Accuracy of Self Monitoring Blood Glucose Systems in a Clinical Setting: Application of New Planned ISO- Standards

Hasslacher, Christoph; Kulozik, Felix; Platten, Isabel

doi:10.7754/clin.lab.2012.120710

Cited by 19 publications

(18 citation statements)

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“…12 In our study using a clinical setting, only 12 devices (44%) met these requirements, which is in line with Freckmann et al's results and confirms our previous study with a smaller number of devices. 13 Responses to the consultation process on the new ISO criteria included the suggestion that instead of testing accuracy at BG < 100 mg/dl and > 100 mg/dl, it should be tested at a number of different BG level ranges, making it possible to further differentiate between devices with regard to overall performance. [3][4][5][6] The aim of this more detailed approach to accuracy testing is to identify devices that produce highly accurate measurements, making them suitable for use by patients on intensified insulin therapy.…”

Section: Discussionmentioning

confidence: 99%

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Hasslacher

Kulozik

Platten

2014

J Diabetes Sci Technol

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Glucose monitoring systems (GMS) are routinely used by patients with diabetes to monitor glycemic control and modify treatment as needed. In this respect, the analytical performance of GMS is of course of crucial importance. The accuracy of GMS is usually assessed according to the Guidelines of the International Organization for Standardization (ISO). A new standard has recently been published with more stringent criteria than in the previous edition.1,2 Minimum acceptable system accuracy requirements for GMS now specify that ≥95% of the glucose meter results may not differ more than ±15 mg/dl from the reference method at glucose concentrations < 100 mg/dl (previously < 75 mg/dl) and ±15% (previously ±20%) at glucose concentrations ≥ 100 mg/dl.1 Furthermore, concerning prevalence and range of outliers, it is now specified that >99% of measured glucose values must fall in zones A and B of the consensus error grid.During the consultation process of the new criteria it has been suggested that the analytical performance of GMS is highly dependent on its intended use.3-6 For example, insulin-dependent patients under intensified glycemic control require highly accurate devices for adequate insulin dosing, whereas patients with Type 2 diabetes who are treated with medication with no or little risk of hypoglycemia could use less accurate GMS. It has, therefore, been suggested that the analytical accuracy of GMS should be tested not only in relation to BG level ranges below and above 100 mg/dL but also in relation to different glycemic ranges, as already previously proposed for continuous glucose monitoring systems. The aim of the present study was to analyze test results from 27 GMS obtained in a clinical setting, with regard to (1) analytical accuracy according to the new ISO accuracy limits as well as after stratification into 5 different BG level ranges and (2) frequency and extent of outliers. AbstractWe 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. 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. 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...

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Section: Discussionmentioning

confidence: 99%

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Hasslacher

Kulozik

Platten

2014

J Diabetes Sci Technol

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“…10 This standard was developed primarily for home glucose testing and may not be applicable for use in other health care settings. 13 Furthermore, the standard is designed to compare results to a reference method and not to repeat measurements by the same method. The ISO 15197 standard is being revised with more strict requirements to meet accuracy goals for glucose testing performed in the hospital setting for insulin administration protocols.…”

Section: Commentmentioning

confidence: 99%

Reliability of Point-of-Care Capillary Blood Glucose Measurements in the Critical Value Range

