Actively Recruiting
Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
Led by University of Colorado, Denver · Updated on 2025-11-13
36
Participants Needed
1
Research Sites
34 weeks
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
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.
CONDITIONS
Official 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 as determined by the investigator
- No more than 20% of participants can have A1c less than 7.5% confirmed by recent medical record or test within 3 months
- Age 18 years or older and 80 years or younger
- Does not meet ADA physical activity guidelines (less than 150 minutes of aerobic exercise per week)
- Owns a smartphone compatible with Fitbit
You will not qualify if you...
- Doing more than 60 minutes of moderate to vigorous activity per week
- Any medical condition deemed unsafe by the investigator, such as untreated cancer, unstable heart disease, advanced kidney disease, or eating disorders
- History of unstable coronary artery disease or heart problems preventing moderate exercise, or recent heart procedures within 12 months
- Planned major surgery during the study period
- Blood disorder or recent use of hydroxyurea interfering with HbA1c measurement
- Use or planned use of oral or injectable steroids in the past or during the study
- Planning to move from Colorado within 3 months
- Currently pregnant or planning pregnancy within 3 months
- Unable to safely follow study procedures or reporting due to impairments
- Cannot speak English as the study does not support other languages
- Currently participating in another diabetes-related clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado, Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jessica Parascando, MPH
CONTACT
E
Elizabeth Westfeldt, BSN, RN
CONTACT
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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