Type 2 DiabetesFIT T2DNCT07005362
Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
An observational study of Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Fitbit and AI Chatbot and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to 14 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care adult patients diagnosed with type 2 diabetes who do not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing).
Who may be able to join
- Diagnosed with type 2 diabetes per investigator discretion
- No more than 20% of the sample will have A1c < 7.5% (confirmed by medical record review or an A1c completed within 3 months of the screening visit)
- Age ≥18 years and ≤ 80 years
- Does not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing)
- Has a smartphone compatible with a Fitbit
Who cannot join
- Completing more than 60 minutes of moderate to vigorous activity per week defined as activity where you cannot sing (moderate) or can't say more than a few words without gasping for breath (vigorous)(14)
- Any medical condition which, in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders.
- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12- months
- Any planned surgery during the study which could be considered major in the opinion of the investigator
- Blood disorder or dyscrasia within 3 months before screening, or the use of hydroxyurea, which, in the investigator's opinion, could interfere with the determination of HbA1c
- Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study, as they may interfere with the determination of HbA1c.
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- Planning to move from Colorado within 3 months
- Current Pregnancy or planning on pregnancy in the next 3 months
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision that impacts ability to see FitBit, impaired memory)
- Unable to speak English as this is a small feasibility study that does not have the resources to adapt the intervention for Spanish
- Current participation in another diabetes-related clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Anschutz
Aurora, Colorado, 80045
About this study
Official title: Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages.
The main question it aims to answer is:
Does providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes?
Participants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), T2DM (Type 2 Diabetes Mellitus), T2D, T2DM, Remote Patient Monitoring
- Being tested
- Fitbit and AI Chatbot, Routine Care
- Keywords
- type 2 diabetes, artificial intelligence, fitbit, primary care, remote patient monitoring, physical activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit and AI ChatbotBehavioural
Participants will wear their Fitbit devices daily for 12-weeks and will receive personalized messages from the AI Chatbot every week with a new exercise recommendation based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support and education.
Routine CareOther
The control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Fitbit and AI Chatbot | Participants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve. Receives: Behavioral: Fitbit and AI Chatbot | |
| Active Comparator: Controls | The control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment
Recruitment of 36 adults within 6 months.
Measured: 6 months
Feasibility - Retainment
Retainment of 85% of participants for post-assessments.
Measured: 6 months
Feasibility - Fitbit wear
Fitbit wear ≥ 5 days/week > 12 hours per day, wear at night > 3 nights/week.
Measured: 12 Weeks
Feasibility - Text message responses
Responding to 80% of text messages when prompted.
Measured: 12 Weeks
Feasibility - Technical issues
Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).
Measured: 12 Weeks
Acceptability - Participant Experience and Satisfaction
Obtaining > 60% satisfaction from participants via a satisfaction survey.
Measured: 12 Weeks
Secondary outcomes (10)
Change in HbA1c
Change in HbA1c from baseline to post-intervention.
Measured: 12 Weeks
Change in Body Mass Index
Change in Body Mass Index (BMI) from baseline to post-intervention.
Measured: 12 Weeks
Change in lipid panel
Change in lipid panel from baseline to post-intervention.
Measured: 12 Weeks
Change in weight
Change in weight from baseline to post-intervention.
Measured: 12 Weeks
Change in blood pressure
Change in blood pressure from baseline to post-intervention.
Measured: 12 Weeks
Change in diabetes distress
Change in diabetes distress as measured by the T2-DDAS: The Type 2 Diabetes Distress Assessment System from baseline to post-intervention.
Measured: 12 Weeks
Experience with technology
Patient experience with technology as measured via the System Usability Scale (SUS).
Measured: 12 Weeks
Experience with technology
Patient experience with technology as measured via the FACETS Comfort with Technology assessment.
Measured: 12 Weeks
Cost
Cost of delivering remote patient monitoring intervention as measured via time-diaries and patient logs.
