Cetero Research, formerly DGD Research Associates, San Antonio, Texas, USA.
Diabetes Technol Ther. 2009 Oct;11(10):649-55. doi: 10.1089/dia.2009.0020.
The complications of diabetes may be minimized by adequate glycemic control, which is aided by self-monitoring of blood glucose (SMBG) levels. A new SMBG system, TRUE2go (Home Diagnostics, Inc., Fort Lauderdale, FL), does not require calibration of test strips, thereby eliminating the potential source of error in blood glucose determination associated with mis-calibration. This study tested the performance of the TRUE2go system. The very small size and attachment of the meter to a vial of test strips make the TRUE2go system unique.
The studies were carried out with adult patients with type 1 or 2 diabetes, using procedures for testing accuracy as specified in International Organization for Standardization (ISO) 15197:2003. The evaluation included patients' compliance with the TRUE2go system's written instructions, ease of understanding the supplied instructions, and ease of use of the system.
The study demonstrated the accuracy and precision of the TRUE2go system, with 100% of glucose test results falling within ISO-recommended limits for glucose concentrations ranging from 24 mg/dL to 549 mg/dL. There was agreement between data obtained with TRUE2go when used by healthcare professionals and by lay users on capillary blood from both fingertip and a forearm sticks. Lay users' understanding of and compliance with TRUE2go system instructions were excellent, as was their satisfaction with the system.
The TRUE2go system is accurate and convenient to use, and its instructions are easily understood by lay users. TRUE2go features that contribute to convenience, and therefore could improve compliance with monitoring regimens, include its small size, attachment to the vial of strips, easy-to-read display, automatic calibration for test strips, and suitability for fingertip as well as forearm testing.
通过自我监测血糖（SMBG）水平，可以充分控制血糖，从而最大程度地减少糖尿病的并发症。一种新的 SMBG 系统 TRUE2go（Home Diagnostics，Inc.，佛罗里达州劳德代尔堡）不需要校准测试条，从而消除了与校准错误相关的血糖测定中潜在的错误源。本研究测试了 TRUE2go 系统的性能。血糖仪非常小巧，并与测试条小瓶相连，这使 TRUE2go 系统独具特色。
使用国际标准化组织（ISO）15197：2003 规定的测试准确性程序，对 1 型或 2 型糖尿病成年患者进行了这些研究。评估包括患者对 TRUE2go 系统书面说明的遵守情况、对所提供说明的理解难易程度以及对系统的易用性。
该研究证明了 TRUE2go 系统的准确性和精密度，从 24mg/dL 到 549mg/dL 的范围内，100％的血糖测试结果均符合 ISO 推荐的葡萄糖浓度限值。医护人员和非医护人员使用 TRUE2go 从指尖和前臂采集的毛细血管血获得的数据之间具有一致性。非医护人员对 TRUE2go 系统说明的理解和遵守情况非常出色，对该系统的满意度也很高。
TRUE2go 系统准确易用，非医护人员也很容易理解其说明。TRUE2go 系统具有一些便于使用的特点，因此可能会提高监测方案的依从性，这些特点包括其小巧的尺寸、与测试条小瓶相连、易于读取的显示屏、测试条的自动校准以及适合指尖和前臂测试。
