GIM DiagnosisNCT07229833
Validation of Fitbit Measurements in Hospitalized General Medicine Patients
An observational study of GIM Diagnosis and Medicine, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GIM Diagnosis, Medicine, Admission to GIM
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be General Internal Medicine inpatients on the GIM wards. Patients who can provide informed consent will be approached for enrollment. Exclusion criteria are patients who are purely palliative and therefore in which vital sign measurement would be inappropriate.
Subject inclusion criteria.
- General internal medicine patients admitted to General Medicine Wards.
- Able to consent.
- 18 years of age or older
Subject 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Keywords
- wearable, sleep, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fitbit Sense 2 vs. StepWatch for activity (step count)
Comparisons of step counts between Fitbit and Modus StepWatch
Measured: Collected over 24 hours in 1 min bins
Fitbit Sense 2 vs. Nox T3 for heart rate (bpm)
Comparisons of HR between Fitbit and Nox pulse oximeter
Measured: Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins
Fitbit Sense 2 vs. Nox T3 for respiratory rate (breaths per minute)
Comparisons of RR between Fitbit and Nox RIP (respiratory inductive plethysmograph)
Measured: Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins.
Fitbit Sense 2 vs. Nox T3 for oxygen saturation (SpO2, %)
Comparisons of SpO2 between Fitbit and Nox T3
Measured: Fitbit collected over 24 hours in 1 min bins and Nox collected during nighttime sleep in 1 sec bins.
Fitbit Sense 2 vs. Nox T3 for total sleep time (min)
Comparisons of sleep TST between Fitbit and Nox T3
Measured: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Nox T3 for sleep efficiency (%)
Comparisons of SE between Fitbit and Nox T3
Measured: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Nox T3 for sleep stages (%, min)
Comparisons of sleep stages (NREM - stage 1-3, REM) between Fitbit and Nox T3
Measured: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Nox T3 for wake after sleep onset (min)
Comparisons of WASO between Fitbit and Nox T3
Measured: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Nox T3 for time of sleep onset and wake time
Comparisons of sleep onset time and wake time between Fitbit and Nox T3
Measured: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Secondary outcomes (7)
Fitbit Sense 2 vs. Sleep Diary for total sleep time (min)
Comparisons of total sleep time between Fitbit and self-reported sleep diary.
Measured: Collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Sleep Diary for sleep efficiency (%)
Comparisons of sleep efficiency between Fitbit and self-reported sleep diary.
Measured: Collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Sleep Diary for time of sleep schedule
Comparisons of time of sleep between Fitbit and self-reported sleep diary.
Measured: Collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Sleep Diary for wake after sleep onset (min)
Comparisons of WASO between Fitbit and self-reported sleep diary.
Measured: Collected during nighttime sleep (1 night)
Subgroup analysis based on gender
Gender-based subgroup analysis of outcomes
Measured: Collected at study baseline
Subgroup analysis based on comorbidities
Descriptive data on participant comorbidities (e.g., presence of mobility limiting conditions, etc; yes/no) or subgroup analysis by comorbidities
Measured: Collected at study baseline
Subgroup analysis based on use of walking aids
Subgroup analysis by walking aid usage or descriptive data on walking aid use among participants (e.g., yes vs. no)
Measured: Collected at study baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Jun 2025
- Primary completion31 Aug 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GIM DiagnosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Wu, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229833
- Sponsor's protocol ID
- 24-5399
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This study requested sharing of IPD in the ethics application.
Publications
Lee S, Tu A, Li Y, Kendzerska T, Wu R. Fitbit Sense 2 in hospitalized general medicine patients: A pilot study assessing feasibility and validity of specific measures. Int J Med Inform. 2026 Sep 2;222:106704. doi: 10.1016/j.ijmedinf.2026.106704. Online ahead of print.
PubMed 42691870
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Fitbit Measurements in Hospitalized General Medicine Patients
- ClinicalTrials.gov ID
- NCT07229833
- Acronym / sponsor ID
- 24-5399
- Conditions
- GIM Diagnosis, Medicine, Admission to GIM
- Keywords
- wearable, sleep, heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be General Internal Medicine inpatients on the GIM wards. Patients who can provide informed consent will be approached for enrollment. Exclusion criteria are patients who are purely palliative and therefore in which vital sign measurement would be inappropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fitbit Sense 2 vs. StepWatch for activity (step count)
Time frame: Collected over 24 hours in 1 min bins
Comparisons of step counts between Fitbit and Modus StepWatch
Fitbit Sense 2 vs. Nox T3 for heart rate (bpm)
Time frame: Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins
Comparisons of HR between Fitbit and Nox pulse oximeter
Fitbit Sense 2 vs. Nox T3 for respiratory rate (breaths per minute)
Time frame: Fitbit collected over 24 hours in 1 min bins and Nox T3 collected during nighttime sleep in 1 sec bins.
Comparisons of RR between Fitbit and Nox RIP (respiratory inductive plethysmograph)
Fitbit Sense 2 vs. Nox T3 for oxygen saturation (SpO2, %)
Time frame: Fitbit collected over 24 hours in 1 min bins and Nox collected during nighttime sleep in 1 sec bins.
Comparisons of SpO2 between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for total sleep time (min)
Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Comparisons of sleep TST between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for sleep efficiency (%)
Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Comparisons of SE between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for sleep stages (%, min)
Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Comparisons of sleep stages (NREM - stage 1-3, REM) between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for wake after sleep onset (min)
Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Comparisons of WASO between Fitbit and Nox T3
Fitbit Sense 2 vs. Nox T3 for time of sleep onset and wake time
Time frame: Fitbit and Nox T3 collected during nighttime sleep (1 night)
Comparisons of sleep onset time and wake time between Fitbit and Nox T3
7 secondary outcomes
Fitbit Sense 2 vs. Sleep Diary for total sleep time (min)
Time frame: Collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Sleep Diary for sleep efficiency (%)
Time frame: Collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Sleep Diary for time of sleep schedule
Time frame: Collected during nighttime sleep (1 night)
Fitbit Sense 2 vs. Sleep Diary for wake after sleep onset (min)
Time frame: Collected during nighttime sleep (1 night)
Subgroup analysis based on gender
Time frame: Collected at study baseline
Subgroup analysis based on comorbidities
Time frame: Collected at study baseline
Subgroup analysis based on use of walking aids
Time frame: Collected at study baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Derived from this study: PubMed 42691870Lee S, Tu A, Li Y, Kendzerska T, Wu R. Fitbit Sense 2 in hospitalized general medicine patients: A pilot study assessing feasibility and validity of specific measures. Int J Med Inform. 2026 Sep 2;222:106704. doi: 10.1016/j.ijmedinf.2026.106704. Online ahead of print.
- Individual participant dataSharing planned: No. This study requested sharing of IPD in the ethics application.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GIM Diagnosis and Medicine, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitbit Sense 2 vs. StepWatch for activity (step count) (time frame: Collected over 24 hours in 1 min bins). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.