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

Zusammenfassung Nach Manifestation eines Typ-1-Diabetes ist die Unterst?tzung der Integration der betroffenen Kinder in Kindertagesst?tte (Kita) und Schule eine zentrale Aufgabe des Diabetesteams in enger Zusammenarbeit mit Eltern und Betreuenden in der Einrichtung. Daf?r ist u.?a. eine individuelle Schulung der Betreuer und Lehrer vor Ort notwendig, die es erm?glicht, diabetesspezifisches Grundlagenwissen zu vermitteln und Unsicherheiten und ?ngste vor der Wiedereingliederung abzubauen. Durchf?hrung und Finanzierung dieser Schulung finden je nach Region sehr verschieden statt. Noch sehr viel heterogener gestalten sich innerhalb der einzelnen Bundesl?nder die Modelle der Integration, die sogar innerhalb der Kommunen v?llig unterschiedliche Regularien aufweisen. Die Arbeitsgruppe (AG) ?Inklusion? der AGPD (Arbeitsgemeinschaft P?diatrische Diabetologie der Deutschen Diabetesgesellschaft) f?hrte deshalb zur Bestandsaufnahme eine bundesweite Befragung von 66 kinderdiabetologischen Zentren (N?=?9700 Patienten) durch. In der vorliegenden Arbeit werden als erster Schritt die Daten zur initialen Schulung pr?sentiert. So findet diese in fast 90?% der Nennungen durch qualifizierte Fachkr?fte, ?berwiegend individuell und vor Ort in der Einrichtung statt. In knapp 80?% der erfassten F?lle im Bereich Kita und in 70?% der F?lle im Bereich Schule wird diese Erstschulung jedoch durch Spenden, Ehrenamt oder eine Querfinanzierung von Geldern innerhalb der Diabeteseinrichtung gew?hrleistet. Damit gilt f?r die vorliegende Stichprobe, dass die Schulungen in ?berwiegendem Ma?e abh?ngig sind von privatem Engagement oder von Zugest?ndnissen der kaufm?nnischen Entscheidungstr?ger. Das hei?t: Eine Leistung, die essenziell f?r die Aufnahme eines Kindes mit dem Handicap Diabetes in?eine Einrichtung und damit f?r die Krankheitsakzeptanz der Stoffwechselerkrankung ist, muss immer wieder durch Privatinitiative erarbeitet oder in Verhandlungen ausgefochten werden. Daher fordern wir ? neben Ma?nahmen, die die Dauerbetreuung gew?hrleisten ? verbindliche Regelungen f?r die Durchf?hrung und Finanzierung von Schulungen f?r Betreuer in Kindertagest?tten sowie Lehrer und Betreuungspersonal in Schulen.

No abstract

BACKGROUND The COVID-19 pandemic poses new challenges to healthcare providers to deliver continuous care. Although diabetes technology is increasingly established today, data rarely gets assessed, and telemedicine has not been sufficiently integrated into clinical workflows. OBJECTIVE This project sought to remotely support children with type 1 diabetes and their caregivers to enhance clinical outcomes and quality-of-life, engage multiple stakeholders through a participatory approach, evaluate the feasibility of using an interoperable open-source platform in a university hospital setting, and analyze success factors and barriers in transitioning from conventional to digital care. METHODS Service design methods were used to adapt clinical workflows. Remote consultations were performed monthly and on-demand. Device data were uploaded from patients’ homes to an open-source platform. Clinical and patient-reported outcomes were assessed before, during and after the lockdown period in Germany due to COVID-19. RESULTS A total of 28 children with type 1 diabetes and their caregivers enrolled and completed 6 months of remote visits. Of them, 16 participants opted to perform at least one of their regular visits online. After 3 months, Time-in-Range, Time-in-Hyperglycemia, psychosocial health and diabetes-related quality-of-life had significantly improved whilst Time-in-Hypoglycemia did not increase. Improvements were maintained during the COVID-19 related lockdown between month 3 and 6 of the study. CONCLUSIONS Remote consultations and data access can improve clinical outcomes and quality-of-life in children with type 1 diabetes even during challenging circumstances. Service design helped to deliver a comprehensive and holistic solution taking multiple stakeholders into consideration. These findings can inform further integration and use of digital tools into clinical care during the pandemic and beyond. CLINICALTRIAL Clinical Trial registration number: DRKS00016170, IRB: Charité ethics approval number: EA2/125/18

No abstract