An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01112696|
Recruitment Status : Completed
First Posted : April 28, 2010
Results First Posted : August 27, 2012
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus||Device: Sensor wear||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
All subjects that wear sensors (all subjects)
Device: Sensor wear
All subjects to wear sensors
Other Name: Enlite Sensor
- Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria [ Time Frame: Days one through six of sensor use ]The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
- Device Related Moderate or Device Related Severe Adverse Events [ Time Frame: days one through six of sensor wear ]
Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy.
Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment.
Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112696
|United States, California|
|AMCR Institute, Inc.|
|Escondido, California, United States, 92026|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|United States, Washington|
|Rainier Clinical Research Center, Inc.|
|Renton, Washington, United States, 98057|
|Study Director:||Scott Lee, MD||Medtronic Diabetes|