Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational Survey of Adults With Type 1 Diabetes.

BACKGROUND: Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity. OBJECTIVE: This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study. METHODS: Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID. RESULTS: In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics. CONCLUSIONS: Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items.

Real-world evidence on clinical outcomes of people with type 1 diabetes using open-source and commercial automated insulin dosing systems: A systematic review.

AIMS: Several commercial and open-source automated insulin dosing (AID) systems have recently been developed and are now used by an increasing number of people with diabetes (PwD). This systematic review explored the current status of real-world evidence on the latest available AID systems in helping to understand their safety and effectiveness. METHODS: A systematic review of real-world studies on the effect of commercial and open-source AID system use on clinical outcomes was conducted employing a devised protocol (PROSPERO ID 257354). RESULTS: Of 441 initially identified studies, 21 published 2018-2021 were included: 12 for Medtronic 670G; one for Tandem Control-IQ; one for Diabeloop DBLG1; two for AndroidAPS; one for OpenAPS; one for Loop; three comparing various types of AID systems. These studies found that several types of AID systems improve Time-in-Range and haemoglobin A1c (HbA1c ) with minimal concerns around severe hypoglycaemia. These improvements were observed in open-source and commercially developed AID systems alike. CONCLUSIONS: Commercially developed and open-source AID systems represent effective and safe treatment options for PwD of several age groups and genders. Alongside evidence from randomized clinical trials, real-world studies on AID systems and their effects on glycaemic outcomes are a helpful method for evaluating their safety and effectiveness.

Emotional and Physical Health Impact in Children and Adolescents and Their Caregivers Using Open-source Automated Insulin Delivery: Qualitative Analysis of Lived Experiences.

BACKGROUND: Given the limitations in the access and license status of commercially developed automated insulin delivery (AID) systems, open-source AID systems are becoming increasingly popular among people with diabetes, including children and adolescents. OBJECTIVE: This study aimed to investigate the lived experiences and physical and emotional health implications of children and their caregivers following the initiation of open-source AID, their perceived challenges, and sources of support, which have not been explored in the existing literature. METHODS: Data were collected through 2 sets of open-ended questions from a web-based multinational survey of 60 families from 16 countries. The narratives were thematically analyzed, and a coding framework was identified through iterative alignment. RESULTS: A range of emotions and improvements in quality of life and physical health were reported, as open-source AID enabled families to shift their focus away from diabetes therapy. Caregivers were less worried about hypoglycemia at night and outside their family homes, leading to increased autonomy for the child. Simultaneously, the glycemic outcomes and sleep quality of both the children and caregivers improved. Nonetheless, the acquisition of suitable hardware and technical setup could be challenging. The #WeAreNotWaiting community was the primary source of practical and emotional support. CONCLUSIONS: Our findings show the benefits and transformative impact of open-source AID and peer support on children with diabetes and their caregivers and families, where commercial AID systems are not available or suitable. Further efforts are required to improve the effectiveness and usability and facilitate access for children with diabetes, worldwide, to benefit from this innovative treatment. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/15368.

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.

Why #WeAreNotWaiting-Motivations and Self-Reported Outcomes Among Users of Open-source Automated Insulin Delivery Systems: Multinational Survey.

BACKGROUND: Automated insulin delivery (AID) systems have been shown to be safe and effective in reducing hyperglycemia and hypoglycemia but are not universally available, accessible, or affordable. Therefore, user-driven open-source AID systems are becoming increasingly popular. OBJECTIVE: This study aims to investigate the motivations for which people with diabetes (types 1, 2, and other) or their caregivers decide to build and use a personalized open-source AID. METHODS: A cross-sectional web-based survey was conducted to assess personal motivations and associated self-reported clinical outcomes. RESULTS: Of 897 participants from 35 countries, 80.5% (722) were adults with diabetes and 19.5% (175) were caregivers of children with diabetes. Primary motivations to commence open-source AID included improving glycemic outcomes (476/509 adults, 93.5%, and 95/100 caregivers, 95%), reducing acute (443/508 adults, 87.2%, and 96/100 caregivers, 96%) and long-term (421/505 adults, 83.3%, and 91/100 caregivers, 91%) complication risk, interacting less frequently with diabetes technology (413/509 adults, 81.1%; 86/100 caregivers, 86%), improving their or child's sleep quality (364/508 adults, 71.6%, and 80/100 caregivers, 80%), increasing their or child's life expectancy (381/507 adults, 75.1%, and 84/100 caregivers, 84%), lack of commercially available AID systems (359/507 adults, 70.8%, and 79/99 caregivers, 80%), and unachieved therapy goals with available therapy options (348/509 adults, 68.4%, and 69/100 caregivers, 69%). Improving their own sleep quality was an almost universal motivator for caregivers (94/100, 94%). Significant improvements, independent of age and gender, were observed in self-reported glycated hemoglobin (HbA1c), 7.14% (SD 1.13%; 54.5 mmol/mol, SD 12.4) to 6.24% (SD 0.64%; 44.7 mmol/mol, SD 7.0; P<.001), and time in range (62.96%, SD 16.18%, to 80.34%, SD 9.41%; P<.001). CONCLUSIONS: These results highlight the unmet needs of people with diabetes, provide new insights into the evolving phenomenon of open-source AID technology, and indicate improved clinical outcomes. This study may inform health care professionals and policy makers about the opportunities provided by open-source AID systems. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/15368.

