A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes

Background Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management. Objective Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care. Design Randomized trial from 2019 to 2023. Participants A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care. Intervention CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes. Measures Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups. Results Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group ( p = 0.24). There were also no significant between-group differences in systolic blood pressure ( p = 0.29), met social needs ( p = 0.25), CRN ( p = 0.18), and perceived financial burden ( p = 0.31). In subgroup analyses, participants with household incomes 100–400% FPL (1.93 (SE = 0.76), p