- Fitbit on Wednesday announced its first large-scale, virtual study to assess how well its wearable technology can identify episodes of irregular heart rhythm that might signal atrial fibrillation. The study is open to people in the U.S. ages 22 years and older with a current Fitbit device that tracks heart rate.
The Fitbit Heart Study, which aims to enroll hundreds of thousands of volunteers, is part of the company's efforts to accelerate diagnosis of complex conditions like atrial fibrillation — the most common type of irregular heartbeat and a significant risk factor for stroke. The research effort is meant to support the company’s future submissions to FDA and other regulatory bodies worldwide.
The step forward by Fitbit follows the years-long, more than 400,000-participant Apple Heart Study. Fitbit also announced last October it was partnering with the Bristol-Myers Squibb-Pfizer Alliance on efforts to identify the condition sooner.
Technology companies like Apple and Fitbit have been increasingly focused on ventures in healthcare, ramping up large-scale research meant to demonstrate the benefits of wearables in tracking various conditions.
The companies behind the devices have eyed atrial fibrillation, which affects nearly 33.5 million people globally.
Fitbit contends its wearables have the potential to accelerate AFib detection due to their 24/7 heart rate tracking capabilities that can ultimately provide long-term irregular rhythm assessment, including when users are asleep. In its new heart study, a Fitbit algorithm will look for irregularities by leveraging photoplethysmography, or PPG, technology, which measures blood flow directly from a user’s wrist. This heart rhythm tool is meant to identify irregular rhythm episodes with no symptoms that might otherwise go undetected.
Fitbit is also developing a new electrocardiogram feature for spot-check AFib detection. The company says it has completed a pivotal clinical trial of the ECG capability and plans to seek review by the FDA and global regulatory authorities.
In November, researchers from the Stanford University School of Medicine presented mixed results from the Apple Heart Study, a virtual surveillance effort with more than 400,000 participants, which found that wearable technology can safely identify heart rate irregularities that subsequent testing confirmed to be atrial fibrillation, although not yet necessarily with perfect precision.
At the time, Apple also announced that it was teaming with the American Heart Association and Brigham and Women’s Hospital to study how heart rate and mobility relate to hospitalizations, falls, heart health and quality of life in order to promote healthy movement and improved cardiovascular health.