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Completed

NCT Number: NCT07144774

Wearable Devices on Health Promotion in Diabetes

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.

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Key information

Conditions

Diabetes (DM) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific University

Hillsboro, Oregon, 97123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Fitbit wrist-worn Inspire 2® activity tracker (Fitbit Inc., San Francisco, CA, USA)

Device

Visual feedback of the physical activity level

Primary outcomes

  1. Step Counts

    Time frame: 4 weeks

    Daily step counts (steps/day) were collected using the activity tracker and mobile app.

  2. Walking distance

    Time frame: 4 weeks

    Daily walking distance (meters/day) was collected using the activity tracker and mobile app.

  3. Energy expenditure

    Time frame: 4 weeks

    Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app.

  4. 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.

  5. 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.

  6. Augmentation index

    Time frame: 4 weeks

    Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).

  7. 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).

  8. 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).

Secondary outcomes

  1. Metabolic measures

    Time frame: 4 weeks

    Fasting glucose level

  2. Body mass index

    Time frame: 4 weeks

    Body weight (kilograms) and height (meters) were measured and used to calculate body mass index (kg/m^2).

  3. Waist-to-hip ratio

    Time frame: 4 weeks

    Waist and hip circumferences (centimeters) were measured and used to calculate the waist-to-hip ratio.

Other outcomes

  1. Quality of life via survey

    Time frame: 4 weeks

    The quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

    All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Sponsors and collaborators

Lead sponsor

Pacific University

Other

Registry information

Official study title

The Effectiveness of Wearable Devices on Health Promotion in Individuals With Diabetes Mellitus

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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