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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
PLA Army General Hospital
Beijing, China
Sir Run Run Shaw Hospital School of Medicine Zhejiang University
Hangzhou, China
Shanghai Sixth People's Hospital
Shanghai, China
Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI \<= 80 mg/dL) during YSI frequent sampling testing (FST) days.
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)
Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%).
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B represents sensor values that deviate YSI reference values by more than 20%, but "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B.
Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B.
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Time frame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)