Type 1 Diabetes Extension Study

To further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov records NCT00129259 and NCT00965458).

Type 1 diabetes mellitus (T1DM) is an autoimmune disease. This means that the immune system (the part of the body that helps fight infections) mistakenly attacks the cells that produce insulin (beta cells in the pancreas). As beta cells are destroyed by the immune cells, the ability to produce insulin is decreased and diabetes develops. Insulin helps keep blood glucose levels normal.

People with diabetes who have the ability to produce some of their own insulin (even though they still need to take insulin) may be able to achieve better glucose control than people who produce no insulin at all. Better glucose control has been shown to reduce the long-term complications of diabetes.

Several Immune Tolerance Network (ITN) drug treatment studies have been completed and have shown that some participants with new onset T1DM had partial disease remissions with therapy. Prior participants in these trials, had measured insulin secretion, at six month intervals, up to two years after diabetes diagnosis. It is unclear, however, if any of the interventions have produced a continuing disease remission in patients. For persons who have completed drug treatment trials, longer term follow-up is important for continued evaluation for effect of therapy on insulin production.