Clinical accuracy of the Omron M3 Comfort^® and the Omron Evolv^® for self-blood pressure measurements in pregnancy and pre-eclampsia – validation according to the Universal Standard Protocol

Abstract

BackgroundElectronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and in special populations such as pregnancy.ObjectiveTo evaluate the accuracy of the Omron Evolv® (HEM-7600T-E) and the Omron M3 Comfort® (HEM-7134-E) devices in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol.MethodsBoth devices, the Evolv and the M3 Comfort, measure BP at the brachial level using the oscillometric method. The study was performed according to the recently published protocol, the so-called “modified Advancement of Medical Instrumentation (AAMI)/British Hypertension Society (BHS)/European Society of Hypertension (ESH) protocol” or the “Universal Standard Protocol.” Validation of each device included 45 pregnant women in the second and third gestational trimester of whom 15 had pre-eclampsia, 15 had gestational hypertension and 15 were normotensives. BP differences between the observer and the device BP values were classified into three categories (≤5, ≤10, and ≤15 mmHg) and the mean BP differences (test vs reference) and its SD were calculated.ResultsBoth devices, the Evolv and the M3 Comfort, achieved a grade A/A in both pregnancy and pre-eclampsia. The mean difference (SD) between the mercury standard and the device BP values in pregnancy were: 1) for the Evolv of −0.7±2.3 mmHg for systolic blood pressure (SBP) and −0.1±1.8 mmHg for diastolic blood pressure (DBP); 2) for the M3 Comfort of −1.6±2.8 mmHg for SBP and −0.1±2.3 mmHg for DBP.ConclusionBoth devices, the Evolv and the M3 Comfort, achieved a grade A/A for both SBP and DBP and fulfill the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, these two devices can be recommended for home BP measurements in this specific population.

Wearable device signals and home blood pressure data across age, sex, race, ethnicity, and clinical phenotypes in the Michigan Predictive Activity & Clinical Trajectories in Health (MIPACT) study: a prospective, community-based observational study

“…The accuracy of the Apple Watch and Omron Evolv Wireless Blood Pressure Monitor has been demonstrated previously. [8][9][10][11][12] Large-scale observational studies have shown that the MyDataHelps app is user friendly and enables high-fidelity data collection. [13][14][15] Participants were asked to wear their watch for 12 h per day or longer and to do daily or weekly tasks, including home blood pressure measurement.…”

“…Systolic blood pressure, mm Hg 129 ( 8) 125 ( 9) 129 ( 11) 126 ( 10) 130 ( 10) 128 (10) Diastolic blood pressure, mm Hg 82 ( 8) 82 ( 7) 83 ( 7) 81 ( 7) 79 ( 6) 76 (7) Heart rate, bpm 77 ( 8) 82 ( 7) 76 ( 8) 78 ( 8) 72 ( 8) 76 (7) Resting heart rate, bpm 63 ( 8) 67 ( 8) 63 ( 9) 66 ( 8) 59 ( 8) 63 (7) Walking heart rate, bpm 97 ( 9) 104 ( 9) 93 ( 10) 97 ( 9) 88 ( 9) 93 ( 9)…”

Association between Periodontitis and High Blood Pressure: Results from the Study of Periodontal Health in Almada-Seixal (SoPHiAS)

“…Using an automated sphygmomanometer device (Omron M3 Comfort ® ), BP readings were carried as a one-single measure [33]. Patients avoided caffeine, exercise and smoking in the 30 min prior to BP measurement.…”

Effects of slow and deep breathing on reducing obstetric intervention in women with pregnancy-induced hypertension: a feasibility study protocol

“…The women will also self-monitor BP at home using an automated BP monitor (Omron M3 Comfort, Intelli Wrap Cuff). This model has been validated for use with pregnant women with high BP (35). They will be asked to take 1 measurement daily at a similar time of day, following 5 minutes of rest.…”