The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children (Gerber RTSA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Seattle Children's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 2, 2009 | ||||||||
| Last Updated Date | August 4, 2011 | ||||||||
| 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 ] [ Designated as safety issue: Yes ] | ||||||||
| 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 ] [ Designated as safety issue: Yes ] | ||||||||
| 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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated 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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| Gender | Both | ||||||||
| Ages | 3 Months to 3 Years (Child) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| 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 | ||||||||
| Plan to Share Data | Not Provided | ||||||||
| IPD Description | 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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| Information Provided By | Seattle Children's Hospital | ||||||||
| Verification Date | August 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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