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Background <p>The purpose of this study was to evaluate the accuracy and precision of three glucometer-strip systems (GSSs) used in professional practice.</p> Methods <p>This was a prospective single-centre study. The cPG triplets were investigated on 3 GSSs: (1) Galileo, (2) Calla, both of which use glucoseoxidase strips (Wellion, Austria); (3) Contour Plus (Ascensia, Switzerland) employing glucosedehydrogenase strips was used. For each GSS, three devices and one lot of strips were employed. Following the cPG readings, venous blood was taken to measure venous plasma glucose (vPG) on a Cobas Integra 400 analyser employing hexokinase. A total of 258 pairs of cPGs and vPGs were compared using the Wilcoxon signed rank test with Bonferroni correction and the software IBM SPSS Statistics for Windows, V. 23.0. The precision was estimated using the standard deviation (SD) of the average differences between individual cPG measurements. <i>P</i> &lt; 0.05 was considered significant.</p> Results <p>Deviations (mean ± SD) from vPG ≥ 5.55 mmo/L (≥ 100&#xa0;mg/dL): Galileo 0.25 ± 0.49 mmol/L (5 ± 9&#xa0;mg/dL), Calla − 1.25 ± 1.08 mmol/L (-23 ± 19&#xa0;mg/dL), Contour − 0.63 ± 0.71 mmol/L (-11 ± 13&#xa0;mg/dL). The cPG values within the interval ± 15% of the vPG were as follows: Galileo, 196/207 (94.7%); Calla, 162/207 (78.3%); and Contour, 200/207 (96.6%). For vPG values &lt; 5.55 mmol/L (&lt; 100&#xa0;mg/dL), the interval ± 0.83 mmol/L (15&#xa0;mg/dL) reached Galileo 11/51 (21.6%), Calla 48/51 (94.1%), and Contour 51/51 (100%). For Galileo, after the subtraction of 0.7 mmol/L (13&#xa0;mg/dL) from any cPG &lt; 7.0 mmol/L (&lt; 126&#xa0;mg/dL), 51/51 (100%) measurements reached the required interval.</p> Conclusions <p>A borderline accuracy of Galileo was found for a cPG ≥ 7 mmol/L (≥ 126&#xa0;mg/dL), whereas for a cPG &lt; 7 mmol/L (&lt; 126&#xa0;mg/dL), a correction of -0.7 mmol/L (-13&#xa0;mg/dL) appears to be advisable. The accuracy of Contour was confirmed.</p>

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Accuracy and precision of the certified glucometer-strips systems Galileo, Calla and Contour Plus One in clinical practice

  • 期刊论文

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  • 发表日期：

    2025年7月23日

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  • Rudolf Chlup,
  • Hana Zálešáková,
  • Blanka Doubravová,
  • Emilia Ďurajková,
  • Martin Nezval,
  • Jiřina Gottwaldová,
  • Jana Zapletalová

摘要

Background

The purpose of this study was to evaluate the accuracy and precision of three glucometer-strip systems (GSSs) used in professional practice.

Methods

This was a prospective single-centre study. The cPG triplets were investigated on 3 GSSs: (1) Galileo, (2) Calla, both of which use glucoseoxidase strips (Wellion, Austria); (3) Contour Plus (Ascensia, Switzerland) employing glucosedehydrogenase strips was used. For each GSS, three devices and one lot of strips were employed. Following the cPG readings, venous blood was taken to measure venous plasma glucose (vPG) on a Cobas Integra 400 analyser employing hexokinase. A total of 258 pairs of cPGs and vPGs were compared using the Wilcoxon signed rank test with Bonferroni correction and the software IBM SPSS Statistics for Windows, V. 23.0. The precision was estimated using the standard deviation (SD) of the average differences between individual cPG measurements. P < 0.05 was considered significant.

Results

Deviations (mean ± SD) from vPG ≥ 5.55 mmo/L (≥ 100 mg/dL): Galileo 0.25 ± 0.49 mmol/L (5 ± 9 mg/dL), Calla − 1.25 ± 1.08 mmol/L (-23 ± 19 mg/dL), Contour − 0.63 ± 0.71 mmol/L (-11 ± 13 mg/dL). The cPG values within the interval ± 15% of the vPG were as follows: Galileo, 196/207 (94.7%); Calla, 162/207 (78.3%); and Contour, 200/207 (96.6%). For vPG values < 5.55 mmol/L (< 100 mg/dL), the interval ± 0.83 mmol/L (15 mg/dL) reached Galileo 11/51 (21.6%), Calla 48/51 (94.1%), and Contour 51/51 (100%). For Galileo, after the subtraction of 0.7 mmol/L (13 mg/dL) from any cPG < 7.0 mmol/L (< 126 mg/dL), 51/51 (100%) measurements reached the required interval.

Conclusions

A borderline accuracy of Galileo was found for a cPG ≥ 7 mmol/L (≥ 126 mg/dL), whereas for a cPG < 7 mmol/L (< 126 mg/dL), a correction of -0.7 mmol/L (-13 mg/dL) appears to be advisable. The accuracy of Contour was confirmed.