The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients

Sachse, Daniel; Bolstad, Nils; Jonsson, Magnus; Sæves, Ingjerd; Johansson, Carolina Backman; Delezuch, Weronika; Hagve, Martin; Hardang, Ingrid Marie M.; Isaksson, Helena S.; Ivarsson, Anna; Lehto, Liisa; Keikkala, Elina; Mattsson, Niklas; Ranta, Jenni K.; Stavelin, Anne; Sudmann, Åshild Amelie; Varsi, Kristin

doi:10.3109/00365513.2012.677544

Cited by 10 publications

(5 citation statements)

References 13 publications

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“…Before the introduction of the FGM system, we used 3 high-quality BG meters in our department. The ACM is a user-friendly BG meter using a cassette containing 50 test spots instead of test strips and is very popular in adolescents [30, 31]. The CNL meter communicates with the Paradigm® Veo TM insulin pump and is mainly used by children treated with continuous subcutaneous insulin infusion [32].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

et al. 2018

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Background/Aims: The FreeStyle® Libre Flash Glucose Monitoring System (FGM, Abbott) measures glucose concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aged > 4 years in January 2016. Experience in children is still limited. We evaluated the accuracy and usability of the FGM in children with type 1 diabetes mellitus (DM). Methods: 67 children with type 1 DM (35 girls), aged 4–18 years, were included. Subjects wore a sensor on the back of their upper arm. For the first 14 days, they regularly measured capillary blood glucose (BG) with their usual BG meter (Accu-Chek® Mobile [ACM], Roche [n = 24]; Contour® Next Link [CNL], Bayer [n = 26]; OneTouch® Verio® IQ [OTV], LifeScan [n = 17]) followed by a sensor glucose (SG) scanning. SG readings were compared to BG measurements by consensus error grid (CEG) analysis; the mean difference (MD), the mean relative difference (MRD), the mean absolute difference (MAD), and the mean absolute relative difference (MARD) were calculated. After 14 days, subjects were asked to fill in a questionnaire on the usability of the FGM. Results: 2,626 SG readings were paired with BG results. FGM readings were highly correlated with BG (r = 0.926, p < 0.001). 80.3% of the data pairs were in zone A (= no effect on clinical action) and 18.4% were in zone B (= altered clinical action with little or no effect on the clinical outcome) of the CEG. Overall MD was +7.5 mg/dL; MD varied with the BG meter: ACM +10.4 mg/dL, CNL +14.2 mg/dL, OTV –3.6 mg/dL (p < 0.001). Overall, MARD was 16.7%. We observed a large interindividual variability in the accuracy parameters. MD and MRD were inversely related to BMI (r = –0.261 [p < 0.05]; r = –0.266 [p < 0.05], respectively). MARD was inversely related to age (r = –0.266 [p < 0.05]). Twenty-nine patients (43.3%) reported sensor problems, mainly early detachment of the sensor. Nonetheless, the usability questionnaire indicated high levels of satisfaction. Conclusions: Our results showed a reasonable agreement between the FGM SG readings and capillary BG measurements in children. There was, however, a large interindividual variability. The wearing of the sensor requires special attention. Further studies in children are imperative in order to document the accuracy and safety of the FGM in the paediatric population.

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Section: Discussionmentioning

confidence: 99%

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

et al. 2018

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“…The revised performance guidelines published by the International Standardisation Organisation (ISO) 15197:2013 stipulate in the new criteria that for glucose values above 100mg/dL, the accuracy is expected to increase from ±20% to ±15% of the reference value; and this shall apply to at least 95% of results [6]. Many recent studies have highlighted the limitations of most glucometers in meeting these recommendations [9-11], very few of which were carried out in SSA [12]. Because of limited resources in most SSA countries, glucometers are used beyond their intended purpose, including for diabetes diagnosis for instance.…”

Section: Introductionmentioning

confidence: 99%

Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study

Choukem¹,

Sih²,

Nebongo³

et al. 2019

Pan Afr Med J

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Introduction capillary glucose measurement using point-of-care glucometers is an essential part of diabetes care. We determined the technical accuracy, clinical accuracy and precision of commonly available glucometers against standard spectrophotometry in Cameroon. Methods a sample of four glucometers was selected. In the 108 diabetic and non-diabetic participants, blood glucose values obtained by glucometers were compared to the reference laboratory method to determine their technical and clinical accuracies. Precision was determined by repeated measurements using standard solutions of different concentrations. Results accu-Chek ® Active, CodeFree™, Mylife™ Pura™ and OneTouch ® Ultra ® 2 values had correlation coefficients of 0.96, 0.87, 0.97 and 0.94 respectively with reference values, and biases of 18.7%, 29.1%, 16.1% and 13.8% respectively. All glucometers had ≥ 95% of values located within the confidence limits except OneTouch ® Ultra ® 2. Accu-Chek ® Active, CodeFree™, Mylife™ Pura™ and OneTouch ® Ultra ® 2 had 99%, 93.1%, 100% and 98.0% of values in Parke's zones A and B. The coefficients of variation of the glucometers were all below 5% at all standard concentrations, except for Accu-Chek ® Active for glucose concentrations at100 and 200mg/dL. Conclusion no glucometer met all the international recommendations for technical accuracy. Accu-Chek™ Active and Mylife™, Pura™ met the International Organization for Standardization 2013 recommendations for clinical accuracy based on Parke's consensus error grid analysis. All glucometers assessed except Accu-Chek ® Active showed a satisfactory level of precision at all concentrations of standard solutions used.

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“…Some recent studies on the subject have either evaluated the performance of a recently introduced glucometer or compared the accuracy and precision of one glucometer to another ( 2 , 7 - 10 ). Few studies have precisely quantified the accuracy, reliability and bias of glucometers that are to be used in a research laboratory ( 2 ).…”

Section: Introductionmentioning

confidence: 99%

A model for managing and monitoring the quality of glucometers used in a high-volume clinical setting

et al. 2016

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IntroductionThe aim of this study is to present a model for assuring the quality of a large number of glucometers being used in a high-volume hospital clinical setting.Materials and methodsInternal quality-control samples and blood samples from two patients were used to determine the accuracy of 83 glucometers used at our hospital. On each glucometer three levels of control were used for glucose concentrations determination. In addition, the difference between the results from patient samples obtained with the glucometers and the hexokinase reference method were compared. The differences were assessed based on the International Organization for Standardization (ISO 15197) standards.ResultsThe glucose concentrations were as follows: 2.51 ± 0.34 mmol/L for the hypo-control samples; 5.12 ± 0.32 mmol/L for the low-control samples; and 16.11 ± 1.03 mmol/L for high-control samples. All results were within the expected ranges. For Patient I, the result with the first group of 52 glucometers was 11.56 ± 0.5 mmol/L, while the result for Patient II with the second group of 31 glucometers was 10.52 ± 0.62 mmol/L. All data points of the study complied with the requirements of the Clarke error grid.ConclusionAll quality-control and comparison assay results were appropriate for evaluating glucometers used in a high-volume hospital setting. The method used in this study can be suggested as a model for laboratory managers, especially in similar high-volume hospitals.

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The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients

Abstract: Accu-Chek Mobile is a user-friendly glucometer that in a normo- and hyperglycemic range fulfils the ISO 15197 accuracy requirement, also in the hands of diabetes patients.

Cited by 10 publications

References 13 publications

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes

Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study

A model for managing and monitoring the quality of glucometers used in a high-volume clinical setting

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