The Clinical Performance and Ease of Use of a Blood Glucose Meter that Uses a 10-Test Disk

Abstract

Patient and health care provider evaluations are critical in establishing the accuracy and usability of new blood glucose meter systems. The objective of our study was to evaluate the clinical performance and ease of use of a blood glucose meter that uses a 10-test disk (Ascensia Breeze meter system, Bayer Healthcare LLC, Elkhart, IN). Meter capillary blood glucose results were compared with laboratory glucose results from 100 subjects with diabetes at two diabetes centers. Five health care professionals also tested subject blood samples. The subjects completed a questionnaire rating the ease of use of the meter, and their ability to learn to use the meter was also evaluated. Analytical accuracy of the meter system was assessed using ISO 15197:2003 performance criteria. Subject and health care professional meter glucose results were within 20% of laboratory glucose results [or 15 mg/dL (0.83 mmol/L) for specimens with less than 75 mg/dL (4.17 mmol/L) glucose levels] for 93.4% and 94.4% of results, respectively. Clinical accuracy of the system was evaluated using Parkes error grid analysis. The error grid analyses showed that 100% of subject and health care professional meter blood glucose results were in Zones A (92%) and B (8%). In the ease-of-use questionnaire, 91% of subject ratings of the meter were favorable. Subjects learned to operate the meter properly using the meter instructional material with little or no assistance from the health care professionals. The 10-test disk was rated as a prominent favorable feature. The new meter was accurate and precise in the hands of subjects with diabetes and health care professionals. Subjects found the meter easy and intuitive to learn to use. The study subjects were able to correctly use the meter after independently reviewing the user guide.

Physical Activity Improves Glucose Tolerance Independent of Weight Loss in Severe Obesity

“…Capillary blood was obtained by finger prick. The results of this blood glucose meter correlate well with laboratory blood glucose measurements (r=0.97) [16]. Directly thereafter subjects consumed a standard 300 ml glucose drink containing 75 g of glucose dissolved in water.…”

Glicemia do sangue capilar e venoso de cães saudáveis: mensuração por método eletroquímico versus enzimático laboratorial

“…A variação da média da glicemia obtida pelo glicosímetro digital portátil, na amostra capilar e A variação da média da glicemia obtida pelo glicosímetro digital portátil, na amostra capilar e venosa, foi de 16,6%; na amostra periférica capilar versus método laboratorial foi de 12,6% e a variação da amostra venosa versus método laboratorial foi de 15%. Vandresen et al (2009) compararam os valores glicêmicos, obtidos por glicosímetro digital portátil (sistema capilar) e por método laboratorial, de 36 pacientes humanos sendo estes tomados em quatro momentos, e observaram que não houve diferença estatística significativa entre os métodos, embora o teste de Kappa mostrasse maior concordância em diferentes momentos. Da mesma forma, um estudo realizado com 39 gatos hiperglicêmicos, cuja glicemia era superior a162 mg/dL, mostrou maiores coeficientes de variação na mensuração com glicosímetro (3,5%) em relação aos obtidos pelo método laboratorial (0,9%) (ZINI et al, 2009).…”

“…De acordo com International Organization for Standardization (ISO 15197:2003), os resultados obtidos da glicemia capilar e através de métodos laboratoriais podem sofrer variações de 20% e isso ocorre porque as medições de glicose analisam todo o sangue (GARG et al, 2004) e estabelecer esta precisão torna-se difícil, pois a glicose é instável em todo sangue. A diferença entre os valores do sangue venoso aferido pelo glicosímetro e pelo método laboratorial pode ocorrer devido a análise imediata obtida com glicosímetro e o tempo inerente gasto com o método laboratorial, pois os eritrócitos metabolizam glicose, o que pode acarretar no decréscimo da concentração da glicose na amostra em 5-7% por hora, tanto quanto o soro/ plasma se mantiverem em contato com as células vermelhas do sangue (CHAN; SWAMINATHAN; COCKRAM, 1989).…”

“…Avaliações periódicas da glicemia podem ser realizadas com auxílio de aparelhos portáteis e por método laboratorial (VANDRESEN et al, 2009;ALEIXO et al, 2010;ARGOLLO;FAUSTINO;PEDREIRA, 2010). Os aparelhos portáteis aferem índices glicêmicos do sangue periférico capilar e venoso (ALEIXO et al, 2007;ARGOLLO;FAUSTINO;PEDREIRA, 2010).…”

Self-monitoring of blood glucose with a focus on analytical quality: an overview

“…Studies have shown that half of the patients are self-educated (19). Lately, this aspect has been more focused (19,(89)(90)(91)(92). In the ISO 15197 document, it is recommended that a user evaluation should be performed in addition to testing under standardised conditions (82).…”