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BACKGROUND Despite the fact that commercially developed automated insulin delivery (AID) systems have recently been approved and become available in a limited number of countries, they are not universally available, accessible, or affordable. Therefore, ‘open-source’ AID systems, co-created by an online community of people with diabetes (PwD) and their families behind the hashtag ‘#WeAreNotWaiting’, have become increasingly popular. OBJECTIVE This study focused on lived experiences, physical and emotional health implications of PwD following the initiation of open-source AID, their perceived challenges, and sources of support, which have not been explored by the existing literature. METHODS Data were collected from 383 participants across 29 countries through two sets of open-ended questions of a web-based survey regarding their experience of building and using open-source AID. Narratives were thematically analyzed and a coding framework was identified through iterative alignment. RESULTS Improvements in glycemia, physical health, sleep quality, emotional impact on everyday life and quality of life were consistently reported. Knowledge of open-source AID was largely obtained through the #WeAreNotWaiting community, which was also the primary source of practical and emotional support. Acquisition of the components to build open-source AID and technical set-up were sometimes problematic. CONCLUSIONS The #WeAreNotWaiting movement represents a primary example of how informed and connected patients proactively address their unmet needs, provide peer-support to each other and result in impactful user-driven solutions. Alongside evidence on the safety and efficacy of open-source AID, this qualitative analysis helps understand how patients’ experience and benefits range from psychosocial improvements to a reduction in the burden of managing diabetes. INTERNATIONAL REGISTERED REPORT RR2-10.2196/15368

ZusammenfassungDer Einsatz von Insulin zur Therapie des Diabetes mellitus Typ 1 beim Menschen hat vor 100 Jahren erstmals zum Überleben betroffener Patienten nach Manifestation der Erkrankung geführt. War zuvor die Diagnose mit der Gewissheit verknüpft, dass es sich um eine unmittelbar lebensbedrohliche Erkrankung handelt, wurde mit dem Einsatz des Hormons Insulin ab 1922 die Perspektive eröffnet, den Verlauf der Erkrankung zu beeinflussen und die Prognose für die Patienten damit zu verbessern.Ziel der vorliegenden Arbeit ist die Analyse von 92366 Patienten eines pädiatrischen Patientenkollektivs aus Deutschland, Österreich, Luxemburg und der Schweiz im Hinblick auf den Einsatz der verschiedenen Insulinarten im Zeitraum 1995–2021.Der Anteil der Insulinanaloga stieg insbesondere seit dem Jahr 2000 stark an, auch da die Nutzung von Insulinpumpen mit Analoginsulin im Vergleich zur intensivierten Insulintherapie mit Pen für alle Altersgruppen deutlich anstieg. Bereits im Jahr 2010 betrug der Anteil der Insulinanaloga in der Diabetestherapie bei Kindern insgesamt > 60 %.Im Jahr 2022 können Diabetologen auf mehr als zehn Insulinarten und mindestens fünf verschiedene Therapieformen zur Behandlung des Diabetes mellitus Typ 1 zurückgreifen.

BACKGROUND Treatment of patients with type 1 diabetes requires experience and a specific infrastructure. Therefore, center size might influence outcome in diabetes treatment. OBJECTIVE To analyze the influence of center size on the quality of diabetes treatment in children and adolescents in Germany and Austria. PATIENTS AND METHODS In 2009 and 2018, we analyzed metabolic control, acute complications, and rates of recommended screening tests in the DPV cohort. Diabetes centers were classified according to the number of patients from "XS" to "XL" (

Background: Given the limitations in access and license status of commercially developed automated insulin delivery (AID) systems, open-source AID systems are becoming increasingly popular amongst people with diabetes, including children and adolescents. This study focused on lived experiences, 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 by the existing literature. Methods: Qualitative data were collected through two sets of open-ended questions of a web-based multinational study survey from 60 caregivers of children with diabetes from 16 countries. The narratives were thematically analysed and a coding framework was identified through an iterative process after the alignment discussions among three coders. Results: A range of emotions, improvements of quality of life and physical health were reported as open-source AID enabled the families to shift their focus away from diabetes therapy. Caregivers were less worried about hypoglycaemia at night-time and outside of their family home, leading to increased autonomy for the child. Simultaneously, glycaemic outcomes and sleep quality of both child and caregiver improved. Nonetheless, the acquisition of suitable hardware and technical set-up could be challenging. The #WeAreNotWaiting community was the primary source of practical but also emotional support. Conclusion: Our findings show the benefits and transformative impact open-source AID and peer-support have on children with diabetes, their caregivers, and families, where commercial AID systems are not available or suitable. Further efforts are required to improve effectiveness, usability, and facilitate access for children with diabetes worldwide to benefit from this innovative treatment. Funding: European Commission (H2020-MSCA-RISE-2018), Berlin Institute of Health Digital Clinician Scientist and SPOKES Wellcome Trust Translational Partnership Program. Declaration of Interest: KB received fees for medical consulting and public speaking from Roche Diabetes Care, Dexcom, Medtronic Diabetes, Diabeloop, Novo Nordisk, Sanofi Diabetes and BCG Digital Ventures; outside the submitted work. KR received fees for medical consulting and public speaking from Dexcom, Abbott, Lilly Diabetes Care, Novo Nordisk (Germany) and Springer Healthcare UK; outside the submitted work. All other authors have nothing to disclose. Ethical Approval: Ethical approval was provided by Charite – Universitatsmedizin Berlin (EA2/140/18).

