Zhou Yi, Zhang Wei, Wang Xin-Yu, Zhou Yi, Li Yan, Wang Ji-Guang
Department of Cardiovascular Medicine, State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
National Research Centre for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Hypertens Res. 2025 Aug 27. doi: 10.1038/s41440-025-02345-2.
The aim of this study was to evaluate the accuracy of a watch-type oscillometric BP monitor HUAWEI WATCH D2 for rest and ambulatory BP measurements and compare with a conventional ambulatory BP monitor (A&D TM-2430, Tokyo, Japan). Subjects were recruited to fulfill the age, gender, BP and cuff distributions of the AAMI/ESH/ISO Universal Standard in the general population. Two cuffs of the test device were used for wrist circumference 13-16 (medium) and 16-21 cm (large), respectively. During the ambulatory validation study, subjects were asked to pedal at a low workload to elevate heart rate. For the 24-h ambulatory measurement, two BP monitoring devices were simultaneously worn on the same arm with the A&D cuff on the patient's left arm and the HUAWEI WATCH D2 on the left wrist. In the study on rest BP measurement, 95 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± standard deviation (SD) of the differences between the test device and reference BP readings was -1.6 ± 6.4/-1.9 ± 5.0 mmHg. For criterion 2, the SD of the mean BP differences between the test device and reference BP readings per subject was 5.8/4.7 mmHg. In the ambulatory validation study, the mean difference between the device and observers was -0.9 ± 7.3 mmHg and -0.7 ± 4.9 mmHg for systolic and diastolic BP, respectively. We also compared the 24-h BP data with the HUAWEI WATCH D2 and cuff-based A&D in 35 adults. The mean difference (±SD) in systolic/diastolic BP between the device and A&D were -1.1 ± 6.3/1.0 ± 4.2 mmHg, -2.0 ± 6.5/-0.2 ± 4.7 mmHg and 1.2 ± 6.7/ 4.2 ± 4.4 mmHg for 24-h, daytime and nighttime, respectively. The watch-type oscillometric BP monitor HUAWEI WATCH D2 has met the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2: 2018/AMD 1: 2020) in both rest and ambulatory measurements. Moreover, the HUAWEI WATCH D2 achieved acceptable agreement with 24-h ambulatory BP measurement.
本研究旨在评估华为WATCH D2手表式示波血压监测仪在静息和动态血压测量中的准确性，并与传统动态血压监测仪（日本东京A&D TM-2430）进行比较。招募的受试者符合一般人群中AAMI/ESH/ISO通用标准的年龄、性别、血压和袖带分布。测试设备的两个袖带分别适用于腕围13 - 16厘米（中号）和16 - 21厘米（大号）。在动态验证研究中，要求受试者以低工作量蹬踏板以提高心率。在24小时动态测量期间，将两个血压监测设备同时佩戴在同一只手臂上，A&D袖带戴在患者左臂，华为WATCH D2戴在左手腕。在静息血压测量研究中，招募了95名受试者，其中85名进行了分析。对于验证标准1，测试设备与参考血压读数之间差异的平均值±标准差（SD）为-1.6±6.4 / -1.9±5.0 mmHg。对于标准2，每个受试者测试设备与参考血压读数之间平均血压差异的SD为5.8 / 4.7 mmHg。在动态验证研究中，该设备与观察者之间收缩压和舒张压的平均差异分别为-0.9±7.3 mmHg和-0.7±4.9 mmHg。我们还比较了35名成年人中华为WATCH D2与基于袖带的A&D的24小时血压数据。该设备与A&D在24小时、白天和夜间收缩压/舒张压的平均差异（±SD）分别为-1.1±6.3 / 1.0±4.2 mmHg、-2.0±6.5 / -0.2±4.7 mmHg和1.2±6.7 / 4.2±4.4 mmHg。华为WATCH D2手表式示波血压监测仪在静息和动态测量中均符合AAMI/ESH/ISO通用标准（ISO 81060-2: 2018/AMD 1: 2020）的要求。此外，华为WATCH D2与24小时动态血压测量达成了可接受程度的一致性。
