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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type I
Device: Real-time glucose sensor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Reduce blood glucose variability among 0-3 year old children with type I diabetes. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Observational arm
Experimental: Real-time glucose sensor
Subjects wear real-time glucose sensor
Device: Real-time glucose sensor
Children assigned to this intervention will use a real-time sensor continuously
Other Name: Minimed Paradigm Real-time sensor

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.

  Eligibility

Ages Eligible for Study:   3 Months to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875290

Contacts
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

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
The Gerber Foundation
Medtronic
Investigators
Principal Investigator: Patricia Fechner, MD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Patricia Fechner, M.D., Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00875290     History of Changes
Other Study ID Numbers: GerberPumpStudy
Study First Received: April 2, 2009
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Diabetes Mellitus, Type I
Children
Insulin pump therapy
Continuous glucose monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 14, 2014