The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children (Gerber RTSA)
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ClinicalTrials.gov Identifier: NCT00875290 |
Recruitment Status
: Unknown
Verified August 2011 by Seattle Children's Hospital.
Recruitment status was: Recruiting
First Posted
: April 3, 2009
Last Update Posted
: August 5, 2011
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Sponsor:
Seattle Children's Hospital
Collaborators:
The Gerber Foundation
Medtronic
Information provided by:
Seattle Children's Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | April 2, 2009 | |||
First Posted Date ICMJE | April 3, 2009 | |||
Last Update Posted Date | August 5, 2011 | |||
Study Start Date ICMJE | November 2008 | |||
Estimated Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Reduce blood glucose variability among 0-3 year old children with type I diabetes. [ Time Frame: 1 year ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00875290 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Number of adverse events [ Time Frame: 1 year ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children | |||
Official Title ICMJE | 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. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus, Type I | |||
Intervention ICMJE | Device: Real-time glucose sensor
Children assigned to this intervention will use a real-time sensor continuously
Other Name: Minimed Paradigm Real-time sensor |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
40 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | November 2014 | |||
Estimated Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 3 Months to 3 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00875290 | |||
Other Study ID Numbers ICMJE | GerberPumpStudy | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Patricia Fechner, M.D., Seattle Children's Hospital | |||
Study Sponsor ICMJE | Seattle Children's Hospital | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Seattle Children's Hospital | |||
Verification Date | August 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |