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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

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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