Examining Share plus A Continuous Glucose Monitoring plus Data Sharing Intervention in Older Adults and Their Care Partners: Protocol for a Pilot Study (Preprint)

BACKGROUND Older adults with type 1 diabetes (T1D) are increasingly turning to care partners (CP) as resources to support their diabetes management. With the rise in diabetes technologies, such as continuous glucose monitoring (CGM), there is great potential for CGM data sharing to increase care partner involvement in a way that improves a person with diabetes (PWD) glucose management and reduces distress. OBJECTIVE The specific aims of this paper are to (1) evaluate feasibility, usability, and acceptability of the Share plus intervention compared to the CGM Follow app plus diabetes self-management education and support (DSMES); (2) evaluate the effect of Share plus intervention on time-in-range (primary outcome) and diabetes distress (secondary outcome); and (3) explore differences between groups in PWD and CP dyadic appraisal and coping, quality of life, diabetes self-care, and CP burden at 12 and 24 weeks and associations of dyadic variables on outcomes. METHODS This is a protocol for a feasibility pilot study. Older adults with T1D and their care partner (N=80 dyads) will be randomized 1:1 to the Share plus intervention or Follow+DSME. The evaluation is guided by the dyadic coping model. Patient-level effectiveness outcomes (time-in-range, hemoglobin A1c, diabetes distress, diabetes appraisal, coping, quality of life, diabetes self-care behaviors, and care partner burden) will be assessed, using patient-reported outcomes measures and a home hemoglobin A1c test kit. PWD-level and CP-level acceptability and feasibility will be assessed using surveys and interviews. RESULTS This study is supported by the National Institute of Diabetes and Digestive Disorders. The study procedures have been approved. Recruitment and enrollment started in August 2023. CONCLUSIONS To our knowledge, this will be the first randomized control pilot to evaluate both feasibility and effectiveness outcomes for virtually-delivered Share plus intervention for older adults with T1D and their CP. This research has implications for CGM data sharing in other age groups with T1D and type 2 diabetes. CLINICALTRIAL NCT05937321