Who Is Enrolling? The Path to Monitoring in Type 1 Diabetes TrialNet's Pathway to Prevention.

Abstract

To better understand potential facilitators of individual engagement in type 1 diabetes natural history and prevention studies through analysis of enrollment data in the TrialNet Pathway to Prevention (PTP) study. We used multivariable logistic regression models to examine continued engagement of eligible participants at two time points: <i>1</i>) the return visit after screening to confirm an initial autoantibody-positive (Ab⁺) test result and <i>2</i>) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. Of 5,387 subjects who screened positive for a single autoantibody (Ab), 4,204 (78%) returned for confirmatory Ab testing. Younger age was associated with increased odds of returning for Ab confirmation (age <12 years vs. >18 years: odds ratio [OR] 2.12, <i>P</i> < 0.0001). Racial and ethnic minorities were less likely to return for confirmation, particularly nonwhite non-Hispanic (OR 0.50, <i>P</i> < 0.0001) and Hispanic (OR 0.69, <i>P</i> = 0.0001) relative to non-Hispanic white subjects. Of 8,234 subjects, 5,442 (66%) were identified as eligible to be enrolled in PTP OGTT monitoring. Here, younger age and identification as multiple Ab⁺ were associated with increased odds of returning for OGTT monitoring (age <12 years vs. >18 years: OR 1.43, <i>P</i> < 0.0001; multiple Ab⁺: OR 1.36, <i>P</i> < 0.0001). Parents were less likely to enroll into monitoring than other relatives (OR 0.78, <i>P</i> = 0.004). Site-specific factors, including site volume and U.S. site versus international site, were also associated with differences in rates of return for Ab⁺ confirmation and enrollment into monitoring. These data confirm clear differences between successfully enrolled populations and those lost to follow-up, which can serve to identify strategies to increase ongoing participation.