Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07005362
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Fitbit and AI Chatbot — BEHAVIORAL
    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.
  • Routine Care — OTHER
    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.

Study Details

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.

Key Dates

Start date
Sep 3, 2025
Status verified
May 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
36 participants (estimated)

Arms

  • Arm: Experimental: Fitbit and AI Chatbot
    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.
  • Arm: Active Comparator: Controls
    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.

Primary Outcome Measure

Feasibility - Recruitment [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado, AnschutzAuroraColorado80045-

Find similar trials in Aurora, CO

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Colorado, Anschutz· Aurora, CO

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