Recruiting NCT07005362
Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fitbit and AI Chatbot, Routine Care.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM), T2DM (Type 2 Diabetes Mellitus), T2D. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Overview
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.
Interventions
- Behavioral Fitbit and AI Chatbot
Participants 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. - Other Routine Care
The control group will consist of patients with type 2 diabetes who meet the study's inclusion criteria but have not participated in the intervention.
Primary outcome measures
- Feasibility - Recruitment [Time frame: 6 months]
- Feasibility - Retainment [Time frame: 6 months]
- Feasibility - Fitbit wear [Time frame: 12 Weeks]
- Feasibility - Text message responses [Time frame: 12 Weeks]
- Feasibility - Technical issues [Time frame: 12 Weeks]
- Acceptability - Participant Experience and Satisfaction [Time frame: 12 Weeks]
Secondary outcome measures (10)
- Change in HbA1c [Time frame: 12 Weeks]
- Change in Body Mass Index [Time frame: 12 Weeks]
- Change in lipid panel [Time frame: 12 Weeks]
- Change in weight [Time frame: 12 Weeks]
- Change in blood pressure [Time frame: 12 Weeks]
- Change in diabetes distress [Time frame: 12 Weeks]
- Experience with technology [Time frame: 12 Weeks]
- Experience with technology [Time frame: 12 Weeks]
- Cost [Time frame: Weekly, 12 weeks]
- Revenue [Time frame: Weekly, 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Colorado, Anschutz — Aurora
Identifiers
NCT: NCT07005362 · 24-2577