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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: Completed NA study, sponsored by Arkansas Children's Hospital Research Institute.

NCT00574405 is a NA study that has completed, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 24 participants
Start Date 2005-04
Est. Completion 2011-03
Phase NA

What the finished NCT00574405 record still lists

NCT00574405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

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 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00574405's enrollment target sits among peer trials

24 1736th of 2000 higher than 246 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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Source: ClinicalTrials.gov NCT00574405, the US trial registry maintained by the National Library of Medicine. NCT00574405 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.