NCT07005362Completed
Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 35 (actual)
- First submitted
- 23 May 2025
- Start date
- 3 Sept 2025
- Primary completion date
- 14 Aug 2026
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 2 diabetes
- NCT number
- NCT07005362
What you commit to
- Study type: Observational
- Participants enrolled: 35
- From 3 Sept 2025 to the primary completion date, 14 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
- Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision that impacts ability to see FitBit, impaired memory)
- Current participation in another diabetes-related clinical trial
Lab values
- 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.
Other
- 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)
- Planning to move from Colorado within 3 months
- Current Pregnancy or planning on pregnancy in the next 3 months
- Unable to speak English as this is a small feasibility study that does not have the resources to adapt the intervention for Spanish
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Anschutz Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.