Accuracy Of Blood Glucose Monitoring System Research Articles

Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management.

The accuracy of blood glucose monitoring systems (BGMS) is crucial for the safe and effective management of diabetes mellitus. Despite standardization of accuracy assessment procedures and requirements, various studies have shown that the accuracy of BGMS on the market can vary considerably. This article therefore provides health care professionals and users with an intuitive illustration of the impact of BGMS accuracy on clinical decision making. Several hypothetical patient scenarios based on blood glucose (BG) levels in the low, normal, and high BG range are devised. Using data from a recent BGMS accuracy study, a method for calculating the expected range of BG readings from four examined BGMS at the selected BG levels is introduced. Based on these ranges, it is illustrated how clinical decisions and subsequent outcomes of the hypothetical patients are affected by the expected inaccuracies of the BGMS. The range of expected BGMS readings for the same true BG level can vary considerably between different BGMS. The discussion of hypothetical patient scenarios revealed that the use of some BGMS could be associated with an increased risk of adverse events such as failure to detect hypoglycemia, driving with an unsafe BG level, delay of treatment intervention in diabetes during pregnancy, or the failure to prevent diabetic ketoacidosis. This article can support both health care professionals and patients to understand the impact of BGMS accuracy in a relatable, clinical context. Furthermore, it is suggested that current accuracy requirements might be insufficient for the prevention of adverse clinical outcomes in certain circumstances.

Accuracy of a blood glucose monitoring system that recognizes insufficient sample blood volume and allows application of more blood to the same test strip

ABSTRACTBackground: Self-monitoring of blood glucose (SMBG) can play a key role in diabetes management. The CONTOUR®NEXT ONE (Ascensia Diabetes Care, Parsippany, NJ, USA) blood glucose monitoring system (BGMS) has been developed for use with CONTOUR®NEXT test strips. The meter connects to the CONTOUR™ Diabetes application on a mobile device, and the Second-Chance® sampling feature recognizes insufficient sample volume, prompting the patient to apply more blood to the same strip if needed (sample re-application).Research design and methods: Two studies evaluated CONTOUR®NEXT ONE BGMS accuracy with sample re-application: a laboratory study (performance under various controlled conditions) and a clinical study (performance in the hands of 52 people with diabetes). A formal International Organization for Standardization (ISO) evaluation has been reported previously; here, accuracy criteria in the laboratory and clinical studies were aligned with ISO 15197:2013 sections 6.3.3 and 8.2, respectively.Results: All results under all conditions in the laboratory study, and with glucose concentrations <100 and ≥100 mg/dL in the clinical study, were within ±15 mg/dL or ±15% of reference measurements. In both studies, all results were within Zone A of the Parkes-Consensus Error Grid.Conclusions: These data demonstrate that the accuracy of the CONTOUR®NEXT ONE BGMS was maintained with sample re-application.

Measures of Accuracy for Continuous Glucose Monitoring and Blood Glucose Monitoring Devices

Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.

The Financial Impact of Inaccurate Blood Glucose Monitoring Systems.

Objective:An in silico study of type 1 diabetes (T1DM) patients utilized the UVA-PADOVA Type 1 Diabetes Simulator to assess the effect of patient blood glucose monitoring (BGM) system accuracy on clinical outcomes. We applied these findings to assess the financial impact of BGM system inaccuracy.Methods:The study included 43 BGM systems previously assessed for accuracy according to ISO 15197:2003 and ISO 15197:2013 criteria. Glycemic responses for the 100 in silico adult T1DM subjects were generated, using each meter. Changes in estimated HbA1c, severe hypoglycemic events, and health care resource utilization were computed for each simulation. The HbA1c Translator modeling approach was used to calculate the financial impact of these changes.Results:The average cost of inaccuracy associated with the entire group of BGM systems was £155 per patient year (PPY). The average additional cost of BGM systems not meeting the ISO 15197:2003 standard was an estimated £178 PPY more than an average system that fulfills the standard and an estimated £235 PPY more than an average system that appears to meet the ISO 15197:2013 standard.Conclusion:There is a clear relationship between BGM system accuracy and cost, with the highest costs being associated with BGM systems not meeting the ISO 15197:2003 standard. Lower costs are associated with systems meeting the ISO 15197:2013 system accuracy criteria. Using BGM systems that meet the system accuracy criteria of the ISO 15197:2013 standard can help reduce the clinical and financial consequences associated with inaccuracy of BGM devices.

Fundamental Importance of Reference Glucose Analyzer Accuracy for Evaluating the Performance of Blood Glucose Monitoring Systems (BGMSs).

