Validation of Fitbit Measurements in Hospitalized General Medicine Patients

NCT ID: NCT07229833

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-31

Brief Summary

Patients admitted to the General Internal Medicine ward are sick and in need of monitoring that cannot be provided at home or treatments best administered in hospital. Standard care currently includes vital signs measurements and in some cases ECG. Wearable devices that continuous monitor patients could provided added information to improve the care of inpatients. This could include more monitoring and catching deterioration before it happens. Wearables have been shown to be largely accurate for monitoring heart rate, however it is still necessary to determine if they can reliably measure sleep, activity, and other health metrics. For this, study investigators are evaluating the validity of FitBit Sense 2 (or other FitBit devices) for measurement of sleep, activity, heart rate, respiratory rate, and oxygen saturation.

Conditions

GIM Diagnosis; Medicine; Admission to GIM

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

General internal medicine patients admitted to General Medicine Wards

Intervention: Fitbit Sense 2 (Fitbit, San Francisco, CA, USA)

Gold standard devices: To compare measures, patients will be asked to wear the following for 24 hours:

• Sleep study device - Nox T3 chest band with oximeter. Participants will be asked to wear this for 24 hours. The Nox T3 monitors chest movement and determines sleep stages. It is paired with a Nonin oximeter. This provides continuous oxygen saturation monitoring as well as heart rate and respiratory rate.
• Step counter - An ankle-worn Stepwatch Activity Monitor which has been validated in hospital patients who move slowly.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• General internal medicine patients admitted to General Medicine Wards.
• Able to consent.
• 18 years of age or older

Exclusion Criteria

• Patients who are purely palliative "comfort measures only" where measuring vital signs would not be appropriate and will be excluded.
• To reduce the potential risk of transmitting nosocomial infections, patients under contact precautions for methicillin resistant Staphylococcus aureus (MRSA) and Clostridium difficile infections will also be excluded.
• This study will also exclude patients at risk of vascular compromise of the arm or leg on which the wearable device was to be placed, such as patients with deep venous thrombosis, dialysis fistulas, and severe upper extremity trauma.
• Expected discharge less than 24 hours

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Robert Wu

Clinician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

24-5399

Identifier Type: -

Identifier Source: org_study_id