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Fitbit and AI Chatbot for Type 2 Diabetes

This observational study is looking at how well a 12-week program using a Fitbit and an AI chatbot works for people with Type 2 Diabetes (T2D) who are not very active. The Fitbit tracks your activity, and the AI chatbot sends personalized exercise suggestions each week. The main goal is to see if this program is practical and acceptable, and if it can help improve health outcomes for people with T2D. You might be able to join if you are between 18 and 80 years old, have T2D, and don't currently meet physical activity guidelines. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This is an observational study with an unclear status, planning to enroll 36 participants. It compares a group using a Fitbit and AI chatbot to a control group receiving routine care.
What's involved
Participants will complete a baseline visit, wear a Fitbit and respond to text messages for 12 weeks, and then complete a final visit.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks for Fitbit wear, and for 6 months for recruitment and retainment feasibility.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07005362

Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

Completed
Not specifiedAges 18–80Observational
University of Colorado, Denver
~35 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Fitbit and AI ChatbotRoutine Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility - Recruitment
Measured over 6 months
+5 more outcomes measured

Conditions

Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
T2DM (Type 2 Diabetes Mellitus)
T2D
T2DM
Remote Patient Monitoring
Artificial Intelegence

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Seth Kramer, DO, MPH · PRINCIPAL_INVESTIGATOR · University of Colorado Anschutz Medical School

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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

What this trial measures

  • Feasibility - Recruitment6 months

    Recruitment of 36 adults within 6 months.

  • Feasibility - Retainment6 months

    Retainment of 85% of participants for post-assessments.

  • Feasibility - Fitbit wear12 Weeks

    Fitbit wear ≥ 5 days/week \> 12 hours per day, wear at night \> 3 nights/week.

  • Feasibility - Text message responses12 Weeks

    Responding to 80% of text messages when prompted.

  • Feasibility - Technical issues12 Weeks

    Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).

  • Acceptability - Participant Experience and Satisfaction12 Weeks

    Obtaining \> 60% satisfaction from participants via a satisfaction survey.