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Glukoz Ölçümünde Kullanılan Glukometreler ile Merkez Laboratuvar Ölçümleri Arasındaki Uyumun Araştırılması

Year 2025, Volume: 9 Issue: 1, 68 - 73, 21.04.2025
https://doi.org/10.46332/aemj.1456343

Abstract

Amaç: Kan şekeri ölçümü farklı klinik birimler, farklı hastalık ve hasta gruplarında komplikasyonların önüne geçilmesi, mortalite ve morbiditenin azaltılmasında büyük önem taşımaktadır. Bu çalışmada, hastane alımlarına esas teşkil etmesi adına glukometreler ve otoanalizör arasındaki uyumun değerlendirilmesi amaçlanmıştır.

Araçlar ve Yöntem: Çalışmada kırk yedi venöz kan örneği kullanıldı. G1 ve G2 glukometreleri ile glukoz ölçümü yapılmasının ardından otoanalizör ile glukoz ölçümü yapıldı. Sonuçların değerlendirilmesinde korelasyon ve Passing Bablok regresyon analizi ve Bland-Altman farklar grafiği kullanıldı. Klinik uyumun değerlendirilmesinde Clarke Error Grid (CEG) analizi kullanıldı. p<0.05 değeri istatistiksel olarak anlamlı kabul edildi.

Bulgular: Korelasyon analiz sonuçları G1 için r=0.929 (% 95 CI, 0.876-0.960) ve G2 için r=0.947 (%95 CI, 0.907-0.971) idi. Passing Bablok regresyon eşitliği G1 için y=1.1235x+3.4662 iken G2 için y=0.8846x+10.0076 idi. CEG analizinde verilerin %99 oranında A ya da B zonunda olması kriteri iki glukometre için de karşılandı.

Sonuç: CLSI’ın POCT12-A3 dokümanında yer alan kriterlere göre hedef değere göre <100 mg/dl’deki sonuçların %95 ve daha fazlası ±12 mg/dl arasında olması gerekir iken G1 için oran %38, G2 için %94’tü. Hedef değere göre >100 mg/dl’deki sonuçların %95 ve daha fazlası ±%12.5 arasında olması gerekir iken G1 için oran %47, G2 için %100 idi. Hedef değere göre <75 mg/dl’de ±15 mg/dl’yi, ≥75 mg/dl’de ise ±%20 sınırını aşan sayı <%2 olmalı idi. Bu oran G1 için %54, G2 için %0 idi. Bu çalışma da glukometreler performans hedeflerini tam olarak karşılamamaktaydı. CEG’e göre klinik performans yeterli olsa da alım sonrası glukometrelerin yakından takip edilmesi gerektiği düşünüldü.

References

  • 1. Moghissi ES, Korytkowski MT, DiNardo M, et al. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009;32(6):1119-1131.
  • 2. Umpierrez GE, Hellman R, Korytkowski MT, et al. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(1):16-38.
  • 3. Klonoff DC. Point-of-Care Blood Glucose Meter Accuracy in the Hospital Setting. Diabetes Spectr. 2014;27(3):174-179.
  • 4. Jendrike N, Baumstark A, Kamecke U, Haug C, Freckmann G. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017;11(6):1275-1276.
  • 5. Türkiye Health Ministary, Turkey Country Assessment. World Diabetes Day 2020. https://sggm.saglik.gov.tr/TR,76887/dunya-diyabet-gunu-2020.html. Accessed date 17 May, 2024.
  • 6. Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183:109119.
  • 7. American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1994;17(1):81-86.
  • 8. Tonyushkina K, Nichols JH. Glucose meters: a review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009;3(4):971-980.
  • 9. Freckmann G, Schmid C, Baumstark A, Rutschmann M, Haug C, Heinemann L. Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy. J Diabetes Sci. 2015;9(4):885-894.
  • 10. Bowman CF, Nichols JH. Comparison of Accuracy Guidelines for Hospital Glucose Meters. J Diabetes Sci Technol. 2020;14(3):546-552.
  • 11. Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem. 1974;20(7):825-833.
  • 12. Jacobs E, Naskalski J. W, Fogh-Andersen, N, et al. Blood glucose point-of-care testing quality assessment and harmonization with central laboratory assays. Point of Care. 2009;8(2):82-86.
  • 13. Kılıç Baygutalp N, Bakan E, Bayraktutan Z, Umudum F. The comparison of two glucose measurement systems: POCT devices versus central laboratory. Turk J Biochem. 2018;43(5):510-519.
  • 14. Krouwer JS. The new glucose standard POCT12-A3 misses the mark. J Diabetes Sci Technol. 2013;7(5): 1400-1402.
  • 15. McPherson RA., Pincus MR. Henry's Clinical Diagnosis and Management by Laboratory Methods. 24th Ed, Germany: Elsevier Health Science; 2021.
  • 16. Solnica B, Naskalski JW. Quality control of self-monitoring of blood glucose: why and how? J Diabetes Sci Technol. 2007;1(2):164-168.
  • 17. Kelly, RT, Callan, JR, Meadows SK. Impact of new medical technology on user performance. Proceedings of the Human Factors Society Annual Meeting 1991;35(10):699-702.
  • 18. Skeie S, Thue G, Sandberg S. Patient-derived quality specifications for instruments used in self-monitoring of blood glucose. Clin Chem. 2001;47(1):67-73.
  • 19. Turkish Biochemical Association. Consensus Report: Recommendations for Selection Criteria for Point-of-Care Glucose Meters Used in Hospitals. https://www.turkbiyokimyadernegi.org.tr/upload/48/Dosyalar/tmp/20183713149.pdf. Access date 1 March, 2024.
  • 20. Fobker M. Stability of glucose in plasma with different anticoagulants. Clin Chem Lab Med. 2014;52(7): 1057-1060.
  • 21. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622-628.

Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements

Year 2025, Volume: 9 Issue: 1, 68 - 73, 21.04.2025
https://doi.org/10.46332/aemj.1456343

Abstract

Purpose: Blood glucose measurement is of great importance in preventing complications and reducing mortality and morbidity for several diseases. Glucometers are used by any healthcare professionals. We conducted this study to show the compatibility between glucometers and autoanalyzers as a basis for hospital procurement.

Materials and Methods: Fourty seven venous samples were used. Correlation, Passing Bablok regression analysis, and Bland-Altman difference plot were used to evaluate the results (glucometers and autoanalyzer). Clarke Error Grid analysis was used to assess the clinical agreement (p<0.05).

Results: The correlation coefficient for G1 was 0.9294 (p<0.001; 95% CI: 0.8761-0.9603) and 0.9473 (p<0.001; 95% CI: 0.9069-0.9705) for G2. Regression equations were G1 y=1.1235x+3.4662 G2 y=0.8846x+10.0076. In Clarke Error Grid analysis, the criterion of 99% of the data being in zone A or B was met for both glucometers.

Conclusion: According to the relevant document, based on the result obtained with the reference method as the target value, 95% of all results less than 100 mg/dl should be within ±12 mg/dl of the target value. 95% of all results above 100 mg/dl should be within ±12.5% of the target value. In addition, the ratio of the sum of results less than 75 mg/dl exceeding ±15 mg/dl and results greater than 75 mg/dl exceeding ±20% of the target value to all results should be less than 2%. Glucometers didn’t fully meet the performance targets. We think that glucometer analysis results should be closely monitored and verified after procurement.