As blood glucose monitoring system (BGMS) accuracy is based on comparison of BGMS and laboratory reference glucose analyzer results, reference instrument accuracy is important to discriminate small differences between BGMS and reference glucose analyzer results. Here, we demonstrate the important role of reference glucose analyzer accuracy in BGMS accuracy evaluations. Two clinical studies assessed the performance of a new BGMS, using different reference instrument procedures. BGMS and YSI analyzer results were compared for fingertip blood that was obtained by untrained subjects' self-testing and study staff testing, respectively. YSI analyzer accuracy was monitored using traceable serum controls. In study 1 (N = 136), 94.1% of BGMS results were within International Organization for Standardization (ISO) 15197:2013 accuracy criteria; YSI analyzer serum control results showed a negative bias (-0.64% to -2.48%) at the first site and a positive bias (3.36% to 6.91%) at the other site. In study 2 (N = 329), 97.8% of BGMS results were within accuracy criteria; serum controls showed minimal bias (<0.92%) at both sites. These findings suggest that the ability to demonstrate that a BGMS meets accuracy guidelines is influenced by reference instrument accuracy.

A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in Spain.

Self-monitoring of blood glucose is crucial for the effective self-management of diabetes. The present study evaluated the accuracy of the Contour® XT blood glucose monitoring system (BGMS) compared to the reference method in a large multicenter study under routine lab conditions at each hospital site. This study was conducted at 21 leading hospitals in Spain using leftover whole blood samples (n = 2100). Samples were tested with the BGMS using 1 commercial strip lot and the local laboratory hexokinase method. BGMS accuracy was assessed and results were compared to ISO 15197:2013 accuracy limit criteria and by using mean absolute relative difference analysis (MARD), consensus (Parkes) error grid (CEG), and surveillance error grid analyses (SEG). Pooled analysis of 2100 measurements from all sites showed that 99.43% of the BGMS results were within the ranges accepted by the accuracy limit criteria. The overall MARD was 3.85%. MARD was 4.47% for glucose concentrations < 70 mg/dL and 3.81% for concentrations of 70-300 mg/dL. In CEG, most results (99.8%) were within zone A ("no effect on clinical action"); the remaining ones (0.2%) were in zone B ("little to no effect on clinical action"). The SEG analysis showed that most of the results (98.4%) were in the "no risk" zone, with the remaining results in the "slight, lower" risk zone. This is the largest multicenter study of Contour XT BGMS to date, and shows that this BGMS meets the ISO 15197:2013 accuracy limit criteria under local routine conditions in 21 leading Spanish hospitals.

Comparative Accuracy of 3 Blood Glucose Monitoring Systems that Communicate with An Insulin Pump

This study compared the accuracy of the Contour® Next Link blood glucose monitoring system (BGMS) with 2 other BGMSs (OneTouch® UltraLink® and Nova Max Link™), all 3 of which can communicate wirelessly with an insulin pump. Study staff tested fingerstick samples from 112 subjects aged ≥18 years with each BGMS. All BGMS results were compared to YSI 2300 STAT Plus™ Glucose Analyzer results from the same sample source. To safely obtain a wide range of glucose values, 3 blood samples were obtained from each subject (1 sample was tested fresh from the fingertip [unmodified], and the other 2 samples were modified to raise or lower the glucose concentration). The primary endpoint evaluated was difference in accuracy among the BGMSs across the entire tested glucose range (34 to 561 mg/dL). Additional comparisons were made of accuracy in the low (≤80 mg/dL) and high (>180 mg/dL) glucose ranges. BGMS accuracy was assessed by mean absolute relative difference (MARD). The Contour® Next Link BGMS had a statistically significantly lower MARD from the reference value than the other BGMSs across the entire tested glucose range, calculated using all samples as well as only unmodified (i.e., natural) samples. In the low and high glucose ranges, the Contour® Next Link also had a statistically significantly lower MARD from the reference value than the other BGMSs. As assessed by MARD, the Contour® Next Link BGMS was significantly more accurate than the other BGMSs evaluated, all of which can communicate wirelessly with an insulin pump.

Accuracy of blood-glucose monitoring system by using glucose oxidase or glucose dehydrogenase

Blood samples were detected by 24 blood-glucose meters using glucose oxidase and another 18 glucose meters using glucose dehydrogenase. The plasma glucose was detected by the auto-chemistry analyzer as control. According to ISO1 5197 and EF9-A2, the bias of results from both glucose meters 100% fall in the range of ±0. 56 mmol/L( ＜4. 2 mmol/L) and ≥99. 7% in the range of ±20% ( ≥4. 2 mmol/L), predicted bias were all less than the true bias(Bc). As κ＞0. 6, the results from both glucose meters were in accordance with the results from autochemistry analyzer in judging hyperglycemia ( ＞6. 11 mmol/L) and hypoglycemia ( ＜ 3.89 mmol/L). Between the results from the two blood-glucose meters, κ＜0. 6. The accuracy of both glucose-meters are accepted for the purpose of clinical diagnosis and treatment. Key words: Blood glucose; Measurement; Accuracy