CancerNCT05124405
Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
A study testing Fitbit and Continuous Glucose Monitor in people with Cancer and Diabetes, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Fitbit and Continuous Glucose Monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2018to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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 detailed 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.
- Being tested
- Fitbit, Continuous Glucose Monitor
- Medical subject headings
- Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
wearable activity tracker
Continuous Glucose MonitorOther
wearable activity tracker
| Study group | Role | What they receive |
|---|---|---|
| Heart Rate Tracker (Fitbit) | Experimental | continuous heart rate activity Receives: Other: Fitbit; Other: Continuous Glucose Monitor |
| Continuous Glucose Monitor (CGM) | Experimental | monitoring daily exercise-related activities Receives: Other: Fitbit; Other: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of the ( PA) Physical Activity intervention.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start24 May 2018
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124405
- Sponsor's protocol ID
- 2018-0299
- Other IDs
- NCI-2019-02652
- Status last verified
- May 2026
- First submitted
- 20 May 2019
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liao Y, Brannon GE, Rethorst CD, Baum M, Bevers TB, Schembre SM, Basen-Engquist KM. Using Continuous Glucose Monitoring as a Biological Feedback Strategy to Motivate Physical Activity in Cancer Survivors: A Mixed-Methods Pilot Study. Cancer Control. 2025 Jan-Dec;32:10732748251359406. doi: 10.1177/10732748251359406. Epub 2025 Jul 28.
PubMed 40719638
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
- ClinicalTrials.gov ID
- NCT05124405
- Acronym / sponsor ID
- 2018-0299
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Tracker (Fitbit) | Experimental | Other: Fitbit, Other: Continuous Glucose Monitorcontinuous heart rate activity |
| Continuous Glucose Monitor (CGM) | Experimental | Other: Fitbit, Other: Continuous Glucose Monitormonitoring daily exercise-related activities |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbitwearable activity tracker | Other | Continuous Glucose Monitor (CGM), Heart Rate Tracker (Fitbit) |
| Continuous Glucose Monitorwearable activity tracker | Other | Continuous Glucose Monitor (CGM), Heart Rate Tracker (Fitbit) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 40719638Liao Y, Brannon GE, Rethorst CD, Baum M, Bevers TB, Schembre SM, Basen-Engquist KM. Using Continuous Glucose Monitoring as a Biological Feedback Strategy to Motivate Physical Activity in Cancer Survivors: A Mixed-Methods Pilot Study. Cancer Control. 2025 Jan-Dec;32:10732748251359406. doi: 10.1177/10732748251359406. Epub 2025 Jul 28.
- M D Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Basen-Engquist, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit and Continuous Glucose Monitor in people with Cancer and Diabetes, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feasibility of the ( PA) Physical Activity intervention. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124405, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.