Diabetes Mellitus Clinical Trial
Official title:
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
This study is a multi-center, randomized, prospective single-sample correlational 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.
Each subject will wear the following devices:
• Two Enlite Sensors each connected to an iPro2 for approximately 6 days
Sensor Location:
• The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will
insert sensors and connect to the iPro2s.
During the study, each subject will be randomized and undergo one Yellow Springs Instrument
(YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).
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 study meter) for the management of their
diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite
Sensor.
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