Fitbit launched a large-scale study to test the efficacy of its technology in identifying irregular heart rhythms, which could indicate potential cases of atrial fibrillation. Fitbit said it plans to enroll hundreds of thousands of people into the virtual study, which could affect its regulatory submissions. It will compare the accuracy of Fitbit’s alert to detect AFib compared to a physician-interpreted ECG patch.
“Until recently, tools for detecting AFib had a number of limitations and were only accessible if you visited a doctor,” Dr. Steven Lubitz, a cardiologist at Massachusetts General Hospital and principal investigator of the Fitbit Heart Study, said in a news release. “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.”
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
Fitbit first mentioned plans to submit its atrial fibrillation algorithm for FDA clearance in 2018. The company has been offering heart rate monitoring in its activity trackers for years, which use an LED light to measure how fast blood is moving through a users’ veins.
A study of the Apple Watch 3 and Fitbit Charge 2 showed they were generally accurate in measuring heart rate, but became less accurate during physical activity. Fitbit acknowledges this, noting overnight assessments, when people sleep, are ideal for identifying irregular heart rhythm.
Both companies have developed atrial fibrillation algorithms, which track episodes of irregular heart rhythm that could indicate potential cases of atrial fibrillation. Atrial fibrillation can be sporadic and difficult to detect, but it is associated with an increased stroke risk and affects nearly 33.5 million people globally.
Apple received FDA clearance in 2018 for its atrial fibrillation algorithm, and more recently launched a virtual study with Johnson & Johnson to see if early detection of AFib combined with educational tools can reduce users’ likelihood of stroke and improve their health.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Fitbit, for its part, struck a partnership with Bristol-Myers Squibb and Pfizer last year to develop programs to identify and support people found to be at increased risk for stroke. Those programs would be implemented after it receives FDA clearance for its AFib algorithm.
“Too many people discover that they are suffering from atrial fibrillation only after experiencing a stroke. In fact, some studies suggest that this is true for more than 25 percent of people who have the condition,” Bristol-Myers Squibb Head of Medical Affairs Dr. Joseph Eid said in a news release. “These efforts with Fitbit exemplify not only our unwavering commitment to addressing the evolving needs of patients with atrial fibrillation, but also our dedication to advancing care by embracing technology as a part of routine clinical practice.”
The Fitbit Heart study is open to anyone in the U.S. age 22 or older that has a Fitbit device that can track heart rate. Fitbit said the study will be used for the clinical evaluation of its atrial fibrillation algorithm, including whether it can successfully identify episodes of irregular heart rhythm.
Photo credit: Fitbit
