Point-of-care test for the early diagnosis of type 1 diabetes

Type 1 Diabetes (T1D) is a chronic autoimmune disease, characterised by progressive destruction of the insulin producing islet beta cells in the pancreas. Globally, 9.4 million people have T1D. The UK has one of the highest rates (? 400,000), increasing by 4-5% each year, particularly in the youngest ages. Currently there is no routine screening programme for T1D in the United Kingdom. T1D usually presents in childhood and, until recently, the only treatment has been insulin replacement therapy. But, following successful trials, pharmaceutical companies are now introducing revolutionary new T1D treatments that target the autoimmune mechanism. These treatments prevent the destruction of islet beta cells and so allow the pancreas to continue producing insulin. This will enable patients to live without the unrelenting regime of diet management, constant glucose monitoring and regular injections of insulin. However, in order to benefit from these treatments, patients must be diagnosed before the islet cells have been irreversibly damaged or destroyed, which means detecting the disease before the onset of symptoms. A minimally invasive, cost effective and accessible test is required to enable easy identification of T1D. Invitron is developing an extremely sensitive and accurate handheld diagnostic device, designed to provide a rapid POC alternative to back-to-lab blood testing. Using a capillary blood sample, obtained by fingerstick, our new device will perform a test in a just few minutes. This project is focussed on the development of a POC test that would enable screening for early stage (pre-symptomatic) T1D by detecting the presence of islet autoantibodies. During this project we will develop prototypes, test clinical feasibility and research diagnostic and treatment pathways. Project findings will be disseminated via conference proceedings and public domain information available for interested parties.