Diabetes (DM)NCT07144774
Wearable Devices on Health Promotion in Diabetes
A study testing Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA) in people with Diabetes (DM), run by Pacific University at 1 site in United States.
Trial summary
This proposed study involves human participants who will be prospectively randomized into either 1) intervention group with a activity tracker or 2) control group without an activity tracker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (DM)
- What is being tested?
- Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 29 Aug 2024
- Phase
- Interventional
- 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
Who may be able to join
- 18 years of age or older
- diagnosed with type 2 diabetes (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL)
- willing to link a fitness tracker (Fitbit®) App to their own smartphone
Who cannot join
- are unable to walk without assistive devices,
- are current smokers,
- are pregnant or breastfeeding,
- already engage in ≥ 150 minutes of moderate-to-vigorous physical activity per week,
- have any medical conditions (e.g., musculoskeletal diseases, cognitive dysfunction) that will interfere with physical activity,
- undergo any insulin treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Wearable Devices on Health Promotion in Individuals With Diabetes Mellitus
This proposed study involves human participants who will be prospectively randomized into either 1) intervention group with a activity tracker or 2) control group without an activity tracker. In addition, the proposed study is designed to evaluate the effect of using an activity tracker on cardiovascular health in the study participants.
- Conditions
- Diabetes (DM)
- Being tested
- Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)Device
Visual feedback of the physical activity level
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in the intervention group were provided with a Fitbit wrist-worn device (Inspire 2® activity tracker) at baseline. Receives: Device: Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA) |
| Control group | No intervention | Participants in the control group did not receive a wearable device but were instructed to carry their smartphones throughout the day to enable step tracking via the MobileTrack feature. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Counts
Daily step counts (steps/day) were collected using the activity tracker and mobile app.
Measured: 4 weeks
Walking distance
Daily walking distance (meters/day) was collected using the activity tracker and mobile app.
Measured: 4 weeks
Energy expenditure
Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app.
Measured: 4 weeks
Time spent in physical activity and sedentary behaviors
Time (hours : minutes) spent in physical activity and sedentary behaviors in a week was collected using the Global Physical Activity Questionnaire (GPAQ). The GPAQ consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport, and recreational activities) and time spent in sedentary behavior.
Measured: 4 weeks
Blood pressure
Brachial systolic and diastolic blood pressure (mmHg) was collected using an automated sphygmomanometer. Pulse pressure and mean arterial pressure were calculated from systolic and diastolic blood pressure.
Measured: 4 weeks
Augmentation index
Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Measured: 4 weeks
Pulse wave velocity
Pulse wave velocity (meter/second), as an arterial stiffness indicator, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Measured: 4 weeks
Subendocardial viability ratio
The subendocardial viability ratio (SEVR) was measured as an index of myocardial perfusion and coronary supply-demand balance, using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Measured: 4 weeks
Secondary outcomes (3)
Metabolic measures
Fasting glucose level
Measured: 4 weeks
Body mass index
Body weight (kilograms) and height (meters) were measured and used to calculate body mass index (kg/m^2).
Measured: 4 weeks
Waist-to-hip ratio
Waist and hip circumferences (centimeters) were measured and used to calculate the waist-to-hip ratio.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start14 Feb 2024
- Primary completion12 Jun 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes (DM)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliza Wu, Pacific University
- Investigators
- Pei Tzu Wu, Principal investigator, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144774
- Sponsor's protocol ID
- 2032697-1 / 048-23
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and statistical analysis plan will be shared.
Publications
Azar KM, Koliwad S, Poon T, Xiao L, Lv N, Griggs R, Ma J. The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 May 27;18(5):e134. doi: 10.2196/jmir.5143.
PubMed 27234480Lystrup R, Carlsen D, Sharon DJ, Crawford P. Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes. Obes Res Clin Pract. 2020 Sep-Oct;14(5):443-448. doi: 10.1016/j.orcp.2020.08.006. Epub 2020 Sep 3.
PubMed 32891527Hodkinson A, Kontopantelis E, Adeniji C, van Marwijk H, McMillian B, Bower P, Panagioti M. Interventions Using Wearable Physical Activity Trackers Among Adults With Cardiometabolic Conditions: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jul 1;4(7):e2116382. doi: 10.1001/jamanetworkopen.2021.16382.
