Frank Joy, Wallace Jane F, Pardo Scott, Parkes Joan Lee
Consumer Product Testing Co., Fairfield, New Jersey, USA.
J Diabetes Sci Technol. 2011 Jan 1;5(1):198-205. doi: 10.1177/193229681100500128.
Self-monitoring of blood glucose (SMBG) remains an important component of diabetes management, engendering a need for affordable blood glucose (BG) meters that are accurate, precise, and convenient. The CONTOUR® TS is a BG meter that endeavors to meet this need. It uses glucose dehydrogenase/flavin dinucleotide chemistry, automatic test strip calibration, and autocompensation for hematocrit along with the ease of use that has come to be expected of a modern meter. The objective of this clinical trial was to determine whether the CONTOUR TS system met these criteria.
The system was evaluated at a single clinical site with 106 subjects with type 1 or type 2 diabetes. Blood glucose values ranged from 60 to 333 mg/dl over all subjects. Both lay users and health care professionals (HCPs) tested the meters, with test strips from three different lots. Results were compared to a reference analyzer of verified precision and accuracy. Forty-nine of the subjects also participated in a home study of the meter. Lay users learned to use the system without assistance and were surveyed on its use at the end of the study.
When used with capillary blood, both subjects and HCPs obtained results that exceeded the International Organization for Standardization 15197:2003 criteria, (i.e., ≥95% of values fell within 20% or 15 mg/dl of the laboratory value for BG levels greater than or less than 75 mg/dl, respectively). Specifically, lay users achieved 97.9% and HCPs 98.6%. When used with venous blood, 99.8% of measurements were within the criteria. All measurements for both capillary and venous blood fell into zones A or B of the Parkes error grid, deemed clinically accurate. Hematocrit was found to have no influence on BG measurements. A large majority of the subjects found the system easy to learn and to use.
The CONTOUR TS BG meter system gave accurate and reproducible results with both capillary and venous blood; subjects learned to use the meter system by following the user guide and quick reference guide.
自我血糖监测（SMBG）仍是糖尿病管理的重要组成部分，这就需要价格合理、准确、精密且方便的血糖仪。拜安易®TS血糖仪致力于满足这一需求。它采用葡萄糖脱氢酶/黄素二核苷酸化学反应、试纸自动校准以及血细胞比容自动补偿功能，同时具备现代血糖仪所应有的易用性。本临床试验的目的是确定拜安易TS系统是否符合这些标准。
该系统在一个临床地点对106名1型或2型糖尿病患者进行了评估。所有受试者的血糖值范围为60至333毫克/分升。普通用户和医护人员（HCPs）使用来自三个不同批次的试纸对血糖仪进行了测试。将结果与经证实具有精密度和准确性的参考分析仪进行比较。其中49名受试者还参与了该血糖仪的家庭研究。普通用户在无协助的情况下学会使用该系统，并在研究结束时接受了关于其使用情况的调查。
当与毛细血管血一起使用时，受试者和医护人员获得的结果均超过了国际标准化组织15197:2003标准（即，对于高于或低于75毫克/分升的血糖水平，分别有≥95%的值落在实验室值的20%或15毫克/分升范围内）。具体而言，普通用户达到了97.9%，医护人员达到了98.6%。当与静脉血一起使用时，99.8%的测量值在标准范围内。毛细血管血和静脉血的所有测量值均落在帕克斯误差网格的A区或B区，被认为在临床上是准确的。发现血细胞比容对血糖测量没有影响。绝大多数受试者认为该系统易于学习和使用。
拜安易TS血糖仪系统使用毛细血管血和静脉血均能给出准确且可重复的结果；受试者通过遵循用户指南和快速参考指南学会了使用该血糖仪系统。
