Glucose Monitor Accuracy Investigation (Ⅰ)

Glucose Monitor Accuracy Investigation (Ⅰ)

According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of fingertips and vein as samples to evaluate the accuracy of portable BGM.

The clinical medical technologists collected blood samples from 308 volunteers including 87 diabetics and 221 healthy people. The range of the blood glucose concentration was from 41.2mg/dL to 521mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches the requirement of ISO15197(2003).

Inclusion Criteria:

• volunteers with diabetes and non-diabetes

Exclusion Criteria:

• hypertension,fever,AIDS,hemophilia