Effectiveness Trial to Support Adoption of Hybrid Closed Loop Therapy in Underserved Adults with Type 1 Diabetes: Impact of System Functionality and Features on Lived Experience - Individuals with type 1 diabetes (T1D) from certain ethnic/racial minority and lower socio-economic groups have higher average A1c levels and rates of hospitalizations, complications, and mortality than the general T1D population. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in patients who have greater access to medical support. More automated systems could potentially better match the needs of individuals from medically underserved communities (defined as lower socio-economic status, ethnic/minority groups and rural populations) with competing life demands that limit diabetes self-care; however, the potential benefits of automation are at the cost of less personal control of the system, including adjustments for work-shift changes and activity. To address disparities in the prevalence, access to medical care, and the effectiveness of HCL systems, three Specific Aims are proposed. In Specific Aim 1 we plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer (9 month) follow up than the pivotal HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in adults with T1D-related health disparities. Primary outcome will be % time-in-range 70-180 mg/dL, and secondary outcomes will include % time < 70 mg/dL, DKA events and body weight. The HCL arm in the trial will include three HCL systems (BetaBionics iLet, Insulet OP 5, Tandem Control IQ) that vary in degree of automation and user input required for operation. Specific Aim 2 incorporates the novel application of Ecological Momentary Assessment to examine the lived experience with HCL (including benefits and burdens, the impact of life stressors impact on HCL use, and how the match between HCL system functionality and the individual’s needs and expectations impacts on user experience). In Specific Aim 3, in collaboration with a user-centered designer, we will apply the learnings from the study to develop: 1) Improved HCL patient education and clinician support tools; and 2) Decision-aids to guide patient selection of the HCL system that is most aligned with personal preferences and needs. These optimized training materials and decision-aids will set the stage for the translation of our research findings into broader adoption of HCL in primary care and improved shared decision-making by patients and clinicians in the selection of HCL systems.
