Small Business Innovation Research (SBIR) to Develop New Methods and Technologies for Assessment of Risk and for Early Diagnosis and Prognosis of Type 1 Diabetes (T1D) (R43/R44)

Early identification of T1D risk and the onset of autoimmunity provide the basis for a variety of major ongoing studies seeking to prevent or delay the disease.  Already, research on the natural history of the development of T1D in at-risk neonates has shown that early identification of those at risk can foster early diagnosis of T1D and avoid life-threatening diabetic ketoacidosis (DKA).  Also, clinical trials are currently in progress to identify ways to prevent or reverse the autoimmunity of T1D.  Investigators have used a combination of islet autoantibody positivity, autoantibody seroconversion, biomarkers of genetic susceptibility, and beta cell functional assays as criteria to select individuals at high risk of developing T1D.  However, current technology for identification of at-risk individuals is costly, requires participation of research laboratories, and may not be suitable for public health screening that would ensue should effective preventative interventions be established.  Methods for more efficient identification of individuals at risk of T1D who may be eligible for preventative intervention would include low-cost, high-throughput, accurate and predictive assays/devices that could be used at the point of care level.  Application of such technologies could facilitate and expedite testing when effective ways to prevent or delay T1D become available and would be essential for identifying individuals who can benefit from such treatments.  Population-based screening of individuals would be required, as the majority of people with newly diagnosed T1D (~70-80%) have no affected relatives.  Thus, it is necessary to promote and support novel developments in this field as new biomarkers/assays/devices are needed to improve the identification of individuals at risk of developing T1D, determine prognosis, monitor progression, and assess the efficacy of therapeutic interventions. The development of these technologies would facilitate recruitment for clinical research focused on identifying environmental triggers of T1D, T1D natural history, and interventions to prevent T1D.  It will also facilitate clinical implementation of measures subsequently proven effective in delaying or preventing T1D in those at risk.  Use of such assays in organ donors could also facilitate provision of autoimmune pancreas to researchers.

Examples of topics relevant to this announcement include but are not limited to:

• Development of techniques or products useful for predicting, preventing or delaying progression of diabetes, including tests for identifying patients at risk, and methods of monitoring disease progression.
• Development of high-throughput assays (reliable, accurate, cost-effective, highly sensitive/specific, standardized, having rapid turnaround time) for autoantibody detection and other autoimmune/inflammatory/metabolic markers for diagnosis and follow up.
• Development of point-of-care low-cost/portable devices for subjects at risk for diabetes and for diagnosis of diabetes.
• Development of methods to measure changes in the immune status that may be used as markers to follow the immune-modulatory activity and beneficial effect of agents tested in clinical trials for the prevention and/or treatment of T1D.
• Development of non-invasive imaging as well as other methods/biomarkers for the in vivo measurement/ evaluation of pancreatic beta cell mass, function, or inflammation for the in vivo diagnosis and prognosis of a pre-diabetic/clinically silent stage and subsequent follow up.
• Development of high-throughput assays based on biologic pathways likely involved in the pathogenesis of diabetes that could be used to develop novel predictive/diagnostic systems/platforms.