Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D (FIT T2D)

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Artificial Intelegence; Type 2 Diabetes Mellitus (T2DM); T2DM; Remote Patient Monitoring; Type 2 Diabetes; T2D; T2DM (Type 2 Diabetes Mellitus)

Treatments: Other: Routine Care; Behavioral: Fitbit and AI Chatbot

Study type: Observational

Funder types: Other

Identifiers

NCT07005362

24-2577

Details and patient eligibility

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 2 patient groups

Experimental: Fitbit and AI Chatbot

Description:

Participants will wear their Fitbit devices daily and receive personalized messages from the AI Chatbot weekly with setting a new exercise goal based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support, education, and goal setting. Participants will interact throughout the week on completing their goal or where they might improve.

Treatment:

Behavioral: Fitbit and AI Chatbot

Active Comparator: Controls

Description:

The control group will be established through a rigorous retrospective chart review of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.

Treatment:

Other: Routine Care