CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00574405
NCT00574405N/ACompleted

Preservation of Pancreatic Beta Cell Function Through Insulin Pump Therapy

Arkansas Children's Hospital Research Institute·interventional·Posted Dec 17, 2007·Updated Sep 13, 2017

In Brief

A clinical study evaluating MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) and CSII (Animas Corporation insulin pump, model IR 1200) for Diabetes Mellitus. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2007
Enrollment StartApr 1, 2005
Primary CompletionMar 1, 2010
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 18.5 years ago

Interventions

MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®])drug

MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration.

CSII (Animas Corporation insulin pump, model IR 1200)device

CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.