Christiansen Mark, Greene Carmine, Pardo Scott, Warchal-Windham Mary Ellen, Harrison Bern, Morin Robert, Bailey Timothy S
1 Diablo Clinical Research, Walnut Creek, CA, USA.
2 Ascensia Diabetes Care, Parsippany, NJ, USA.
J Diabetes Sci Technol. 2017 May;11(3):567-573. doi: 10.1177/1932296817691301. Epub 2017 Feb 1.
These studies investigated the accuracy of the new ContourNext ONE blood glucose monitoring system (BGMS) that is designed to sync with the Contour™ Diabetes app on a smartphone or tablet.
A laboratory study tested fingertip capillary blood samples from 100 subjects in duplicate using 3 test strip lots, based on ISO 15197:2013 Section 6.3 analytical accuracy standards. A clinical study assessed accuracy per ISO 15197:2013 Section 8 criteria. Subjects with (n = 333) or without (n = 43) diabetes and who had not used the BGMS previously were enrolled. Each subject performed a self-test using the BGMS, which was repeated by a site staff member. Alternate site tests and venipunctures were also performed for analysis. A questionnaire was provided to assess user feedback on ease of use.
In the laboratory study, 100% (600/600) of combined results for all 3 test strip lots met ISO 15197:2013 Section 6.3 accuracy criteria. In the clinical study, among subjects with diabetes, 99.4% (327/329) of subject self-test results, 99.7% (331/332) of results obtained by study staff, 97.2% (309/318) of subject palm results, and 100% (330/330) of venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 97.6% (321/329) of subject self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results indicated that most subjects considered the system easy to use.
The BGMS exceeded ISO 15197:2013 accuracy criteria in the laboratory and in a clinical setting.
这些研究调查了新型ContourNext ONE血糖监测系统（BGMS）的准确性，该系统旨在与智能手机或平板电脑上的Contour™糖尿病应用程序同步。
一项实验室研究根据ISO 15197:2013第6.3节分析准确性标准，使用3批测试条对100名受试者的指尖毛细血管血样进行了重复检测。一项临床研究根据ISO 15197:2013第8节标准评估准确性。招募了患有（n = 333）或未患有（n = 43）糖尿病且之前未使用过BGMS的受试者。每位受试者使用BGMS进行自我检测，现场工作人员会重复检测。还进行了替代部位检测和静脉穿刺以进行分析。提供了一份问卷以评估用户对易用性的反馈。
在实验室研究中，所有3批测试条的综合结果中有100%（600/600）符合ISO 15197:2013第6.3节准确性标准。在临床研究中，在糖尿病受试者中，99.4%（327/329）的受试者自我检测结果、99.7%（331/332）的研究人员获得的结果、97.2%（309/318）的受试者手掌检测结果以及100%（330/330）的静脉检测结果符合ISO 15197:2013第8节准确性标准。此外，97.6%（321/329）的受试者自我检测结果在YSI参考结果的±10 mg/dl（±0.6 mmol/L）或±10%范围内。问卷结果表明，大多数受试者认为该系统易于使用。
BGMS在实验室和临床环境中均超过了ISO 15197:2013准确性标准。