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.

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

[This corrects the article DOI: 10.2196/22161.].

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.

Hackathons as Stepping Stones in Health Care Innovation: Case Study With Systematic Recommendations.

BACKGROUND: Until recently, developing health technologies was time-consuming and expensive, and often involved patients, doctors, and other health care professionals only as passive recipients of the end product. So far, users have been minimally involved in the ideation and creation stages of digital health technologies. In order to best address users' unmet needs, a transdisciplinary and user-led approach, involving cocreation and direct user feedback, is required. In this context, hackathon events have become increasingly popular in generating enthusiasm for user-centered innovation. OBJECTIVE: This case study describes preparatory steps and the performance of a health hackathon directly involving patients and health care professionals at all stages. Feasibility and outcomes were assessed, leading to the development of systematic recommendations for future hackathons as a vehicle for bottom-up innovation in health care. METHODS: A 2-day hackathon was conducted in February 2017 in Berlin, Germany. Data were collected through a field study. Collected field notes were subsequently discussed in 15 informal meetings among the research team. Experiences of conducting two further hackathons in December 2017 and November 2018 were included. RESULTS: In total, 30 participants took part, with 63% (19/30) of participants between 25 and 34 years of age, 30% (9/30) between 35 and 44 years of age, and 7% (2/30) younger than 25 years of age. A total of 43% (13/30) of the participants were female. The participation rate of medical experts, including patients and health care professionals, was 30% (9/30). Five multidisciplinary teams were formed and each tackled a specific health care problem. All presented projects were apps: a chatbot for skin cancer recognition, an augmented reality exposure-based therapy (eg, for arachnophobia), an app for medical neighborhood connectivity, a doctor appointment platform, and a self-care app for people suffering from depression. Patients and health care professionals initiated all of the projects. Conducting the hackathon resulted in significant growth of the digital health community of Berlin and was followed up by larger hackathons. Systematic recommendations for conducting cost-efficient hackathons (n≤30) were developed, including aspects of community building, stakeholder engagement, mentoring, themes, announcements, follow-up, and timing for each step. CONCLUSIONS: This study shows that hackathons are effective in bringing innovation to health care and are more cost- and time-efficient and potentially more sustainable than traditional medical device and digital product development. Our systematic recommendations can be useful to other individuals and organizations that want to establish user-led innovation in academic hospitals by conducting transdisciplinary hackathons.

Open-Source Technology for Real-Time Continuous Glucose Monitoring in the Neonatal Intensive Care Unit: Case Study in a Neonate With Transient Congenital Hyperinsulinism.

BACKGROUND: Use of real-time continuous glucose monitoring (rtCGM) systems has been shown to be a low-pain, safe, and effective method of preventing hypoglycemia and hyperglycemia in people with diabetes of various age groups. Evidence on rtCGM use in infants and in patients with conditions other than diabetes remains limited. OBJECTIVE: This case study describes the off-label use of rtCGM and the use of an open-source app for glucose monitoring in a newborn with prolonged hypoglycemia secondary to transient congenital hyperinsulinism during the perinatal period. METHODS: The Dexcom G6 rtCGM system (Dexcom, Inc) was introduced at 39 hours of age. Capillary blood glucose checks were performed regularly. In order to benefit from customizable alert settings and detect hypoglycemic episodes, the open-source rtCGM app xDrip+ was introduced at 9 days of age. RESULTS: Time in range (45-180 mg/dL) for interstitial glucose remained consistently above 90%, whereas time in hypoglycemia (<45 mg/dL) decreased. Mean glucose was maintained above 70 mg/dL at 72 hours of life and thereafter. Daily sensor glucose profiles showed cyclic fluctuations that were less pronounced over time. CONCLUSIONS: While off-label use of medication is both common practice and a necessity in newborn infants, there are few examples of off-label uses of medical devices, rtCGM being a notable exception. Real-time information allowed us to better understand glycemic patterns and to improve the quality of glycemic control accordingly. Severe hypoglycemia was prevented, and measurement of serum levels of insulin and further lab diagnostics were performed much faster, while the patient's individual burden caused by invasive procedures was reduced. Greater customizability of threshold and alert settings would be beneficial for user groups with glycemic instability other than people with diabetes, and for hospitalized newborn infants in particular. Further research in the field of personal and off-label rtCGM use, efficacy studies evaluating the accuracy of low glucose readings, and studies on the differences between algorithms in translating raw sensor data, as well as customization of commercially available rtCGM systems, is needed.

