Reliable Readings for Diabetes Self-Management

 Prick the fingertip and sample a drop of blood with a test strip, and after a few seconds, the meter displays the result. Many people with diabetes control their blood sugar level on a daily basis with a blood glucose monitoring system. Accurate readings are of high importance to successfully self-manage their diabetes. That's why the ISO has defined guidelines for blood glucose monitoring systems in the ISO 15197:2003 standard.
According to a recent study, Bayer's Contour? meter delivers reliable readings and exceeds the acceptable accuracy requirements of ISO 15197:2003. The device especially showed accurate test results at glucose concentrations below 75 mg/dL (<4.2 mmol/L). At glucose concentrations of 75 mg/dL (4.2 mmol/L) or higher, 99.2% of the results fell within the defined standard of ±20% of the results of the reference method. Further, Bayer's Contour? blood glucose monitoring system not only met the minimum acceptable accuracy requirements of the ISO 15197:2003 standard but also exceeded the criteria. In the combined analysis, a total of 99.3% of results fell within ±15 mg/dL (0.83 mmol/L) and ±20% of the results of the validated laboratory method.
The accuracy of Bayer's Contour? meter for fingertip capillary blood testing was assessed at a single study site of Bayer HealthCare in Mishawaka, IN, involving 105 patients with diabetes. Twenty-five of them had type 1 diabetes and 77 had type 2 diabetes (3 not reported). The patient's fingertip blood was tested by a trained operator with the Contour? blood glucose monitoring system and a laboratory reference method, the YSI glucose analyzer. Each finger-stick sample was tested with three different lots of test strips, with duplicate readings per lot for a total of six readings per sample.
When assessed by an even tighter accuracy standard for blood glucose monitoring systems, accuracy has been achieved. According to proposed tighter accuracy standards, glucose concentrations below 100 mg/dL (5.6 mmol/L) shall fall within ±15 mg/ dL (0.83 mmol/L) and concentrations at 100 mg/dL or higher shall fall within ±15% of the reference value for glucose concentrations. A total of 96.7% of tests delivered these results.
The Clarke Error Grid analysis also confirmed that Bayer's Contour? delivers reliable results. The method evaluates the clinical accuracy of blood glucose monitoring systems compared to a laboratory reference value, classifying them from zones A to E. All results fell within zones A and B, indicating that deviations of meter readings from reference values had no or minimal effect on clinical action. A total of 99.3% of results fell within zone A, and no results within zones C, D, or E. Being evaluated by using the Parkes-Consensus Error Grid analysis, Bayer's Contour? meter showed results similar to those seen with the Clarke Error Grid analysis.
The study has demonstrated that Bayer's Contour? blood glucose monitoring system shows excellent correlation with the laboratory method and exceeds both the ISO 15197:2003 standard and the more stringent accuracy criteria that is currently under consideration. People with diabetes receive reliable, accurate test results that enable them to better understand their blood glucose results, which can help them better manage their condition.
In addition, the device is designed to facilitate successful self-management of diabetes. The No Coding? technology eliminates inaccurate readings due to user miscoding. The technology is particularly important for those one in six patients who do not properly code their blood glucose meter. People with diabetes using meal marker and audible reminder features adjust their diet and exercise according to testing results and show more confidence in self-monitoring their blood sugar level.
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