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<p>We evaluated the accuracy of a ring-type cuffless BP device (CART BP Pro) in detecting awake–asleep BP changes compared to conventional 24-h ambulatory BP monitoring (ABPM), following the validation protocol recommended by the European Society of Hypertension (ESH). Among 84 recruited patients, 35 were selected to satisfy ESH recommendations: 30% (<i>n</i> = 11) with systolic BP (SBP) ≥ 130 mmHg and diastolic BP (DBP) ≥ 80 mmHg and 30% (<i>n</i> = 11) with SBP &lt; 120 mmHg and DBP &lt; 70 mmHg. The remaining 40% (<i>n</i> = 13) were included sequentially based on recruitment order. CART BP Pro was calibrated at least one day prior to simultaneous monitoring with ABPM. Participants simultaneously wore both devices on the non-dominant arm for 24 h. Mean SBP/DBP values and awake–asleep BP changes were compared. Awake–asleep SBP/DBP changes were 15.61 ± 8.74/11.35 ± 6.22 mmHg (ABPM) and 13.87 ± 9.04/11.44 ± 8.62 mmHg (CART BP Pro). Differences in&#xa0;mean awake–asleep BP changes were −1.74 ± 6.47 mmHg (SBP) and 0.08 ± 5.84 mmHg (DBP). Correlation analysis showed clinically significant correlation for both SBP and DBP changes (<i>r</i> = 0.736, <i>p</i> &lt; 0.01). Bland–Altman plots showed acceptable agreement with a mean difference and 95% limits of agreement of −1.74 (−14.42, 10.94) mmHg for SBP and 0.08 (−11.37, 11.53) mmHg for DBP. For four-category dipping classification, CART BP Pro showed moderate agreement with ABPM (weighted κ = 0.58). In conclusion, CART BP Pro showed a meaningful level of agreement with ABPM in detecting awake–asleep BP changes. As this addressed only the awake/asleep test of the ESH protocol, the device cannot yet replace conventional 24-h ABPM pending completion of the remaining validation tests.</p><p></p>

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Validation of ring-type cuffless blood pressure (BP) monitoring device for detecting awake-asleep BP variations compared to ambulatory BP monitoring device

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月5日

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  • Seung-Mok Lee,
  • Hyuktae Kwon,
  • Belong Cho,
  • Jin Ho Park,
  • Sang-Hoon Na,
  • Seung-Pyo Lee,
  • Hae-Young Lee

摘要

We evaluated the accuracy of a ring-type cuffless BP device (CART BP Pro) in detecting awake–asleep BP changes compared to conventional 24-h ambulatory BP monitoring (ABPM), following the validation protocol recommended by the European Society of Hypertension (ESH). Among 84 recruited patients, 35 were selected to satisfy ESH recommendations: 30% (n = 11) with systolic BP (SBP) ≥ 130 mmHg and diastolic BP (DBP) ≥ 80 mmHg and 30% (n = 11) with SBP < 120 mmHg and DBP < 70 mmHg. The remaining 40% (n = 13) were included sequentially based on recruitment order. CART BP Pro was calibrated at least one day prior to simultaneous monitoring with ABPM. Participants simultaneously wore both devices on the non-dominant arm for 24 h. Mean SBP/DBP values and awake–asleep BP changes were compared. Awake–asleep SBP/DBP changes were 15.61 ± 8.74/11.35 ± 6.22 mmHg (ABPM) and 13.87 ± 9.04/11.44 ± 8.62 mmHg (CART BP Pro). Differences in mean awake–asleep BP changes were −1.74 ± 6.47 mmHg (SBP) and 0.08 ± 5.84 mmHg (DBP). Correlation analysis showed clinically significant correlation for both SBP and DBP changes (r = 0.736, p < 0.01). Bland–Altman plots showed acceptable agreement with a mean difference and 95% limits of agreement of −1.74 (−14.42, 10.94) mmHg for SBP and 0.08 (−11.37, 11.53) mmHg for DBP. For four-category dipping classification, CART BP Pro showed moderate agreement with ABPM (weighted κ = 0.58). In conclusion, CART BP Pro showed a meaningful level of agreement with ABPM in detecting awake–asleep BP changes. As this addressed only the awake/asleep test of the ESH protocol, the device cannot yet replace conventional 24-h ABPM pending completion of the remaining validation tests.