Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors

<b>Objective:</b> In this study, accuracy in the hands of intended users was evaluated for five self-monitoring of blood glucose (SMBG) systems based on ISO 15197:2013, and possibly related insulin dosing errors were calculated. In addition, accuracy was assessed in the hands of study personnel. <b>Methods:</b> For each system (Accu-Chek¹ Aviva Connect [A], Contour² Next One [B], FreeStyle Freedom Lite³ [C], GlucoMen⁴ areo [D] and OneTouch Verio⁵ [E]) one test strip lot was evaluated as required by ISO 15197:2013, clause 8. Number and percentage of SMBG measurements within ±15 mg/dl and ±15% of the comparison measurements at glucose concentrations &lt;100 mg/dl and ≥100 mg/dl, respectively, were calculated. In addition, data is presented in surveillance error grids, and insulin dosing errors were modeled. The study was registered at ClinicalTrials.gov (NCT03033849). <b>Results:</b> Four systems (A, B, C, D) fulfilled the tested reagent system lot ISO 15197:2013 accuracy criteria with the tested reagent system lot with at least 95% (lay-users) and 99.5% (study personnel) of results within the defined limits. Measurements with all five systems were within the clinically acceptable zones of the consensus error grid and the surveillance error grid. Median modeled insulin dosing errors were between -0.8 and +0.6 units for measurements performed by lay-users and between -0.7 and +0.8 units for study personnel. Frequent lay-user errors were not checking the test strips’ expiry date, applying blood incorrectly and handling the device incorrectly. <b>Conclusion:</b> In this study, the systems showed slight differences in the number of results within ISO 15197:2013 accuracy limits. Inaccurate SMBG measurements can result in insulin dosing errors and adversely affect glycemic control.

**研究目的：** 本研究依据ISO 15197:2013标准，评估了五款自我血糖监测（self-monitoring of blood glucose, SMBG）系统在目标使用者手中的检测准确度，并计算了可能相关的胰岛素给药误差。此外，本研究还评估了该类系统在研究人员手中的检测准确度。

**研究方法：** 针对每款系统（Accu-Chek¹ Aviva Connect [A]、Contour² Next One [B]、FreeStyle Freedom Lite³ [C]、GlucoMen⁴ areo [D]及OneTouch Verio⁵ [E]），按照ISO 15197:2013第8条款的要求，对一批测试试纸进行了检测。分别计算葡萄糖浓度＜100 mg/dl及≥100 mg/dl时，自我血糖监测值与参照值偏差在±15 mg/dl及±15%范围内的样本数量及占比。此外，本研究以监测误差网格（surveillance error grids）形式呈现数据，并对胰岛素给药误差进行了建模分析。本研究已在ClinicalTrials.gov注册（登记号：NCT03033849）。

**研究结果：** 四款系统（A、B、C、D）符合受试试剂批次的ISO 15197:2013准确度标准，其符合既定限值的结果占比分别至少为95%（普通使用者（lay-users））及99.5%（研究人员）。五款系统的检测结果均处于共识误差网格（consensus error grid）及监测误差网格的临床可接受区间内。普通使用者操作所得检测结果的建模胰岛素给药误差中位数介于-0.8至+0.6单位之间，研究人员操作所得结果的该中位数介于-0.7至+0.8单位之间。普通使用者常见的操作失误包括未检查试纸有效期、采血操作不当及设备使用不当。

**研究结论：** 本研究中，五款系统在符合ISO 15197:2013准确度限值的结果占比上存在细微差异。不准确的自我血糖监测结果可能引发胰岛素给药误差，进而对血糖控制产生不利影响。