Compare the HUAWEI D2 wristwatch blood pressure readings to international BP standard requirements
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
This project will test whether the HUAWEI D2 wrist blood pressure watch gives accurate readings that match international BP standards in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 85 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northumbria University Academic / other |
| Locations | 1 site (Newcastle upon Tyne) |
| Trial ID | NCT07297277 on ClinicalTrials.gov |
What this trial studies
This observational validation compares blood pressure measurements from the HUAWEI D2 watch with the AAMI/ESH/ISO universal standard requirements using standard validation procedures. The device has passed prior testing in China, and investigators will collect measurements from adult participants at a single site in the UK to assess agreement across a different population. Adults over 18 who can give informed consent and do not have arrhythmias, peripheral arterial disease, known heart disease, pregnancy, or secondary hypertension are eligible. Data will be analysed to determine whether the watch meets the predefined accuracy criteria from the international protocol.
Who should consider this trial
Good fit: Ideal candidates are adults aged over 18 without arrhythmias, peripheral arterial disease, known heart disease, pregnancy, or secondary hypertension who can attend the testing site and provide informed consent.
Not a fit: People with cardiac arrhythmias, peripheral arterial disease, known heart disease, pregnancy, or secondary hypertension are unlikely to benefit because the device is not validated for those conditions.
Why it matters
Potential benefit: If successful, the watch could offer a convenient, validated option for at-home blood pressure monitoring across more populations.
How similar studies have performed: Similar AAMI/ESH/ISO validation protocols have been used before and the HUAWEI D2 passed testing in China, though wrist oscillometric devices have shown variable accuracy across different populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Written informed consent provided Exclusion Criteria: * Cardiac Arrythmias * Peripheral Arterial Disease * Known Heart Disease * Pregnancy * Diagnosis of Secondary Hypertension
Where this trial is running
Newcastle upon Tyne
- Northumbria University — Newcastle upon Tyne, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gabriel Cucato, PhD — Northumbria University
- Study coordinator: Helen Llewellyn, MSc
- Email: helen.llewellyn@northumbria.ac.uk
- Phone: +447949026070
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.