New Glucose Sensor Pediatric
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus
In brief
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 performance of the new sensor will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Key facts
- Study ID
- NCT01161043
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 83
- Starts
- 2010-07-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2020-09-04
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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)
Where it is running
- University of Alabama Birmingham — Birmingham, Alabama, United States
- Sutter Institute for Medical Research — Sacramento, California, United States
- Endocrinology/ University of South Florida — St. Petersburg, Florida, United States
- University of Minnesota Amplatz Children's Hospital — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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