Type 1 Diabetes Biomarkers (patent pending):
These biomarkers may potentially provide the first-ever immune cell-based diagnostic tool in T1DM autoimmunity. Currently, the presence of T1DM autoimmunity can be diagnosed in patients with the clinical disease and in pre-diabetics using serum antibodies. However, these serum antibodies are only able to assess the overall risk for developing the clinical disease, not at the level of an individual. These novel biomarkers are to detect and monitor the level of autoimmunity which is different from person to person and even in the same person fluctuate over time, thus enabling us to provide individualised assessment, prognosis and diagnosis. In pre-diabetics, these tests will predict the time when the individual subject gets the clinical disease. In T1DM patients, it will predict the time when they will run out of their own insulin production and become full-blown diabetics. Furthermore, these are also novel tools that could also be built into future diabetes clinical trials to monitor the effectiveness of prevention and intervention clinical trials reducing the patients' exposure, money and time.
This diagnostic modality will undergo further validation during our clinical trial.