The Effectiveness of Wearable Devices on Health Promotion in Individuals With Diabetes Mellitus
Phase: NA
Conditions: Diabetes (DM)
Sponsor: Pacific University

Study Protocol with Statistical Analysis Plan 
Study Title 
The Effectiveness of Wearable Devices on Health Promotion in Individuals with Diabetes 
Mellitus 
Principal Investigator 
Eliza Wu, PT, PhD 
Doctor of Physical Therapy Program 
Pacific University 
Email: eliza.wu@pacificu.edu | Phone: 503-352-7259 
 
 

1. Study Objectives 
This randomized controlled pilot study aims to evaluate the effectiveness of wrist-worn 
activity trackers (Fitbit Inspire 2) on improving physical activity levels, cardiovascular risk 
factors, and quality of life in adults diagnosed with type 2 diabetes over a 4-week period. 
2. Study Design 
- Type: Interventional (Clinical Trial), two-arm parallel design 
- Randomization: Yes (1:1 allocation) 
- Blinding: None 
- Duration: 4 weeks 
- Sample Size: 20 participants (10 per group) 
3. Eligibility Criteria 
Inclusion Criteria: 
- Age ≥ 18 years 
- Diagnosed with type 2 diabetes (HbA1c ≥ 6.5% or fasting glucose ≥ 126 mg/dL) 
- Willing and able to link a fitness tracker app to a smartphone 
Exclusion Criteria: 
- Use of assistive devices for walking 
- Current smokers 
- Pregnant or breastfeeding 
- Already achieving ≥150 min/week of moderate-to-vigorous activity 
- Comorbidities preventing participation in physical activity 
- Current insulin therapy 
4. Intervention and Control Groups 
Intervention Group: Participants receive a Fitbit Inspire 2. 
Control Group: Participants do not receive a wearable device. 
5. Outcome Measures 
Primary Outcomes: 
- Physical activity: Measured using Global Physical Activity Questionnaire (GPAQ) and 
pedometer/mobile app data 
- Cardiovascular risk: Measured using arterial stiffness (SphygmoCor), blood pressure, 
heart rate, fasting glucose, BMI, waist-to-hip ratio 
Secondary Outcomes: 
- Health-related quality of life: Measured using the RAND SF-36 Health Survey 

6. Statistical Analysis 
Descriptive statistics will summarize baseline characteristics. Non-parametric tests will 
be used: 
- Friedman’s test and Wilcoxon signed-rank tests (within-group change) 
- Mann–Whitney U test (between-group comparison) 
- Spearman’s rho for correlations 
Effect sizes (r) will be calculated. All analyses will be conducted using IBM SPSS v29. 
Significance set at p < 0.05. 
7. Data Management and Confidentiality 
Data will be stored in a secure BOX folder regulated by the PI. No identifiable data will 
be stored on local or personal devices. Data will be retained for five years post-study. 
8. Risks and Benefits 
Risks: Minimal; primarily related to fasting and physical exertion. 
Benefits: Participants may gain insight into their physical activity levels and 
cardiovascular health. 
Compensation: None, though participants in the intervention group may retain their Fitbit 
upon study completion. 
9. Ethical Considerations 
IRB Approval: Pacific University IRB #2032697-1 
Informed consent is obtained electronically via Qualtrics in English or Spanish. No 
deception is used. Adverse events will be monitored and reported per IRB policy. 
10. Timeline 
- Recruitment: Upon IRB approval 
- Data Collection: Week 0 (T0) and Week 4 (T1) 
- Analysis & Dissemination: Expected completion within 3 months post-data collection