References

  • 1. Moghissi ES, Korytkowski MT, DiNardo M, et al. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009;32(6):1119-1131.
  • 2. Umpierrez GE, Hellman R, Korytkowski MT, et al. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(1):16-38.
  • 3. Klonoff DC. Point-of-Care Blood Glucose Meter Accuracy in the Hospital Setting. Diabetes Spectr. 2014;27(3):174-179.
  • 4. Jendrike N, Baumstark A, Kamecke U, Haug C, Freckmann G. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017;11(6):1275-1276.
  • 5. Türkiye Health Ministary, Turkey Country Assessment. World Diabetes Day 2020. https://sggm.saglik.gov.tr/TR,76887/dunya-diyabet-gunu-2020.html. Accessed date 17 May, 2024.
  • 6. Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183:109119.
  • 7. American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care. 1994;17(1):81-86.
  • 8. Tonyushkina K, Nichols JH. Glucose meters: a review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009;3(4):971-980.
  • 9. Freckmann G, Schmid C, Baumstark A, Rutschmann M, Haug C, Heinemann L. Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy. J Diabetes Sci. 2015;9(4):885-894.
  • 10. Bowman CF, Nichols JH. Comparison of Accuracy Guidelines for Hospital Glucose Meters. J Diabetes Sci Technol. 2020;14(3):546-552.
  • 11. Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem. 1974;20(7):825-833.
  • 12. Jacobs E, Naskalski J. W, Fogh-Andersen, N, et al. Blood glucose point-of-care testing quality assessment and harmonization with central laboratory assays. Point of Care. 2009;8(2):82-86.
  • 13. Kılıç Baygutalp N, Bakan E, Bayraktutan Z, Umudum F. The comparison of two glucose measurement systems: POCT devices versus central laboratory. Turk J Biochem. 2018;43(5):510-519.
  • 14. Krouwer JS. The new glucose standard POCT12-A3 misses the mark. J Diabetes Sci Technol. 2013;7(5): 1400-1402.
  • 15. McPherson RA., Pincus MR. Henry's Clinical Diagnosis and Management by Laboratory Methods. 24th Ed, Germany: Elsevier Health Science; 2021.
  • 16. Solnica B, Naskalski JW. Quality control of self-monitoring of blood glucose: why and how? J Diabetes Sci Technol. 2007;1(2):164-168.
  • 17. Kelly, RT, Callan, JR, Meadows SK. Impact of new medical technology on user performance. Proceedings of the Human Factors Society Annual Meeting 1991;35(10):699-702.
  • 18. Skeie S, Thue G, Sandberg S. Patient-derived quality specifications for instruments used in self-monitoring of blood glucose. Clin Chem. 2001;47(1):67-73.
  • 19. Turkish Biochemical Association. Consensus Report: Recommendations for Selection Criteria for Point-of-Care Glucose Meters Used in Hospitals. https://www.turkbiyokimyadernegi.org.tr/upload/48/Dosyalar/tmp/20183713149.pdf. Access date 1 March, 2024.
  • 20. Fobker M. Stability of glucose in plasma with different anticoagulants. Clin Chem Lab Med. 2014;52(7): 1057-1060.
  • 21. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622-628.
There are 21 citations in total.

Details

Primary Language English
Subjects Clinical Chemistry, Clinical Sciences (Other)
Journal Section Original Articles
Authors

Esra Yılmaz 0000-0002-2558-5557

Medeni Arpa 0000-0001-8321-4829

Bayram Şen 0000-0002-4541-881X

Mehmet Çingirt 0000-0001-6027-8360

Early Pub Date April 16, 2025
Publication Date April 21, 2025
Submission Date March 21, 2024
Acceptance Date November 22, 2024
Published in Issue Year 2025 Volume: 9 Issue: 1

Cite

APA Yılmaz, E., Arpa, M., Şen, B., Çingirt, M. (2025). Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements. Ahi Evran Medical Journal, 9(1), 68-73. https://doi.org/10.46332/aemj.1456343
AMA Yılmaz E, Arpa M, Şen B, Çingirt M. Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements. Ahi Evran Med J. April 2025;9(1):68-73. doi:10.46332/aemj.1456343
Chicago Yılmaz, Esra, Medeni Arpa, Bayram Şen, and Mehmet Çingirt. “Investigation of the Agreement Between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements”. Ahi Evran Medical Journal 9, no. 1 (April 2025): 68-73. https://doi.org/10.46332/aemj.1456343.
EndNote Yılmaz E, Arpa M, Şen B, Çingirt M (April 1, 2025) Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements. Ahi Evran Medical Journal 9 1 68–73.
IEEE E. Yılmaz, M. Arpa, B. Şen, and M. Çingirt, “Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements”, Ahi Evran Med J, vol. 9, no. 1, pp. 68–73, 2025, doi: 10.46332/aemj.1456343.
ISNAD Yılmaz, Esra et al. “Investigation of the Agreement Between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements”. Ahi Evran Medical Journal 9/1 (April2025), 68-73. https://doi.org/10.46332/aemj.1456343.
JAMA Yılmaz E, Arpa M, Şen B, Çingirt M. Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements. Ahi Evran Med J. 2025;9:68–73.
MLA Yılmaz, Esra et al. “Investigation of the Agreement Between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements”. Ahi Evran Medical Journal, vol. 9, no. 1, 2025, pp. 68-73, doi:10.46332/aemj.1456343.
Vancouver Yılmaz E, Arpa M, Şen B, Çingirt M. Investigation of the Agreement between Glucose Meters Used for Glucose Measurement and Central Laboratory Measurements. Ahi Evran Med J. 2025;9(1):68-73.

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