Measured: Weekly, 12 weeks
Revenue
Revenue modeling from practice perspective of remote patient monitoring intervention as measured via staff and patient time logs.
Measured: Weekly, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start3 Sep 2025
- Primary completion14 Aug 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Family Physicians
- Responsible party
- Sponsor
- Investigators
- Seth Kramer, DO, MPH, Principal investigator, University of Colorado Anschutz Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005362
- Sponsor's protocol ID
- 24-2577
- Acronym
- FIT T2D
- Status last verified
- Aug 2026
- First submitted
- 23 May 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
- ClinicalTrials.gov ID
- NCT07005362
- Acronym / sponsor ID
- FIT T2D / 24-2577
- Conditions
- Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), T2DM (Type 2 Diabetes Mellitus), T2D, T2DM, Remote Patient Monitoring
- Keywords
- type 2 diabetes, artificial intelligence, fitbit, primary care, remote patient monitoring, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Academy of Family Physicians
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 14 Aug 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 5 Jun 2025 (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.
The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages.
The main question it aims to answer is:
Does providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes?
Participants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Fitbit and AI Chatbot | – | Behavioral: Fitbit and AI ChatbotParticipants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve. |
| Active Comparator: Controls | – | Other: Routine CareThe control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care adult patients diagnosed with type 2 diabetes who do not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing).
Key inclusion criteria (5 listed)
- Diagnosed with type 2 diabetes per investigator discretion
- No more than 20% of the sample will have A1c < 7.5% (confirmed by medical record review or an A1c completed within 3 months of the screening visit)
- Age ≥18 years and ≤ 80 years
- Does not meet ADA guidelines for physical activity (< 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing)
- Has a smartphone compatible with a Fitbit
Key exclusion criteria (11 listed)
- Completing more than 60 minutes of moderate to vigorous activity per week defined as activity where you cannot sing (moderate) or can't say more than a few words without gasping for breath (vigorous)(14)
- Any medical condition which, in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders.
- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12- months
- Any planned surgery during the study which could be considered major in the opinion of the investigator
- Blood disorder or dyscrasia within 3 months before screening, or the use of hydroxyurea, which, in the investigator's opinion, could interfere with the determination of HbA1c
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 |
|---|---|---|
| Fitbit and AI ChatbotParticipants will wear their Fitbit devices daily for 12-weeks and will receive personalized messages from the AI Chatbot every week with a new exercise recommendation based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support and education. | Behavioural | Experimental: Fitbit and AI Chatbot |
| Routine CareThe control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention. | Other | Active Comparator: Controls |
Primary outcome
Feasibility - Recruitment
Time frame: 6 months
Recruitment of 36 adults within 6 months.
Feasibility - Retainment
Time frame: 6 months
Retainment of 85% of participants for post-assessments.
Feasibility - Fitbit wear
Time frame: 12 Weeks
Fitbit wear ≥ 5 days/week > 12 hours per day, wear at night > 3 nights/week.
Feasibility - Text message responses
Time frame: 12 Weeks
Responding to 80% of text messages when prompted.
Feasibility - Technical issues
Time frame: 12 Weeks
Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).
Acceptability - Participant Experience and Satisfaction
Time frame: 12 Weeks
Obtaining > 60% satisfaction from participants via a satisfaction survey.
10 secondary outcomes
Change in HbA1c
Time frame: 12 Weeks
Change in Body Mass Index
Time frame: 12 Weeks
Change in lipid panel
Time frame: 12 Weeks
Change in weight
Time frame: 12 Weeks
Change in blood pressure
Time frame: 12 Weeks
Change in diabetes distress
Time frame: 12 Weeks
Experience with technology
Time frame: 12 Weeks
Experience with technology
Time frame: 12 Weeks
Cost
Time frame: Weekly, 12 weeks
Revenue
Time frame: Weekly, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Seth Kramer, DO, MPH principal investigator
University of Colorado Anschutz Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Type 2 Diabetes Mellitus (T2DM), run by University of Colorado, Denver 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 19 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility - Recruitment (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.