Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Trial ID: NCT07005362
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2025-09-03
Completion date: 2026-04-30
Sponsor: University of Colorado, Denver
Collaborators: American Academy of Family Physicians
Conditions: Type 2 Diabetes; Type 2 Diabetes Mellitus (T2DM); T2DM (Type 2 Diabetes Mellitus); T2D; T2DM; Remote Patient Monitoring; Artificial Intelegence
Interventions: Fitbit and AI Chatbot; Routine Care
Locations: University of Colorado, Anschutz
Countries: United States
Enrollment: 36
Age range: 18 Years - 80 Years
Sex: ALL

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:
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

Outcomes:
Feasibility - Recruitment; Feasibility - Retainment; Feasibility - Fitbit wear; Feasibility - Text message responses; Feasibility - Technical issues; Acceptability - Participant Experience and Satisfaction