López-Ortiz Susana, García-Chico Celia, Musso-Daury Lisa, González-Ustio Sara, Peñín-Grandes Saúl, Pinto-Fraga José, Maroto-Izquierdo Sergio, Santos-Lozano Alejandro
i+HeALTH Strategic Research Group, Department of Health Sciences, Miguel de Cervantes European University, 47012 Valladolid, Spain.
Physical Activity and Health Research Group ("PaHerg"), Research Institute of Hospital "12 de Octubre" ("Imas12"), 28041 Madrid, Spain.
Sensors (Basel). 2025 Jun 18;25(12):3793. doi: 10.3390/s25123793.
(1) Background: The use of wearable cuffless devices has emerged as an out-of-office blood pressure (BP) monitor device to improve the management of hypertension. We aimed to validate a new, low-cost smartwatch for the measurement of BP and, secondarily, to assess its reliability for the measurement of blood oxygen saturation (SpO) and heart rate. (2) Methods: We compared 1000 pairs of measurements (n = 100) acquired by a smartwatch (KC08) with those measured by a reference device. (3) Results: A total of 100 participants (41 ± 18 years) completed the measurements. The values for the systolic and diastolic BP, heart rate and SpO measured with the Smartwatch KC08 and the reference devices differed significantly ( < 0.05). In addition, the Smartwatch KC08 showed a low variability and poor reliability for all the assessed outcomes except for the heart rate. Moreover, no significant heteroscedasticity was observed for the heart rate measured by the Smartwatch KC08 and the reference sphygmomanometer. (4) Conclusions: The main findings of the present study suggest that the Smartwatch KC08 is not yet suitable for daily clinical practice, although it showed low intra-subject variability and reliability for the resting heart rate.
(1) 背景：可穿戴无袖带设备已成为一种用于改善高血压管理的诊室外血压（BP）监测设备。我们旨在验证一款新型低成本智能手表用于血压测量的准确性，其次评估其测量血氧饱和度（SpO）和心率的可靠性。(2) 方法：我们将智能手表（KC08）获取的1000对测量值（n = 100）与参考设备测量的结果进行比较。(3) 结果：共有100名参与者（41 ± 18岁）完成了测量。智能手表KC08与参考设备测量的收缩压、舒张压、心率和SpO值存在显著差异（< 0.05）。此外，除心率外，智能手表KC08在所有评估指标上均显示出低变异性和较差的可靠性。而且，智能手表KC08与参考血压计测量的心率未观察到明显的异方差性。(4) 结论：本研究的主要结果表明，尽管智能手表KC08在静息心率方面显示出较低的个体内变异性和可靠性，但它目前仍不适合日常临床实践。
