Clinical trial NCT07005362: Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D
Official title: Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
T2DM (Type 2 Diabetes Mellitus)
T2D
T2DM
Remote Patient Monitoring
Artificial Intelegence
Keywords: type 2 diabetes
artificial intelligence
fitbit
primary care
remote patient monitoring
physical activity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Academy of Family Physicians
First posted: 2025-06-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

Brief 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.


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

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: 6 months
measure: Feasibility - Retainment
timeFrame: 6 months
measure: Feasibility - Fitbit wear
timeFrame: 12 Weeks
measure: Feasibility - Text message responses
timeFrame: 12 Weeks
measure: Feasibility - Technical issues
timeFrame: 12 Weeks
measure: Acceptability - Participant Experience and Satisfaction
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 12 Weeks
measure: Change in Body Mass Index
timeFrame: 12 Weeks
measure: Change in lipid panel
timeFrame: 12 Weeks
measure: Change in weight
timeFrame: 12 Weeks
measure: Change in blood pressure
timeFrame: 12 Weeks
measure: Change in diabetes distress
timeFrame: 12 Weeks
measure: Experience with technology
timeFrame: 12 Weeks
measure: Experience with technology
timeFrame: 12 Weeks
measure: Cost
timeFrame: Weekly, 12 weeks
measure: Revenue
timeFrame: Weekly, 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado Anschutz Medical School
name: Seth Kramer, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References: