Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

NCT07005362 | Recruiting

• 1 other identifier: 24-2577
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

type 2 diabetes; artificial intelligence; fitbit; primary care; remote patient monitoring; physical activity

Outcome Measures

Primary Outcomes (6)

• Feasibility - Recruitment

  Recruitment of 36 adults within 6 months.

  6 months

• Feasibility - Retainment

  Retainment of 85% of participants for post-assessments.

  6 months

• Feasibility - Fitbit wear

  Fitbit wear ≥ 5 days/week \> 12 hours per day, wear at night \> 3 nights/week.

  12 Weeks

• Feasibility - Text message responses

  Responding to 80% of text messages when prompted.

  12 Weeks

• Feasibility - Technical issues

  Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).

  12 Weeks

• Acceptability - Participant Experience and Satisfaction

  Obtaining \> 60% satisfaction from participants via a satisfaction survey.

  12 Weeks

Secondary Outcomes (10)

• Change in HbA1c

  12 Weeks

• Change in Body Mass Index

  12 Weeks

• Change in lipid panel

  12 Weeks

• Change in weight

  12 Weeks

• Change in blood pressure

  12 Weeks

Study Arms (2)

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.

Behavioral: Fitbit and AI Chatbot

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.

Other: Routine Care

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.

Experimental: Fitbit and AI Chatbot

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.

Active Comparator: Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care adult patients diagnosed with type 2 diabetes who do 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Academy of Family Physicians: collaborator

Study Sites (1)

University of Colorado, Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Seth Kramer, DO, MPH

  University of Colorado Anschutz Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Parascando, MPH

CONTACT

303-724-9525; jessica.parascando@cuanschutz.edu

Elizabeth Westfeldt, BSN, RN

CONTACT

elizabeth.westfeldt@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 5, 2025
• Study Start: September 3, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (1)