Schifman

Nguyen

Page

2014

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Point-of-care glucose (POCG) testing on capillary blood specimens is central to maintaining glycemic control in patients with diabetes. Although there are known performance issues with POCG methods, especially for maintaining tight glucose control, there is little information about the accuracy of results in the critical ranges that may involve life-threatening conditions.Objectives.-To evaluate the reliability of POCG measurements in critical, high (.600 mg/dL) and low (,40 mg/dL) ranges.Design.-One-year retrospective analysis of POCG (ACCU-CHEK glucose meter, Roche Diagnostics Corporation, Indianapolis, Indiana) results for routine patient care were obtained. The frequency and accuracy of repeat testing after critical POCG results was analyzed. A convenience sample of noncritical capillary POCG measurements retested on venous blood specimens by another point-of-care device (RAPIDPoint 405 analyzer, Siemens Medical Solutions USA, Malvern, Pennsylvania) was also evaluated.Results.-Critical values were observed in 2.4 per 1000 POCG tests (256 of 105,928; 0.24%), with the highest rate (76 of 2289; 3.32%) from the emergency department. Twice as many critical high values as critical low values were seen. Nearly 80% of critical POCG tests (204 of 256) were repeated within 10 minutes. Of these 204 repeat measurements, 112 (54.9%) met accuracy criteria (615 mg/dL of low and 620% of high initial values). Accuracy was significantly higher when retesting was performed on the same meter or by the same operator (P .05).Comparison of capillary and venous POCG testing of noncritical results showed no significant difference (P ¼ .95), with 89.8% (125 of 139) meeting accuracy criteria.Conclusions.-POCG measurements in the critical range are frequently erroneous, which is likely caused by preanalytic factors associated with sampling capillary blood. POCG testing practices should include retesting to confirm critical results.(Arch Pathol Lab Med. 2014;138:962-966; doi: 10.5858/ arpa.2013-0455-OA) P oint-of-care glucose (POCG) testing on capillary blood specimens is performed for maintaining glycemic control and for detecting acute hypoglycemic and hyperglycemic conditions. Preanalytic factors, such as hypoxia, anemia, interfering substances, and specimen type, have been shown to affect the accuracy of POCG measurements. [1][2][3][4][5] There is limited information, however, about the reliability of POCG measurements in the critical high and low ranges. That knowledge is important because accurate testing and prompt reporting of critical values is an important patient safety goal. 6A previous study 7 has shown that POCG measurements in critical high and low ranges were frequently erroneous when reevaluated by measuring another capillary or venous blood specimen. However, there is little other information about optimal POCG test performance or practices for accurately detecting critical results. For example, retesting is generally not necessary for checking the accuracy of critical values obtained from clinical laboratory ...

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“…17 Consequently, analytical performance or preanalytical factors associated with sample collection and processing that could affect accuracy of results in the critical range may go unrecognized. 6,18 A key observation in this study was that only about half of the POCG measurements in the critical range were retested, and of these, about 19% of repeat measurements did not meet criteria to confirm results. Previous studies conducted in single institutions using similar criteria have shown comparable discrepancy rates when critical POCG measurements were repeated.…”

Section: -16mentioning

confidence: 94%

“…13 However, these standards were intended to be used to validate home use glucose meters against a reference standard. 18 Surveillance error grid analysis, 19 which was designed to take into account clinical significance of POCG results, might be a better alternative for assessing accuracy of POCG measurements, although this system was also designed to be used with a reference method. We used 10 minutes as the time limit for retesting because other studies have used 5 to 10 minutes and, in practice, most repeat measurements are completed within the first few minutes.…”

Section: -16mentioning

confidence: 99%

Point-of-Care Glucose Critical Values: A Q-Probes Study Involving 50 Health Care Facilities and 2349 Critical Results

Schifman

Howanitz

Souers

2016

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Accuracy of blood glucose measurements in the critical value range is important for properly treating patients with severe hypoglycemia and hyperglycemia.Objective.-To evaluate the performance and reliability of point-of-care glucose (POCG) results in the critical value range among multiple facilities.Design.-Q-Probes participants retrospectively collected data from up to 50 POCG results in their critical value range including patient location, type of testing operator, repeat glucose results, and caregiver notification. A repeat measurement at 10 minutes or less that was within 15 mg/ dL of initial critical low or 20% of initial critical high value was considered a confirmed result.Results.-Fifty facilities submitted data. Of 2349 critical POCG measurements, 1386 (59.0%) were retested. The median institutional retest rate was 56%. The retest rate was significantly higher when initial results were in the critical low range, P , .001. Although 30 of 50 facilities (60%) had written procedures for retesting, this was not associated with higher retest rates (P ¼ .34). Among 35 facilities that routinely retested critical POCG results, 23 (65.7%) had criteria defined for interpreting results. The median institutional confirmation rate for retested specimens was 81.7%. The median institutional rate for caregiver notification of critical POCG results was 85.7%. Five hundred eighty-six of 1488 critical POCG notifications (39.4%) were done on patients in whom specimens were not retested.Conclusions.-This study shows that POCG results in the critical range may be unreliable because of testing errors that are not recognized from lack of confirmatory testing. In addition, notification of critical POCG results is not consistently performed.

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Accuracy of Self Monitoring Blood Glucose Systems in a Clinical Setting: Application of New Planned ISO- Standards

Cited by 19 publications

References 0 publications

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Reliability of Point-of-Care Capillary Blood Glucose Measurements in the Critical Value Range

Point-of-Care Glucose Critical Values: A Q-Probes Study Involving 50 Health Care Facilities and 2349 Critical Results

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