Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])
  • MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.
• Device: CSII (Animas Corporation insulin pump, model IR 1200)
  • CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®).
• Experimental: 2
  • CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Primary Measures

• Preservation of endogenous insulin secretion over time, as measured by intermittent meal-stimulated C-peptide testing (via MMTT) during 6 and 12 months of insulin pump therapy, compared with MDI.
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Changes in glycemic control, as assessed by the change in hemoglobin A1c and variations in daily blood glucose measurements (fasting BG and CGMS) from Day 1 of treatment to month 12 of treatment.
  • Time Frame: 12 months
    Safety Issue?: No
• Changes in daily insulin requirements over time
  • Time Frame: 12 months
    Safety Issue?: No
• Frequency of adverse glycemic consequences, i.e., frequency of hypoglycemia, severe hyperglycemia or ketosis.
  • Time Frame: 12 months
    Safety Issue?: Yes
• Patient satisfaction with mode of therapy and patient compliance with treatment recommendations.
  • Time Frame: 12 months
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Arkansas Children's Hospital Research Institute

Overall Clinical Trial Officials and Contacts

Kathryn M Thrailkill, MD Principal Investigator Arkansas Children's Hospital Research Institute  

Overall Contact: Cynthia S Moreau, RN 501-364-1975 moreaucynthias@uams.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00574405

Study ID Number: 29256

ClinicalTrials.gov Identifier: NCT00574405

Health Authority: United States: Institutional Review Board