J Korean Med Sci.  2024 Jan;39(2):e18. 10.3346/jkms.2024.39.e18.

First-in-Human Study for Evaluating the Accuracy of Smart Ring Based Cuffless Blood Pressure Measurement

• Kim J
• Chang SA
• Park SW

• KMID: 2550799
• DOI: http://doi.org/10.3346/jkms.2024.39.e18

Abstract

Background
Recently, a ring-type cuffless blood pressure (BP) measuring device has been developed. This study was a prospective, single arm, first-in-human pivotal trial to evaluate accuracy of BP measurement by the new device.
Methods
The ring-type smart wearable monitoring device measures photoplethysmography signals from the proximal phalanx and transmits the data wirelessly to a connected smartphone. For the BP comparison, a cuff was worn on the arm to check the reference BP by auscultatory method, while the test device was worn on the finger of the opposite arm to measure BP simultaneously. Measurements were repeated for up to three sets each on the left and right arms. The primary outcome measure was mean difference and standard deviation of BP differences between the test device and the reference readings.
Results
We obtained 526 sets of systolic BP (SBP) and 513 sets of diastolic BP (DBP) from 89 subjects, with ranges of 80 to 175 mmHg and 43 to 122 mmHg for SBP and DBP, respectively. In sample-wise comparison, the mean difference between the test device and the reference was 0.16 ± 5.90 mmHg (95% limits of agreement [LOA], −11.41, 11.72) in SBP and −0.07 ± 4.68 (95% LOA, −9.26, 9.10) in DBP. The test device showed a strong correlation with the reference for SBP (r = 0.94, P < 0.001) and DBP (r = 0.95, P < 0.001). There were consistent results in subject-wise comparison.
Conclusion
The new ring-type BP measuring device showed a good correlation for SBP and DBP with minimal bias compared with an auscultatory method.

Keyword

Blood Pressure Monitors; Photoplethysmography; Wearable Electronic Devices

Figure

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  Fig. 1 The ring-type BP measuring device. The ring-type smart wearable BP monitoring device measures and analyzes PPG signals from the proximal phalanx and transmits the data wirelessly to a connected smartphone.LED = light emitting diode, PD = photo diode, BP = blood pressure, PPG = photoplethysmography, SYS = systolic, DIA = diastolic.

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  Fig. 2 Study flow.BP = blood pressure, SBP = systolic blood pressure, DBP = diastolic blood pressure, FA = full analysis, PP = per-protocol.aThese criteria are based on the International Organization for Standardization 81060-2.

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  Fig. 3 Correlation of blood pressure measures between the ring-type device and auscultatory method. (A) Correlation for SBP between the test device and reference, (B) correlation for DBP between the test device and reference, (C) Bland-Altman plot for SBP between the methods, (D) Bland-Altman plot for DBP between the methods.SBP = systolic blood pressure, DBP = diastolic blood pressure, LOA = limits of agreement, SD = standard deviation.

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