Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers

Objective. While automated insulin delivery (AID) systems aim to improve glycemic outcomes, the opportunity psychosocial outcomes is also of critical importance for children and adolescents with type 1 diabetes their caregivers. We evaluated in these groups during a clinical trial tubeless AID system, Omnipod® 5 Automated Insulin Delivery System. Methods. This single-arm, multicenter, prospective study enrolled 83 (6.0–11.9 years) 42 (12.0–17.9 use system 3 months. Participants caregivers completed age- role-appropriate validated questionnaires assess changes outcomes—diabetes distress (PAID), hypoglycemia confidence (HCS), well-being (WHO-5), sleep quality (PSQI), satisfaction (IDSS), usability (SUS)—before after months use. Associations between participant characteristics measures were using linear regression analyses. Results. Improvements found children, adolescents, and/or diabetes-related distress, satisfaction, (all P < 0.05 ). Caregivers saw additional benefits improved general well-being, managing hypoglycemia, id="M2"> Regression analyses showed that improvements generally independent baseline outcomes. Conclusions. The was associated significant number Trial registration: registered NCT04196140.