559-P: Impact of COVID-19 Pandemic on Clinical Trial Participation among Young Adults (YA) with Type 1 Diabetes (T1D)

Introduction: COVID-19 has had profound impacts on clinical research worldwide. We examined COVID-19's impact on recruitment, retention, and individual characteristics, pre- vs. post-pandemic, of YA who enrolled in a randomized trial designed to evaluate a telehealth self-management intervention for T1D. Methods: Participant surveys, A1c, and process data from the ongoing trial were analyzed for differences before and after California's stay-at-home order was issued on 3/18/2020. All surveys except social needs were collected at enrollment, while social needs were assessed post-COVID for all participants. Fisher exact tests and Wilcoxon rank-sum tests were used to compare categorical and continuous variables, respectively. Results: Time from referral to enrollment more than doubled post-COVID. Participants who enrolled post-COVID (n=19) had higher SES (private health insurance, parental education), but poorer psychosocial well-being (diabetes distress, self-efficacy) and higher social needs (e.g., food insecurity, access to healthcare) than those who enrolled pre-COVID (n=41) (Table 1). Discussion: The COVID era has imposed logistical difficulties and competing priorities that create challenges in clinical research. Understanding the impact of COVID on participant and trial characteristics will be critical in interpreting the findings of studies conducted during COVID.