Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting
Open Access
- 18 February 2014
- journal article
- research article
- Published by SAGE Publications in Journal of Diabetes Science and Technology
- Vol. 8 (3), 466-472
- https://doi.org/10.1177/1932296814522804
Abstract
Background: 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. Methods: Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Results: Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between 50 and 150 mg/dl, whereas 19 (70.3%) met these criteria at BG levels above 250 mg/dl. The overall frequency of outliers was low. Conclusions: The assessment of analytical accuracy of GMS at a number of BG level ranges made it possible to further differentiate between devices with regard to overall performance, a process that is of particular importance given the user-centered nature of the devices’ intended use.Keywords
This publication has 15 references indexed in Scilit:
- Accuracy of Self Monitoring Blood Glucose Systems in a Clinical Setting: Application of New Planned ISO- StandardsClinical Laboratory, 2013
- System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197Journal of Diabetes Science and Technology, 2012
- Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197Journal of Diabetes Science and Technology, 2012
- Safety and accuracy of a new long-term subconjunctival glucose sensorJournal of Diabetes, 2012
- New Criteria for Assessing the Accuracy of Blood Glucose Monitors Meeting, October 28, 2011Journal of Diabetes Science and Technology, 2012
- Accuracy in Blood Glucose Measurement: What Will a Tightening of Requirements Yield?Journal of Diabetes Science and Technology, 2012
- The Accuracy of Home Glucose Meters in HypoglycemiaDiabetes Technology & Therapeutics, 2010
- Self-monitoring of blood glucose with a focus on analytical quality: an overviewcclm, 2010
- The Need for Separate Performance Goals for Glucose Sensors in the Hypoglycemic, Normoglycemic, and Hyperglycemic RangesDiabetes Care, 2004
- Accuracy of home blood glucose meters during hypoglycemiaDiabetes Care, 1996