An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance (6-DayFU)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance|
- Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments) [ Time Frame: Days one through six of sensor use ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||March 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Device: MMT-7003 subcutaneous glucose sensor
- Glucose sensor
- Blood sugar sensor
- glucose monitor
- blood sugar monitor
- MiniMed sensor
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 Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor is used as part of the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received regulatory approval from the FDA in 2006.
As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of 72 hours, using only the abdomen area as an insertion site. Recent studies have shown that the useful sensor life could extend beyond three days, and it is reasonable to expect a significant percentage of sensors to last six days. It is the goal of this study to confirm sensor performance accuracy data from one of these recent studies. The sensor is also commonly worn in body areas other than the abdomen (such as the buttock). This study will also demonstrate sensor accuracy when used in an alternate site.
|United States, California|
|Escondido, California, United States, 92026|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|United States, Washington|
|Rainier Clinical Research Center|
|Renton, Washington, United States, 98057|
|Study Director:||John Mastrototaro, PHD||Medtronic Diabetes|