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EVALUATE PERFORMANCE OF PRODIGY   GLUCOSE METER   VERSUS REFERENCE HEXOKINASE METHOD IN ADDIS ABABA, ETHIOPIA

Haymanot Tewabe, Masiresha Tsigie, Birhanu Haile,Tewodros Zerihun, Demirew Bikela, Mistire Wolde

ABSTRACT: Introduction: Point of care glucometer device (POCG) is the most commonly applied method to monitor diabetes mellitus (DM) worldwide. The aim of this study was to assess the accuracy of the prodigy glucose meter by using the hexokinase method as a reference. Methods: A prospective cross-sectional study was done on a total of 52 randomly selected DM suspected patients from March 22 to April 13, 2019, in the Department of Medical Laboratory, Addis Ababa University, Ethiopia. Glucose value was determined by using prodigy glucose meter and the hexokinase method and data were entered and analyzed using SPSS software. The minimum and maximum accuracy of the prodigy glucometer were determined based on ISO 15197:2003 and ISO 15197:2013 criteria. Results: The average serum glucose value measured by prodigy glucose meter and reference hexokinase methods were132.52 mg/dl and 130.94 mg/ dl respectively. There was a statistically significant difference between the two methods (p-value < 0.001). The bias of prodigy from the comparative method was 1.56 with a strong positive relationship (R= 0.975; >80%). Besides, the prodigy glucose meter did not fulfill the minimum accuracy requirements of ISO 15197:2003 and ISO15197:2013. Conclusion: The present study demonstrated that prodigy glucose meter readings are relatively higher than the reference method, In addition, the prodigy glucose meter did not fulfill the expected standards set by ISO. Thus DM patients need to evaluate the device before using it in standard laboratories. Furthermore, large scale studies including both DM and healthy study participants should be undertaken.

KEY WORDS: Prodigy glucometer, diabetes mellitus, Point of care devices

REFERENCES:

  1. Kassahun M, Melak T, Abebe M. Accuracy of SensoCard glucose meter: comparing with reference glucose oxidase method. J Med Diagn Meth. 2014;3(162):2.

  2. A. F. Williams. Hypoglycemia in newborns: a review. BULL WHO 1997; 75: 261-90.

  3. DeFronzo RA, Ferrannini E, Groop L, Henry RR, Herman WH, Holst JJ, Hu FB, Kahn CR, Raz I, Shulman GI, Simonson DC. Type 2 diabetes mellitus. Nature reviews Disease primers. 2015 23;1:15019.

  4. Villena Gonzales W, Mobashsher AT, Abbosh A. The Progress of Glucose Monitoring—A Review of Invasive to Minimally and Non-Invasive Techniques, Devices and Sensors. Sensors. 2019 ;19(4):800.

  5. Krouwer JS, Cembrowski GS. A review of standards and statistics used to describe blood glucose monitor performance..year, volume..number?

  6. MANROA P, KRUPA DOSHI MD. Self-monitoring of blood glucose: Advice for providers and patients. Cleveland Clinic journal of medicine. 2016;83(5):355.

  7. Luppa P, Junker R, editors. Point-of-care testing: Principles and Clinical Applications. Springer; 2018 14. Number? Page number

  8. Wolde M, Tarekegn G, Kebede T. Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia. Journal of diabetes science and technology. 2018 ;12(3):673-9.

  9. Kiechle FL, Main RI. Blood glucose: measurement in the point-of-care setting. Laboratory Medicine. 20001;31(5):276-82.

  10. Hin BY, Bueno I, Lowe CR, Jones S. Clinical Accuracy Study of an GDH-NAD Blood Glucose Monitoring System Using the Performance Criteria of ISO 15197: 2013. Journal of Diabetes Science and Technology. 2017 ;11(2):444.

  11. Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, et al. (2010) System Accuracy Evaluation of 27 Blood Glucose Monitoring Systems According to DIN EN ISO 15197. Diabetes Technol Ther 12: 221-231.

  12. Jendrike N, Baumstark A, Pleus S, Liebing C, Beer A, Flacke F, Haug C, Freckmann G. Evaluation of four blood glucose monitoring systems for self-testing with built-in insulin dose advisor based on ISO 15197: 2013: system accuracy and hematocrit influence. Diabetes technology & therapeutics. 20181;20(4):303-13.

  13. Pleus S, Jendrike N, Baumstark A, Mende J, Haug C, Freckmann G. Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision. Journal of diabetes science and technology. 2019;13(1):111-7.

  14. Raizman JE, Shea J, Daly CH, Karbasy K, Ariadne P, Chen Y, Henderson T, Redmond S, Silverman S, Moore AM, Adeli K. Clinical impact of improved point-of-care glucose monitoring in neonatal intensive care using Nova StatStrip: Evidence for improved accuracy, better sensitivity, and reduced test utilization. Clinical biochemistry. 2016 1;49(12):879-84.

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