What should I know about the Fitbit Heart Study?
The Fitbit Heart Study is a clinical study designed to evaluate Fitbit’s investigational algorithm to detect irregular heart rhythms among Fitbit users with a compatible Fitbit device. This study is being conducted so that Fitbit can determine the accuracy of the algorithm and potentially apply to government agencies for approval to make the algorithm product available to the general public.
The study is open to Fitbit users in the United States who are at least 22 years old, meet certain requirements, and have a compatible Fitbit device:
- Fitbit Charge 3
- Fitbit Charge 4
- Fitbit Inspire HR
- Fitbit Ionic
- Fitbit Versa
- Fitbit Versa Lite Edition
- Fitbit Versa 2
If your device isn’t compatible, you can purchase a new one in the Fitbit Store.
In the Fitbit app on your iPhone, iPad, or Android phone:
- Tap the Discover tab.
- Under Assessments & Reports, tap Heart Study Clinical Trial.
- Follow the on-screen instructions to sign up.
You can also visit Fitbit Heart Study to enroll.
We estimate that the Fitbit Heart Study will last for up to 1 year. The length of your participation in the study depends upon your outcome:
- If you don’t receive an irregular heart rhythm notification, your participation ends when the study concludes.
- If you receive an irregular heart rhythm notification and are eligible to receive an ECG patch, your participation ends after you complete the following 3 steps:
- Wear and return the ECG patch.
- Discuss your results with a doctor.
- Complete the 90-day follow-up survey.
During the study, wear your Fitbit device as much as possible, especially at night. It’s easier to detect an irregular heart rhythm while you're still or asleep.
After you enroll, our algorithm analyzes your previous heart-rate data for up to 30 days. If we detect that you experienced an irregular heart rhythm during that time, you may receive a notification. As a result, it's possible to receive a notification on the same day that you enroll in the study. It’s important that you’re the only person who wears your Fitbit device in the weeks leading up to and during the study.
If Fitbit’s investigational algorithm recently detected an irregular heart rhythm, you receive an email from Fitbit and a notification from the Fitbit app. The software analyzing your heart rhythm hasn’t been approved by the United States Food and Drug Administration (FDA). This detection isn’t a diagnosis, and you shouldn’t rely on the results of the investigational software for any purpose.
After you receive a notification, you’re eligible for 2 video appointments with a doctor through PlushCare, an independent telehealth provider. These appointments will be provided at no cost to you. If you haven’t scheduled an appointment, you receive an email and text message from PlushCare to remind you.
If you receive a notification of an irregular heart rhythm, you’re eligible for 2 video appointments with a doctor through PlushCare, an independent telehealth provider that has partnered with Fitbit for the Fitbit Heart Study. These appointments will be provided at no cost to you. During the first appointment, you meet with the doctor to ensure it's safe for you to proceed in the study and to confirm you meet the eligibility criteria.
If you receive an ECG patch, wear it continuously for up to 1 week along with your Fitbit device. The ECG patch is an FDA-approved clinical device for remote, continuous ECG monitoring. The results from the ECG patch can be used to diagnose heart rhythm irregularities. At the end of the week, return the patch for analysis and schedule the second appointment through PlushCare to discuss your results.
These visits and the patch are provided at no cost, but the visits are intended for study purposes only. Please don’t discuss other medical concerns with the doctor that don’t pertain to the study. If you have questions about your appointment, contact PlushCare at 888-683-8124.
Wear the ECG patch for up to 1 week along with your Fitbit device. Note that the patch may cause minor irritation or itching. The irritation is temporary and is expected to resolve soon after you remove the patch. For some participants, it may be necessary to shave body hair to ensure good contact with the patch. Excessive sweating or prolonged submersion in water may cause the adhesive to wear away more quickly. If the patch comes away from your skin, please don’t attempt to reapply it with any other adhesive or bandage. Remove the patch and return the module to BioTel. For more information, contact PlushCare at 888-683-8124.
Contact PlushCare at 888-683-8124.
We’ll send you a prepaid USPS envelope with additional instructions. Send the package through the USPS for return.
You can withdraw from the study at any time:
- In the Fitbit app, tap the Discover tab.
- Tap the Fitbit Heart Study tile.
- Scroll down, and tap Withdraw From Study.
Note that if you withdraw from the study or delete your Fitbit account, we’ll retain study data that was already collected, but won’t collect new information.
If you receive an ECG patch, your results will be shared with you during the follow-up video call with a doctor through PlushCare. Note that PlushCare will contact you when your results are ready for review through the email address that you entered to enroll in the study.
All data used for study analysis is de-identified and won’t be made available to individual participants. Review the HIPAA Authorization Form for the study for more information on how your data is used and shared.