The large scale virtual clinical FITbit Heart Study will be a big part of the company’s attempts at detecting atrial fibrillation and the goal of helping to reduce the risk of stroke, this will be competing with other companies with heartbeat tracking and ECG-enabled wearables such as the Apple Watch.
Rather than testing a single product the study will be testing several which includes all of the company’s current exercise trackers and smartwatches that are able to measure heart rate, which could enroll hundreds of thousands of users. The results will be the foundation for the company’s regulatory submission to the FDA as well as overseas.
Fit bit hopes that their devices will lead to extended assessments of heart rhythms while people are both awake and sleeping, which is the best way to detect intermittent arrhythmias. The trackers have batteries that last for days as well as 24/7 pulse rate tracking, and use light based technology to measure the rate of blood flow through the wrist, and are suggested to have the unique potential to accelerate Afib detection.
The Fitbit Heart Study will be testing an algorithm that translates data into a heart rhythm and searches for signs of atrial fibrillation. Atrial fibrillation shows no symptoms in many patients, and globally it affects over 30 million people. When/if detected in a trial participant the user will receive a notification and be connected with a doctor for a virtual appointment, additionally they may receive a wearable electrocardiogram patch to confirm if they have an irregular heart rhythm.
“Until recently, tools for detecting AFib had a number of limitations and were only accessible if you visited a doctor,” said Steven Lubitz, M.D., M.P.H, principal investigator of the Fitbit Heart Study, cardiologist at Massachusetts General Hospital and Associate Professor of Medicine at Harvard Medical School. “My hope is that advancing research on innovative and accessible technology, like Fitbit devices, will lead to more tools that help improve health outcomes and reduce the impact of AFib on a large scale.”
Fitbit is also working to develop an integrated electrocardiogram feature, and according to the company they have completed a clinical trial and have plans to seek FDA clearance.
In 2019 Fitbit partnered with a joint venture established by Pfizer and Bristol Myers Squibb to develop arrhythmia detection algorithms and hardware, plans have been made to continue working with them to create content that will inform users of the potential risk of stroke and possible options for care.
“We’re in a new era of healthcare, where we’re not only focused on developing treatments but also looking at the potential of technology and data to help patients learn more about their health,” Angela Hwang, group president of Pfizer’s biopharmaceuticals group, said in a statement. “We are excited about wearables and how our work with BMS and Fitbit may potentially help patients and physicians detect and understand heart rhythm irregularities.”
Google made an offer to acquire Fitbit in November 2019, but this $2.1 billion deal is still under federal review in part due to the large amounts of personal health data that is involved. Google says this move is another way to invest in its own smartwatch products, which are struggling to gain a large market share compared to other companies.
“By working closely with Fitbit’s team of experts, and bringing together the best AI, software and hardware, we can help spur innovation in wearables and build products to benefit even more people around the world,” said Google’s senior vice president of devices and services, Rick Osterloh, in a company blog post.
