Examining the Use of Glucose and Physical Activity Self-Monitoring Technologies in Individuals at Moderate to High Risk of Developing Type 2 Diabetes: Randomized Trial

Abstract

Background: Self-monitoring of behavior (namely, diet and physical activity) and physiology (namely, glucose) has been shown to be effective in type 2 diabetes (T2D) and prediabetes prevention. By combining self-monitoring technologies, the acute physiological consequences of behaviors could be shown, prompting greater consideration to physical activity levels today, which impact the risk of developing diabetes years or decades later. However, until recently, commercially available technologies have not been able to show individuals the health benefits of being physically active. Objective: The objective of this study was to examine the usage, feasibility, and acceptability of behavioral and physiological self-monitoring technologies in individuals at risk of developing T2D. Methods: A total of 45 adults aged .40 years and at moderate to high risk of T2D were recruited to take part in a 3-arm feasibility trial. Each participant was provided with a behavioral (Fitbit Charge 2) and physiological (FreeStyle Libre flash glucose monitor) monitor for 6 weeks, masked according to group allocation. Participants were allocated to glucose feedback (4 weeks) followed by glucose and physical activity (biobehavioral) feedback (2 weeks; group 1), physical activity feedback (4 weeks) followed by biobehavioral feedback (2 weeks; group 2), or biobehavioral feedback (6 weeks; group 3). Participant usage (including time spent on the apps and number of glucose scans) was the primary outcome. Secondary outcomes were the feasibility (including recruitment and number of sensor displacements) and acceptability (including monitor wear time) of the intervention. Semistructured qualitative interviews were conducted at the 6-week follow-up appointment. Results: For usage, time spent on the Fitbit and FreeStyle Libre apps declined over the 6 weeks for all groups. Of the FreeStyle Libre sensor scans conducted by participants, 17% (1798/10,582) recorded rising or falling trends in glucose, and 24% (13/45) of participants changed .1 of the physical activity goals. For feasibility, 49% (22/45) of participants completed the study using the minimum number of FreeStyle Libre sensors, and a total of 41 sensors were declared faulty or displaced. For acceptability, participants wore the Fitbit for 40.1 (SD 3.2) days, and 20% (9/45) of participants and 53% (24/45) of participants were prompted by email to charge or sync the Fitbit, respectively. Interviews unearthed participant perceptions on the study design by suggesting refinements to the eligibility criteria and highlighting important issues about the usability, wearability, and features of the technologies. Conclusions: Individuals at risk of developing T2D engaged with wearable digital health technologies providing behavioral and physiological feedback. Modifications are required to both the study and to commercially available technologies to maximize the chances of sustained usage and behavior change. The study and intervention were feasible to conduct and acceptable to most participants. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 17545949; isrctn.com/ISRCTN17545949