Leveraging NAMs to understand disease triggers, discover early biomarkers and develop new classes of therapeutic strategies for Type 1 Diabetes (U01 Clinical Trial Not Allowed)

This NOFO will support research using human-relevant New Approach Methodologies (NAMs) to advance understanding of the earliest events that initiate and drive Type 1 Diabetes (T1D). Projects will use human cells and tissues and innovative experimental and computational approaches–including organoids, microphysiological systems, and other advanced human-relevant models–to investigate cellular and molecular mechanisms involved in T1D initiation and early disease progression. The research is expected to identify and validate early biomarkers and therapeutic targets and advance new strategies to prevent or interrupt disease progression before substantial pancreatic beta cell loss occurs.

Funded projects will become part of the Human Islet Research Network (HIRN), providing a collaborative environment that brings together complementary expertise, technologies, human biological resources, and datasets. Awardees will be expected to participate in collaborative activities, share tools and data, coordinate the use of scarce human pancreatic tissues, and promote harmonization and interoperability of approaches and datasets where appropriate. Through this coordinated research effort, the initiative seeks to overcome barriers that have limited progress by individual laboratories and accelerate the translation of discoveries about early human T1D into biomarkers, therapeutic targets, and ultimately preventive or treatment strategies.