Evaluation of Hematocrit Influence on Self-Monitoring of Blood Glucose Based on ISO 15197:2013: Comparison of a Novel System With Five Systems With Different Hematocrit Ranges.

Introduction: ISO 15197:2013 recommends testing procedures and acceptance criteria for the evaluation of influence quantities such as hematocrit on measurement results with systems for self-monitoring of blood glucose (SMBG). In this study, hematocrit influence was evaluated for a novel SMBG system (system A) and five other systems with different hematocrit ranges based on ISO 15197:2013.

Methods: Test procedures were performed with one test strip lot for each system.

Assessing System Accuracy of Blood Glucose Monitoring Systems Using Rectangle Target Plots.

Background: Results from accuracy assessments of systems for self-monitoring of blood glucose (SMBG) are often visualized in difference or regression plots. These approaches become more difficult to read as the number of data points displayed increases, thus limiting their use. In the recently presented rectangle target plot (RTP) approach, data from each reagent system lot or product are displayed graphically as a single rectangle, thus allowing the plot to remain comprehensible even when displaying system accuracy data from multiple reagent system lots or products.

Effects of microdialysis catheter insertion into the subcutaneous adipose tissue assessed by the SCGM1 system.

To monitor glucose in patients with diabetes continuously a microdialysis-based glucose sensor system (SCGM1 System, Roche Diagnostics GmbH, Mannheim, Germany) is under clinical development. This system allows monitoring of glucose levels in the subcutaneous interstitial fluid of patients with diabetes for a maximum duration of up to 120 h. The aim of the study was to determine the effect of microdialysis catheter insertion on the stability of the SCGM1 System glucose sensor signal.