RECRUITING

Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D

Conditions

Type 2 Diabetes Type 2 Diabetes Mellitus (T2DM)T2DM (Type 2 Diabetes Mellitus)T2D T2DM Remote Patient Monitoring Artificial Intelegence artificial intelligence fitbit primary care physical activity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings

Quick Facts

Study Start:2025-09-03

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07005362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jessica Parascando, MPH

CONTACT

303-724-9525

jessica.parascando@cuanschutz.edu

Elizabeth Westfeldt, BSN, RN

CONTACT

elizabeth.westfeldt@cuanschutz.edu

Principal Investigator

Seth Kramer, DO, MPH

PRINCIPAL_INVESTIGATOR

University of Colorado Anschutz Medical School

Study Locations (Sites)

University of Colorado, Anschutz

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Seth Kramer, DO, MPH, PRINCIPAL_INVESTIGATOR, University of Colorado Anschutz Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-03

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-09-03

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

type 2 diabetes
artificial intelligence
fitbit
primary care
remote patient monitoring
physical activity

Additional Relevant MeSH Terms

Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
T2DM (Type 2 Diabetes Mellitus)
T2D
T2DM
Remote Patient Monitoring
Artificial Intelegence