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.
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)
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
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).
Cohort
Prospective
Fitbit and AI Chatbot
BehavioralParticipants 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 interventionThe control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.
Feasibility - Recruitment
Recruitment of 36 adults within 6 months.
Feasibility - Retainment
Retainment of 85% of participants for post-assessments.
Feasibility - Fitbit wear
Fitbit wear ≥ 5 days/week \> 12 hours per day, wear at night \> 3 nights/week.
Feasibility - Text message responses
Responding to 80% of text messages when prompted.
Change in HbA1c
Change in HbA1c from baseline to post-intervention.
Change in Body Mass Index
Change in Body Mass Index (BMI) from baseline to post-intervention.
Change in lipid panel
Change in lipid panel from baseline to post-intervention.
Change in weight
Change in weight from baseline to post-intervention.
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University of Colorado, Denver
Lead sponsor
American Academy of Family Physicians
Collaborator
