- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161043
New Glucose Sensor Pediatric
An Evaluation of a New Subcutaneous Glucose Sensor in Pediatric Subjects
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35213
- University of Alabama Birmingham
-
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California
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Sacramento, California, United States, 95816
- Sutter Institute for Medical Research
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Florida
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Saint Petersburg, Florida, United States, 33549
- Endocrinology/ University of South Florida
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Amplatz Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females aged 7 through 17 inclusive
- Diagnosed with Type 1 Diabetes Mellitus
- Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME System
- Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME System
- Subject agrees to comply with the study protocol requirements
- Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject and/or parent/guardian
- The Subject is willing to wear the Guardian REAL-Time System for 14 days (~340 hours).
Exclusion Criteria:
- The Subject has a history of tape allergies that have not been resolved at time of enrollment
- The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of sensor placement that have not been resolved at the time of enrollment and would inhibit them from wearing the sensors
- Subject has a positive pregnancy test on enrollment
- Subject is currently participating in an investigational study (drug or device)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sensor
All subjects that wear sensors (all subjects)
|
All subjects to wear sensors
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use]
Time Frame: Days one through six of sensor use
|
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and SMBG glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between SMBG and paired sensor (within 20 mg/dL if SMBG ≤ 80 mg/dL).
Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
|
Days one through six of sensor use
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Related Moderate or Device Related Severe Adverse Events
Time Frame: days one through six of sensor wear
|
Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy. Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device |
days one through six of sensor wear
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEP232
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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