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