PubMed 34283229
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Wearable Devices on Health Promotion in Individuals With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07144774
- Acronym / sponsor ID
- 2032697-1 / 048-23
- Conditions
- Diabetes (DM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 27 Aug 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.
This proposed study involves human participants who will be prospectively randomized into either 1) intervention group with a activity tracker or 2) control group without an activity tracker. In addition, the proposed study is designed to evaluate the effect of using an activity tracker on cardiovascular health in the study participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)Participants in the intervention group were provided with a Fitbit wrist-worn device (Inspire 2® activity tracker) at baseline. |
| Control group | No intervention | –Participants in the control group did not receive a wearable device but were instructed to carry their smartphones throughout the day to enable step tracking via the MobileTrack feature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- diagnosed with type 2 diabetes (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL)
- willing to link a fitness tracker (Fitbit®) App to their own smartphone
Key exclusion criteria (6 listed)
- are unable to walk without assistive devices,
- are current smokers,
- are pregnant or breastfeeding,
- already engage in ≥ 150 minutes of moderate-to-vigorous physical activity per week,
- have any medical conditions (e.g., musculoskeletal diseases, cognitive dysfunction) that will interfere with physical activity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)Visual feedback of the physical activity level | Device | Intervention group |
Primary outcome
Step Counts
Time frame: 4 weeks
Daily step counts (steps/day) were collected using the activity tracker and mobile app.
Walking distance
Time frame: 4 weeks
Daily walking distance (meters/day) was collected using the activity tracker and mobile app.
Energy expenditure
Time frame: 4 weeks
Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app.
Time spent in physical activity and sedentary behaviors
Time frame: 4 weeks
Time (hours : minutes) spent in physical activity and sedentary behaviors in a week was collected using the Global Physical Activity Questionnaire (GPAQ). The GPAQ consists of 16 questions designed to estimate an individual's level of physical activity in 3 domains (work, transport, and recreational activities) and time spent in sedentary behavior.
Blood pressure
Time frame: 4 weeks
Brachial systolic and diastolic blood pressure (mmHg) was collected using an automated sphygmomanometer. Pulse pressure and mean arterial pressure were calculated from systolic and diastolic blood pressure.
Augmentation index
Time frame: 4 weeks
Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Pulse wave velocity
Time frame: 4 weeks
Pulse wave velocity (meter/second), as an arterial stiffness indicator, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Subendocardial viability ratio
Time frame: 4 weeks
The subendocardial viability ratio (SEVR) was measured as an index of myocardial perfusion and coronary supply-demand balance, using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
3 secondary outcomes
Metabolic measures
Time frame: 4 weeks
Body mass index
Time frame: 4 weeks
Waist-to-hip ratio
Time frame: 4 weeks
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 27 Aug 2025.
- Background: PubMed 27234480Azar KM, Koliwad S, Poon T, Xiao L, Lv N, Griggs R, Ma J. The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 May 27;18(5):e134. doi: 10.2196/jmir.5143.
- Background: PubMed 32891527Lystrup R, Carlsen D, Sharon DJ, Crawford P. Wearable and interactive technology to share fitness goals results in weight loss but not improved diabetes outcomes. Obes Res Clin Pract. 2020 Sep-Oct;14(5):443-448. doi: 10.1016/j.orcp.2020.08.006. Epub 2020 Sep 3.
- Background: PubMed 34283229Hodkinson A, Kontopantelis E, Adeniji C, van Marwijk H, McMillian B, Bower P, Panagioti M. Interventions Using Wearable Physical Activity Trackers Among Adults With Cardiometabolic Conditions: A Systematic Review and Meta-analysis. JAMA Netw Open. 2021 Jul 1;4(7):e2116382. doi: 10.1001/jamanetworkopen.2021.16382.
- Individual participant dataSharing planned: Yes. The study protocol and statistical analysis plan will be shared.
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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.
Pei Tzu Wu principal investigator
Pacific University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA) in people with Diabetes (DM), run by Pacific University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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 27 Aug 2025. 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 United States. 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?
Step Counts (time frame: 4 weeks). The study lists 8 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 NCT07144774, which also lists 3 linked publications.
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 27 Aug 2025.