Wearable Devices on Health Promotion in Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2024-08-29

Brief Summary

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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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Detailed Description

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Conditions

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Diabetes (DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Visual feedback of the physical activity level

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Visual feedback of the physical activity level

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No