[Care of children and adolescents with type 1 diabetes: solutions for technical and psychosocial challenges]. / Versorgung von Kindern und Jugendlichen mit Typ-1-Diabetes: Lösungen für technische und psychosoziale Herausforderungen.

Type 1 diabetes mellitus is the most common endocrine disease in children and adolescents below age 15 years. A cure for the autoimmune disease against the insulin-secreting beta cells is still not in sight. Nevertheless, in recent years technical advances in innovation concerning glucose sensor technology, insulin pumps, and new algorithms that regulate insulin delivery have led to a constant improvement of metabolic control achieved in children and adolescents with type 1 diabetes.This review article shows the current care situation of children and adolescents with type 1 diabetes and their parents. The multidisciplinary care in specialized pediatric diabetes teams of pediatric diabetologists, diabetes educators, social workers, and psychotherapists has been established for many years and has set grounds for a very good quality of care for children and adolescents with type 1 diabetes in Germany. The focus is on diabetes education, in particular self-management, psychosocial support and intervention, and the inclusion of children and adolescents with diabetes in school, kindergarten, and daycare centers. We also address new, social developments in the online diabetes community. A current example is the patient-operated ecosystem of the Do-It-Yourself Artificial Pancreas System (DIY APS) movement, which, as a patient-operated, open-source project, has meanwhile also become an innovator for industry. Finally, we highlight related opportunities and shifts in classical doctor-patient roles.

Out-of-pocket expenses and rationing of insulin and diabetes supplies: findings from the 2022 T1International cross-sectional web-based survey.

Introduction: Continue investigating Out-of-Pocket Expenses (OoPEs) and rationing of insulin and diabetes supplies, including impacts of the COVID-19 pandemic, for people with type 1 diabetes (T1D). Methods: A cross-sectional web-based survey was conducted in English and advertised by T1International's global network of patient advocates from May through September 2022. Participants provided monthly OoPEs and rationing frequency for insulin and supplies, impacts of the COVID-19 pandemic, and open-ended comments. Results: In the seven most represented countries, mean monthly OoPEs were highest in the United States, followed by Panama, Canada, and India, and were much lower in the United Kingdom, Germany, and Sweden. OoPEs were highest for participants with partial healthcare coverage, followed by those with no healthcare coverage. The COVID-19 pandemic negatively impacted access and/or affordability of insulin and/or supplies for over half of participants. Globally, 19.5% reported insulin rationing and 36.6% reported rationing glucose testing supplies. Qualitative analysis of open-ended responses identified themes such as 'mental health impacts' and 'limits to life choices.' Discussion: High OoPEs lead to rationing of insulin and supplies for many people with T1D globally. Healthcare systems improvements and price reductions of insulin and supplies are needed to ensure adequate, equitable access for all.

ISPAD ANNUAL CONFERENCE HIGHLIGHTS 2023.

The 49th Annual Conference of the International Society of Pediatric and Adolescent Diabetes (ISPAD), held from October 18 to 21, 2023, in Rotterdam, Netherlands, showcased significant advancements and diversity in paediatric and adolescent diabetes research and clinical innovations. The conference, renowned for its global impact, brought together experts to discuss cutting-edge developments in the field. Highlights from the plenary sessions included ground-breaking research on immunotherapies and diabetes technologies and offering new insights into personalised treatment approaches. Keynote speakers emphasised the importance of early diagnosis, prevention and the potential of novel biomarkers in predicting disease progression. The symposia covered a broad spectrum of topics, from advancements in continuous glucose monitoring technologies to the latest in hybrid closed loop systems which promise to revolutionise diabetes management for young patients.

The First Regulatory Clearance of an Open-Source Automated Insulin Delivery Algorithm.

