NCT07005362

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Type 2 Diabetes Mellitus (T2DM)
• T2DM (Type 2 Diabetes Mellitus)
• T2D
• T2DM
• Remote Patient Monitoring
• Artificial Intelegence

Interventions

Type	Name	Description
BEHAVIORAL	Fitbit and AI Chatbot	Participants will wear their Fitbit devices daily for 12-weeks and will receive personalized messages from the AI Chatbot every week with a new exercise recommendation based on their previous week's activity level. Additionally, they can engage with the AI Chatbot through text message for further support and education.
OTHER	Routine Care	The control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-06-05
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States