Wearable Devices on Health Promotion in Diabetes

NCT07144774 | Completed

• 1 other identifier: 2032697-1 / 048-23
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes (DM)

Outcome Measures

Primary Outcomes (8)

• Step Counts

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

  4 weeks

• Walking distance

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

  4 weeks

• Energy expenditure

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

  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.

  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.

  4 weeks

• Augmentation index

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

  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).

  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).

  4 weeks

Secondary Outcomes (3)

• Metabolic measures

  4 weeks

• Body mass index

  4 weeks

• Waist-to-hip ratio

  4 weeks

Other Outcomes (1)

• Quality of life via survey

  4 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group were provided with a Fitbit wrist-worn device (Inspire 2® activity tracker) at baseline.

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.

Interventions

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

Visual feedback of the physical activity level

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacific University: lead

Study Sites (1)

Pacific University

Hillsboro, Oregon, 97123, United States

Location

Related Publications (3)

• 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.

  PMID: 27234480 BACKGROUND

• Lystrup 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.

  PMID: 32891527 BACKGROUND

• Hodkinson 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.

  PMID: 34283229 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pei Tzu Wu

  Pacific University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 27, 2025
• Study Start: February 14, 2024
• Primary Completion: June 12, 2024
• Study Completion: August 29, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)