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

This study is looking at how well a new smartwatch from HUAWEI measures blood pressure. High blood pressure is a big health concern, and checking it at home is very helpful. Traditional blood pressure monitors used on the arm can be bulky and uncomfortable, so new, easy-to-use devices like smartwatches are being developed. This HUAWEI watch has already been tested and approved in China to meet top international standards for accuracy. However, scientists need to find out if it works just as well for people from other countries and different backgrounds. This research aims to see if this watch can be a reliable tool for anyone to check their blood pressure at home.

At a glance

Status
Recruiting
Sponsor
Northumbria University
Enrolment target
85
Start
15 Jul 2025
Estimated completion
01 Oct 2027

What is this study about?

Keeping an eye on your blood pressure is really important, especially if you have, or are at risk of, high blood pressure. High blood pressure can lead to serious health problems and affects millions of people globally. Being able to check your blood pressure regularly at home can help you and your doctor manage your health better.

Traditionally, blood pressure machines use a cuff that inflates around your arm. While these are effective, they can sometimes be a bit uncomfortable, bulky, and not always easy to use. This has led to a demand for new, simpler ways to check blood pressure. Modern technology has allowed companies like HUAWEI to create smartwatches that can measure blood pressure from your wrist. These devices are much more convenient and easier to use.

HUAWEI has developed a smartwatch that has been put through strict tests, following international guidelines, and it was found to be accurate enough for people to use at home. However, these initial tests were only done on people living in China. To make sure this watch is truly reliable for everyone, no matter where they live or their background, this new study will test the HUAWEI watch on a wider range of people. The main goal is to see if it works just as well for people in other countries too.

Key takeaways

  • The study assesses a HUAWEI smartwatch for accurate blood pressure measurement.
  • It aims to confirm the watch's accuracy for diverse global populations.
  • Accurate home blood pressure monitoring is crucial for managing hypertension.
  • The watch already meets international standards, but only tested in China so far.
  • Study participants must be over 18 and meet specific health criteria.

Who may be eligible?

To join this study, you need to be at least 18 years old and agree to take part by signing a consent form. This tells us you understand what the study involves and agree to participate.

There are certain health conditions that would prevent you from taking part. For example, if you have irregular heartbeats (like some arrhythmias), problems with blood flow in your arms or legs (peripheral arterial disease), or any known serious heart disease, you wouldn't be able to join. We also can't include pregnant women or people who have high blood pressure due to another underlying medical condition.

These rules are in place to make sure the study results are clear and that it's safe for everyone involved. If you're not sure whether you fit these criteria, your doctor can help you understand.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have a clear understanding of the study and are willing to sign consent?
  3. Are you currently pregnant?
  4. Do you have any irregular heartbeats or known heart disease?
  5. Do you have any problems with blood flow in your arms or legs?
  6. Has your high blood pressure been caused by another medical condition?
Answer every question to see your result.

What does participation involve?

The information provided does not detail the specific steps of participation, such as how many visits would be required, what assessments would be done, if medication would be given, or the total duration of follow-up. It states that the study is evaluating the agreement between the HUAWEI D2 Watch and standard requirements. This typically involves comparing readings from the smartwatch with those from a traditional, validated blood pressure monitor during one or more study visits. More information about the exact procedure would be provided by the study team if you were to consider joining.

Potential risks and benefits

Participating in this study could help us understand if new smartwatch technology can reliably measure blood pressure for a wider range of people. This could lead to more convenient ways for people to monitor their health. There are typically very few risks in studies like this, as it mainly involves taking blood pressure measurements, which are generally safe procedures. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Northumbria University
    Verified postcode
    Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is the study trying to find out?

The study wants to see if a HUAWEI smartwatch accurately measures blood pressure in people outside of China, ensuring it works for everyone.

Why is it important to check blood pressure at home?

Checking your blood pressure at home helps you and your doctor track your health, manage high blood pressure, and make better treatment choices.

Is the HUAWEI watch already approved for use?

Yes, the watch passed initial tests and was approved for self-measurement in China, but this study checks its accuracy for a wider group of people.

Who can't join this study?

People under 18, pregnant women, or those with certain heart conditions or blood vessel problems cannot take part.

Will taking part affect my current medical treatment?

No, taking part in this study should not affect your existing medical care or treatment plan.

How to find out more

Helen Llewellyn, MSc

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Evaluating the Level of Agreement Between AAMI/ESH/ISO Unive…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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