Psychosocial Outcomes Among Users and Nonusers of Open-Source Automated Insulin Delivery Systems: Multinational...

Emerging research suggests that open-source automated insulin delivery (AID) may reduce diabetes burden and improve sleep quality and quality of life (QoL). However, the evidence is mostly qualitative or uses unvalidated, study-specific, single items. Validated person-reported outcome measures (PROMs) have demonstrated the benefits of other diabetes technologies. The relative lack of research investigating open-source AID using PROMs has been considered a missed opportunity.

This study aimed to examine the psychosocial outcomes of adults with type 1 diabetes using and not using open-source AID systems using a comprehensive set of validated PROMs in a real-world, multinational, cross-sectional study.

Adults with type 1 diabetes completed 8 validated measures of general emotional well-being (5-item World Health Organization Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), diabetes-specific QoL (modified DAWN Impact of Diabetes Profile), diabetes-specific positive well-being (4-item subscale of the 28-item Well-Being Questionnaire), diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire), diabetes distress (20-item Problem Areas in Diabetes scale), fear of hypoglycemia (short form of the Hypoglycemia Fear Survey II), and a measure of the impact of COVID-19 on QoL. Independent groups 2-tailed t tests and Mann-Whitney U tests compared PROM scores between adults with type 1 diabetes using and not using open-source AID. An analysis of covariance was used to adjust for potentially confounding variables, including all sociodemographic and clinical characteristics that differed by use of open-source AID.

In total, 592 participants were eligible (attempting at least 1 questionnaire), including 451 using open-source AID (mean age 43, SD 13 years; n=189, 41.9% women) and 141 nonusers (mean age 40, SD 13 years; n=90, 63.8% women). Adults using open-source AID reported significantly better general emotional well-being and subjective sleep quality, as well as better diabetes-specific QoL, positive well-being, and treatment satisfaction. They also reported significantly less diabetes distress, fear of hypoglycemia, and perceived less impact of the COVID-19 pandemic on their QoL. All were medium-to-large effects (Cohen d=0.5-1.5). The differences between groups remained significant after adjusting for sociodemographic and clinical characteristics.

Adults with type 1 diabetes using open-source AID report significantly better psychosocial outcomes than those not using these systems, after adjusting for sociodemographic and clinical characteristics. Using validated, quantitative measures, this real-world study corroborates the beneficial psychosocial outcomes described previously in qualitative studies or using unvalidated study-specific items.