i-SENS TEE2 - Performance Characteristics; Precision Analysis; Accuracy Analysis

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PerformanceCharacteristics
The performance of TEE2 Blood Glucose Monitoring System has
been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the TEE2 BGM System (Model
GM505KAB,GM505KBB)wasassessedbycomparingblood
glucose results obtained by patients with those obtained using
a YSI Model 2300 Glucose Analyser, a laboratory instrument. The
following results were obtained by diabetic patients at clinic
centres.
Slope 1.02
Y-intercept -0.41 mmol/L
Correlation coefficient (r) 0.992
Number of sample 122
Range tested 2.2 ~ 32.1 mmol/L
Within ± 0.28 mmol/L
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
47/111 (42%) 89/111 (80%) 109/111 (98%) 111/111 (100%)
11/11 (100%)
Accuracy results for glucose concentration < 4.2 mmol/L
Accuracy results for glucose concentration ≥ 4.2 mmol/L
11/11 (100%) 11/11 (100%)
Within ± 0.56 mmol/L
Within ± 0.83 mmol/L
Within Run Precision
Blood avg. 2.3 mmol/L SD = 0.1 mmol/L
Blood avg. 4.4 mmol/L SD = 0.2 mmol/L
Blood avg. 7.2 mmol/L CV = 2.6%
Blood avg. 11.2 mmol/L CV = 3.1%
Blood avg. 19.4 mmol/L CV = 2.7%
Precision:The precision studies were performed in a laboratory
using TEE2 BGM Systems.
Total Precision
Control avg. 2.0 mmol/L SD = 0.07 mmol/L
Control avg. 6.5 mmol/L CV = 2.3%
Control avg. 17.9 mmol/L CV = 2.4%
This study shows that there could be variation of up to 3.1%.