The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
90
Accuracy and safety assessment of a continuous glucose monitoring device
John Muir Physician Network Clinical Research Center
Concord, California, United States
AMCR Institute
Escondido, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Atlanta Diabetes Care
CGM Relative Difference to Laboratory Reference Reported as MARD
Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.
Time frame: 90 days
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