Aktiia G1 BP Monitor for High Blood Pressure

(WEARABLE-BP Trial)

This trial tests a new wearable blood pressure monitor, the Aktiia G1, to compare it with the traditional upper arm cuff used at home. The researchers aim to determine if this bracelet-style monitor provides better insights into controlling high blood pressure over six months. Individuals with uncontrolled high blood pressure (systolic blood pressure over 135 mm Hg) who take up to two blood pressure medications might be suitable for this study. Participants must be willing to wear the device, have a smartphone, and attend a couple of study visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance blood pressure management.

The trial does not specify if you need to stop taking your current medications. It mentions that participants can be on 0, 1, or 2 antihypertensive medications, so you may be able to continue your current treatment.

Research has shown that the Aktiia G1 BP monitor is generally safe for use. It carries a CE mark as a class IIa medical device under the EU's Medical Device Regulation, indicating it meets safety and effectiveness standards. Studies have found that the Aktiia G1 provides accurate blood pressure readings comparable to traditional cuff monitors. As a non-invasive wearable device, it does not require needles or surgery, offering a comfortable option for monitoring blood pressure. No major reports of problems have emerged from its use, suggesting that most people can use it without issues.¹²³⁴⁵

Researchers are excited about the Aktiia G1 BP monitor because it offers a new, convenient way to track blood pressure continuously, unlike traditional upper arm cuffs that provide only snapshot readings. This wrist-worn device automatically measures blood pressure throughout the day and night, providing a more comprehensive picture of one's cardiovascular health. By potentially offering greater insight into how blood pressure fluctuates over time, it could help in tailoring more effective treatment plans for those with high blood pressure.

Research has shown that the Aktiia G1 BP monitor effectively measures blood pressure. Studies have found it accurate according to international standards when used while sitting. In this trial, participants in Group 1 will use the Aktiia G1 BP monitor throughout the 12-month study period. Group 2 participants will initially use a traditional upper-arm cuff BP monitor for a 6-month comparison period before switching to the Aktiia G1 BP monitor for the follow-up period. The Aktiia device provides results similar to traditional methods, like the upper-arm cuff, even for older adults. Regular use of the Aktiia monitor has been associated with lower blood pressure in people with high blood pressure. It uses light sensors and smart technology for continuous, cuff-free monitoring, delivering consistent readings that match those from other trusted devices.⁶⁷⁸⁹¹⁰