System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197

Freckmann, Guido; Schmid, Christina; Baumstark, Annette; Pleus, Stefan; Link, Manuela; Haug, Cornelia

doi:10.1177/193229681200600510

Cited by 216 publications

(216 citation statements)

References 34 publications

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“…With respect to the Bland-Altman plots, most of the canine data (96% of dogs, 96% of cats) were included in the 95% limits of agreement calculated from the PBGM and the reference glucose values. However, the ISO 15197:2013 requirements are considered strict clinical indices according to previous studies (Freckmann et al 2012, Brito-Casillas et al 2014, Khositseth et al 2015. Therefore, the GLUCOCARD X-mini plus is not applicable for veterinary practice, especially in dogs and cats.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of portable blood glucose meters using canine and feline pooled blood samples

Mori¹,

Oda²,

Onozawa³

et al. 2016

Polish Journal of Veterinary Sciences

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This study evaluated the accuracy and reproducibility of a human portable blood glucose meter (PBGM) for canine and feline whole blood. Reference plasma glucose values (RPGV) were concurrently measured using glucose oxidation methods. Fifteen healthy dogs and 6 healthy cats were used for blood sampling. Blood glucose concentrations and hematocrits were adjusted using pooled blood samples for our targeted values. A positive correlation between the PBGM and RPGV was found for both dogs (y = 0.877, x = -24.38, r = 0.9982, n = 73) and cats (y = 1.048, x = -27.06, r = 0.9984, n = 69). Acceptable results were obtained in error grid analysis between PBGM and RPGV in both dogs and cats; 100% of these results were within zones A and B. Following ISO recommendations, a PBGM is considered accurate if 95% of the measurements are within ± 15 mg/dl of the RPGV when the glucose concentration is <100 mg/dl and within ±15% when it is ≥100 mg/dl; however, small numbers of samples were observed inside the acceptable limits for both dogs (11%, 8 of 73 dogs) and cats (39%, 27 of 69 cats). Blood samples with high hematocrits induced lower whole blood glucose values measured by the PBGM than RPGV under hypoglycemic, normoglycemic, and hyperglycemic conditions in both dogs and cats. Therefore, this device is not clinically useful in dogs and cats. New PBGMs which automatically compensate for the hematocrit should be developed in veterinary practice.

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Section: Discussionmentioning

confidence: 99%

Evaluation of portable blood glucose meters using canine and feline pooled blood samples

Mori¹,

Oda²,

Onozawa³

et al. 2016

Polish Journal of Veterinary Sciences

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“…[13][14][15] A direct comparison of the BGStar system accuracy evaluated by the clamp method and a reduced scale protocol of the ISO 15197:2013 guideline showed good agreement between both test procedures with MARD within 0.8% from another and both methods identified a similar amount of outliers, typically in the range of 1-2% for the standard 15/15 limits of ISO15197:2013 and 9-10% for more restrictive 10/10 limits. 16 These comparisons indicate that the glucose clamp approach can provide robust and valuable data about the accuracy of BG system performance.…”

Section: Discussionmentioning

confidence: 99%

A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range

Zijlstra

Heinemann

Fischer

et al. 2016

J Diabetes Sci Technol

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The performance of blood glucose (BG) measurement systems (BG meters plus test strips) is a much debated and researched topic. Reliable BG measurements are needed to ensure that patients with diabetes make the same clinical decisions (eg, select appropriate insulin dose) as they would do if the glucose measurements were made with a laboratory or even better with a reference method. 1 BG systems are considered accurate if they show high precision and high trueness, that is, both the random error (measurement imprecision or variability) and the systematic error (measurement bias) are low. 2 The evaluation of BG systems should be performed in accordance with standard guidelines like the International Organization for Standardization (ISO) (ISO 15197:2013 In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus). Such guidelines describe in detail test procedures to be followed. They also specify the allowed measurement deviation of the measurement results from the laboratory measurements and the maximum number of inaccurate results or outliers acceptable. The analytical goals defined by the ISO guidelines are now widely adopted by manufacturers of BG systems and regulatory agencies.Despite the prerequisite of demonstrating compliance with ISO 15197 before market approval of a new BG system, the performance of currently available BG systems (= after market approval) has been fiercely debated after reports Abstract Background: The objective was to evaluate the performance (in terms of accuracy, precision, and trueness) of 5 CE-certified and commercially available blood glucose (BG) systems (meters plus test strips) using an innovative clinical-experimental study design with a 3-step glucose clamp approach and frequent capillary BG measurements. Methods:Sixteen subjects with type 1 diabetes participated in this open label, single center trial. BG was clamped at 3 levels for 60 minutes each: 60-100-200 mg/dL. Medical staff performed regular finger pricks (up to 10 per BG level) to obtain capillary blood samples for paired BG measurements with the 5 BG systems and a laboratory method as comparison. Conclusions: This 3 range glucose clamp approach enables a systematic performance evaluation of BG systems under controlled and reproducible conditions. The random error of the tested BG systems was comparable, but some showed a lower systematic error than others. These BG systems allow an accurate glucose measurement at low, normal and high BG levels. Results