Open-source Automated Insulin Dosing (OS-AID) algorithms are made publicly accessible so that every facet of their operation can be understood. Currently, commercial AID algorithms are kept proprietary trade secrets, despite the role they take in making life and death decisions for people living with type 1 diabetes. Loop was the second OS-AID algorithm, developed initially by Nate Racklyeft and Pete Schwamb. In 2018, the nonprofit organization Tidepool (Palo Alto, CA) announced the launch of the "Tidepool Loop" initiative with the aim to generate real-world evidence and obtain regulatory clearance. By the end of 2020, the U.S. Food and Drug Administration received Tidepool's application for an interoperable automated glycemic controller based on Loop. After 2 years, the FDA approved the Tidepool Loop on January 23, 2023.

Variability of Glycemic Outcomes and Insulin Requirements Throughout the Menstrual Cycle: A Qualitative Study on Women With Type 1 Diabetes Using an Open-Source Automated Insulin Delivery System.

BACKGROUND: The impact of hormone dynamics throughout the menstrual cycle on insulin sensitivity represents a currently under-researched area. Despite therapeutic and technological advances, self-managing insulin therapy remains challenging for women with type 1 diabetes (T1D). METHODS: To investigate perceived changes in glycemic levels and insulin requirements throughout the menstrual cycle and different phases of life, we performed semi-structured interviews with 12 women with T1D who are using personalized open-source automated insulin delivery (AID) systems. Transcripts were analyzed using thematic analysis with an inductive, hypothesis-generating approach. RESULTS: Participants reported significant differences between the follicular phase, ovulation, and luteal phase of the menstrual cycle and also during puberty, pregnancy, and menopause. All participants reported increased comfort and safety since using AID, but were still required to manually adjust their therapy according to their cycle. A lack of information and awareness and limited guidance by health care providers were frequently mentioned. Although individual adjustment strategies exist, achieving optimum outcomes was still perceived as challenging. CONCLUSIONS: This study highlights that scientific evidence, therapeutic options, and professional guidance on female health-related aspects in T1D are insufficient to date. Further efforts are required to better inform people with T1D, as well as for health care professionals, researchers, medical device manufacturers, and regulatory bodies to better address female health needs in therapeutic advances.

Quality of life and psychological well-being among children and adolescents with diabetes and their caregivers using open-source automated insulin delivery systems: Findings from a multinational survey.

BACKGROUND: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in children and adolescents with type 1 diabetes (T1D) in real-world studies. However, there is a lack of evidence on the effect on their caregivers' quality-of-life (QoL) and well-being. The aim of this study was to assess the QoL of caregivers and children and adolescents using open-source AID systems using validated measures. METHODS: In this cross-sectional online survey we examined the caregiver-reported QoL and well-being of users and non-users. Validated questionnaires assessed general well-being (WHO-5), diabetes-specific QoL (PAID, PedsQL) and sleep quality (PSQI). RESULTS: 168 caregivers from 27 countries completed at least one questionnaire, including 119 caregivers of children using open-source AID and 49 not using them. After inclusion of covariates, all measures but the PAID and one subscale of the PedsQL showed significant between-group differences with AID users reporting higher general (WHO-5: p = 0.003), sleep-related (PSQI: p = 0.001) and diabetes-related QoL (PedsQL: p < 0.05). CONCLUSIONS: The results show the potential impact of open-source AID on QoL and psychological well-being of caregivers and children and adolescents with T1D, and can therefore help to inform academia, regulators, and policymakers about the psychosocial health implications of open-source AID.

Barriers to uptake of Open-Source automated insulin delivery Systems: Analysis of socioeconomic factors and perceived challenges of adults with type 1 diabetes from the OPEN survey.

AIMS: Social and technical trends are empowering people with diabetes to co-create or self-develop medical devices and treatments to address their unmet healthcare needs, for example, open-source automated insulin delivery (AID) systems. This study aims to investigate the perceived barriers towards adoption and maintaining of open-source AID systems. METHODS: This is a multinational study based on a cross-sectional, retrospective web-based survey of non-users of open-source AID. Participants (n = 129) with type 1 diabetes from 31 countries were recruited online to elicit their perceived barriers towards building and maintaining of an open-source AID system. RESULTS: Sourcing the necessary components, lack of confidence in one's own technology knowledge and skills, perceived time and energy required to build a system, and fear of losing healthcare provider support appear to be major barriers towards the uptake of open-source AID. CONCLUSIONS: This study identified a range of structural and individual-level barriers to uptake of open-source AID. Some of these individual-level barriers may be overcome over time through the peer support of the DIY online community as well as greater acceptance of open-source innovation among healthcare professionals. The findings have important implications for understanding the possible wider diffusion of open-source diabetes technology solutions in the future.

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.

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.