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Background  Stroke, as a leading cause of death around the globe, has become a heavy burden on our society. Studies show that stroke can be predicted and prevented if a person’s blood pressure (BP) status is appropriately monitored via an ambulatory blood pressure monitor (ABPM) system. However, currently there exists no efficient and user-friendly ABPM system to provide early warning for stroke risk in real-time. Moreover, most existing ABPM devices measure BP during the deflation of the cuff, which fails to reflect blood pressure accurately.    Objective  In this study, we sought to develop a new ABPM mobile health (mHealth) system that was capable of monitoring blood pressure during inflation and could detect early stroke-risk signals in real-time.    Methods  We designed an ABPM mHealth system that is based on mobile network infrastructure and mobile apps. The proposed system contains two major parts: a new ABPM device in which an inflation-type BP measurement algorithm is embedded, and an abnormal blood pressure data analysis algorithm for stroke-risk prediction services at our health data service center. For evaluation, the ABPM device was first tested using simulated signals and compared with the gold standard of a mercury sphygmomanometer. Then, the performance of our proposed mHealth system was evaluated in an observational study.    Results  The results are presented in two main parts: the device test and the longitudinal observational studies of the presented system. The average measurement error of the new ABPM device with the inflation-type algorithm was less than 0.55 mmHg compared to a reference device using simulated signals. Moreover, the results of correlation coefficients and agreement analyses show that there is a strong linear correlation between our device and the standard mercury sphygmomanometer. In the case of the system observational study, we collected a data set with 88 features, including real-time data, user information, and user records. Our abnormal blood pressure data analysis algorithm achieved the best performance, with an area under the curve of 0.904 for the low risk level, 0.756 for the caution risk level, and 0.912 for the high-risk level. Our system enables a patient to be aware of their risk in real-time, which improves medication adherence with risk self-management.    Conclusions  To our knowledge, this device is the first ABPM device that measures blood pressure during the inflation process and has obtained a government medical license. Device tests and longitudinal observational studies were conducted in Peking University hospitals, and they showed the device’s high accuracy for BP measurements, its efficiency in detecting early signs of stroke, and its efficiency at providing an early warning for stroke risk.

An Ambulatory Blood Pressure Monitor Mobile Health System for Early Warning for Stroke Risk: Longitudinal Observational Study