Pfützner Andreas, Demircik Filiz, Kirsch Valeria, Pfützner Johannes, Strobl Stephanie, Hanna Mina, Spatz Jan, Pfützner Anke H
1 Pfützner Science & Health Institute, Mainz, Germany.
2 Sciema UG, Mainz, Germany.
J Diabetes Sci Technol. 2019 May;13(3):507-513. doi: 10.1177/1932296819841353. Epub 2019 Apr 11.
In recent randomized clinical trials, an unusual reporting pattern of glycemic data and hypoglycemic events potentially related to an internet enabled blood glucose meter (MyGlucoHealth, BGM) was observed. Therefore, this clinical study was conducted to evaluate the system accuracy of the BGM in accordance with the ISO15197:2015 guidelines with additional data collection.
To investigate system accuracy, 10 of 3088 devices and 6 of 23 strip lots, used in the trials, were selected by a randomization procedure and a standard repeatability assessment. YSI 2300 STAT Plus was used as the standard reference method. The samples were distributed as per the ISO15197:2015 recommendations with 20 additional samples in the hypoglycemic range. Each sample was tested with 6 devices and 6 strip lots with double determinations.
Overall, 121 subjects with blood glucose values 26-423 mg/dL were analyzed, resulting in 1452 data points. In all, 186/1452 readings (12.8%) did not meet the ISO acceptance criteria. Data evaluated according to the FDA guidelines showed that 336/1452 (23.1%) readings did not meet the acceptance criteria. A clear bias toward elevated values was observed for BG <100 mg/dL (MARD: 11.0%).
The results show that the BGM, although approved according to standard regulatory guidelines, did not meet the level of analytical accuracy required for clinical treatment decisions according to ISO 15197:2015 and FDA requirements. In general, caution should be exercised before selection of BGMs for patients and in clinical trials.
在最近的随机临床试验中，观察到血糖数据和低血糖事件的一种异常报告模式，这可能与一款联网血糖仪（MyGlucoHealth，BGM）有关。因此，开展了这项临床研究，以根据ISO15197:2015指南并通过额外的数据收集来评估该血糖仪的系统准确性。
为研究系统准确性，通过随机程序和标准重复性评估，从试验中使用的3088台设备中选取了10台，从23批试纸条中选取了6批。采用YSI 2300 STAT Plus作为标准参考方法。样本按照ISO15197:2015的建议进行分配，在低血糖范围内额外增加了20个样本。每个样本用6台设备和6批试纸条进行检测，每次检测做双份测定。
总体而言，对121名血糖值在26 - 423mg/dL的受试者进行了分析，得到1452个数据点。总计186/1452次读数（12.8%）不符合ISO验收标准。根据FDA指南评估的数据显示，336/1452次读数（23.1%）不符合验收标准。对于血糖<100mg/dL的情况，观察到明显的偏高偏差（平均相对偏差：11.0%）。
结果表明，该血糖仪尽管已根据标准监管指南获得批准，但根据ISO 15197:2015和FDA的要求，其分析准确性未达到临床治疗决策所需的水平。一般而言，在为患者选择血糖仪以及在临床试验中使用时应谨慎。
