Further Problems in Tester Calibration and Control Solution in Home Monitoring of Pre-Diabetes

Abstract

In previous publications, the author has reported some specific problems in checking glycaemia level in marginal diabetes, mainly due to the accuracy of the checks in that very narrow range of values, an issue particular important because above the upper limit, 125 mg/dL, the diabetes disease is considered to have already begun, while below that max value a diet is considered sufficient.

Since the off-shelf calibration of the testers used for home glucose level checks has been found not stable over time, the systematic use of control solutions provided by tester manufacturers is mandatory. However, the procedure for identifying potential calibration problems, even after a home calibration of both the batch and tester, is largely inaccessible to most patients, as demonstrated in the paper. Thus, improvements in the precision of the strip testers is urgently needed for that range, and, if stability of the standard solution cannot be ensured over a sufficient long term, the deadline for recalibration must be specified and the certificate of the control solution should be provided according to ISO Standards—and also reported on the tester/strip instruction sheets. Finally, relevant Standards should be more specific about this critical range.