practice remain, feeding the need for unifying and making interoperable the tools for remote care. Also, 45.5% of professionals reported to feel stressed by the need for extra-time for telemedicine consultations. CONCLUSIONS: Telemedicine was rapidly and broadly adopted during the pandemic globally. Some issues related to its use were promptly addressed by local institutions. Challenges with the use of different platforms and for the need of extra-time still remain to be solved.

[Mobile applications (apps) for diagnosis and treatment control in pediatric and adolescent medicine]. / Mobile Applikationen (Apps) zu Diagnosefindung und Therapiesteuerung in der Kinder- und Jugendmedizin: Chancen und Grenzen.

Digitalization is finding its way into medicine in many different forms. Whether patient-centered, networking, supporting medical personnel or in (clinical) research: digital technologies have become an integral part of everyday medical life not only since the pandemic triggered by the SARS-CoV-2 virus. For example, mobile smartphone applications are among the most frequent developments; however, the multitude of available products and the lack of time in medical practice often make a reliable assessment of the quality, safety and functionality difficult. This review article summarizes current developments in mobile technologies in the field of pediatrics and adolescent medicine and illustrates available applications with concrete examples. The aim is to encourage readers to make their own experiences and to sharpen their view of possible risks.

Costs and underuse of insulin and diabetes supplies: Findings from the 2020 T1International cross-sectional web-based survey.

AIMS: To investigate self-reported out-of-pocket expenses (OoPE) associated with insulin and diabetes supplies for people living with type 1 diabetes (T1D) worldwide. METHODS: A web-based, cross-sectional survey was conducted from August to December 2020. The analysis included comparisons between responses from countries with no, partial, and full healthcare coverage. RESULTS: 1,066 participants from 64 countries took part in the study. ~25% of respondents reported having underused insulin at least once within the last year due to perceived cost. A significant correlation was observed between OoPEs and reported household income for respondents with partial healthcare coverage. 63.2% of participants reported disruption of insulin supplies and 25.3% reported an increase of prices related to the COVID-19 pandemic. CONCLUSIONS: This study confirms previous reports of ~25% of people in the United States with T1D using less insulin and/or fewer supplies at least once in the last year due to cost, a trend associated with the extent of healthcare coverage. Similar trends were observed in some middle/low income countries. Moreover, patients reported an increase in insulin prices and disruption of supplies during the COVID-19 pandemic. This study highlights the importance of self-reported OoPEs and its association with underuse/rationing of insulin.

Shaping Workflows in Digital and Remote Diabetes Care During the COVID-19 Pandemic via Service Design: Prospective, Longitudinal, Open-label Feasibility Trial.

BACKGROUND: The COVID-19 pandemic poses new challenges to health care providers and the delivery of continuous care. Although many diabetes technologies, such as insulin pumps and continuous glucose monitors, have been established, the data from these devices are rarely assessed. Furthermore, telemedicine has not been sufficiently integrated into clinical workflows. OBJECTIVE: We sought to remotely support children with type 1 diabetes and their caregivers, enhance the clinical outcomes and quality of life of children with diabetes, increase multiple stakeholders' engagement with digital care via a participatory approach, evaluate the feasibility of using an interoperable open-source platform in a university hospital setting, and analyze the success factors and barriers of transitioning from conventional care to digital care. METHODS: Service design methods were used to adapt clinical workflows. Remote consultations were performed on a monthly and on-demand basis. Diabetes device data were uploaded from patients' homes to an open-source platform. Clinical and patient-reported outcomes were assessed before, during, and after the COVID-19 lockdown period in Germany. RESULTS: A total of 28 children with type 1 diabetes and their caregivers enrolled in this study and completed 6 months of remote visits. Of these 28 participants, 16 (57%) also opted to attend at least one of their regular visits remotely. After 3 months of remote visits, participants' time in range (P=.001) and time in hyperglycemia (P=.004) significantly improved, and their time in hypoglycemia did not increase. These improvements were maintained during the COVID-19 lockdown period (ie, between months 3 and 6 of this study). Participants' psychosocial health improved after 6 months. CONCLUSIONS: Remote consultations and commonly shared data access can improve the clinical outcomes and quality of life of children with type 1 diabetes, even during challenging circumstances. A service design approach helped with the delivery of comprehensive and holistic solutions that accounted for the needs of multiple stakeholders. Our findings can inform the future integration of digital tools into clinical care during and beyond the pandemic. TRIAL REGISTRATION: German Clinical Trials Register DRKS00016170; https://tinyurl.com/skz4wdk5.

Undergraduate Medical Competencies in Digital Health and Curricular Module Development: Mixed Methods Study.

BACKGROUND: Owing to an increase in digital technologies in health care, recently leveraged by the COVID-19 pandemic, physicians are required to use these technologies appropriately and to be familiar with their implications on patient care, the health system, and society. Therefore, medical students should be confronted with digital health during their medical education. However, corresponding teaching formats and concepts are still largely lacking in the medical curricula. OBJECTIVE: This study aims to introduce digital health as a curricular module at a German medical school and to identify undergraduate medical competencies in digital health and their suitable teaching methods. METHODS: We developed a 3-week curricular module on digital health for third-year medical students at a large German medical school, taking place for the first time in January 2020. Semistructured interviews with 5 digital health experts were recorded, transcribed, and analyzed using an abductive approach. We obtained feedback from the participating students and lecturers of the module through a 17-item survey questionnaire. RESULTS: The module received overall positive feedback from both students and lecturers who expressed the need for further digital health education and stated that the field is very important for clinical care and is underrepresented in the current medical curriculum. We extracted a detailed overview of digital health competencies, skills, and knowledge to teach the students from the expert interviews. They also contained suggestions for teaching methods and statements supporting the urgency of the implementation of digital health education in the mandatory curriculum. CONCLUSIONS: An elective class seems to be a suitable format for the timely introduction of digital health education. However, a longitudinal implementation in the mandatory curriculum should be the goal. Beyond training future physicians in digital skills and teaching them digital health's ethical, legal, and social implications, the experience-based development of a critical digital health mindset with openness to innovation and the ability to assess ever-changing health technologies through a broad transdisciplinary approach to translate research into clinical routine seem more important. Therefore, the teaching of digital health should be as practice-based as possible and involve the educational cooperation of different institutions and academic disciplines.