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

This study is currently recruiting participants.
Verified August 2011 by Seattle Children's Hospital
Sponsor:
Collaborators:
The Gerber Foundation
Medtronic
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00875290
First received: April 2, 2009
Last updated: August 4, 2011
Last verified: August 2011

April 2, 2009
August 4, 2011
November 2008
November 2014   (final data collection date for primary outcome measure)
Reduce blood glucose variability among 0-3 year old children with type I diabetes. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00875290 on ClinicalTrials.gov Archive Site
Number of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type I
Device: Real-time glucose sensor
Children assigned to this intervention will use a real-time sensor continuously
Other Name: Minimed Paradigm Real-time sensor
  • No Intervention: Control
    Observational arm
  • Experimental: Real-time glucose sensor
    Subjects wear real-time glucose sensor
    Intervention: Device: Real-time glucose sensor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
3 Months to 3 Years
No
Contact: Patricia Fechner, M.D. 206-987-5037 patricia.fechner@seattlechildrens.org
Contact: Joyce Yi-Frazier, Ph.D. 206-987-5037 joyce.yi-frazier@seattlechildrens.org
United States
 
NCT00875290
GerberPumpStudy
No
Patricia Fechner, M.D., Seattle Children's Hospital
Seattle Children's Hospital
  • The Gerber Foundation
  • Medtronic
Principal Investigator: Patricia Fechner, MD Seattle Children's Hospital
Seattle Children's Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP