Diabetes Mellitus Clinical Trial
Official title:
A Pivotal Study to Evaluate Guardian™ Connect CGM System Performance in China
The purpose of this study is to demonstrate the performance and safety of the Guardian™ Sensor (3) over 170 hours (7 days) when inserted in the abdomen used in subjects age 14 - 75 years with the Guardian™ Connect System.
This study is a multi-center, prospective single-arm design without controls. Up to 72
subjects will be enrolled in order to have approximately 60 subjects complete the study.
Three investigational centers in China will be used during this study.
During the study, each subject will be randomly assigned to one day of the Yellow Springs
Instrument (YSI™*) frequent sample testing (FST) (Day 1, 3-5, or 7).Subjects will wear two
Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7
days (one which will be paired to the Guardian Connect app and the other will function as a
glucose recorder.).
The Guardian Sensor (3)s will be worn in the abdomen area and self-inserted by the subject on
same side or opposite sides.
On the evening prior to FST, subjects will be asked to fast for approximately 12 hours and
adjust their insulin and medications according to routine care (for example as they would do
for fasting lipid panel). Subjects may fast for shorter period of time based on investigator
discretion.
The subject should be in fasting status upon arrival hospital to start FST process. The
feeding protocol may be modified based on investigator discretion. The duration of FST will
be approximately 7 hours.
During the study, subjects will continue with their current diabetes regimen independent of
the study devices. Subjects will be instructed by the investigational center that they are
not to use the study devices (except for the CONTOUR™* study meter) for the management of
their diabetes. The CONTOUR™* study meter may be used for treatment decisions and calibration
of Guardian™ Sensor (3).
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