28
Clinical Study for Blood Glucose
The
Keto-Mojo
®
GK+
Blood Glucose and β-Ketone Dual Monitoring System was tested
by 352 lay users using capillary blood samples and three
Keto-Mojo
®
Blood Glucose test
strip lots. The results were compared to the YSI Model 2300 STAT PLUS Glucose
Analyzer, a laboratory instrument. The tables below show how well the two methods
compared.
Table 1-Linear Regression Results
Slope 0.9960
Y-Intercept -0.2740 mg/dL
Correlation coefficient (R) 0.9974
Number of sample 352
Range tested 38.6-548.9 mg/dL
Table 2-Consumers Accuracy Results
The numbers and percentages represented in this table are the number of meter results
compared to a laboratory result.
Difference range between the true blood
glucose level and the
Keto-Mojo
®
GK+
Blood
Glucose and β-Ketone meter result.
Within
±5%
Within
±10%
Within
±15%
Within
±20%
The percent (and number) of meter results
that match true blood glucose level within x%
61.6%
(217/352)
95.5%
(336/352)
100%
(352/352)
100%
(352/352)
Accurate Results
(Meter result is +/-15% of laboratory result)
352 out of 352 (100% of results)
More Accurate Results
(Meter result is +/-10% of laboratory result)
336 out of 352 (95.5% of results)
Most Accurate Results
(Meter result is +/-5% of laboratory result)
217 out of 352 (61.6% of results)
Clinical Study for Blood β-Ketone
The
Keto-Mojo
®
GK+
Blood Glucose and β-Ketone Dual Monitoring System was tested
by 102 lay persons using capillary blood samples and three
Keto-Mojo
®
Blood β-Ketone
test strip lots. The results were compared to the Randox RX Imola Chemistry Analyzer.
The tables below show how well the two methods compared.
Table 1-Linear Regression Results
Slope 1.0037
Y-Intercept -0.0083 mmol/L
Correlation coefficient(R) 0.9927
Number of sample 102
Range tested 0.11-1.52 mmol/L
