University of Colorado, Anschutz
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT07005362
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 6 months
Recruitment of 36 adults within 6 months.
Time frame: 6 months
Retainment of 85% of participants for post-assessments.
Time frame: 12 Weeks
Fitbit wear ≥ 5 days/week > 12 hours per day, wear at night > 3 nights/week.
Time frame: 12 Weeks
Responding to 80% of text messages when prompted.
Time frame: 12 Weeks
Participation with ≤10% technical issues (battery life, data sync between device and app/dashboard, device failure).
Time frame: 12 Weeks
Obtaining > 60% satisfaction from participants via a satisfaction survey.
Time frame: 12 Weeks
Change in HbA1c from baseline to post-intervention.
Time frame: 12 Weeks
Change in Body Mass Index (BMI) from baseline to post-intervention.
Time frame: 12 Weeks
Change in lipid panel from baseline to post-intervention.
Time frame: 12 Weeks
Change in weight from baseline to post-intervention.
Time frame: 12 Weeks
Change in blood pressure from baseline to post-intervention.
Time frame: 12 Weeks
Change in diabetes distress as measured by the T2-DDAS: The Type 2 Diabetes Distress Assessment System from baseline to post-intervention.
Time frame: 12 Weeks
Patient experience with technology as measured via the System Usability Scale (SUS).
Time frame: 12 Weeks
Patient experience with technology as measured via the FACETS Comfort with Technology assessment.
Time frame: Weekly, 12 weeks
Cost of delivering remote patient monitoring intervention as measured via time-diaries and patient logs.
Time frame: Weekly, 12 weeks
Revenue modeling from practice perspective of remote patient monitoring intervention as measured via staff and patient time logs.
Contact information is provided by the study sponsor or research team.
Elizabeth Westfeldt, BSN, RN
CONTACT
Jessica Parascando, MPH
CONTACT
University of Colorado, Denver
Other
Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings
Acronym: FIT T2D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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