Clinical and numerical precision of capillary glucose measurement devices available in the basic health plan for Colombia
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Keywords

blood glucose monitor
blood glucose accuracy
Blood glucose self-monitoring
Diabetes

How to Cite

Gómez Medina, A. M., Jojoa, R. I., Henao, D. C., Parra, D. A., Muñoz, Óscar M., Rubio, C. P., & Piñeros, M. (2022). Clinical and numerical precision of capillary glucose measurement devices available in the basic health plan for Colombia. Revista Colombiana De Endocrinología, Diabetes &Amp; Metabolismo, 8(3). https://doi.org/10.53853/encr.8.3.625

Abstract

Introduction: Self-Monitoring blood glucose (SMBG) has a critical role in the management of patients treated with insulin. Technical and environmental factors significantly affect the accuracy of glucometers. The objective is to establish the clinical and numerical precision of the glucometers used in Colombia, compared to central blood glucose.

Methods: Study of diagnostic tests, glucometers of the basic health plan (GluNeo, GlucoQuick, Optium Neo, Select Plus and Gluco Quick Diamond Voice) were evaluated. Adults treated with an insulin infusion pump integrated with a continuous monitoring system were included. The samples were classified as:>100mg dL,>70 and 100 mg/dL, ?70 mg/dL. For glucose ?100 mg/dL a bolus of insulin was delivered using the bolus wizard feature. The numerical precision was evaluated using the mean absolute relative difference (MARD) and the clinical precision according to the proportion measurements in the zones A + B of Clarke and Parkes (Consensus) error grids.

 Results. 830 measurements were analyzed. All devices met precision requirements for glucose >100mg / dL. Optium Neo and Gluco Quick Diamond Voice, achieved compliance standards by combining all measurement levels of 12.1% and 13.9%, respectively. The clinical precision for these two devices was 98% and >95% according to the Parkes (Consensus) and Clarke error grids, respectively. Greater variability of the results was evidenced in the range ?70mg/dL.

Conclusions. The numerical precision was adequate for the devices evaluated for capillary glucose values >100mg/dL and decreases with values ??<100mg/dL. Gluco Quick Diamond Voice and Optium Neo had adequate global numerical and clinical precision.

https://doi.org/10.53853/encr.8.3.625
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References

Solnica B, Naskalski JW, Sieradzki J. Analytical performance of glucometers used for routine glucose self-monitoring of diabetic patients. Clin Chim Acta. 2003 May;331(1–2):29–35.

Casas Oñate ML, Montoya Martínez D. ¿Son Fiables Los Medidores De Glucemia Capilar? Av en Diabetol. 2012;28(5):110–3.

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, et al. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: A European multicenter study with 453 subjects. Diabetes Technol Ther. 2012;14(4):330–7.

Thomas LE, Kane MP, Bakst G, Busch RS, Hamilton RA, Abelseth JM. A glucose meter accuracy and precision comparison: The freestyle flash versus the accu-chek advantage, accu-chek compact plus, ascensia contour, and the BD logic. Diabetes Technol Ther. 2008;10(2):102–10.

Kimberly MM, Vesper HW, Caudill SP, Ethridge SF, Archibold E, Porter KH, et al. Variability among five over-the-counter blood glucose monitors. Clin Chim Acta. 2006;364(1–2):292–7.

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocker S, Tshiananga J, et al. System Accuracy Evaluation of 27 Blood Glucose. Diabetes Technol Ther. 2010;12(3):221–31.

Choukem SP, Sih C, Nebongo D, Keunmoe P, Kengne AP. Accuracy and precision of four main glucometers used in a sub-saharan african country: A cross-sectional study. Pan Afr Med J. 2019;32:1–10.

Kermani SK, Khatony A, Jalali R, Rezaei M, Abdi A. Accuracy and precision of measured blood sugar values by three glucometers compared to the standard technique. J Clin Diagnostic Res. 2017;11(4):OC05–8.

Freckmann G. Basics and use of continuous glucose monitoring (CGM) in diabetes therapy. J Lab Med. 2020;44(2):71–9.

Clarke WL. The Original Clarke Error Grid Analysis (EGA). Diabetes Technol Ther. 2005;7(5):776–9.

Pfützner A, Klonoff DC, Pardo S, Parkes JL. Technical aspects of the Parkes error grid. J Diabetes Sci Technol. 2013;7(5):1275–81.

International Standards Organization. ISO 15197:2013. In vitro diagnostic test systems – requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. Disponible en internet en https://www.iso.org/standard/54976.html. Consultado el 7 de oct de 2021.

Care M. Standards of Medical Care in diabetes — 2020. 2020;43(January).

American Diabetes Association. Diabetes Technology: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S77–88.

Leelarathna L, Wilmot EG. Flash forward: a review of flash glucose monitoring. Diabet Med. 2018 Apr;35(4):472–82.

Macleod K, Katz LB, Cameron H. Capillary and Venous Blood Glucose Accuracy in Blood Glucose Meters Versus Reference Standards: The Impact of Study Design on Accuracy Evaluations. J Diabetes Sci Technol. 2019 May;13(3):546–52.

Andelin M, Kropff J, Matuleviciene V, Joseph JI, Attvall S, Theodorsson E, et al. Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated with Capillary Values Using Capillary or Venous Glucose Levels as a Reference. J Diabetes Sci Technol. 2016;10(4):876–84.

Usmani HA, Khan II, Mughal FH. A study of the accuracy of the precision Q.I.D. TM glucometer. J Pak Med Assoc. 1998;48(4):114–5.

Kirchsteiger H, Heinemann L, Freckmann G, Lodwig V, Schmelzeisen-Redeker G, Schoemaker M, et al. Performance comparison of CGM systems: MARD values are not always a reliable indicator of CGM system accuracy. J Diabetes Sci Technol. 2015;9(5):1030–40.

Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, et al. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. 2018;41(August):1681–8.

Brunner GA, Ellmerer M, Sendlhofer G, Wutte A, Trajanoski Z, Schaupp L, et al. Validation of Home Blood Glucose. 1998;21(4).

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