medigraphic.com
ISSN 1560-4381 (Print)

2014, Number 4

<< Back Next >>

Correo Científico Médico 2014; 18 (4)

Assessment of blood glucose levels by two analytic methods in the emergency room

Pérez BAM, Rodríguez DM, Hernández PG, Tribín RK, Pérez PA

Language: Spanish
References: 21
Page: 664-675
PDF size: 319.03 Kb.


ABSTRACT

Introduction: measurement of a medical parameter through different methods demands assessment of the agreement between them.
Objective: to determine the disagreement between glucose levels obtained by a glucometer and the customary method of laboratory, in the emergency room.
Methods: an observational study was performed in patients attended at emergency room of Vladimir I. Lenin Hospital, in Holguín, Cuba, with requested determination of blood glucose levels. The study was carried out during March, 2013. The sample size was calculated taking into account a 5 % of accepted disagreement by the International Organization of Standardization criteria (ISO 15197:2003), being 72 the obtained number. A simple random sampling and exclusion criteria were also applied. Glucose blood levels were assessed using RapiglucoTest reference method and a glucometer SUMASENSOR SXT.
Results: patients were 58.7± 18.3 years, 54.2 % were female, 51.4% diabetics, and 70.8 % nonfasting. Mean absolute relative error was 9.5 ± 8.07%. There was 4.8% of disagreement between methods. Skew and precision were 0.40 mmol/L and ± 0.65 mmol/l, respectively. 94.4% of values were between the limits of 1.96 standard deviation (Bland-Altman method). Both Intraclass coefficient correlation (0.995) and determination coefficient (0.98) reached high values. No significant disparity between absolute differences were assessed depending upon fasting state (p=0.3103).
Conclusions: the disagreement between methods corresponded to the admissible threshold stablished by ISO criteria. This and the rest of the analysis indicate that this glucometer is both accurate and precise for its intended use in the emergency room setting, even in nonfasting individuals.


REFERENCES

  1. Tonyushkina K, Nichols JH. Glucose Meters: A Review of Technical Challenges to Obtaining Accurate Results. J Diabetes Sci Technol. 2009 [citado 14 mar 2013]; 3(4):971-80. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769957/pdf/dst-03-0971.pdf

  2. Alfonso Ortiz S, González Quintero A, Morales Villaurrutia D, Mora Sánchez MN, López Brauet L. Sistema de monitoreo de glucosa en sangre SUMA SENSOR SXT: su control y certificación de la calidad. Memorias Convención Internacional de Salud Pública; 2012 dic 3-7. La Habana: Palacio de las Convenciones; 2012. [citado 14 mar 2013]; Disponible en: http://www.convencionsalud2012.sld.cu/index.php/convencionsalud/2012/paper/viewFile/1666

  3. Alonso C. Exploración del metabolismo de los Carbohidratos. En: Suardíaz JH, Cruz CL, Colina A. Laboratorio Clínico. La Habana: Editorial Ciencias Médicas; 2004.p. 95-113.

  4. Jacques Wallach MD. Interpretación clínica de las pruebas de laboratorio. 4ª ed. La Habana: Editorial Ciencias Médicas; 2006.

  5. Mahoney J, Ellison J. Assessing the Quality of Glucose Monitor Studies: A Critical Evaluation of Published Reports. Clinical Chemistry. 2007 [citado 24 mar 2014]; 53(6):1122–8. Disponible en: www.clinchem.org/cgi/pmidlookup?view=long&pmid=17478560

  6. Esquivel Molina CG, Velasco Rodríguez VM, Martínez Rubin de Celis E, Barbachano Rodríguez E, González Ávila G, Castillo Ruiz CE. Coeficiente de correlación intraclase vs correlación de Pearson de la glucemia capilar por reflectometría y glucemia plasmática. Med Int Mex. 2006 [citado 24 mar 2014]; 22(3):165-71. Disponible en: http://new.medigraphic.com/cgi-bin/resumen.cgi?IDREVISTA=83&IDARTICULO=14418&IDPUBLICACION=1480

  7. European Committee for Standardization. DIN EN ISO 15197: In Vitro Diagnostic Test Systems Requirements for Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus (ISO 15197:2003). Brussels: European Committee for Standardization; 2003. [citado 24 mar 2014] Disponible en: http://www.iso.org/iso/catalogue_detail.htm?csnumber=26309

