Blood Pressure MonitoringNCT07297277
Evaluating the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor
An observational study of Blood Pressure Monitoring, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Monitoring
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age >18 years
- Written informed consent provided
Who cannot join
- Cardiac Arrythmias
- Peripheral Arterial Disease
- Known Heart Disease
- Pregnancy
- Diagnosis of Secondary Hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gabriel Cucato, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Northumbria University
Newcastle upon Tyne, NE1 8ST
Helen Llewellyn, MSc, +447949026070, helen.llewellyn@northumbria.ac.uk
About this study
Official title: An Observational Cross-Sectional Blind Comparison to Evaluate the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor
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.
Read the detailed description
Accurate measurement of blood pressure (BP) is a necessity for the reliable diagnosis and proficient management of hypertension. However, validation of blood pressure monitoring devices only began in the 1980's, followed by a series of ad-hoc validation protocols from differing organisations such as the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society (BHS), the German Hypertension League, the European Society of Hypertension (ESH), and the International Organisation for Standardization (ISO) over the subsequent three decades. The need for a universally acceptable protocol was recognised and members of the AAMI, ESH, and ISO committees collaborated to re-examine the aspects of validation to achieve a consensus on an optimal validation standard.
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
- Blood Pressure Monitoring
- Keywords
- Blood Pressure, Auscultatory, Oscillometric, Watch Type Monitor, Validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Jul 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood Pressure MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Cucato, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297277
- Sponsor's protocol ID
- 10374
- Status last verified
- Oct 2025
- First submitted
- 9 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36960816Zhang 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.
PubMed 35687029O'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.
PubMed 18277314Stergiou 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.
PubMed 30702492
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cross-Sectional Blind Comparison to Evaluate the Level of Agreement Between AAMI/ESH/ISO Universal Standard Requirements and the HUAWEI D2 Watch-Type Wrist Blood Pressure Monitor
- ClinicalTrials.gov ID
- NCT07297277
- Acronym / sponsor ID
- 10374
- Conditions
- Blood Pressure Monitoring
- Keywords
- Blood Pressure, Auscultatory, Oscillometric, Watch Type Monitor, Validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Accurate measurement of blood pressure (BP) is a necessity for the reliable diagnosis and proficient management of hypertension. However, validation of blood pressure monitoring devices only began in the 1980's, followed by a series of ad-hoc validation protocols from differing organisations such as the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society (BHS), the German Hypertension League, the European Society of Hypertension (ESH), and the International Organisation for Standardization (ISO) over the subsequent three decades. The need for a universally acceptable protocol was recognised and members of the AAMI, ESH, and ISO committees collaborated to re-examine the aspects of validation to achieve a consensus on an optimal validation standard.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age >18 years
- Written informed consent provided
Key exclusion criteria (5 listed)
- Cardiac Arrythmias
- Peripheral Arterial Disease
- Known Heart Disease
- Pregnancy
- Diagnosis of Secondary Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of Agreement Between Auscultatory and HUAWEI D2 Watch Blood Pressure Measurements.
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 36960816Min 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.
- Background: PubMed 35687029Zhang 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.
- Background: PubMed 18277314O'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.
- Background: PubMed 30702492Stergiou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel Cucato, PhD contact
Gabriel Cucato, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Monitoring, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Llewellyn, MSc (+447949026070, helen.llewellyn@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Agreement Between Auscultatory and HUAWEI D2 Watch Blood Pressure Measurements. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07297277, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.