Actively Recruiting
Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Led by University of Colorado, Denver · Updated on 2026-05-19
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
American Academy of Family Physicians
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility and acceptability of a 12-week program using Fitbit and AI-delivered diabetes self-management education and support (DSMES) with personalized text messages for adults with type 2 diabetes. The main goal is to find out if using a wearable fitness tracker combined with AI-tailored support can improve clinical outcomes for people with this condition. Participants in the intervention group will wear Fitbit devices daily and receive weekly personalized exercise goals and support messages from an AI Chatbot based on their activity levels. They can also interact with the AI Chatbot via text for additional education and goal setting. A control group will be identified through a review of medical records of patients who meet the study criteria but do not receive the intervention. Participants will have a baseline visit, wear the Fitbit and engage with the AI Chatbot for 12 weeks, and then complete a final visit. Researchers will measure feasibility aspects such as recruitment, retention, Fitbit use, response to messages, and technical issues. They will also assess participant satisfaction and changes in clinical measures like HbA1c, body mass index, blood pressure, lipid panel, weight, and diabetes distress during the 12-week period.
CONDITIONS
Brief Title
Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes per investigator discretion
- No more than 20% of the sample will have A1c < 7.5% confirmed by recent medical records
- Age 18 years or older and 80 years or younger
- Does not meet ADA guidelines for physical activity (less than 150 minutes of aerobic exercise weekly)
- Has a smartphone compatible with a Fitbit device
You will not qualify if you...
- Completing more than 60 minutes of moderate to vigorous activity per week
- Any medical condition posing unacceptable safety risk as judged by investigator, including untreated malignancy, unstable cardiac disease, unstable or end-stage kidney disease, and eating disorders
- Unstable coronary artery disease or recent heart procedures within 12 months
- Planned major surgery during the study
- Blood disorders or use of hydroxyurea affecting HbA1c measurement
- Use or planned use of oral or injectable steroids within 8 weeks
- Planning to move from Colorado within 3 months
- Current pregnancy or planning pregnancy in next 3 months
- Unable to safely follow study procedures due to vision or memory issues
- Unable to speak English
- Current participation in another diabetes-related clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants wear Fitbit devices daily for 12 weeks and receive weekly personalized exercise recommendations from an AI Chatbot via text messages. They can interact with the AI Chatbot throughout the week for support, education, and goal setting.
Weekly visits or check-ins
Duration - 12 weeks
Participants who undergo routine care are observed for outcomes without active intervention.
Visits as per routine healthcare
Trial Site Locations
Total: 1 location
1
University of Colorado, Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jessica Parascando, MPH
E
Elizabeth Westfeldt, BSN, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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