To describe clinical presentation/longterm outcomes of patients with ABCC8/KCNJ11 variants in a large cohort of patients with diabetes.We analyzed patients in the Diabetes Prospective Follow-up (DPV) registry with diabetes and pathogenic variants in the ABCC8/KCNJ11 genes. For patients with available data at three specific time-points-classification as KWe identified 93 cases with ABCC8 (n = 54)/KCNJ11 (n = 39) variants, 63 of them with neonatal diabetes. For 22 patients, follow-up data were available. Of these, 19 were treated with insulin at diagnosis, and the majority of patients was switched to sulfonylurea thereafter. However, insulin was still administered in six patients at the most recent visit. Patients were in good metabolic control with a median (IQR) A1c level of 6.0% (5.5-6.7), that is, 42.1 (36.6-49.7) mmol/mol after 2 years and 6.7% (6.0-8.0), that is, 49.7 (42.1-63.9) mmol/mol at the most recent visit. Five patients were temporarily without medication for a median (IQR) time of 4.0 (3.5-4.4) years, while two other patients continue to be off medication at the last follow-up.ABCC8/KCNJ11 variants should be suspected in children diagnosed with diabetes below the age of 6 months, as a high percentage can be switched from insulin to oral antidiabetic drugs. Thirty patients with diabetes due to pathogenic variants of ABCC8 or KCNJ11 were diagnosed beyond the neonatal period. Patients maintain good metabolic control even after a diabetes duration of up to 11 years.

Background: Open-source automated insulin delivery (AID) systems have shown to be safe and effective in clinical and real-world studies and to increase quality of life (QoL) in adult users. However, there is a lack of evidence on the effect on health-related QoL and general wellbeing in children and their caregivers. Therefore, the aim of this study was to assess the QoL of children and adolescents with diabetes using open-source AID systems using validated measures. Method: In this cross-sectional, population-based global online survey we examined the caregiver-reported QoL and psychological well-being of users and non-users of open-source AID. Validated questionnaires assessed general emotional wellbeing (WHO-5 Well-being Index) , diabetes-specific QoL (Problem Areas in Diabetes Survey - Parent Revised version (PAID-PR) , Pediatric Quality of Life Inventory (PedsQL, diabetes module) and subjective sleep quality (Pittsburgh Sleep Quality Index (PSQI)) . Results: In total 188 caregivers from 27 countries completed at least one questionnaire on behalf of their children, including 132 children with type 1 diabetes using open-source AID (mean age 11.5 (SD 3.5) , 48% female) and 56 children with type 1 diabetes who were non-users at the time of the survey (mean age 10.4 (SD 3.3) , 41% female) . All questionnaire scores showed significant between-group differences with the AID users reporting higher general (WHO-5: p Discussion: The results show the beneficial impact that open-source AID systems have on the QoL and psychological well-being of children and adolescents, and can therefore help to inform academia, regulatory decision- and policymakers about the potential that open-source AID systems hold. Further research is needed to examine the reasons for the differences between the groups. Disclosure C.Knoll: None. K.Raile: Other Relationship; Dexcom, Inc. K.Braune: None. H.Ballhausen: None. J.Schipp: None. T.C.Skinner: None. M.Wäldchen: None. S.O'donnell: None. K.A.Gajewska: None. B.Cleal: None. Funding European Commission's Horizon 2020 Research and Innovation Program under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange (RISE) (grant agreement number 823902)

Der aktuelle Stand telemedizinischer Anwendungen und deren zu erwartendes Potenzial werden aus der Perspektive der padiatrischen Diabetologie beleuchtet. Kontinuierliche Glukosemesssysteme (CGM [„continuous glucose measurement“]) und Insulinpumpen lassen sich zunehmend auch uber interoperable oder herstellerbasierte Datenplattformen auslesen und teilen und ermoglichen es den Diabetesteams, eine Beratung auf Basis dieser Daten auch ohne physischen Kontakt in die kontinuierliche Versorgung einzubauen. Videosprechstunden konnen dabei zunachst ein erganzendes Angebot darstellen, unterliegen oft langeren Implementierungsprozessen und sind u. a. abhangig von datenschutzkonformer Videochatsoftware, koordinierten Arbeitsablaufen sowie technischem Support. Telemedizin kann derzeit schon bestehende Beratungsstrukturen in Kliniken und Praxen erganzen und helfen, das Potenzial digital dokumentierter Daten aus CGM- und automatisierten Insulinabgabesystemen voll auszuschopfen, wobei telemedizinische Anwendungen bisher kein direktes Einsparungspotenzial bezuglich Zeit und Aufwand des medizinischen Personals und damit der Personalkosten bieten.