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“…To detect sodium in urine by potentiometry, we used an ISE (27504-30; Cole-Palmer). We prepared a series of urine samples with different levels of sodium from standard urine samples (Liquicheck Urine Chemistry Control; BioRad) and used an ionic strength adjustment buffer (4 M NH 4 Cl with 4 M NH 4 OH) to adjust the pH to ∼9.5. To perform the measurement, we dipped the ISE into each sample, and recorded the potential difference between the RE and the WE.…”

Section: Methodsmentioning

confidence: 99%

“…Although useful in a variety of settings, these methodswith the important exception of blood glucose meters (3,4)-are generally limited to well-resourced laboratories run by skilled personnel. If simplified and made inexpensive, however, these versatile methods could become broadly applicable tools in the hands of healthcare workers, clinicians, farmers, and military personnel who need accurate and quantitative results in the field, especially in resource-limited settings.…”

mentioning

confidence: 99%

Universal mobile electrochemical detector designed for use in resource-limited applications

Nemiroski¹,

Christodouleas²,

Hennek³

et al. 2014

Proc. Natl. Acad. Sci. U.S.A.

266

192

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This paper describes an inexpensive, handheld device that couples the most common forms of electrochemical analysis directly to "the cloud" using any mobile phone, for use in resource-limited settings. The device is designed to operate with a wide range of electrode formats, performs on-board mixing of samples by vibration, and transmits data over voice using audio-an approach that guarantees broad compatibility with any available mobile phone (from low-end phones to smartphones) or cellular network (second, third, and fourth generation). The electrochemical methods that we demonstrate enable quantitative, broadly applicable, and inexpensive sensing with flexibility based on a wide variety of important electroanalytical techniques (chronoamperometry, cyclic voltammetry, differential pulse voltammetry, square wave voltammetry, and potentiometry), each with different uses. Four applications demonstrate the analytical performance of the device: these involve the detection of (i) glucose in the blood for personal health, (ii) trace heavy metals (lead, cadmium, and zinc) in water for in-field environmental monitoring, (iii) sodium in urine for clinical analysis, and (iv) a malarial antigen (Plasmodium falciparum histidine-rich protein 2) for clinical research. The combination of these electrochemical capabilities in an affordable, handheld format that is compatible with any mobile phone or network worldwide guarantees that sophisticated diagnostic testing can be performed by users with a broad spectrum of needs, resources, and levels of technical expertise.electrochemistry | mHealth | point-of-care diagnostics | low-cost potentiostat | telemedicine E lectrochemistry provides a broad array of quantitative methods for detecting important analytes (e.g., proteins, nucleic acids, metabolites, metals) for personal and public health, clinical analysis, food and water quality, and environmental monitoring (1, 2). Although useful in a variety of settings, these methodswith the important exception of blood glucose meters (3, 4)-are generally limited to well-resourced laboratories run by skilled personnel. If simplified and made inexpensive, however, these versatile methods could become broadly applicable tools in the hands of healthcare workers, clinicians, farmers, and military personnel who need accurate and quantitative results in the field, especially in resource-limited settings. Furthermore, if results of testing were directly linked to "the cloud" through available mobile technology, expertise (and archiving of information) could be geographically decoupled from the site of testing. To enable electrochemical measurements to be performed and communicated in any setting, a useful technology must be (i) able to perform complete electrochemical analyses while remaining low in cost, simple to operate, and as independent of infrastructure as possible; and (ii) compatible with any generation of mobile telecommunications technology, including the low-end phones and 2G networks that continue to dominate communications in much o...

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System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197

Cited by 216 publications

References 34 publications

Evaluation of portable blood glucose meters using canine and feline pooled blood samples

Evaluation of portable blood glucose meters using canine and feline pooled blood samples

A Comprehensive Performance Evaluation of Five Blood Glucose Systems in the Hypo-, Eu-, and Hyperglycemic Range

Universal mobile electrochemical detector designed for use in resource-limited applications

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