Is the Blood Pressure-Enabled Smartwatch Ready to Drive Precision Medicine? Supporting Findings From a Validation Study.

Background

The popular wrist-worn wearables recording a variety of health metrics such as blood pressure (BP) in real time could play a potential role to advance precision medicine, but these devices are often insufficiently validated for their performance to enhance confidence in its use across diverse populations. The accuracy of BP-enabled smartwatch is assessed among the multi-ethnic Malaysians, and findings is discussed in comparison with conventional automated upper-arm BP device.

Methods

Validation procedures followed the guidelines by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Quota sampling was employed to obtain eligible patients with normal and abnormal BP as per guideline. The measurements of BP were taken at wrist using HUAWEI WATCH D (test BP); and the readings were assessed against reference BP by the mercury sphygmomanometer. Agreement statistics and linear regression analyses were performed.

Results

BP measurements (234 data pairs) from 78 patients that fulfilled AAMI/ESH/ISO protocol were analyzed. The BP readings taken by the HUAWEI WATCH D were comparable to reference BP by sphygmomanometer based on 1) Criterion 1: systolic blood pressure (SBP) = -0.034 (SD 5.24) and diastolic blood pressure (DBP) = -0.65 (SD 4.66) mm Hg; and 2) Criterion 2: SBPs = -0.034 (SD 4.18) and DBPs = -0.65 (SD 3.94) mm Hg. Factors of sociodemographic characteristics, anthropometric measurements, cardiovascular comorbidities, and wrist hair density were not significantly associated with the mean BP differences.

Conclusions

HUAWEI WATCH D fulfilled criteria 1 and 2 of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) guidelines. It can be recommended for clinical use across a wider population. The rich data from real-time BP measurements in concurrent with other health-related parameters recorded by the smartwatch wearable offer opportunities to drive precision medicine in tackling therapeutic inertia by personalizing BP control regimen.

Informations de copyright

Copyright 2023, Lee et al.

Déclaration de conflit d'intérêts

LWL received funding from Huawei Technologies (Malaysia).