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 and 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.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).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: p0.05).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.

Background: Diet modification has the potential to influence glycemic control and diabetes outcome in patients with type 1 diabetes (T1D). This cross-sectional study aimed to assess types of diets being reported by patients with T1D and documented in the Diabetes Patients Follow-Up Registry (DPV). Methods: The DPV registry was screened for additional free text entries containing information about certain diets and/or physician-based diagnoses requiring special diets e. g. celiac disease. Descriptive analysis and unadjusted comparisons between patients with T1D following at least one special diet and controls (T1D without diet) were performed. Results: Overall, 113,894 patients with T1D of all ages were included. In 2.3% (n = 2,595; median age 11.3 yrs [Q1; Q3: 7.0; 15.2]), at least one kind of diet was documented. These patients were significantly younger at diabetes onset than controls (median age 7.5 yrs [Q1; Q3: 3.9; 11.4] vs. 11.1 yrs [6.6; 16.7]; p < 0.001) and showed a significantly lower BMI-SDS (median [Q1; Q3]: 0.220 [−0.427;0.812] vs. 0.450 [−0.211;1.088]). Diet was more often reported in females (55.7% vs. 44.3%, p < 0.001). The three most common diets were gluten-free diet due to celiac disease, low-protein diet, and lactose-restricted diet due to lactoseintolerance. A combination of two diagnoses in one patient (n = 44, 1.7% of the entire diet group) was predominantly intolerance to both fructose and lactose. Among all diet subgroups the highest BMI-SDS was found in the group diets for weight loss. Conclusions: This study revealed a wide range of eating habits in patients with T1D. A special diet was more frequently documented in females. The main reason for adhering to a diet was a concomitant disease. As any diet modification could impact glycemic control, health care providers should be encouraged to regularly ask their patients about their eating habits and provide training and support by specialized dietitians.

Aim To determine the prevalence of inflammatory bowel disease (IBD) in patients with type 1 diabetes (T1D) and to characterise patients with both diseases. Methods Data of 65.147 patients with T1D ≤18 years of 379 centres in Germany and Austria participating in the DPV initiative were analysed. A total of 63 children had comorbid IBD; IBD prevalence was 0.1%. Regression models were used to analyse differences in metabolic control, acute complications and steroid intake. Results Mean BMI‐SDS in patients with T1D and IBD was lower (−0.15 ± 0.11) compared to patients with T1D only (0.27 ± 0.00, p

Objectives: We analyzed uptake, volume and covariates of telemedicine use in children and adolescents with type 1 diabetes in 2020 with focus on the COVID-19 lockdown in Germany and provide first outcome data associated with telemedicine use. Research design and methods: Based on data from the German Diabetes Prospective Follow-up Registry (DPV) in 2020, we included 247 pediatric diabetes centers following 26,365 children and adolescents with type 1 diabetes. Centers and individuals were characterized according to telemedicine use. Effects of the lockdown from March 13th to May 13th 2020 versus the entire years 2020 and 2019 were analyzed.Results: During the lockdown in 2020, telemedicine visits increased from pre-lockdown 0.6% of all patient visits to 12.8% and remained 3.5 % until end of 2020. Among 247 centers only 11 provided telemedicine to more than 50 patients, while telephone contacts were the preferred telemedicine-mode during lockdown. Patients receiving telemedicine in 2020 had lower HbA1c, longer distance to diabetes centers, less frequently migration background and higher use of insulin pumps or CGMS. Discussion: Telemedicine experienced a dramatic boost during and after the strict lockdown in Germany. Anyhow absolute numbers of telemedicine in outpatient contacts remained below 5% and thus telemedicine did not take a load-carrying role in pediatric diabetes care in Germany. Having migration background and not using diabetes technology possibly reflect barriers to scale up digital communication.

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 RR2-10.2196/15368

Congenital hearing loss is a common disorder worldwide. Heterogeneous gene variation accounts for approximately 20-25% of such patients. We investigated a five-generation Chinese family with autosomal-dominant nonsyndromic sensorineural hearing loss (SNHL). No wave was detected in the pure-tone audiometry, and the auditory brainstem response was absent in all patients. Computed tomography of the patients, as well as of two sporadic SNHL cases, showed bilateral inner ear anomaly, cochlear maldevelopment, absence of the osseous spiral lamina, and an enlarged vestibular aqueduct. Such findings were absent in nonaffected persons. We used linkage analysis and exome sequencing and uncovered a heterozygous missense mutation in the PI4KB gene (p.Gln121Arg) encoding phosphatidylinositol 4-kinase β (PI4KB) from the patients in this family. In addition, 3 missense PI4KB (p.Val434Gly, p.Glu667Lys, and p.Met739Arg) mutations were identified in five patients with nonsyndromic SNHL from 57 sporadic cases. No such mutations were present within 600 Chinese controls, the 1000 genome project, gnomAD, or similar databases. Depleting pi4kb mRNA expression in zebrafish caused inner ear abnormalities and audiosensory impairment, mimicking the patient phenotypes. Moreover, overexpression of 4 human missense PI4KB mutant mRNAs in zebrafish embryos resulted in impaired hearing function, suggesting dominant-negative effects. Taken together, our results reveal that PI4KB mutations can cause SNHL and inner ear malformation. PI4KB should be included in neonatal deafness screening.

Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

AIMS: To update and extend a previous cross-sectional international comparison of glycaemic control in people with type 1 diabetes.METHODS: Data were obtained for 520,392 children and adults with type 1 diabetes from 17 population and five clinic-based data sources in countries or regions between 2016 and 2020. Median HbA1c (IQR) and proportions of individuals with HbA1c < 58 mmol/mol (RESULTS: Median HbA1c varied from 55 to 79 mmol/mol (7.2 to 9.4%) across data sources and age groups so a pooled estimate was deemed inappropriate. OR (95% CI) for HbA1c < 58 mmol/mol (CONCLUSIONS: Glycaemic control of type 1 diabetes continues to vary substantially between age groups and data sources. While some improvement over time has been observed, glycaemic control remains sub-optimal for most people with Type 1 diabetes.

Aims: This study assessed hemoglobin A1c (HbA1c) across the lifespan in people with type 1 diabetes (T1D) in Germany/Austria, Sweden, and the United States between 2011 and 2017 to ascertain tempor...

KCNQ1/Kv7 is a voltage-gated K+ channel that regulates heart rhythm, glucose and salt homeostasis. Mutations of KCNQ1 are primarily associated with long-QT syndrome and type 2 diabetes; however, thus far KCNQ1 mutations have not been associated with monogenetic diabetes. Here, we identified a homozygous KCNQ1 missense mutation (R397W) in an individual with permanent neonatal diabetes (PND). To identify the mechanisms that link the mutation to the disease, we introduced the mutation into human embryonic stem cells (hESCs), and used them to derived pancreatic β-like cells (hESC-β cell). In early β-like cells, we observed atypical membrane electrical activity, increased levels of cytoplasmic Ca2+, and a hypersecretion of insulin. Upon extended culture, their insulin secretion decreased and the number of apoptotic cells increased, resulting in a reduction in the numbers of β-like cells. Late-stage β-like cells exhibited a decrease in the expression of metabolic genes, e.g. HNF4α, PDX1 and GLUT1, providing a possible mechanism for β-cell dysfunction. Our study identifies KCNQ1 as a novel candidate gene of monogenetic diabetes and shows that KCNQ1 regulates β-cell function and survival.

Context Little is known about the physical health of individuals with 46,XY disorders of sex development (DSD). Objective To assess physical and reported subjective health of individuals with XY DSD. Methods As part of the dsd-LIFE study, patients with an XY DSD condition were analyzed in different diagnosis groups for metabolic parameters, comorbidities, metabolic syndrome, bone outcomes, and reported subjective health. Findings were evaluated by descriptive statistics. Results A total of 222 patients with XY DSD were included with a mean age of 28.8 ± 12.2 years, mean height of 175.3 ± 7.7 cm, mean weight of 74.3 ± 20.0 kg, and mean body mass index of 24.1 ± 6.0 kg/m2. Obesity rate was not increased when descriptively compared with Eurostat data. Fourteen patients had metabolic syndrome (14/175; 8.0%). In descriptive comparison with data from the DECODE study and World Health Organization, subjects fared better in the categories waist circumference, glucose, triglyceride, cholesterol, and high-density lipoprotein. Of participants with available bone health data, 19/122 (15.6%) patients had a Z-score ≤ –2.0 at lumbar spine indicating lowered bone mineral density (BMD). Mostly gonadectomized individuals with complete androgen insensitivity syndrome (CAIS) and no estrogen therapy had lowered BMD at lumbar spine. Individuals with XY DSD performed poorly in the category subjective health in descriptive comparison with Eurostat data. Conclusion Participants reported a lower subjective health status than Eurostat data but their overall metabolic health status was good. Decreased BMD at lumbar spine was especially present in gonadectomized individuals with CAIS and no estrogen therapy.

Background: Despite observational evidence for the efficacy and safety of open-source automated insulin delivery (OS-AID) there is a lack of guidance for healthcare providers. The ethics of providing care for those using unregulated technology is a concern. Methods: Consensus guidelines are in development, through the OPEN project, by an experienced multi-disciplinary group of endocrinologists, diabetes care and education specialists, exercise physiologists and psychologists. Results: The principles of biomedical ethics - autonomy, justice, beneficence and non-maleficence - provide a framework for analysis. Autonomy requires that the user understands system risks and benefits. OS-AID provides complete transparency and customization, facilitating understanding and control. Algorithms used in commercial systems are proprietary, impeding the ability to discuss and personalize operation. Justice requires burdens and benefits be distributed fairly. Commercial systems are not uniformly accessible. OS-AID provides freely available software and allows the mixing and matching of compatible CGMs and pumps, supporting equity. Beneficence means doing good for the individual. In real-world observational trials both open-source (OpenAPS: n=34, mean TIR 71->80% at max 2.5 years; Loop: n=558, mean TIR 67->73% at 6 months) and commercial AID systems (670G: n=3141, mean TIR 66->73% at 3 months; Control-IQ: n=1659, median TIR: 68->78% at 1 month) provide a statistically significant and clinically meaningful increase in TIR at the population level. Non-maleficence requires treatment does not harm the individual. AID systems can reduce burden, hypoglycemia and hyperglycemia. Conclusions: The international consensus group concludes OS-AID is ethical, but unregulated. We recommend legal interpretations and frameworks be clarified and updated so that individuals are not deprived of beneficial therapy. Commercial AID systems may benefit from transparency and equity offered by OS-AID systems. Disclosure K. Braune: None. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. T. C. Skinner: Advisory Panel; Self; Liva Health Care, Novo Nordisk. K. Raile: Advisory Panel; Self; Abbott Diabetes, Lilly Diabetes, Research Support; Self; Dexcom, Inc. C. Johnston: None. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. S. Hussain: Speaker’s Bureau; Self; Novo Nordisk. M. Quigley: None. L. Petruzelkova: None. G. Scheiner: Advisory Panel; Self; Capillary Biomedical, Inc., Companion Medical, Eli Lilly and Company, Consultant; Self; ADOCIA, Ascensia Diabetes Care, mySugr, Triple Jump, Ypsomed, Speaker’s Bureau; Self; Dexcom, Inc., Xeris Pharmaceuticals, Inc. P. Winterdijk: None. S. Schmidt: None. L. H. Raimond: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. Funding National Institute of Diabetes and Digestive and Kidney Diseases (T32DK007217, 1K12DK122550, 1K23DK122017, P30DK116074); European Commission’s Horizon 2020 Research and Innovation Programme/Marie Sklodowska-Curie Action Research and Innovation Staff Exchange (RISE) grant agreement number 823902

OBJECTIVES With this study, our aim was to quantify the relative risk (RR) of diabetic ketoacidosis at diagnosis of type 1 diabetes during the year 2020 and to assess whether it was associated with the regional incidence of coronavirus disease 2019 (COVID-19) cases and deaths. METHODS Multicenter cohort study based on data from the German Diabetes Prospective Follow-up Registry. The monthly RR for ketoacidosis in 2020 was estimated from observed and expected rates in 3238 children with new-onset type 1 diabetes. Expected rates were derived from data from 2000 to 2019 by using a multivariable logistic trend regression model. The association between the regional incidence of COVID-19 and the rate of ketoacidosis was investigated by applying a log-binomial mixed-effects model to weekly data with Germany divided into 5 regions. RESULTS The observed versus expected frequency of diabetic ketoacidosis was significantly higher from April to September and in December (mean adjusted RRs, 1.48–1.96). During the first half of 2020, each increase in the regional weekly incidence of COVID-19 by 50 cases or 1 death per 100 000 population was associated with an increase in the RR of diabetic ketoacidosis of 1.40 (95% confidence interval, 1.10–1.77; P = .006) and 1.23 (1.14–1.32; P < .001), respectively. This association was no longer evident during the second half of 2020. CONCLUSIONS These findings suggest that the local severity of the pandemic rather than health policy measures appear to be the main reason for the increase in diabetic ketoacidosis and thus the delayed use of health care during the pandemic.

Hintergrund Die diabetische Ketoacidose (DKA) ist ein lebensbedrohlicher Notfall bei Manifestation eines Diabetes mellitus Typ 1 (DM1) bei Kindern und Jugendlichen, häufig bei verspäteter Diagnosestellung oder vorheriger Fehldiagnose. Während der Zeit des „Coronavirus-disease-2019(COVID-19)-Lockdowns“ in Deutschland stellten sich weniger Patienten in Notfallambulanzen und Arztpraxen vor. Fragestellung Hat sich der Anteil der DKA bei Manifestation eines DM1 in der pädiatrischen Population in diesem Zeitraum verändert, und welche Gruppen sind besonders gefährdet, eine DKA zu erleiden? Material und Methoden Die DKA-Häufigkeit in der Zeit vom 13.03.2020 bis 13.05.2020 wurde bei Patienten

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; PP 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. CLINICALTRIAL INTERNATIONAL REGISTERED REPORT RR2-10.2196/15368

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. CLINICALTRIAL German Clinical Trials Register DRKS00016170; https://tinyurl.com/skz4wdk5

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 ( 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.

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.

