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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014