About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fitbit and AI Chatbot
  • Routine Care

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

1
University of Colorado, Anschutz80045, AuroraColorado, United States

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

American Academy of Family Physicians

Collaborator