This study assessed HbA1c across the lifespan in people with T1D in Austria/Germany, Sweden, and the United States (U.S.) between 2011 and 2017. Data extracted from the DPV, Austria/Germany (n = 25651 in 2011, n = 29442 in 2017); SWEDIABKIDS/NDR, Sweden (n = 44474 in 2011, n = 53690 in 2017); and T1D Exchange, U.S. (n = 16198 in 2011, n= 17087 in 2017) registries were included in the analysis. Mean HbA1c across the lifespan in 2017 and changes in mean HbA1c between 2011 and 2017 overall and by age cohorts were analyzed. In 2017 mean HbA1c for adults ≥45 years converged across registries; HbA1c levels for subjects Disclosure A. Albanese-O’Neill: Consultant; Self; American Diabetes Association. J. Hermann: None. A. Svensson: None. K. Miller: None. K. Raile: None. K. Akesson: None. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. K. Eeg-Olofsson: None. D.M. Maahs: Advisory Panel; Self; Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S. Consultant; Self; Abbott, Sanofi. Research Support; Self; Bigfoot Biomedical, Dexcom, Inc., Roche Diabetes Care, Tandem Diabetes Care. R.W. Holl: None. R. Hanas: Advisory Panel; Self; Abbott, Novo Nordisk A/S. Speaker’s Bureau; Self; Sanofi. Other Relationship; Self; AstraZeneca. Funding German Center for Diabetes Research; The Leona M. and Harry B. Helmsley Charitable Trust (G-2016PG-T1D053)

Background: Automated insulin delivery (AID) systems have been shown to be safe and effective in reducing hyper- and hypoglycaemia, but are not universally available, accessible, and affordable. Therefore, user-driven open-source AID systems are becoming increasingly popular. Methods: This study investigated motivations why people with diabetes or their caregivers decide to build and use a personalised open-source AID. A cross-sectional online survey was conducted to assess personal motivations and associated self-reported clinical outcomes. Findings: Of 897 participants from 35 countries, 80·4% were adults with diabetes and 19·6% were caregivers of children with diabetes. Primary motivations to commence open-source AID included: improving glycaemic outcomes (94% of adults, 95% of caregivers), reducing acute (87%/96%) and long-term (83%/91%) complication risk, interacting less frequently with diabetes technology (81%/76%), improving their/child’s sleep quality (72%/80%), increasing their/child’s life expectancy (72%/85%), lack of commercially available AID systems (71%/70%), and unachieved therapy goals with available therapy options (68%/69%). Improving their own sleep quality was an almost universal motivator for caregivers (94%). Significant improvements, independent of age and gender, were observed in self-reported HbA1C, 7·14±1·13% (54·5±12·4 mmol/mol) to 6·24±0·64% (44·7±7·0 mmol/mol; p

Diabetes mellitus Typ 1 ist die häufigste endokrinologische Erkrankung bei Kindern und Jugendlichen unter 15 Jahren. Eine Heilungsperspektive bezüglich der Autoimmunreaktion gegen die insulinbildenden Betazellen ist weiterhin nicht in Sicht. Dennoch konnte durch technische Innovationsschübe bei Glukosesensoren, Insulinpumpen und Steuerungsalgorithmen innerhalb der letzten Jahre die Stoffwechselkontrolle optimiert werden. Diese Entwicklungen führen zusammen mit individuellen Diabetesschulungen und psychosozialer Unterstützung zu einer deutlichen Verbesserung der Versorgung. In diesem Übersichtsartikel wird die aktuelle Versorgungssituation von Kindern und Jugendlichen mit Typ-1-Diabetes sowie ihren Eltern dargestellt. In Deutschland ist die multidisziplinäre, spezialisierte Versorgung durch Teams aus Kinder- und Jugenddiabetolog*innen, Diabetesberater*innen, Sozialarbeiter*innen und Kinder- und Jugendpsychotherapeut*innen seit vielen Jahren etabliert und führt zu einer im internationalen Vergleich sehr guten Versorgungsqualität. Fokussiert werden die Diabetesschulung mit dem Schwerpunkt, das Selbstmanagement optimal zu unterstützen, die psychosoziale Begleitung und Intervention sowie die Inklusion in Schulen und Kindertagesstätten. Wir gehen außerdem auf neue soziale Entwicklungen der Diabetes-Online-Community ein. Ein aktuelles Beispiel ist die patientenbetriebene Bewegung „Do-It-Yourself Artificial Pancreas System“ (DIY-APS), die als Open-Source-Projekt mittlerweile Innovationsgeber auch für Medizinproduktehersteller ist. Zum Schluss beleuchten wir die damit verbundenen Chancen, aber auch die Verschiebung der klassischen Arzt-Patienten-Rollen., 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.

Diabetes mellitus ist eine Stoffwechselerkrankung charakterisiert durch eine chronische Hyperglykamie als Resultat einer fehlenden Insulinsekretion, einer gestorten Insulinwirkung oder von beidem. Eine eindeutige Zuordnung der Diabetesform ist fur Betroffene von hoher prognostischer und therapeutischer Relevanz.

