Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor
NCT ID: NCT07297277
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
85 participants
OBSERVATIONAL
2025-07-15
2027-10-31
Brief Summary
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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.
Detailed Description
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With an increased prevalence of hypertension, causing approximately 9.4 million deaths per year worldwide, the demand for non-invasive arterial pressure monitoring devices has also increased to help patients manage blood pressure (BP). Traditionally, non-invasive BP measurement techniques include auscultatory and oscillometric devices, however, these can present with several limitations in terms of cuff size, instruments' bulky volume, and discomfort caused by external pressure. Advancements in technology has meant that wearable devices are becoming readily available for various health related measurements, including BP. The HUAWEI Technology have developed an automated oscillometric wearable wrist watch-type device for BP measurement that has recently been validated in accordance with the AAMI/ESH/ISO Universal Standard requirements and can be recommended for self-measurement. However, while this research concluded the HUAWEI watch fulfilled the requirements for self-measurement in the general population, it should be noted that the study was conducted within the Chinese population only. Consequently, to ensure generalisation to a wider population, it is important to examine the HUAWEI watch validity within differing populations. Therefore, the aim of this study will be to explore if the HUAWEI D2 watch-type blood pressure monitor meets the AAMI/ESH/ISO Universal Standard requirements in differing populations.
Conditions
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Keywords
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Written informed consent provided
Exclusion Criteria
* Peripheral Arterial Disease
* Known Heart Disease
* Pregnancy
* Diagnosis of Secondary Hypertension
18 Years
ALL
Yes
Sponsors
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Northumbria University
OTHER
Responsible Party
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Principal Investigators
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Gabriel Cucato, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Locations
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Northumbria University
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Helen Llewellyn, MSc
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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10374
Identifier Type: -
Identifier Source: org_study_id