This is an evaluation of the CDx SensoCard Plus blood glucose meter with the SensoCard test strip which is intended for home use for diabetics.
The system, which uses non-wipe biosensor technology to measure glucose in capillary blood, has the ability to provide instructions and test results via synthesised speech for visually-impaired people with diabetes. The system requires 0.5 l of blood, has a measurement time of five seconds, is simple to operate and requires minimal maintenance.
In the clinical study when results were compared with those obtained using the hexokinase method, there was a significant variation in bias between the results from the two batches of test strips. However, there was no significant meter-to-meter variation in bias. Error grid analysis against the hexokinase-adjusted results would classify the system as clinically acceptable for both meters tested, with all of the results falling into Zone A. The system also met the criterion for acceptable imprecision and acceptable total error.