Wearable Devices on Health Promotion in Diabetes

Pacific University

Status: Completed

Conditions: Diabetes (DM)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07144774

2032697-1 / 048-23

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

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

Control group

No Intervention group

Description:

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.