Diabetes Clinical Trial
Official title:
An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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