Fitbit has successfully trialled proprietary ECG technology as it awaits FDA approval. It is now looking to recruit thousands of users for a large-scale consumer Heart Study.
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Wearable brand Fitbit is researching whether its devices can be used to detect irregular heart rhythm suggestive of atrial fibrillation (AFib) via heart rate sensors and an algorithm. This is the most common type of heart arrhythmia. It effects about 8 million people in the US and more than 30 million people world-wide. To this end the company is looking to enrol between 200,000 and a quarter of a million device owners for the Fitbit Heart Study.
The research will analyse wearers’ heart rhythms using the photoplethysmography (PPG) sensors that can be found on most of its wearables. The company has already had a successful clinical trial of an ECG feature ahead of regulatory approval. Now it is looking to do the same for its PPG AFib algorithm. The ultimate aim is to get FDA approval for its devices to be used for self-monitoring of possible Afib.
Volunteers who opt into the new study will have the latest Afib algorithm look for irregularities in the blood flow from their wrist. If something is amiss, the user will get an alert. They will then have the option to connect to a doctor for a virtual appointment free of charge. What’s more, device owners with suspected Afib may also get an ECG patch via mail to confirm the reading.
Apple has similar functionality in its smartwatches. The difference is that Fitbit is only using the heart rate monitor to spot irregularities. On an Apple Watch, users can take a reading on demand by launching the ECG app and resting their finger against the digital crown. This creates a closed circuit between the digital crown and the sensor on the back. Built in electrodes will then work to detect electrical impulses from the heart.
Early identification of AFib, is key to reducing the risk of a life-threatening event like stroke. Fitbit’s heart rate monitors work 24/7 so are in an ideal position to passively monitor for the condition and alert if abnormalities are spotted. But this is only one part of the picture.
The company is looking to provide users with both “long and short-term AFib assessment options”. The PPG-based heart rhythm looks for irregular rhythm episodes with no symptoms, while an ECG feature can record an actual ECG trace for evaluation by users and doctors.
Who can participate in the Fitbit Heart Study?
To join the Fitbit Heart Study you must live in the US and be 22 years or older. You also must own a heart-rate enabled device such as Charge 3, Charge 4, Inspire HR, Ionic, Versa, Versa 2 or Versa Lite. Upon enrollment the algorithms will sift through your previous month of data to look for potential arrhythmia.
“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.”
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