Garg Satish K, Carter Judy A, Mullen Lucy, Folker Amy C, Parkes Joan Lee, Tideman Ann M
Department of Medicine and Pediatrics, Barbara Davis Center for Childhood Diabetes, University of Colorado Health Sciences Center, Denver, Colorado, USA.
Diabetes Technol Ther. 2004 Aug;6(4):495-502. doi: 10.1089/1520915041705983.
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.
患者和医疗保健提供者的评估对于确定新型血糖仪系统的准确性和易用性至关重要。我们研究的目的是评估一种使用10次测试盘的血糖仪（拜耳医疗保健有限责任公司，印第安纳州埃尔克哈特的Ascensia Breeze血糖仪系统）的临床性能和易用性。在两个糖尿病中心，将血糖仪毛细血管血糖结果与100名糖尿病患者的实验室血糖结果进行了比较。五名医疗保健专业人员也对受试者的血样进行了检测。受试者完成了一份对血糖仪易用性进行评分的问卷，并对他们学习使用血糖仪的能力进行了评估。使用ISO 15197:2003性能标准评估血糖仪系统的分析准确性。受试者和医疗保健专业人员的血糖仪血糖结果分别有93.4%和94.4%在实验室血糖结果的20%以内[对于血糖水平低于75mg/dL（4.17mmol/L）的标本为15mg/dL（0.83mmol/L）以内]。使用帕克斯误差网格分析评估该系统的临床准确性。误差网格分析表明，受试者和医疗保健专业人员的血糖仪血糖结果100%处于A区（92%）和B区（8%）。在易用性问卷中，91%的受试者对血糖仪的评价良好。受试者在几乎没有或没有医疗保健专业人员协助的情况下，通过使用血糖仪的指导材料学会了正确操作血糖仪。10次测试盘被评为一个显著的有利特征。这种新型血糖仪在糖尿病患者和医疗保健专业人员手中准确且精确。受试者发现该血糖仪易于学习且直观。研究受试者在独立查阅用户指南后能够正确使用该血糖仪。
