Status:
COMPLETED
An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
Lead Sponsor:
Medtronic Diabetes
Conditions:
Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine s...
Detailed Description
The Medtronic MiniMed Subcutaneous Glucose Sensor was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The...
Eligibility Criteria
Inclusion
- Males and females aged 18 through 75 inclusive
- Type 1 Diabetes Mellitus treated using either CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for a minimum of 3 months
- Willingness to perform required study and data collection procedures and adhere to operating requirements of the Guardian REAL-Time and CGMS iPro Systems
- Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-Time and iPro Systems
- Willing to participate in a 12 hour frequent blood sampling session during the study
- Subject agrees to comply with the study protocol requirements
- Informed Consent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject
- The Subject is willing to wear both the Guardian REAL-Time and CGMS iPro Systems for 6 days (\~144 hours).
Exclusion
- The Subject has a history of tape allergies that have not been resolved
- The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
- Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the Subject from completing the study
- Subject is currently participating in an investigational study (drug or device)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00865345
Start Date
March 1 2009
End Date
January 1 2010
Last Update
November 6 2012
Active Locations (3)
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1
AMCR Institute
Escondido, California, United States, 92026
2
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
3
Rainier Clinical Research Center
Renton, Washington, United States, 98057