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NCT Number: NCT07005362

Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Anschutz

Aurora, Colorado, 80045, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility - Recruitment

    Time frame: 6 months

    Recruitment of 36 adults within 6 months.

  2. Feasibility - Retainment

    Time frame: 6 months

    Retainment of 85% of participants for post-assessments.

  3. Feasibility - Fitbit wear

    Time frame: 12 Weeks

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

  4. Feasibility - Text message responses

    Time frame: 12 Weeks

    Responding to 80% of text messages when prompted.

  5. Feasibility - Technical issues

    Time frame: 12 Weeks

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

  6. Acceptability - Participant Experience and Satisfaction

    Time frame: 12 Weeks

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

Secondary outcomes

  1. Change in HbA1c

    Time frame: 12 Weeks

    Change in HbA1c from baseline to post-intervention.

  2. Change in Body Mass Index

    Time frame: 12 Weeks

    Change in Body Mass Index (BMI) from baseline to post-intervention.

  3. Change in lipid panel

    Time frame: 12 Weeks

    Change in lipid panel from baseline to post-intervention.

  4. Change in weight

    Time frame: 12 Weeks

    Change in weight from baseline to post-intervention.

  5. Change in blood pressure

    Time frame: 12 Weeks

    Change in blood pressure from baseline to post-intervention.

  6. Change in diabetes distress

    Time frame: 12 Weeks

    Change in diabetes distress as measured by the T2-DDAS: The Type 2 Diabetes Distress Assessment System from baseline to post-intervention.

  7. Experience with technology

    Time frame: 12 Weeks

    Patient experience with technology as measured via the System Usability Scale (SUS).

  8. Experience with technology

    Time frame: 12 Weeks

    Patient experience with technology as measured via the FACETS Comfort with Technology assessment.

  9. Cost

    Time frame: Weekly, 12 weeks

    Cost of delivering remote patient monitoring intervention as measured via time-diaries and patient logs.

  10. Revenue

    Time frame: Weekly, 12 weeks

    Revenue modeling from practice perspective of remote patient monitoring intervention as measured via staff and patient time logs.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Westfeldt, BSN, RN

CONTACT

[email protected]

Jessica Parascando, MPH

CONTACT

[email protected]

303-724-9525

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Academy of Family Physicians

Registry information

Official study title

Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings

Acronym: FIT T2D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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