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Find a Research Study

Find a Research Study

Find a Research Study

Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults with Type 2 Diabetes in Primary Care Settings (FIT T2D)

The primary outcome variable will be to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and AI-delivered diabetes self-management education and support (DSMES) with tailored text messages. 


Why this Research Matters

-Text Messaging Interventions in Type 2 Diabetes Mellitus Mobile health (mHealth) interventions, particularly those using text messaging, have emerged as promising tools for improving health behaviors and outcomes in patients with type 2 diabetes mellitus (T2DM).3 Text messaging interventions (TMIs) are widely accessible, can be used for various purposes such as medication reminders, patient education, and motivation. A key benefit of text messaging is its ability to provide continuous education, reminders, and support between clinic visits without intensive staff management. Some studies have demonstrated that text messaging interventions can improve glycemic control3 -Need for Scalable Solutions Given the prevalence of T2D nationally and within primary care settings and the scarcity of specialized resources, scalable and sustainable interventions are urgently required to assist patients in reaching their activity goals and improving their overall health outcomes. Remote patient monitoring (RPM) of physiologic data, including physical activity, presents an opportunity to bridge this gap and provide accessible support to patients, especially when integrated into the routine care provided by primary care practices. Importantly, RPM services are billable and reimbursable within primary care, creating a distinct avenue for sustainable implementation. 4,5 -Rationale Recent studies have explored integrating personal fitness technology, such as Fitbit activity trackers, into the management of T2D.6,7 These studies provide promising evidence of the potential benefits of incorporating technology-assisted interventions to improve behavioral, clinical, and psychosocial outcomes for sedentary patients with T2D. Jiwani et al. (2021) conducted focus group interviews among older adults with T2D using a behavioral lifestyle intervention that integrated Fitbit technology.8 Participants reported favorable experiences, including increased knowledge of health behaviors, improved diabetes management, and enhanced quality of life. Hodgson et al. (2021) conducted a mixed-methods study using Fitbit activity trackers among adults with T2D.6 Participants showed increased physical activity and reduced sedentary behavior, with positive experiences and motivation attributed to Fitbit technology. Health professionals also expressed support for using Fitbit trackers in T2D care. Beyond activity tracking, tailored text messaging interventions have also been shown to improve glycemic management in multiple studies of patients with T2D, as demonstrated in a 2019 systematic review and meta-analysis of 13 distinct studies by Sahin et al. (2019).9


Who can Participate

Adult

The population to be enrolled in this study will be adults between 18 and 80 years old with type 2 diabetes who do not meet the American Diabetes Association’s goals for physical activity defined as greater than 150 minutes of moderate-intensity aerobic activity per week. -Eligible patients must meet the following: 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: Patients will be excluded if they meet any of the following: 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


Study ID

Protocol Number: 24-2577


Meet the Team

Image of Principal Investigator

Erik Kramer, DO, MPH

Principal Investigator