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The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children — Gerber RTSA  

Diabetes Mellitus, Type I Clinical Trial

Official title:
Gerber Pump Trial: Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Real-Time Sensor Augmentation (RTSA) in 0-3 Years Old Diabetes Patients; A One Year Randomized Controlled Clinical Trial.

Clinical Trial Summary

The purpose of this study is to see if the use of a real-time glucose sensor improves diabetes control in young children (less than 4 years old) with Type I diabetes when they are initiated on insulin pump therapy.

Clinical Trial Description

A randomized controlled clinical trial involving patients 0-3 yrs old with type 1 diabetes. After successful screening the subjects will be randomized into one of two groups: a CSII group alone and a CSII group + Real Time Sensor Augmentation group (RTSA) group. The CSII group will serve as the control for the CSII+RTSA group. The trial will last for one year. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00875290
Study type Interventional
Source Seattle Children's Hospital
Contact Patricia Fechner, M.D.
Phone 206-987-5037
Email patricia.fechner@seattlechildrens.org
Status Recruiting
Phase Phase 3
Start date November 2008
Completion date November 2014
View Details
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