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

Phase 3

• Conditions: Diabetes Mellitus, Type I
• Interventions: Device: Real-time glucose sensor

• Registration Number: NCT00875290
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-02
• Study First Posted: 2009-04-03
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children less than 4 years of age with Type I diabetes for at least 3 months

Exclusion Criteria

• Children greater than 4 years of age
• Monogenic diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-time glucose sensor	Real-time glucose sensor	Subjects wear real-time glucose sensor

Primary Outcome Measures

Name	Time	Method
Reduce blood glucose variability among 0-3 year old children with type I diabetes.	1 year

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	1 year

Trial Locations

Locations (1)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States