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- Title
Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers.
- Authors
Hood, Korey K.; Polonsky, William H.; MacLeish, Sarah A.; Levy, Carol J.; Forlenza, Gregory P.; Criego, Amy B.; Buckingham, Bruce A.; Bode, Bruce W.; Hansen, David W.; Sherr, Jennifer L.; Brown, Sue A.; DeSalvo, Daniel J.; Mehta, Sanjeev N.; Laffel, Lori M.; Bhargava, Anuj; Huyett, Lauren M.; Vienneau, Todd E.; Ly, Trang T.
- Abstract
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.
- Subjects
CAREGIVER attitudes; RESEARCH; STATISTICS; MULTIPLE regression analysis; TYPE 1 diabetes; PATIENTS' attitudes; T-test (Statistics); INSULIN pumps; DESCRIPTIVE statistics; QUESTIONNAIRES; DATA analysis software; DATA analysis; LONGITUDINAL method; CHILDREN; ADOLESCENCE
- Publication
Pediatric Diabetes, 2023, pN.PAG
- ISSN
1399-543X
- Publication type
Article
- DOI
10.1155/2023/8867625