MedTrace Logo

Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM

NCT00476788 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-04-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Omnipod Insulin Management System

Initiation of insulin pump therapy within three months of the diagnosis of type 1 diabetes mellitus

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Elaine C Moreland, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-08-31
Completion
2009-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476788 on ClinicalTrials.gov