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

August 4, 2011 updated by: Seattle Children's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Minimed Paradigm Real-time sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduce blood glucose variability among 0-3 year old children with type I diabetes.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

Medtronic
The Gerber Foundation

Investigators

  • Principal Investigator: Patricia Fechner, MD, Seattle Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ANTICIPATED)

November 1, 2014

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (ESTIMATE)

April 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GerberPumpStudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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