drugset / Trial / NCT00574405

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

NCT00574405

RandomizedParallel-groupOpen-labelTreatment

Summary

Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.

Timeline

Start
2005-04
Primary completion
2010-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic
Comparator Insulin Lispro Protein / enzyme biologic
Comparator insulin aspart Protein / enzyme biologic
Comparator insulin glargine Protein / enzyme biologic