The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children (Gerber RTSA)
Primary Purpose
Diabetes Mellitus, Type I
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Real-time glucose sensor
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type I focused on measuring Diabetes Mellitus, Type I, Children, Insulin pump therapy, Continuous glucose monitor
Eligibility 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
Sites / Locations
- Seattle Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Real-time glucose sensor
Arm Description
Observational arm
Subjects wear real-time glucose sensor
Outcomes
Primary Outcome Measures
Reduce blood glucose variability among 0-3 year old children with type I diabetes.
Secondary Outcome Measures
Number of adverse events
Full Information
NCT ID
NCT00875290
First Posted
April 2, 2009
Last Updated
August 4, 2011
Sponsor
Seattle Children's Hospital
Collaborators
The Gerber Foundation, Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00875290
Brief Title
The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Seattle Children's Hospital
Collaborators
The Gerber Foundation, Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type I
Keywords
Diabetes Mellitus, Type I, Children, Insulin pump therapy, Continuous glucose monitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Observational arm
Arm Title
Real-time glucose sensor
Arm Type
Experimental
Arm Description
Subjects wear real-time glucose sensor
Intervention Type
Device
Intervention Name(s)
Real-time glucose sensor
Other Intervention Name(s)
Minimed Paradigm Real-time sensor
Intervention Description
Children assigned to this intervention will use a real-time sensor continuously
Primary Outcome Measure Information:
Title
Reduce blood glucose variability among 0-3 year old children with type I diabetes.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Fechner, M.D.
Phone
206-987-5037
Email
patricia.fechner@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Joyce Yi-Frazier, Ph.D.
Phone
206-987-5037
Email
joyce.yi-frazier@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Fechner, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children
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