Validation of a Remote Monitoring Blood Pressure Device in a General Population Cohort

Abstract Background Remote blood pressure (BP) monitoring has emerged as a promising solution to overcome barriers to hypertension care access, yet validation of devices is lacking. Methods We conducted the validation of the Ideal Life BP Manager™ BP device, a remote BP monitoring device, using the AAMI/ESH/ISO protocol. From June 2021 to May 2022, participants were screened and systolic BP (SBP) and diastolic BP (DBP) measurements were conducted by trained staff using the Ideal Life BP Manager™ and a mercury sphygmomanometer. Statistical analyses were performed to assess agreement of SBP and DBP. Results Of the 90 individuals screened, 79 were included, with a mean age of 50.9 years (standard deviation (SD) 15.6) and the majority being female (68.8%). The mean ± SD differences between the Ideal Life BP Manager™ and mercury sphygmomanometer measurements were 2.20 ± 7.37 mmHg for SBP and 1.49 ± 7.31 mmHg for DBP, satisfying AAMI/ESH/ISO protocol criterion 1. Criterion 2 was also met, with participant-level standard deviations of the mean paired differences (6.54 mmHg for SBP, 6.30 mmHg for DBP) falling below the protocol-specified thresholds. Bland-Altman plots demonstrated limits of agreement of –12.0 to 16.9 mmHg for systolic blood pressure and –12.8 to 15.9 mmHg for diastolic blood pressure. Conclusion The Ideal Life BP Manager™ met the AAMI/ESH/ISO validation criteria.