OBJECTIVE To investigate the prevalence of asthma in young patients with type 1 diabetes mellitus (T1D) from Austria and Germany and its influence on their metabolic control. METHODS This prospective, multicenter observational cohort study was based on the DPV-registry (German/Austrian DPV initiative) including 51 926 patients with T1D (

Pancreatic β cells store insulin within secretory granules which undergo exocytosis upon elevation of blood glucose levels. Crinophagy and autophagy are instead responsible to deliver damaged or old granules to acidic lysosomes for intracellular degradation. However, excessive consumption of insulin granules can impair β cell function and cause diabetes. Atp6ap2 is an essential accessory component of the vacuolar ATPase required for lysosomal degradative functions and autophagy. Here, we show that Cre recombinase-mediated conditional deletion of Atp6ap2 in mouse β cells causes a dramatic accumulation of large, multigranular vacuoles in the cytoplasm, with reduction of insulin content and compromised glucose homeostasis. Loss of insulin stores and gigantic vacuoles were also observed in cultured insulinoma INS-1 cells upon CRISPR/Cas9-mediated removal of Atp6ap2. Remarkably, these phenotypic alterations could not be attributed to a deficiency in autophagy or acidification of lysosomes. Together, these data indicate that Atp6ap2 is critical for regulating the stored insulin pool and that a balanced regulation of granule turnover is key to maintaining β cell function and diabetes prevention.

BACKGROUND Digital innovations in health care have traditionally followed a top-down pathway, with manufacturers leading the design and production of technology-enabled solutions and those living with chronic conditions involved only as passive recipients of the end product. However, user-driven open-source initiatives in health care are becoming increasingly popular. An example is the growing movement of people with diabetes, who create their own “Do-It-Yourself Artificial Pancreas Systems” (DIYAPS). OBJECTIVE The overall aim of this study is to establish the empirical evidence base for the clinical effectiveness and quality-of-life benefits of DIYAPS and identify the challenges and possible solutions to enable their wider diffusion. METHODS A research program comprising 5 work packages will examine the outcomes and potential for scaling up DIYAPS solutions. Quantitative and qualitative methodologies will be used to examine clinical and self-reported outcome measures of DIYAPS users. The majority of members of the research team live with type 1 diabetes and are active DIYAPS users, making Outcomes of Patients’ Evidence With Novel, Do-It-Yourself Artificial Pancreas Technology (OPEN) a unique, user-driven research project. RESULTS This project has received funding from the European Commission’s Horizon 2020 Research and Innovation Program, under the Marie Skłodowska-Curie Action Research and Innovation Staff Exchange. Researchers with both academic and nonacademic backgrounds have been recruited to formulate research questions, drive the research process, and disseminate ongoing findings back to the DIYAPS community and other stakeholders. CONCLUSIONS The OPEN project is unique in that it is a truly patient- and user-led research project, which brings together an international, interdisciplinary, and intersectoral research group, comprising health care professionals, technical developers, biomedical and social scientists, the majority of whom are also living with diabetes. Thus, it directly addresses the core research and user needs of the DIYAPS movement. As a new model of cooperation, it will highlight how researchers in academia, industry, and the patient community can create patient-centric innovation and reduce disease burden together. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15368

Objective: Little is known about why PwD leave traditional pathways and turn to DIY technology. This study aims to examine the motivations of Do-it-Yourself Artificial Pancreas System (DIYAPS) users and caregivers to build and maintain these systems. Methods: An online survey with 34 items was distributed to DIYAPS users and caregivers of children with DIYAPS through Facebook (“Looped” and regional subgroups) and Twitter (Diabetes Online Community). Results: 1058 participants from 34 countries responded to the survey. The majority were adult users (80.2%; 43% female; median age 41 years) with T1D (98.9%) for 25.2 years ±13.3. 19.8% were caregivers of children (47.4% female; median age 10 years) with T1D (99.4%) for 5.1 years ±3.9. With 10.1m ±17.6 on DIYAPS, HbA1c improved from 7.07% ±1.07 to 6.24% ±0.68 %. Time in Range improved from 63.21% ±16.27 to 83.07% ±10.11. Additional out-of-pocket costs of 712 USD/year were spent. Motivations to build a DIYAPS are shown in Fig.1. Conclusions: Improved glycemic control, need for an ‘autopilot’ and less acute and long-term complications were key motivations in both groups; as well as better sleep for caregivers. Users were also able to access and afford the required tools. These results may provide a better understanding of unmet needs of PwD and current challenges to uptake, in order to facilitate the involvement of patient-led and open source approaches in healthcare. Disclosure K. Braune: Advisory Panel; Self; Medtronic MiniMed, Inc. Speaker’s Bureau; Self; Dexcom, Inc. S. O’Donnell: None. B. Cleal: None. D.M. Lewis: Consultant; Self; Diabeloop SA, Roche Diabetes Care. A. Tappe: Consultant; Self; IME-DC GmbH. Employee; Self; Hi.health, Gruber-Debong GmbH. Speaker’s Bureau; Self; Dexcom, Inc., Roche Diabetes Care, Ypsomed AG. Other Relationship; Self; SOOIL Developments Co., Ltd. B. Hauck: Consultant; Self; Bayer AG, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S, Roche Diabetes Care, Roche Pharma. I. Willaing: None. R. Scibilia: Speaker’s Bureau; Self; Roche Diabetes Care. E. Rowley: None. W. Ko: None. G. Doyle: None. T.C. Skinner: None. K. Raile: Advisory Panel; Self; Abbott, Lilly Diabetes. Funding European Union

