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<0.001) , diabetes-related (PAID: p=0.029; PedsQL: p=0.016) and sleep-related QoL (PSQI: p<0.001) .
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.
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.
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)