Status:
COMPLETED
New Glucose Sensor Pediatric
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
7-17 years
Phase:
NA
Brief Summary
The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performan...
Detailed Description
The first generation Medtronic MiniMed Subcutaneous Glucose Sensor (Sof-Sensor) was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on J...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01161043
Start Date
July 1 2010
End Date
November 1 2010
Last Update
September 4 2020
Active Locations (4)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35213
2
Sutter Institute for Medical Research
Sacramento, California, United States, 95816
3
Endocrinology/ University of South Florida
St. Petersburg, Florida, United States, 33549
4
University of Minnesota Amplatz Children's Hospital
Minneapolis, Minnesota, United States, 55455