Jul 2026· Frontiers in Medical Technology· Vol 8· 0 citations· 24 references
Medicine
TL;DR
It is demonstrated that a training-phase evaluation of Type T mode continuous automated non-invasive sphygmomanometer repeated SBP, DBP, and MAP measurement of oCare™ BP100 in Type T mode are stable across various analysis periods and patients.
Abstract
Objective This study aimed to conduct a training-phase evaluation of a novel continuous automated non-invasive sphygmomanometer, oCare™ BP100, in intensive care unit (ICU) Taiwanese patients according to ISO 81060-3:2022 in Type T mode. The evaluation included stability testing and blood pressure change tracking. Methods A total of forty ICU patients were recruited from the National Taiwan University Hospital Hsin-Chu Branch. All enrolled patients had undergone unilateral radial artery catheterization in the forearm as part of routine clinical care. The catheter was connected to Philips patient monitors (Models: IntelliVue MX800 and X2) to obtain invasive blood pressure measurements for calibration purposes. Each subject underwent simultaneous monitoring with oCare™ BP100 sensors placed on the fingers of both hands. Paired measurements of the same side were further processed and followed ISO 81060-3:2022, for the defined Type T blood pressure monitor, the well-established stability method and the blood pressure change method were implemented and analyzed. Results The present study belongs to the training phase and therefore the study was not carried out completely according to the ISO 81060-3:2022 protocol, e.g., the distribution of gender and the eligible subject in BP change test not fulfilled. For all 6 analysis periods, for the corrected standard deviations of SBP, DBP, and MAP parameter defined ISO target thresholds (A) scorr ≤ 6 mmHg for each analysis period. In the Blood Pressure Change Test, at most 22 subjects the minimum requirement of 50 change points per subject, the for the change requirements were (B1) E¯50th≤25% and (B2) E¯85th≤50% error for blood pressure. Conclusion The present study demonstrated that a training-phase evaluation of Type T mode continuous automated non-invasive sphygmomanometer repeated SBP, DBP, and MAP measurement of oCare™ BP100 in Type T mode are stable across various analysis periods and patients. oCare™ BP100 in Type T Mode can track blood pressure changes in ICU patients during different activities. Even with the absence of females in the sex ratio and an insufficient number of participants in the blood pressure change test, the exploratory study still showed training-phase results that were within ISO target thresholds, full ISO validation remains to be completed.
The iHealth Track KN-550BT upper-arm oscillometric upper-arm automated BP monitor fully complies with the requirements of ISO 81060-2:2018+AMD1:2020/AMD2:2024, and can be recommended for clinical application and home self-BP measurement among pregnant patients.
Ying Zhang, Dongmei Wang, Chunmei Cui et al.· Blood Pressure Monitoring· 0 citations
The Arm-Type Fully Automatic Blood Pressure Monitor (model: DBP-62F4B-P) meets the accuracy and consistency requirements of the AAMI/ESH/ISO standard for SBP and DBP measurement in adolescents and adults with arm circumference 22.0-42.0 cm and is suitable for home use based on its design features and validation performance.
This represents the first evaluation of a Device Type 3 cuffless blood pressure algorithm (automated, wearable, demographic-calibrated, not at heart level) meeting ESH awake/asleep test criteria, suggesting Alysis-001's potential as a clinically viable alternative for ambulatory blood pressure monitoring in hypertensive patients.
Aim. To evaluate the effectiveness of a developed remote monitoring system for patients with chronic heart failure (CHF) based on single-channel electrocardiogram (ECG) analysis using machine learning models.
Design. A multicenter, randomized, comparative study with consecutive patient enrollment.
Materials and methods. The study included 251 patients hospitalized for decompensated CHF at the Cardiology Clinic of the Sechenov First Moscow State Medical University (Sechenov University) and the City Clinical Hospital No. 1 named after N.I. Pirogov. All patients underwent standard clinical, laboratory, and echocardiographic examinations. Before discharge, patients were randomized into two groups. In Group 1 (daily remote monitoring, n = 110), patients were monitored remotely using a personal recorder for complaints, body weight, blood pressure, and single-channel ECG parameters (including analysis of systolic and diastolic myocardial dysfunction). Patients in Group 2 (n = 141) were followed up as outpatients as part of standard practice; their condition was assessed after 4–6 months via telephone survey. The average follow-up period was 4.8 months.
Results. In the remote monitoring group, 118 remote and 41 in-person consultations were conducted; therapy adjustments were made 122 times in 78 patients. Patients in this group showed a statistically significant reduction in the number of hospitalizations due to CHF decompensation (p = 0.025), atrial fibrillation paroxysms (p = 0.04), and blood pressure destabilization (p = 0.002), as well as in the incidence of stroke (p = 0.005) and hypertensive crises (p = 0.04). A positive trend toward a decrease in cardiovascular mortality was noted (p = 0.12).
Conclusion. Remote monitoring of patients with CHF using artificial intelligence algorithms has proven its high clinical efficacy, significantly reducing the incidence of complications and readmissions for cardiovascular pathology.
Keywords: heart failure, remote monitoring, machine learning, single-channel electrocardiogram, cardiovascular mortality, hospitalization, myocardial dysfunction
P. Chomakhidze, D. Mesitskaya, R. R. Galimova et al.· Doctor Ru· 0 citations
Aim. To evaluate the effectiveness of outpatient monitoring of patients with arterial hypertension using an automatic remote blood pressure (BP) monitoring system and compare it with the effectiveness of traditional self-monitoring of BP in a metropolitan urban clinic.
