Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor

NCT07297277 | Recruiting

• 1 other identifier: 10374
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Getting an accurate blood pressure (BP) reading is essential for diagnosing high blood pressure and managing it effectively. High blood pressure is a major health problem, causing about 9.4 million deaths worldwide each year. More people need to monitor their BP at home, so there is greater demand for easy-to-use devices. Traditional BP monitors with arm cuffs can be bulky, uncomfortable, and awkward to use. Modern technology has made it possible to measure BP using wearable devices like smartwatches. HUAWEI has developed a wrist watch that can measure BP and has been tested to meet international standards. The watch passed these tests and was approved for people to use at home to check their own BP. However, the HUAWEI watch was only tested on people in China and the investigators need to know if it works for people from other countries and ethnic backgrounds.

Conditions

Blood Pressure Monitoring

Keywords

Blood Pressure; Auscultatory; Oscillometric; Watch Type Monitor; Validation

Outcome Measures

Primary Outcomes (1)

• Level of Agreement Between Auscultatory and HUAWEI D2 Watch Blood Pressure Measurements.

  The level of agreement between auscultatory systolic blood pressure (mmHg) and diastolic blood pressure (mmHg), and the HUAWEI D2 watch systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) measurements will be determined using the AAMI/ESH/ISO standard requirements for blood pressure device validation.

  Baseline

Study Arms (1)

Blood Pressure Measurements

All participants will have blood pressure measurements taken in accordance with the AAMI/ESH/ISO validation guidelines. Blood pressure cuff placed on upper arm and HAUWEI D2 watch placed on wrist of same arm. Participants seated in silence for at least 5 minutes. Two observers will undertake reference BP measurements simultaneously, blinded to each other's measurements. Same arm sequential method of testing with a 60-second rest between each measurement as follows: Baseline BP: reference BP measurement/test device BP measurement. Validation BP measurements for accuracy evaluation: 1st reference BP measurement;1st test device measurement; 2nd reference BP measurement; 2nd test device measurement; 3rd reference BP measurement; 3rd test device measurement; 4th reference BP measurement. If there is observer disagreement \>4mmHg in Systolic or Diastolic for reference BP then another pair of BP readings (test and reference) is taken up to a maximum of 8 pairs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A convenience sample with normotensive, pre-hypertensive, and hypertensive blood pressure values recruited from diverse ethnic populations in the Tyne and Wear area.

You may qualify if:

• Age \>18 years
• Written informed consent provided

You may not qualify if:

• Cardiac Arrythmias
• Peripheral Arterial Disease
• Known Heart Disease
• Pregnancy
• Diagnosis of Secondary Hypertension

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria University

Newcastle upon Tyne, NE1 8ST, United Kingdom

RECRUITING

Related Publications (4)

• Min S, Kim DH, Joe DJ, Kim BW, Jung YH, Lee JH, Lee BY, Doh I, An J, Youn YN, Joung B, Yoo CD, Ahn HS, Lee KJ. Clinical Validation of a Wearable Piezoelectric Blood-Pressure Sensor for Continuous Health Monitoring. Adv Mater. 2023 Jun;35(26):e2301627. doi: 10.1002/adma.202301627. Epub 2023 May 11.

  PMID: 36960816 BACKGROUND

• Zhang W, Zhou YN, Zhou Y, Wang JG. Validation of the watch-type HUAWEI WATCH D oscillometric wrist blood pressure monitor in adult Chinese. Blood Press Monit. 2022 Oct 1;27(5):353-356. doi: 10.1097/MBP.0000000000000608. Epub 2022 May 27.

  PMID: 35687029 BACKGROUND

• O'Brien E, Atkins N. State-of-the-market from the dableducational.org website. Blood Press Monit. 2007 Dec;12(6):377-9. doi: 10.1097/MBP.0b013e328244de94.

  PMID: 18277314 BACKGROUND

• Stergiou GS, Palatini P, Asmar R, Ioannidis JP, Kollias A, Lacy P, McManus RJ, Myers MG, Parati G, Shennan A, Wang J, O'Brien E; European Society of Hypertension Working Group on Blood Pressure Monitoring. Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO). J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039.

  PMID: 30702492 BACKGROUND

Study Officials

• Gabriel Cucato, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Llewellyn, MSc

CONTACT

+447949026070; helen.llewellyn@northumbria.ac.uk

Gabriel Cucato, PhD

CONTACT

gabriel.cucato@northumbria.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)