The first study comparing a wearable watch‐type blood pressure monitor with a conventional ambulatory blood pressure monitor on in‐office and out‐of‐office settings

Abstract

Wearable blood pressure (BP) monitoring devices which measure BP levels accurately both in and out of the office are valuable for hypertension management using digital technology. The authors have conducted the first comparison study of BPs measured by a recently developed wrist‐worn watch‐type oscillometric BP monitoring (WBPM) device, the “HeartGuide,” versus BPs measured by an ambulatory BP monitoring (ABPM) device, A&D TM‐2441, in the office (total of 4 readings alternately measured in the sitting position) and outside the office (30‐minutes interval measurements during daytime) in 50 consecutive patients (mean age 66.1 ± 10.8 years). The 2 BP monitoring devices were simultaneously worn on the same non‐dominant arm throughout the monitoring period. The mean difference (±SD) in systolic BPs (average of 2 readings) between WBPM and ABPM was 0.8 ± 12.8 mm Hg (P = .564) in the office and 3.2 ± 17.0 mm Hg (P < .001) outside the office. The proportion of differences that were within ±10 mm Hg was 58.7% in the office and 47.2% outside the office. In a mixed‐effects model analysis, the temporal trend in the difference between the out‐of‐office BPs measured by the two devices was not statistically significant. In conclusion, the difference between the WBPM and ABPM device was acceptable both in and out of the office.

Management of Hypertension in the Digital Era

“…Mean difference in SBP values (average of 2 readings) between the wearable HEM6410T devices and ABPM were 0.8±12.8 mm Hg in the office ( P =0.564) and 3.2±17.0 mm Hg outside the office ( P <0.001). 61 The proportion of differences that were within ±10 mm Hg was 58.7% in the office and 47.2% outside the office. In a mixed-effects model analysis, the temporal trend in the difference between the out-of-office BP values measured by the 2 devices was not statistically significant, indicating that there was an acceptable difference between the devices with respect to BP measurements.…”

“…In a mixed-effects model analysis, the temporal trend in the difference between the out-of-office BP values measured by the 2 devices was not statistically significant, indicating that there was an acceptable difference between the devices with respect to BP measurements. 61 An example of BP readings taken using the wearable device from the above study and ABPM is shown in Figure 4 . In another study, 24-hour BP measurements with the Model T2 wearable cuff-less device (TMART Technologies Ltd) in volunteers were within acceptable limits compared with ABPM, but BP measures showed systematic differences from HBPM determined over 7 days.…”

“…Smartphone apps are not yet useful in this setting, and none have currently been approved by the US FDA or European Commission. 113 However, recent research shows that wearable devices produced by companies specializing in BP monitoring technology are validated and reliable, 58 , 59 , 61 , 70 , 71 , 81 , 82 opening the way for their use in clinical practice. Wrist-worn wearable devices have also been shown to perform well against current out-of-office BP measurement approaches.…”

“…Wrist-worn wearable devices have also been shown to perform well against current out-of-office BP measurement approaches. 61 , 62 Initial data suggest that wearable technology could also be useful for detecting arrhythmias, such as atrial fibrillation. 114 …”

How to assess the agreement between different methods of blood pressure measurement?

“…Kario et al showed that the discrepancies in BP measurements using watch-type blood pressure monitor (WBPM) and ambulatory blood pressure monitor (ABPM) are clinically accepted. 1 Their conclusion is based on small differences between the mean values of multiple readings obtained with both devices. However, a comparison of two methods should take into account the variability in differences between measured parameters.…”