Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

Not yet recruiting

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

• Registration Number: NCT07005362
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-06-02
• Study First Posted: 2025-06-05
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-15
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility - Recruitment	6 months	Recruitment of 36 adults within 6 months.
Feasibility - Retainment	6 months	Retainment of 85% of participants for post-assessments.
Feasibility - Text message responses	12 Weeks	Responding to 80% of text messages when prompted.
Feasibility - Fitbit wear	12 Weeks	Fitbit wear ≥ 5 days/week \> 12 hours per day, wear at night \> 3 nights/week.
Feasibility - Technical issues	12 Weeks	Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).
Acceptability - Participant Experience and Satisfaction	12 Weeks	Obtaining \> 60% satisfaction from participants via a satisfaction survey.

Secondary Outcome Measures

Name	Time	Method
Cost	Weekly, 12 weeks	Cost of delivering remote patient monitoring intervention as measured via time-diaries and patient logs.
Change in HbA1c	12 Weeks	Change in HbA1c from baseline to post-intervention.
Change in Body Mass Index	12 Weeks	Change in Body Mass Index (BMI) from baseline to post-intervention.
Change in lipid panel	12 Weeks	Change in lipid panel from baseline to post-intervention.
Change in weight	12 Weeks	Change in weight from baseline to post-intervention.
Change in blood pressure	12 Weeks	Change in blood pressure from baseline to post-intervention.
Change in diabetes distress	12 Weeks	Change in diabetes distress as measured by the T2-DDAS: The Type 2 Diabetes Distress Assessment System from baseline to post-intervention.
Experience with technology	12 Weeks	Patient experience with technology as measured via the FACETS Comfort with Technology assessment.
Revenue	Weekly, 12 weeks	Revenue modeling from practice perspective of remote patient monitoring intervention as measured via staff and patient time logs.

Trial Locations

Locations (1)

University of Colorado, Anschutz; 🇺🇸 Aurora, Colorado, United States