Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2024-12, Vol.26 (12), p.5569-5579
• Main Authors: MacLeish, Sarah A., Hood, Korey K., Polonsky, William H., Wood, Jamie R., Bode, Bruce W., Forlenza, Gregory P., Laffel, Lori M., Buckingham, Bruce A., Criego, Amy B., Schoelwer, Melissa J., DeSalvo, Daniel J., Sherr, Jennifer L., Hansen, David W., Conroy, Lindsey R., Huyett, Lauren M., Vienneau, Todd E., Ly, Trang T.
• Format: Article
• Language: English
• Subjects: Adult; Attitude surveys; Automation; Caregivers; Caregivers - psychology; Child, Preschool; Children; clinical trial; Diabetes; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1 - blood; Diabetes Mellitus, Type 1 - drug therapy; Diabetes Mellitus, Type 1 - psychology; Disease management; Female; Humans; Hypoglycemia; Hypoglycemia - chemically induced; Hypoglycemia - prevention & control; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - therapeutic use; Insulin; Insulin - administration & dosage; Insulin - therapeutic use; Insulin Infusion Systems; insulin pump therapy; insulin therapy; Male; patient‐reported outcomes; Sleep; Sleep Quality; Surveys; Surveys and Questionnaires; Usability; Well being
• ISSN: 1462-8902; 1463-1326; 1463-1326
• DOI: 10.1111/dom.15906

Aim Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children. Materials and Methods This 3‐month single‐arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0–5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes—diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well‐being (World Health Organization 5 Well‐Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use. Results Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes‐related psychosocial outcomes (Problem Areas in Diabetes; p