Office of Technology Development (OTD)

Martin Hessner, PhD

Type 1 diabetes mellitus (T1DM) is an autoimmune disorder in which autoreactive T cells attack pancreatic β-cells, leading to a life-long dependency on insulin. This autoimmune attack on β-cells has been shown to be associated with increased levels of circulating inflammatory cytokines, including IL-1, IL-6, IL-8, IL-18, and TNF-α, which are often very difficult to accurately quantify in patient serum. Predicting which patients will develop T1DM is currently a significant challenge for clinicians. Prior to clinical onset of T1DM, patients often develop autoantibodies toward GAD65, IA-2, and insulin. Additionally, genetic factors may also play a role with certain (HLA)-DR,DQ genotypes showing strong association with T1DM.

The present invention is based on the inventor's discovery that serum from recent-onset type 1 diabetes mellitus (T1DM) subjects and subjects at high risk to develop T1DM induces expression of a subset of genes that are involved in cytokine-mediated inflammatory processes that have previously been associated with other autoimmune diseases. By monitoring expression of these genes alone or in combination with monitoring the presence of relevant autoantibodies, this invention allows greater ability to predict T1DM disease progression and to monitor the effectiveness of therapeutic intervention. The ability to screen for patients and catch them in the early phase of this disease provides early intervention opportunities. Additionally, recent evidence suggests this subset of cytokine-regulated genes may also play a role in the progression of type 2 diabetes mellitus (T2DM), which would allow this invention to monitor T2DM disease progression.

•    Provides a method of diagnosing patients having early stage (honeymoon phase) type 1 diabetes mellitus
•    Provides a method of diagnosing patients likely to develop type 1 diabetes
•    Provides a method to monitor disease progression in patients undergoing therapeutic intervention for type 1 diabetes mellitus
•    May have applicability toward monitoring disease progression in type 2 diabetes mellitus patients

Ex vivo clinical studies