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Continuous Glucose Monitoring
The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children (Gerber RTSA Trial)
Phase 3
Waitlist Available
Led By Patricia Fechner, MD
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Children less than 4 years of age with Type I diabetes for at least 3 months
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
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.
Eligible Conditions
- Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Real-time glucose sensorExperimental Treatment1 Intervention
Subjects wear real-time glucose sensor
Group II: ControlActive Control1 Intervention
Observational arm
Find a Location
Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
310 Previous Clinical Trials
5,231,190 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,048 Total Patients Enrolled
The Gerber FoundationOTHER
43 Previous Clinical Trials
6,099 Total Patients Enrolled
Patricia Fechner, MDPrincipal InvestigatorSeattle Children's Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled