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/

Share the Post:

BDI Monthly Events

June 5 - 8: It will be a busy time at the American Diabetes Association’s 85th Scientific Sessions (New Orleans, LA), with new projects to be developed, old friends to see, and much to learn. Dr. Polonsky, BDI President, will serve a co-author on four poster presentations

May 13: 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.

August 14 - 16. Taking Control of Your Diabetes (TCOYD) will be hosting the in-person ONE event, an amazing weekend experience here in San Diego for more than 500 people with type 1 diabetes and their loved ones. Dr. Polonsky is honored to be one of the presenters, and we will hope to see many of you there. There are still a few spaces left, so if you’d like to know more, please visit

On October 24, BDI will host a live, one-day, CME workshop: Engaging the Disengaged: Innovative Strategies for Promoting Behavior Change in Diabetes. Run by Dr. Polonsky (BDI President) and Dr. Guzman (BDI Clinic Director), Participants will deepen their skills in recognizing and addressing common barriers to effective self-care and cardiometabolic medication initiation and maintenance, while fostering respectful, stigma-free clinical encounters.