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Active, not recruitingNCT05124405ClinicalTrials.gov record

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

Cancer · Diabetes

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
35 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Read the 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not randomized
Masking
No masking
Heart Rate Tracker (Fitbit)

continuous heart rate activity

Other: Fitbit · Other: Continuous Glucose Monitor

Continuous Glucose Monitor (CGM)

monitoring daily exercise-related activities

Other: Fitbit · Other: Continuous Glucose Monitor

Fitbit OTHER

wearable activity tracker

Continuous Glucose Monitor OTHER

wearable activity tracker

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

To evaluate the feasibility of the ( PA) Physical Activity intervention.

Time frame: through study completion, an average of 1 year

The use of CGM through the following criteria: CGM-specific refusal rate \<20% at the participant recruitment phase and protocol adherence rates \>80% at the end of the monitoring period.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

M D Anderson Cancer CenterHouston, Texas, United StatesStatus unknown

Study team and timeline

Lead sponsor
M.D. Anderson Cancer Center
Study start
May 24, 2018 Actual
Primary completion
Jan 31, 2027 Estimated
Study completion
Jan 31, 2027 Estimated
First posted
Nov 18, 2021 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026