Fitbit and AI chatbot support for sedentary adults with type 2 diabetes
Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
This 12-week program tests whether giving sedentary adults with type 2 diabetes a Fitbit plus an AI chatbot that sends tailored diabetes tips and text messages can help increase activity and improve diabetes control.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07005362 on ClinicalTrials.gov |
What this trial studies
This observational 12-week program enrolls adults aged 18–80 with type 2 diabetes who are insufficiently active. Participants receive a Fitbit, interact with an AI-delivered diabetes self-management education and support program via tailored text messages, and continue routine care. Data are collected at a baseline visit and a final visit, and activity is passively recorded by the wearable while clinical measures such as A1c are obtained from medical records or study testing. The study tests feasibility, acceptability, and whether engagement with these remote tools relates to changes in activity and clinical outcomes.
Who should consider this trial
Good fit: Adults 18–80 with diagnosed type 2 diabetes who do less than 150 minutes of aerobic activity per week, have a compatible smartphone, and are willing to wear a Fitbit and answer text messages are ideal candidates.
Not a fit: People who are already regularly active (exceeding the study's activity thresholds), have coronary artery disease or other unstable medical conditions, or lack a compatible smartphone are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could increase physical activity, improve blood sugar control, and offer scalable remote self-management support for people with type 2 diabetes.
How similar studies have performed: Previous studies of wearables and digital DSMES have shown modest improvements in activity and glycemic outcomes, but delivering DSMES via AI chatbots in primary care populations is a relatively new approach with limited high-quality evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado, Anschutz — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Seth Kramer, DO, MPH — University of Colorado Anschutz Medical School
- Study coordinator: Jessica Parascando, MPH
- Email: jessica.parascando@cuanschutz.edu
- Phone: 303-724-9525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.