Last updated on May 2011

Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

Brief description of study

The aim of this study is to determine if early and tight restoration of metabolic control at the onset of Type 1 diabetes (T1DM) will improve insulin secretion (C-peptide production) versus routine diabetes management.

Detailed Study Description

There is evidence that early, intensive diabetes management may preserve C-peptide secretion possibly by allowing decreased islet cell activity or "islet cell rest". Less metabolically active islet cells result in a decreased inflammatory response and decreased autoantigen expression. This leads to a decrease in the destruction of beta cells and possibly to an increase in beta cell regeneration. In addition, the decreased hyperglycemia which results from intensive management may be less toxic to islet cells and make them less susceptible to cytokine mediated destruction. A closed-loop system (consisting of an in vivo glucose sensor, implantable insulin pump, and a feedback control algorithm to automatically determine insulin delivery rate) may optimally decrease the number of hours each day that islets are exposed to hyperglycemia. Used at the onset of T1DM, this may effectively decrease early "glucotoxicity" to allow earlier restoration of islet cell function, and perhaps alter islet antigen presentation to the immune system. The experimental therapy consists of a short course (minimum of 4 days) of closed-loop diabetic control at the onset of diabetes followed by continuous real-time glucose monitoring associated with continuous subcutaneous insulin infusion therapy (CSII) for two years. The standard therapy group will receive intensive management of their diabetes through frequent home glucose monitoring and multiple injections or CSII for two years. The implementation of any such therapy in this group will be determined by their treating diabetologist.

Clinical Study Identifier: NCT00505206

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