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

Authors: Sarah A MacLeish, Korey K Hood, William H Polonsky, Jamie R Wood, Bruce W Bode, Gregory P Forlenza, Lori M Laffel, Bruce A Buckingham, Amy B Criego, Melissa J Schoelwer, Daniel J DeSalvo, Jennifer L Sherr, David W Hansen, Lindsey R Conroy, Lauren M Huyett, Todd E Vienneau, Trang T Ly; Omnipod 5 in Preschoolers Study Group

Abstract

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 < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well-being (World Health Organization 5 Well-Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001).

Conclusions: Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management.

Source: https://pubmed.ncbi.nlm.nih.gov/39300963/

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BDI Monthly Events

March 12Case Consultation Meeting
March 12: BDI hosts the San Diego-wide, monthly case consultation meeting (for mental health professionals working in the field of diabetes). Contact us at [email protected] if you are in the greater San Diego area and would like further information about this program.
March 19-22International Conference
18th International Conference for ATTD (Advanced Technologies and Treatments for Diabetes) in Amsterdam, Dr. Polonsky (BDI President) has three presentations.
March 19Type 2 Presentation
On March 19, Dr. Polonski will present CGM is Wonderful, But… at the Roche-sponsored symposium, “Translating the Power of Prediction into Diabetes Management”, and Insulin Therapy Experience: Considering the Needs of People Living with Diabetes (with Professor Cukierman-Yaffe) at the Sanofi-sponsored symposium, Confidence and Simplicity in Diabetes Management”. https://attd.kenes.com/
March 20Type 2 Presentation
On March 20, Dr. Polonski will present Improved Patient- and Physician-Reported Outcomes with IGlarLixi When Switching From Premixed Insulin in People with Type 2 Diabetes: The Soli-Switch Study. https://cslide.ctimeetingtech.com/attd25/attendee/confcal/session/calendar/2025-03-20