An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor
Completed · Not applicable
Conditions studied: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
In brief
The purpose of the study is to assess the performance of a new subcutaneous glucose sensor over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Key facts
- Study ID
- NCT01112696
- Run by
- Medtronic MiniMed, Inc.
- People needed
- 100
- Starts
- 2010-04-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2018-01-16
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
- Diagnosed with Type 1 or type 2 Diabetes Mellitus, using insulin to treat their diabetes (Each site's and overall study enrollment of subjects with Type 2 diabetes will target 20% of the total number)
- Willingness to perform required study and data collection procedures and to 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 CGMS iPro Systems
- Willingness to participate in a 10 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 14 days (\~340 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, Inc. — Escondido, California, United States
- Sansum Diabetes Research Institute — Santa Barbara, California, United States
- Rainier Clinical Research Center, Inc. — Renton, Washington, United States
Full record on ClinicalTrials.gov
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