The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children (Gerber RTSA)
This study is currently recruiting participants.
Verified August 2011 by Seattle Children's Hospital
Sponsor:
Seattle Children's Hospital
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
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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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
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
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 May 19, 2013