Renewal of Type 1 Diabetes TrialNet

May 2023 Council

Lead Division/Office

DEM

Point(s) of Contact

Lisa Spain

Executive Summary

This initiative will fund the TrialNet Coordinating Center (TNCC) and the Clinical Network Hub (Hub) for the ongoing TN network. The TNCC and the Hub together support the consortium in the design and conduct of intervention trials aimed at preservation of insulin-producing cells in people at pre-clinical stages and early after diagnosis of T1D. The renewal will build on promising results and continue to make progress towards the durable prevention of T1D. TN aims to continuously improve the efficiency and outcomes of its trials and therefore conducts and collaborates on studies that explore mechanisms of disease pathology and measurements of disease activity. In this competing renewal, the TNCC will: (1) support a wide range of clinical trials and studies in varying stages of development, implementation, and completion, and (2) provide data and sample management, including standardized acquisition, quality control, dissemination, and public accessibility. The TNCC will be responsible for the peer-reviewed selection and funding of Clinical Centers to conduct TN clinical studies. Clinical Center directors will form the majority of the voting members of the Steering Committee, and play a major role in trial selection, design, and implementation. The main objective of the Hub is to enhance screening, recruitment, and trial implementation through coordination among network investigators and the T1D community, and to increase operational efficiency and flexibility of the network.