NCT00875290

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Months – 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type I

Interventions

Type	Name	Description
DEVICE	Real-time glucose sensor	Children assigned to this intervention will use a real-time sensor continuously

Timeline

• Start date: 2008-11-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2009-04-03
• Last updated: 2011-08-05

Locations

1 site across 1 country: United States