An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
Completed · Not applicable
Conditions studied: Diabetes
In brief
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 sensor safety and accuracy when used for six days. This study will also test sensor safety and accuracy when inserted in an alternate body location (buttock area in addition to abdomen area). The study hypothesis is that the sensor performance will not greatly diminish when used for six days, or in an alternate insertion area.
Key facts
- Study ID
- NCT00865345
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 63
- Starts
- 2009-03-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2012-11-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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)
Where it is running
- AMCR Institute — Escondido, California, United States
- Sansum Diabetes Research Institute — Santa Barbara, California, United States
- Rainier Clinical Research Center — Renton, Washington, United States
Full record on ClinicalTrials.gov
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