  8. Pita Fernández S, Pértegas Díaz S. La fiabilidad de las mediciones clínicas: el análisis de concordancia para variables numéricas. Cuad Atenc Prim. 2003 [citado 24 mar 2014]; 10 (4): 290-6. Disponible en: http://dialnet.unirioja.es/servlet/articulo?codigo=2330578

  9. Castaño López MÁ, Fernández de Liger Serrano JL, Robles Rodríguez JL, Márquez Márquez T. Validación de un glucómetro en una unidad de cuidados intensivos. Endocrinol Nutr. 2012 [citado 24 mar 2014]; 59 (1): Disponible en: http://zl.elsevier.es/es/revista/endocrinologia-nutricion-12/validacion-un-glucometro-una-unidad-cuidados-intensivos-90093430-originales-2012

  10. Tanani DS, Khoudri I, Bennis RN, Abidi K, Cherrah Y, Zeggwagh AA. Évaluation de la fiabilité de la mesure de la glycémie capillaire dans une unité de soins intensifs. Ann Biol Clin.2006 [citado 24 mar 2012]; 64 (1): 77-81. Disponible en: http://www.ncbi.nlm.nih.gov/pubmed/?term=

  11. Lacara T, Domagtoy C, Lickliter D, Quattrocchi K, Snipes L, Kuszaj J, et al. Comparison of Point-of-Care and Laboratory Glucose Analysis in Critically ill Patients. Am J Crit Care. 2007 [citado 24 mar 2012]; 16(4):336-46. Disponible en: http://ajcc.aacnjournals.org/content/16/4/

  12. Krouwer J S, Cembrowski G S. A Review of Standards and Statistics Used to Describe Blood Glucose Monitor Performance. J Diabetes Sci Technol. 2010 [citado 24 mar 2012]; 4(1):75-83. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2825627

  13. Ginsberg BH. Factors Affecting Blood Glucose Monitoring: Sources of Errors in Measurement. J Diabetes Sci Technol. 2009 [citado 24 mar 2012]; 3(4):903-13. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769960

  14. Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 [citado 24 mar 2012]; 6(5):1076-86. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3570841

  15. Karon BS, Griesmann L, Scott R, Bryant SC, Dubois JA, Shirey TL, et al. Evaluation of the impact of hematocrit and other interference on the accuracy of hospital-based glucose meters. Diabetes Technol Ther. 2008 [citado 24 mar 2012]; 10(2):111–20. Disponible en: http://online.liebertpub.com/doi/abs/10.1089/dia.2007.0257

  16. Foss Freitas MC, Andrade RC, Figueiredo RC, Pace AE, Martinez EZ, Dal Fabro AL, et al. Comparison of venous plasma glycemia and capillary glycemia for the screening of type 2 diabetes mellitus in the Japanese Brazilian communit y of Mombuca (Guatapará-SP). Diabetology & Metabolic Síndrome. 2010 [citado 24 mar 2012]; 2(6). Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2828405/

  17. Il'iasov IR, Kartavenkov SA, Mishchenko BP, Smirnov VA. The multicentral clinical laboratory study of precision of the portative glucometer "Satellite Plus". Klin Lab Diagn. 2012[citado 24 mar 2012]; (8):23-5. Disponible en: http://europepmc.org/abstract/MED/23097987

  18. Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly. 2012[citado 24 mar 2012]; 12(142):13631. Disponible en: http://www.smw.ch/content/smw-2012-13631

  19. Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, et al. System Accuracy Evaluation of 27 Blood Glucose Monitoring Systems According to DIN EN ISO 15197. Diabetes Technol Ther.2010 [citado 24 mar 2012]; 12 (3): 221-30. Disponible en: http://www.researchgate.net/publication/41426182_System

  20. Commendatore V, González C, Zamboni M, Frías P, Buttazzoni E, Motura S, et Al. Confiabilidad clínica de un glucómetro biosensor utilizado en pulpejo, eminencia tenar e hipotenar. Rev SAD. 2008 [citado 24 mar 2012]; 42(3):168-75. Disponible en: http://webcache.googleusercontent.com/search?q=cache:IsMLswMtwQoJ:revistasad.org.ar/resumen.php%3FIdArticulo%3D411+&cd=1&hl=es&ct=clnk&gl=es

  21. WentholT IME, Hart AAM, Hoekstra JBL, Devries JH. How to Assess and Compare the Accuracy of Continuous Glucose Monitors? Diabetes Technology & Therapeutics. 2008 [citado 24 mar 2012]; 10(2): 57-68. Disponible en: http://online.liebertpub.com/doi/abs/10.1089/dia.2007.0216




2020     |     www.medigraphic.com