The validity of the Medisafe self-monitoring blood glucose system.

Self-monitoring blood glucose (SMBG) meters are widely used in the management of diabetes. The new SMBG meter Medisafe, which is based on the optoelectric colorimetry method, has been introduced. The objective of this study was to validate the Medisafe SMBG meters in comparison with the reference autoanalyzer (Hitachi 717) and to assess the repeatability of the instrument as well as variations of tip replacement. Samples of capillary and venous blood from 299 patients were tested. The correlation coefficients between the Medisafe-measured capillary and venous blood glucose levels and the reference autoanalyzer venous plasma glucose levels were 0.976 and 0.975, respectively. The range of differences from the reference value was examined; only 4% was in excess of +/- 20% of the reference laboratory value, and more than 40% of the values were within 5% of the reference laboratory value. Moreover, repeatability of the Medisafe capillary blood samples measured in three patients with three different blood glucose levels was determined. The coefficients of variation of blood glucose values are within 5%. In addition, the results of mean and SEM from each replication in three patients and glucose measurement from different lots of tips showed no significant difference (p > 0.05). It is concluded that the Medisafe SMBG meter has shown good results in terms of validity and repeatability. Furthermore, it provides safety from blood contamination, which is recommended in countries with a high prevalence of human immunodeficiency virus.