The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days). This is a multi-center study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
317
CGM and frequent sample testing
AMCR Institute
Escondido, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Percentage of Readings Within 20% Agreement
Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSI™\*) reference value (within 20 mg/dL \[1.1 mmol/L\] when sensor values \< 80 mg/dL) \[4.4 mmol/L\]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data.
Time frame: 7 days (170 hours)
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