Design. Prospective, interventional, randomized, open-label study.
Materials and methods. We recruited 60 patients (40% men, aged 25–65 years, median age 59.5 [48.5; 69.0] years) undergoing outpatient monitoring with a diagnosis of stage 1 or 2 essential (primary) hypertension. Participants were randomized into two groups using the envelope randomization method. The main group consisted of 30 people who were given certified automatic tonometers for measuring BP with remote online data transmission to the physician's computer. The control group included 30 patients who measured their blood pressure at home using their own automatic tonometers and completed self-monitoring diaries. Pulse rate was recorded two or three times, simultaneously with blood pressure measurements. All patients underwent a comprehensive examination, including a general clinical and biochemical blood test, and a urinalysis. Adherence to therapy was assessed using the Morisky — Greene scale, and anxiety and depression were assessed using the Hospital Anxiety and Depression Scale. The observation period was 6 months, during which two follow-up visits were conducted: on day 3 and at 180 ± 2 days, and a phone call at 90 ± 2 days.
Results. When assessing the dynamics of office BP, a statistically significant decrease in systolic and diastolic BP was found in the main and in the control groups (for all indicators p < 0.001) at visit 3 compared with the values at visit 1. By visit 3, in the main group, target values of outpatient BP were achieved in 26 (86.7%) patients, while in the control group — in 23 (76.7%) (p = 0.011). In the main group, the number of patients prescribed drugs in the form of fixed-dose combinations increased from 15 (50%) to 22 (73.3%) people (p < 0.001), in the control group — from 15 (50%) to 19 (63.3%) people (p < 0.001). An intergroup comparison revealed a statistically significant difference in the frequency of taking fixed-dose combinations of AHT agents at visit 3: 22 (73.3%) patients in the main group and 19 (63.3%) patients in the control group (p = 0.005). In patients in the main group, the severity of anxiety (p = 0.016) and depression (p = 0.014) decreased significantly from visit 1 to visit 3, while in the control group — only depression (p = 0.036). According to the Morisky — Greene scale, adherence to therapy in the main group increased statistically significantly (p = 0.007). Improved adherence to treatment was noted in 29 (96.7%) patients. In an intergroup comparison at visit 3, the number of points on the Morisky — Greene scale was statistically significantly lower in the main group than in the control group: 1 [0; 1] versus 3 [2; 3] points (p = 0.001).
Conclusion. Remote BP monitoring is a promising method that can significantly improve hypertension control in real-life clinical practice in patients aged 25–65 years.
Keywords: telemedicine, telemonitoring, remote monitoring of blood pressure, dispensary observation, arterial hypertension
O. Tsygankova, O. Timoshchenko, L. D. Latyntseva et al.· Doctor Ru· 0 citations
To explore the effects of personalized exercise prescriptions and 5G‐supported remote rehabilitation on adherence, lipid levels, cardiorespiratory fitness, and vascular function in patients after percutaneous coronary intervention (PCI), as well as to conduct a correlation analysis. This study employed a randomized, prospective clinical trial design, enrolling 155 patients at the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from September 2024 to September 2025. Patients were divided into a conventional group (n = 81) and a 5G remote monitoring group (n = 74), with the intervention lasting for 12 months. The 5G group utilized wearable devices for real‐time monitoring. There were no statistically significant differences in baseline characteristics between the two groups (p > 0.05), indicating comparability. Correlation analysis revealed strong positive correlations among peak oxygen uptake (peak VO2), peak work rate (Peak WR), oxygen uptake at anaerobic threshold (VO2 at AT), and peak metabolic equivalents (peak METs) in the overall observed parameters (r > 0.8); peak VO2 was positively correlated with left ventricular ejection fraction (LVEF) (r > 0.4). Vascular function showed positive correlations between Flow‐Mediated Slowing of pulse wave velocity (FMS) and left atrial diameter (LA), the ratio of early mitral inflow velocity to mitral annulus velocity (E/e'), and left ventricular end‐diastolic diameter (LVEDD), while carotid‐femoral pulse wave velocity (cf‐PWV) was negatively correlated with CPET parameters, and there was a strong positive correlation between bilateral ankle‐brachial index (ABI). The Gini index ranking indicated that cf‐PWV, LVEF, age, peak VO2, and Peak WR had the most significant impact on FMS. After a 12‐month follow‐up, the improvements in LDL‐C in the traditional group were superior to those in the 5G remote monitoring group (p < 0.05). However, the 5G remote monitoring group showed significant improvements in LVEF, E/e', LA, LVEDD, FMS, and cf‐PWV compared to the traditional group (all p < 0.05). Factor analysis indicated that in the 5G remote monitoring group, VO2 at AT and Peak WR were the main positively correlated influencing factors for FMS (p < 0.05), while Peak WR was a key factor affecting cf‐PWV in relation to LDL‐C (p < 0.05). The integrated remote comprehensive rehabilitation program established through 5G wearable real‐time monitoring significantly enhanced the rehabilitation compliance and exercise endurance of PCI patients. FMS and cf‐PWV can intuitively reflect the vascular improvement effects brought about by multidimensional interventions and serve as core indicators for assessing the recovery of vascular injury after PCI. Although literature supports that 5G may confer benefits through the shear stress–eNOS–NO and ox‐LDL–MMP pathways, this study did not measure the relevant biomarkers; thus, this mechanism remains hypothetical and requires validation in future research.
Yuping Long, Tao Xu, Zong-Hua Xiong et al.· The FASEB Journal· 0 citations