Wearable Devices on Health Promotion in Diabetes

Not Applicable

Completed

• Conditions: Diabetes (DM)

• Registration Number: NCT07144774
• Lead Sponsor: Pacific University

Brief 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. In addition, the proposed study is designed to evaluate the effect of using an activity tracker on cardiovascular health in the study participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-14
• Primary Completion: 2024-06-12
• Study Completion: 2024-08-29
• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. 18 years of age or older
2. diagnosed with type 2 diabetes (HbA1c ≥ 6.5% or fasting plasma glucose ≥ 126 mg/dL)
3. willing to link a fitness tracker (Fitbit®) App to their own smartphone

Exclusion Criteria

1. are unable to walk without assistive devices,
2. are current smokers,
3. are pregnant or breastfeeding,
4. already engage in ≥ 150 minutes of moderate-to-vigorous physical activity per week,
5. have any medical conditions (e.g., musculoskeletal diseases, cognitive dysfunction) that will interfere with physical activity,
6. undergo any insulin treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Step Counts	4 weeks	Daily step counts (steps/day) were collected using the activity tracker and mobile app.
Walking distance	4 weeks	Daily walking distance (meters/day) was collected using the activity tracker and mobile app.
Energy expenditure	4 weeks	Daily energy expenditure (calories/day) was collected using the activity tracker and mobile app.
Time spent in physical activity and sedentary behaviors	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	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	4 weeks	Augmentation index (%), as an indicator of arterial stiffness, was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, Sydney, Australia).
Pulse wave velocity	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	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 Outcome Measures

Name	Time	Method
Metabolic measures	4 weeks	Fasting glucose level
Body mass index	4 weeks	Body weight (kilograms) and height (meters) were measured and used to calculate body mass index (kg/m\^2).
Waist-to-hip ratio	4 weeks	Waist and hip circumferences (centimeters) were measured and used to calculate the waist-to-hip ratio.

Trial Locations

Locations (1)

Pacific University; 🇺🇸 Hillsboro, Oregon, United States