Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

Launched by UNIVERSITY OF COLORADO, DENVER · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether using a Fitbit, a type of wearable fitness tracker, along with a smart AI chatbot can help people with type 2 diabetes manage their condition better. The main focus is to see if this combination, which includes personalized text messages about diabetes management, can lead to improved health outcomes over 12 weeks.

To participate, you need to be between 18 and 80 years old, have been diagnosed with type 2 diabetes, and currently do not engage in much physical activity (less than 150 minutes of exercise per week). If you are interested, you will start with a visit to determine your eligibility, then wear a Fitbit and respond to text messages for 12 weeks, followed by another visit to assess the results. It's important to note that this trial is not yet recruiting participants, so you'll need to wait for it to start. If you have any significant health issues or are pregnant, you may not be eligible to join.

Gender

ALL

Eligibility criteria

• 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