Gómez Medina Ana María, Henao Carrillo Diana Cristina, León Vargas Fabian Mauricio, Jojoa Jojoa Ruby Isabel, Quijano Naranjo Jossie Esteban, Rondón-Sepulveda Martin Alonso, García Jaramillo Maira Alejandra, Muñoz Velandia Oscar Mauricio
Unidad de endocrinología, Pontificia Universidad Javeriana, Hospital Universitario San Ignacio, Bogotá, Colombia.
Universidad Antonio Nariño, Bogotá, Colombia.
Endocrinol Diabetes Nutr (Engl Ed). 2023 Mar;70(3):212-219. doi: 10.1016/j.endien.2023.03.009. Epub 2023 Mar 24.
There are data capture devices that attach to the FreeStyle Libre sensor and convert its communication from NFC (Near-field communication) to Bluetooth technology, generating real-time continuous glucose monitoring. The accuracy of hypoglycemia measurements displayed by smartphone apps using this device has not been established.
Study of diagnostic tests. Numerical accuracy was evaluated, utilizing the absolute difference with respect to capillary glucometry (ISO 15197:2015 standard) and clinical accuracy, using the Clarke and Parkes (Consensus) error grids, for glucose measurements less than 70mg/dL performed with the FreeStyle Libre system and with the digital estimation xDrip+ app, in diabetic patients managed with insulin therapy.
Twenty-seven patients were included (TIR 73.4%, TBR70 5.6%), who contributed 83 hypoglycemic events. Numerical accuracy was adequate in similar proportions with the FreeStyle Libre system compared to the xDrip+ app (81.92% vs. 68.67%, p=0.0630). The clinical accuracy evaluation showed that 92.8% of the measurements for xDrip+ and 98.8% for FreeStyle libre met the criteria according to the Parkes (Consensus) grid (p=0.0535); and 79.5% and 91.6% of the measurements met the criteria according to the Clarke grid (p=0.0273), being higher with FreeStyle libre.
The use of the NFC-Bluetooth transmitter (Miao-Miao) associated with the xDrip+ app does not improve numerical or clinical accuracy for detecting hypoglycemic events in diabetic patients managed with insulin therapy, compared to the FreeStyle Libre device.
有一些数据采集设备可连接到FreeStyle Libre传感器，并将其通信从NFC（近场通信）转换为蓝牙技术，从而实现实时连续血糖监测。使用该设备的智能手机应用程序所显示的低血糖测量准确性尚未得到确定。
诊断测试研究。在接受胰岛素治疗的糖尿病患者中，使用FreeStyle Libre系统和数字估算xDrip+应用程序对低于70mg/dL的血糖测量，利用相对于毛细血管血糖测定法（ISO 15197:2015标准）的绝对差值评估数值准确性，并使用克拉克和帕克斯（共识）误差网格评估临床准确性。
纳入了27名患者（总体达标时间率73.4%，血糖低于70mg/dL的时间占比5.6%），他们贡献了83次低血糖事件。与xDrip+应用程序相比，FreeStyle Libre系统在类似比例下数值准确性良好（81.92%对68.67%，p = 0.0630）。临床准确性评估显示，根据帕克斯（共识）网格，xDrip+的测量中有92.8%符合标准，FreeStyle Libre的测量中有98.8%符合标准（p = 0.0535）；根据克拉克网格，测量中有79.5%和91.6%符合标准（p = 0.0273），FreeStyle Libre的符合率更高。
与FreeStyle Libre设备相比，将NFC - 蓝牙发射器（苗苗）与xDrip+应用程序结合使用，在检测接受胰岛素治疗的糖尿病患者低血糖事件时，并未提高数值或临床准确性。
