Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arkansas Children's Hospital Research Institute
• Treatments: Insulin; Insulin Aspart; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Medical history and clinical presentation consistent with the diagnosis of Type 1 DM.

• Age: 8-18 years

Exclusion Criteria:

• Clinical presentation consistent with Type 2 DM.

• History of other chronic systemic inflammatory or autoimmune disease or other severe medical conditions.

• Concurrent pregnancy.

• Participation in other research protocols or use of other investigational agents within 30 days of enrollment.