Described herein are methods and compositions for the treatment and monitoring the progress of autoimmune diseases. In some embodiments, the methods include the stimulation of regulatory T cells specific to autoantigens associated with the autoimmune disease. A specific embodiment relates to diabetes mellitus, and the prevention or delay of loss of residual β-cell mass, providing a longer remission period and delaying the onset of diabetes related, progressive, complications through immunotherapeutic induction of regulatory T cells specific for human insulin B chain. In addition, the methods described herein can be used to predict whether a subject, e.g., a subject with ongoing anti-insulin autoimmunity, will progress to T1DM, and to evaluate a subject's response to a therapeutic intervention.
