Barriers to Inclusive Clinical Trials for Diabetes: A Survey of Clinical Trial Awareness and Engagement Among People With Diabetes and Their Caregivers

OBJECTIVE To assess awareness, participation, and perceptions of clinical trials and regulatory processes among people with diabetes and their caregivers, with a focus on identifying barriers and motivators to participation and evaluating disparities by race, ethnicity, and diabetes type. RESEARCH DESIGN AND METHODS A cross-sectional survey was conducted in two phases (August–September 2023 and April–May 2024) among adults with diabetes or their caregivers. The 31-item questionnaire, developed by the research team, assessed awareness, motivators, barriers, understanding, and satisfaction with clinical trial participation. A total of 5,487 responses were analyzed using descriptive statistics. RESULTS Although clinical trial awareness was generally high, people from racial and ethnic minority communities (PREM) were less likely than White participants to know what a clinical trial was (1.2 times less), be informed by their care team (1.5 times less), or have participated in a trial (3.3 times less). PREM more often cited financial compensation (74.5%) as motivation and fear of harm (39.4%) or participation costs (34.9%) as barriers, compared with White participants. They had lower understanding of trial purposes (70% vs. 99.6%), receipt of results after participation (57% vs. 99.5%), and awareness of study design and regulatory engagement opportunities (22.7% vs. 97.7%), compared with White participants. CONCLUSIONS Significant disparities in clinical trial awareness, engagement, and satisfaction exist among racial and ethnic minority populations with diabetes. These inequities reflect social determinants of health including limited access to care, economic barriers, and historical mistrust and underscore the need for proactive clinician communication, culturally responsive outreach, and equitable inclusion across all stages of research.