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Long-term accuracy and stability of blood pressure measurements from a smartwatch: Prospective validation study

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064211%3A_____%2F26%3AW0000025" target="_blank" >RIV/00064211:_____/26:W0000025 - isvavai.cz</a>

  • Result on the web

    <a href="https://oadoi.org/10.1177/20552076261415923" target="_blank" >https://oadoi.org/10.1177/20552076261415923</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1177/20552076261415923" target="_blank" >10.1177/20552076261415923</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Long-term accuracy and stability of blood pressure measurements from a smartwatch: Prospective validation study

  • Original language description

    Background Regular monitoring of blood pressure (BP) provides early detection of hypertension. Automated cuff-based oscillometric devices are commonly used for simplicity and reduced observer subjectivity. However, these devices can be uncomfortable, prompting the development of non-invasive, cuffless BP monitoring in smartwatches. Current validation standards, including ISO 81060-2:2018 and IEEE 1708TM-2019, specify accuracy criteria, yet most studies focus on short-term performance and do not address their long-term stability across the calibration period.Objective This prospective single-arm study aimed to assess the long-term accuracy and stability of BP measurements obtained from a smartwatch throughout its recommended calibration interval.Methods Thirty-seven participants completed a 28-day protocol, consisting of an initial calibration on day 0 followed by 27 consecutive days of paired measurements of systolic BP (SBP) and diastolic BP (DBP). BP was simultaneously measured using a Samsung Galaxy Watch 5 and a validated reference sphygmomanometer Omron M4. Accuracy was assessed against ISO and IEEE standards, and the recalibration test consistent with European Society of Hypertension (ESH) guidelines was performed using the last three measurements before scheduled recalibration.Results The smartwatch met the accuracy criteria based on ISO and IEEE standards in all but one measure, with mean absolute differences, mean differences (MD), and standard deviations for SBP and DBP within acceptable limits. Bland-Altman analysis revealed negligible MD for SBP (-0.34 mmHg) and DBP (0.62 mmHg), with minimal drift over the calibration period (-0.19 mmHg for SBP and 1.02 mmHg for DBP). However, when reference BP was 10 mmHg away from the calibration point, MD was 3.4 mmHg for SBP and 5.1 mmHg for DBP.Conclusions The smartwatch demonstrated acceptable long-term stability and accuracy for BP monitoring and trend tracking. However, accuracy declined as values diverged from the calibration point. Cuff-based confirmation is advised when BP fluctuates substantially or when diagnostic or therapeutic decisions are planned.Trial Registration ClinicalTrials.gov NCT06098092

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30401 - Health-related biotechnology

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2026

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    DIGITAL HEALTH

  • ISSN

    2055-2076

  • e-ISSN

  • Volume of the periodical

    12

  • Issue of the periodical within the volume

    2026

  • Country of publishing house

    GB - UNITED KINGDOM

  • Number of pages

    14

  • Pages from-to

    -

  • UT code for WoS article

    001667414300001

  • EID of the result in the Scopus database