Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting.

We investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients.

Accuracy of self monitoring blood glucose systems in a clinical setting: application of new planned ISO- standards.

Background: The accuracy of glucose meters (GMs) for self-monitoring of blood glucose (BG) is essential for preventing insulin dosage errors in insulin injecting diabetic patients. We evaluated the accuracy of 19 commercially available GMs in a clinical setting applying the new planned ISO criteria.

Methods: Capillary blood was taken at 10-minute intervals in insulin dependent patients during induction of a BG increase and decrease by administration of a standardized carbohydrate rich meal and/or injection of an appropriate dosage of insulin under medical supervision.