Psychosocial outcomes among adults with type 1 diabetes using a tubeless automated insulin delivery system compared with sensor augmented pump therapy: A randomised, parallel‐group clinical trial sub‐study

AIMS: Beyond their glycaemic benefits, automated insulin delivery (AID) systems can provide psychosocial benefits for people with type 1 diabetes (T1D) and improve quality of life. In this study, we evaluated psychosocial outcomes in adults with T1D using the tubeless Omnipod® 5 AID System compared with sensor augmented pump (SAP) therapy. MATERIALS AND METHODS: As part of a 13-week multicentre, parallel-group, randomised controlled trial comparing intervention (tubeless AID) and control (SAP) groups (2:1), adults aged 18-70 years with T1D completed validated psychosocial questionnaires assessing health-related quality of life (European Quality of Life 5 Dimensions 3 Level Version [EQ-5D-3L] index score and visual analogue scale [VAS]), the impact of diabetes on quality of life (DAWN2 Impact of Diabetes Profile [DIDP]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), system usability (System Usability Scale [SUS]) and perceptions before and experiences after using AID systems (INsulin Dosing Systems: Perceptions, Ideas, Reflections and Expectations [INSPIRE]). RESULTS: The intervention group saw greater score improvements than the control group for all measures evaluated, including health-related quality of life (EQ-5D-3L VAS, p = 0.01; EQ-5D-3L index score, p = 0.002), impact of diabetes on quality of life (DIDP, p = 0.004), perceived system usability (SUS, p < 0.0001) and sleep quality (PSQI, p = 0.03). INSPIRE scores, determined only for the intervention group, were high at baseline and follow-up, suggesting positive perceptions of tubeless AID. CONCLUSIONS: This randomised controlled trial demonstrated that the use of a tubeless AID system improved psychosocial measures to a greater extent than SAP therapy. These results contribute to the growing body of evidence demonstrating that AID may improve quality of life and alleviate some of the burden associated with diabetes self-management in adults with T1D.