There is currently a wave of interest in Do-it-Yourself Artificial Pancreas Systems (DIYAPS) but knowledge about how the use of these systems impacts on the lives of those that develop and use them remains limited. Until now, only a select few have been able to give voice to their experiences in a research context. In this study we present data that addresses this shortcoming, detailing the lived experiences of people using DIYAPS in an extensive and diverse way. An online survey with 34 items was distributed to DIYAPS users recruited through the Facebook groups “Looped” (and regional sub-groups) and Twitter pages of the Diabetes Online Community (DOC). Participants were posed two open-ended questions in the survey, where personal DIY APS stories were garnered; including knowledge acquisition, decision-making, support and emotional aspects in the initiation of DIY APS, perceived changes in clinical and quality of life (QoL) outcomes after initiation and difficulties encountered in the process. All answers were analysed using thematic content analysis. In total, 886 adults responded to the survey and there were a combined 656 responses to the two open-ended items. Knowledge of DIYAPS was largely obtained via exposure to the communication fora that constitute the DOC. The DOC was also a primary source of practical and emotional support. Dramatic improvements in clinical and QoL outcomes were consistently reported. The emotional impact on everyday life was overwhelmingly positive. Acquisition of the requisite devices to initiate DIYAPS was sometimes problematic. The extensive testimony from users of DIYAPS acquired in this study provides new insights regarding the contours of this evolving phenomenon, highlighting factors inspiring people to adopt such solutions and underlining the transformative impact effective closed-loop systems bring to bear on the everyday lives of people with diabetes. Disclosure B. Cleal: None. K. Braune: Advisory Panel; Self; Medtronic MiniMed, Inc. Speaker’s Bureau; Self; Dexcom, Inc. S. O’Donnell: None. B. Hauck: Consultant; Self; Bayer AG, Eli Lilly and Company, LifeScan, Inc., Novo Nordisk A/S, Roche Diabetes Care, Roche Pharma. D.M. Lewis: Consultant; Self; Diabeloop SA, Roche Diabetes Care. T.C. Skinner: None. K. Raile: Advisory Panel; Self; Abbott, Lilly Diabetes.

Background Studying patients with rare Mendelian diabetes has uncovered molecular mechanisms regulating β‐cell pathophysiology. Previous studies have shown that Class IIa histone deacetylases (HDAC4, 5, 7, and 9) modulate mammalian pancreatic endocrine cell function and glucose homeostasis. Methods We performed exome sequencing in one adolescent nonautoimmune diabetic patient and detected one de novo predicted disease‐causing HDAC4 variant (p.His227Arg). We screened our pediatric diabetes cohort with unknown etiology using Sanger sequencing. In mouse pancreatic β‐cell lines (Min6 and SJ cells), we performed insulin secretion assay and quantitative RT‐PCR to measure the β‐cell function transfected with the detected HDAC4 variants and wild type. We carried out immunostaining and Western blot to investigate if the detected HDAC4 variants affect the cellular translocation and acetylation status of Forkhead box protein O1 (FoxO1) in the pancreatic β‐cells. Results We discovered three HDAC4 mutations (p.His227Arg, p.Asp234Asn, and p.Glu374Lys) in unrelated individuals who had nonautoimmune diabetes with various degrees of β‐cell loss. In mouse pancreatic β‐cell lines, we found that these three HDAC4 mutations decrease insulin secretion, down‐regulate β‐cell‐specific transcriptional factors, and cause nuclear exclusion of acetylated FoxO1. Conclusion Mutations in HDAC4 disrupt the deacetylation of FoxO1, subsequently decrease the β‐cell function including insulin secretion, resulting in diabetes.

BACKGROUND Patient-driven initiatives have made uptake of Do-it-Yourself Artificial Pancreas Systems (DIYAPS) increasingly popular amongst people with diabetes of all ages. Observational studies show improvements in glycemic control and quality of life amongst adults. However, there remains a lack of research examining experiences of children and adolescents with DIYAPS in everyday life and their social context. OBJECTIVE This study assesses self-reported clinical outcomes of the pediatric population using DIYAPS in real-world use. METHODS An online survey was distributed to caregivers, assessing HbA1c and Time in Range (TIR) before and after, and problems during DIYAPS use. RESULTS 209 caregivers from 21 countries responded. Children were 47.4% female with a median age of 10y; a mean diabetes duration of 5.1y ±3.9 and 10.3m ±10.0 experience with DIYAPS. Clinical outcomes improved significantly, including HbA1c (from 6.91% ±0.88 to 6.27% ±0.67; P CONCLUSIONS Improved glycemic outcomes were found across all pediatric age groups including adolescents and very young children. These findings are in line with clinical trial results from commercially developed closed-loop systems. CLINICALTRIAL The study was approved by the Charité ethics committee (EA2/140/18).