Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
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.
Status: Completed (N/A). Started on April 1st, 2005.
Enrollment: 30 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Open Label
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog�� [or Humalog��]) (Novolog�� or Humalog��)
- Device: CSII (Animas Corporation insulin pump, model IR 1200) (Animas Corporation insulin pump, model IR 1200)
Eligibility
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.
- Gender
Both
- Mininum Age
8 Years
- Maximum Age
18 Years
- Healthy Volunteers
No
Resources
Source: Arkansas Children's Hospital Research Institute
Authority: United States: Institutional Review Board
Locations
-
Arkansas Children's Hospital/Research Institute
Little Rock
Arkansas
72202
United States
Officials
Kathryn M Thrailkill, MD (Principal Investigator, Arkansas Children's Hospital Research Institute)
Sponsors
Arkansas Children's Hospital Research Institute (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- May 1st, 2011
- First Received
- May 25th, 2011
- Last Changed
- May 25th, 2011
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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