MEDTRUM TECHNOLOGIES Inc. FM008 ユーザーズマニュアル
8.5 CGM System Accuracy
A multi-center, randomized clinic study is designed to determine the Sensor
accuracy in adults with Type 1 or Type 2 diabetes. In-clinic testing consisted of
frequent venous blood sample testing (by Yellow Springs Instrument 2300 STAT
Plus™ Glucose Analyzer, YSI) on a random day in the 7-day Sensor life. The
accuracy is based on the percentage of CGM glucose readings that are within ±
20%, 30% or 40% of YSI values at glucose values at or above (>=) 100 mg/dL
(5.6 mmol/L), or within ±20 mg/dL (1.1 mmol/l), 30 mg/dL (1.7 mmol/L) or 40
mg/dL (2.2 mmol/L) of YSI values at glucose values below (<) 100 mg/dL (5.6
mmol/L).
accuracy in adults with Type 1 or Type 2 diabetes. In-clinic testing consisted of
frequent venous blood sample testing (by Yellow Springs Instrument 2300 STAT
Plus™ Glucose Analyzer, YSI) on a random day in the 7-day Sensor life. The
accuracy is based on the percentage of CGM glucose readings that are within ±
20%, 30% or 40% of YSI values at glucose values at or above (>=) 100 mg/dL
(5.6 mmol/L), or within ±20 mg/dL (1.1 mmol/l), 30 mg/dL (1.7 mmol/L) or 40
mg/dL (2.2 mmol/L) of YSI values at glucose values below (<) 100 mg/dL (5.6
mmol/L).
Table. Percentage of CGM Glucose Readings within ±20%/20 mg/dL , ±30%/30
mg/dL, or ±40%/40 mg/dL of the YSI; Calibrating every 12 hours, Abdomen
insertion site.
mg/dL, or ±40%/40 mg/dL of the YSI; Calibrating every 12 hours, Abdomen
insertion site.
Number of
Matched Pairs
CGM-YSI
Matched Pairs
CGM-YSI
±20%/20 mg/dL
±30%/30 mg/dL
±40%/40
mg/dL
mg/dL
1678
91%
97%
99%