Wednesday, April 17, 2024

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Fitbit to Launch a Study for the Detection of AFib

Product laydown photography for Fitbit Charge 4.

Fitbit has launched a new research study regarding the sensory detection of atrial fibrillation. They are looking at the enrolment of hundreds and thousands of their smartwatches and fitness tracker users.

It has been named the Fitbit Heart Study, the aim of this study is to continuously and passively monitor the user’s heart rate with the help of the device called the photoplethysmography (PPG) sensor. An appropriate algorithm will elucidate the findings and mark possible fluctuations for follow-up which includes:

  1. A visit by a doctor via telehealth which would be completely free.
  2. And if the need arises, the delivery of an ECG strip with interpretation via mail order to authenticate the abnormality.

“The main goals are to see how well this model of healthcare – passive monitoring, virtual visits, comparing with a clinical diagnostic test – works for screening for atrial fibrillation,” Tony Faranesh, a researcher and a scientist told in an interview. “We’re very excited for this study. We feel that our devices are really well suited for detecting a-fib, in that, because it’s a disease that comes and goes, it’s important that we have a long battery life … and people don’t have to take it off at night.”

Recruitment in the USA for the Fitbit Heart Study has been started and owners of any Fitbit gadget from ages 22 and beyond can participate in the study. The following devices by Fitbit have a built-in HR tracker:

  • Inspire HR
  • Ionic
  • Charge 4 devices
  • Charge 3 devices
  • Devices from the Versa series

The sharing of information will be between the company and the partners in this study. The company also plans on notifying the individuals in case of the detection of any significant arrhythmias.

Although it is a given that many of the participants will be less likely to get any of the arrhythmia notices, Tony Faranesh commented that they are looking forward to enrolling anywhere from 200,000 to 250,000 individuals with Fitbit devices so that the regulators of the study are satisfied. Hitting those numbers would also assist Fitbit in showing that this approach will not give numerous false positives, said co-founder and CTO Eric Friedman.

“The regulatory community, while they want people who are sick to go to the hospital, they’re also equally interested in [making sure] people who aren’t sick don’t go to the hospital,” said Eric Friedman in an interview. “Because we’re a consumer product, they want to make sure we have scope backing our proof that people won’t overwhelm the medical system. That’s part of the reason for the large size of this study.”

While being on Fitbit’s controlled efforts, the company announced that there is an advancement in the formation of onboard ECG property for the gadgets. According to Friedman, Fitbit has completed a significant trial and is waiting on the approval from the authorities after the submission of its newly formed ECG feature. Friedman also stressed on the fact that realtime detection of AFib via the ECG and the PPG “guardian angel” approach of the Fitbit Heart Study are interdependent endeavours for continuous monitoring of a person’s health.

“ECG has a role, and we’re working on ECG as well,” said he. “But because we have a 24-hour product, we have the unique ability to understand what is happening in the human body holistically throughout the day.”

“You can almost think of these working in parallel, where if you have an event and you’re awake, we can alert you and say ‘Hey, now might be a good time to take an ECG.’ But that’s not necessarily required, so these kind of work in tandem with each other instead of in opposition.”

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