Studies on accuracy of a device for self-monitoring of blood glucose "Glucocard Diablue" being compliant with ISO 15197

概要

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There are currently two groups of devices for selfmonitoring of blood glucose (SMBG) in Japan. One group of the devices gives glucose levels close to those of venous plasma, while it uses fingertip blood as a blood sample. SMBG devices of the other group show glucose levels close to those of fingertip blood plasma. In 2003, ISO 15197 became into effect. In this document it is clearly required that measurements from SMBG devices should be comparable to reference glucose levels of the plasma portion of the same capillary blood determined by a validated measurement procedure.<BR>A new SMBG devise, "Glucocard Diablue" or "Glutest Ace Ri" (other trade name), was evaluated for its accuracy depending on the ISO 15197 requirements. Fingertip capillary blood samples from 88 volunteer patients with diabetes mellitus were analyzed for glucose levels with the SMBG device. From the same capillary blood samples, plasma was separated by centrifugation and the glucose levels were measured using an automated analyzer.<BR>The values of 8 samples obtained with the SMBG device with glucose levels measured below 75 mg/dl by the automated analyzer were all within ±15mg/dl, which is the allowance limit required by ISO 15197, and 98.9% of values from 94 other samples obtained with the SMBG device above 75 mg/dl, were all within ±20%, which meets the criteria of ISO 15197. In conclusion, this new device for SMBG cleared the accuracy required by ISO 15197.