NCT07005362 Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
| NCT ID | NCT07005362 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2025-09-03 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Seth Kramer, DO, MPH
PRINCIPAL INVESTIGATOR
University of Colorado Anschutz Medical School
Frequently Asked Questions
Who can join the NCT07005362 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07005362 currently recruiting?
Yes, NCT07005362 is actively recruiting participants. Contact the research team at jessica.parascando@cuanschutz.edu for enrollment information.
Where is the NCT07005362 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07005362 clinical trial?
NCT07005362 is sponsored by University of Colorado, Denver. The principal investigator is Seth Kramer, DO, MPH at University of Colorado Anschutz Medical School. The trial plans to enroll 36 participants.
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