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NCT00574405 · ClinicalTrials.gov registry record · NA
Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy
A NA study, sponsored by Arkansas Children's Hospital Research Institute.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT00574405 is a NA study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 24 participants.
The verdict
NCT00574405, a NA study, has completed, sponsored by Arkansas Children's Hospital Research Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DRUG MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])
- DEVICE CSII (Animas Corporation insulin pump, model IR 1200)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-04 |
| Est. Completion | 2011-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00574405
The ClinicalTrials.gov registry entry for NCT00574405 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arkansas Children's Hospital Research Institute, which has 97 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) is the first listed.
NCT00574405 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00574405 about?
NCT00574405 is a clinical study titled "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...
What is the current status of trial NCT00574405?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2005-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00574405?
The interventions under investigation include: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) (DRUG), CSII (Animas Corporation insulin pump, model IR 1200) (DEVICE).
Who is sponsoring clinical trial NCT00574405?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
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