The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children
Gerber RTSA
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.
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedAugust 5, 2011
August 1, 2011
6 years
April 2, 2009
August 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduce blood glucose variability among 0-3 year old children with type I diabetes.
1 year
Secondary Outcomes (1)
Number of adverse events
1 year
Study Arms (2)
Control
NO INTERVENTIONObservational arm
Real-time glucose sensor
EXPERIMENTALSubjects wear real-time glucose sensor
Interventions
Children assigned to this intervention will use a real-time sensor continuously
Eligibility Criteria
You may qualify if:
- Children less than 4 years of age with Type I diabetes for at least 3 months
You may not qualify if:
- Children greater than 4 years of age
- Monogenic diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- The Gerber Foundationcollaborator
- Medtroniccollaborator
Study Sites (1)
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Fechner, MD
Seattle Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
November 1, 2008
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
August 5, 2011
Record last verified: 2011-08