Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices

M.D. Anderson Cancer Center

Status: Active, not recruiting

Conditions: Diabetes; Cancer

Treatments: Other: Continuous Glucose Monitor; Other: Fitbit

Study type: Interventional

Funder types: Other

Identifiers

NCT05124405

NCI-2019-02652 (Other Identifier)

2018-0299

Details and patient eligibility

About

To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.

Full description

Primary objective:

To evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and Fitbit®.

Secondary objectives:

To examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention.

Exploratory objective:

Examine cancer-related biomarkers and their associations with daily glucose pattern.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women at least 18 years old
• Body mass index (BMI) 25 kg/m2
• Engage in less than 150 minutes of moderate-intensity PA per week in the past month
• Capable of participating in moderate-vigorous unsupervised exercise (as determined by the Physical Activity Readiness Questionnaire (PARQ) or a medical release from their physician)
• Self-reported ability to walk one block without pain or discomfort
• Have a smart phone with daily internet access that is compatible with the LibreLink app
• Ability to speak, read, and write in English
• For the cancer survivor cohort (participant accession number #21 and beyond), individuals must have been diagnosed with stage I-III breast or colorectal cancer and completed adjuvant therapy (i.e., chemo and/or radiation therapy).

Exclusion criteria

• Self-reported current diagnosis or history of type 1 diabetes or type 2 diabetes
• Self-reported use of oral antidiabetic agents (OADs)
• Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator)
• Current use of a continuous glucose monitor
• Fasting glucose > 125 mg/dL
• Pregnancy
• Self-reported health issues that limit physical activity
• On dialysis
• Work overnight shifts
• Unwilling to use CGM
• Current participation in other wellness or weight loss-related program or intervention
• Currently on a low-carb diet
• Unable to receive REDCap survey through their mobile phones

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Heart Rate Tracker (Fitbit)

Experimental group

Description:

continuous heart rate activity

Treatment:

Other: Fitbit

Other: Continuous Glucose Monitor

Continuous Glucose Monitor (CGM)

Experimental group

Description:

monitoring daily exercise-related activities

Treatment:

Other: Fitbit

Other: Continuous Glucose Monitor