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Updated: May 23, 2025

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Published on: June 11, 2012
Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1
Korey K Hood1, William H Polonsky2,3, Sarah A MacLeish4
1Department of Pediatrics, Psychiatry & Behavioral Sciences, Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA.
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.
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