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 weara
| Condition(s) | Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), T2DM (Type 2 Diabetes Mellitus), T2D, T2DM, Remote Patient Monitoring, Artificial Intelegence |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 u |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | University of Colorado, Denver |
| Locations | Aurora, Colorado, United States |
| Start date | 2025-09-03 |
| NCT ID | NCT07005362 |
| Official listing | https://clinicaltrials.gov/study/NCT07005362 |