Type 1 Diabetes TrialNet Clinical Network Hub

Type 1 Diabetes (T1D) affects 2.5 million children and adults in the US requiring life-long insulin therapy for survival, and carries enormous clinical, financial, and psychological burdens as well as a more than 10-year reduction in life expectancy. Thus, there is a significant unmet need for new therapies that focus on underlying immune mediated beta cell destruction rather than the current symptom focused treatment. TrialNet’s mission is to address this unmet need by conducting clinical trials aimed at “altering the T1D disease course by preserving beta cell function before or after diagnosis”. As the world’s leading clinical trial group in prediction and prevention of T1D, TrialNet has made significant contributions to the field in describing the natural history of disease before and after diagnosis, testing multiple therapies to alter the disease process, and increasing understanding of disease mechanisms and response to therapy. For the past decade, the TrialNet HUB has been integral to all aspects of TrialNet activities, thus having a major impact on these accomplishments. The following specific aims address the HUB’s mission to “increase the efficiency of critical network activities through collaborative and innovative approaches for screening, recruitment, retention, trial implementation, and dissemination of results”. In Specific Aim 1, the HUB will develop and disseminate content to describe, educate, and promote TrialNet’s mission of screening individuals at risk and enrolling in clinical trials. In addition, the HUB will develop new branding and messaging to address the recent shift to screening and treatment in the context of clinical care, and also expand opportunities for all to join in TrialNet research studies. In Specific Aim 2, the HUB will support TrialNet’s clinical trial and ancillary study operations by developing participant-facing recruitment and retention materials, developing and disseminating study-specific content for clinical teams and the public, managing participant communication and developing media strategies for reporting results. The HUB will also manage participant communication and media strategies. In addition, the HUB will integrate a new comparative effectiveness study with ongoing protocols, develop and implement a mobile app for participants, increase options for home study visits, and expand opportunities to incorporate direct data entry. In Specific Aim 3, the HUB in partnership with the TrialNet Coordinating Center will coordinate network activities including developing an Ambassador program, supporting the Emerging Leaders program, working with the Community Advisory Board, establishing an External Advisory Board to address changes in the landscape, networking with leaders of general population screening programs, and expanding education about T1D prediction and therapy to those providing clinical care.