NCT07005362Recruiting
Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
University of Colorado, Denver
Start Date
9/3/2025
Completion Date
8/30/2026
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. 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.
Eligibility Criteria
Age Range: 18 years to 80 years
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
BEHAVIORAL
Fitbit and AI Chatbot
OTHER
Routine Care
Conditions
Type 2 DiabetesType 2 Diabetes Mellitus (T2DM)T2DM (Type 2 Diabetes Mellitus)T2DT2DMRemote Patient MonitoringArtificial Intelegence
Locations
University of Colorado, Anschutz
Aurora, Colorado 80045
United States