Evaluating Agreement Between AAMI/ESH/ISO Standards and the HUAWEI D2 Wrist Blood Pressure Monitor in a Cross-Sectional Observational Study

What this Trial Is About

Accurate blood pressure measurement is crucial for diagnosing and managing high blood pressure, a major health problem causing millions of deaths worldwide each year. Traditional blood pressure monitors with arm cuffs can be bulky and uncomfortable, leading to increased interest in wearable devices like smartwatches. The HUAWEI D2 watch-type wrist blood pressure monitor has been developed and tested to meet international standards, but prior testing was only conducted in the Chinese population, so this study aims to evaluate its accuracy in people from other countries and ethnic backgrounds. Participants will have their blood pressure measured using both the standard upper arm cuff method and the HUAWEI D2 wristwatch on the same arm. Measurements will follow the AAMI/ESH/ISO validation guidelines, including a sequence of reference and test device readings with rest periods in between. Observers will take simultaneous reference measurements while blinded to each other's results to ensure accuracy. If readings differ significantly, additional measurements will be taken. During the study, participants will be seated quietly for at least five minutes before measurements. Researchers will compare blood pressure readings from both methods to assess the agreement between the traditional and wearable devices. The study will involve baseline and validation blood pressure measurements to evaluate the watch's accuracy. This observational study is expected to continue until October 2027, and participants will be monitored under these standardized procedures throughout their involvement.

Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor