Ashley Leinbach

Payment for services (e.g., consulting fees, honoraria, paid authorship)

NIDDK Type 1 Diabetes TrialNet Data Coordinating Center

The goal of Type 1 Diabetes TrialNet is the identification of individuals at- risk for development of type 1 diabetes (T1DM). Identification of individuals at elevated risk of developing the disease will provide more information about risk factors, leading to a better understanding of disease pathogenesis. This proposal addresses support of the new Biomarker and Mechanisms Panel and the design and implementation of mechanistic studies using TrialNet subjects to add to our understanding of pathogenesis. Enrolling at-risk individuals in intervention studies to test treatments intended to delay or prevent the onset of type 1 diabetes and enrolling newly diagnosed individuals in intervention studies to test treatments intended to preserve remaining insulin secretion may result in new strategies to prevent, delay or reverse T1DM. This project will enrich this process by supporting new approaches to recruitment and the developing partnership with the recently formed TrialNet HUB. The TrialNet Coordinating Center will contribute to the design of new protocols to replace existing studies or to target new populations (such as individuals diagnosed asymptomatically) with new and innovative end points. Funds are also requested for operations to maintain study protocols, provide project oversight, coordination, communication, statistical analyses and capability to collect longitudinal data and results of laboratory analyses of biological specimens from individuals at-risk for diabetes.