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

Diabetes Mellitus, Type I Clinical Trial

— Gerber RTSA  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT00875290
• Other study ID #: GerberPumpStudy
• Status: Recruiting
• Phase: Phase 3
• First received: April 2, 2009
• Last updated: August 4, 2011
• Start date: November 2008
• Est. completion date: November 2014

Study information

• Verified date: August 2011
• Source: Seattle Children's Hospital
• Contact: Patricia Fechner, M.D.
• Phone: 206-987-5037
• Email: patricia.fechner[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 3 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type I

Intervention

Device:
• Real-time glucose sensor
Children assigned to this intervention will use a real-time sensor continuously

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Medtronic, The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce blood glucose variability among 0-3 year old children with type I diabetes.		1 year	Yes
Secondary	Number of adverse events		1 year	Yes