Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Colorado, Denver
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Aurora
Source: ClinicalTrials.gov · NCT07005362 · last updated 2026-05-19