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NCT00476788 · ClinicalTrials.gov registry record · NA
Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT00476788: Completed NA study, sponsored by University of Alabama at Birmingham.
NCT00476788 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00476788, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The outcomes of interest are the feasibility and potential metabolic benefits of this approach. We anticipate that the initiation of this CSII device in the immediate post-diagnosis period in this population will result in good glycemic control and greater parental satisfaction when compared to intensive insulin injection therapy.
Primary Outcome
Measure of glycemic control (A1c) over preceding 8 weeks. Normal for a patient between ages 1 and 10 years would be 7.0-8.5%.
Interventions
- DEVICE Omnipod Insulin Management System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2007-04 |
| Est. Completion | 2009-09 |
| Phase | NA |
What the finished NCT00476788 record still lists
NCT00476788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Omnipod Insulin Management System is the first listed.
NCT00476788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00476788 about?
NCT00476788 is a clinical study titled "Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM". This study evaluates early initiation of continuous subcutaneous insulin infusion (CSII) therapy in young children using a novel delivery method in the form of a self-contained, lightweight, and disposable insulin pump unit controlled with a wireless handheld device. The outcomes of interest are the...
What is the current status of trial NCT00476788?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2007-04. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00476788?
The interventions under investigation include: Omnipod Insulin Management System (DEVICE).
Who is sponsoring clinical trial NCT00476788?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00476788's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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