COmparing Efficacies of DSMES vs. CGM Use in MAnaging Type 2 Diabetes of Rural Southern US Diabetics (OMEGA-T2D): A Randomized Controlled Trial Proposal (Preprint)

Abstract

UNSTRUCTURED Type 2 diabetes is a chronic condition characterized by elevated blood glucose that is a major contributor to health care costs, lower quality of life, morbidity and mortality. According to the Health Resources & Services Administration of the U.S. Department of Health & Human Services, the prevalence of diabetes in adults is significantly higher for those residing in rural areas than in urban areas. Residents in rural Southern United States communities experience a higher risk for of diabetes due to a variety of socioeconomic and lifestyle factors, including lack of access to affordable healthcare. This, coupled with the geographic isolation characteristic of rural areas, impacts the ability of those in rural areas to have access in optimal diabetes care. For this reason, it is crucial to choose the best feasible, effective intervention that would allow for this population to manage their diabetes. One option is a virtual DSMES program. Technology could potentially aid rural residents with diabetes in gaining access to DSMES programs, specifically in areas where in-person DSMES programs are not available. Additionally, participants have access to the same DSMES resources and tools available as that in an in-person program. Thus, a virtual DSMES program can reduce the logistical barrier related to transportation or lack of available providers, thereby facilitating greater participation can help achieve health equity by making DSMES services accessible to underserved communities. Another option is a continuous glucose device (CGM). CGMs provide individuals with real-time information about their glucose levels that can help them make more informed decisions about their diet, exercise, and medication. By seeing how their glucose levels respond to different foods, exercise, and medications, they can adjust your habits to keep their glucose levels in a healthy range. CGMs eliminate the need for frequent fingersticks, making it easier to manage one’s diabetes. The objective of this study is to conduct a randomized controlled trial comparing Diabetes Self-Management Education and Support (DSMES) program delivered virtually versus continuous glucose monitoring (CGM). The primary outcome is change from baseline in hemoglobin A1c. Secondary outcomes will be acceptability of the assigned intervention and change in diabetes-related distress, assessed by standardized questionnaires. The study population will consist of approximately 150 adults from the rural southern United States who have type 2 diabetes and hemoglobin A1c ≥ 9.0%. Participants will be recruited from selected emergency rooms as well as primary care practices that are affiliated with a large, academic medical center. Study staff will screen the clinic schedules of these practices for patients. Potential participants who agree to enroll will be randomized into one of two interventions. Intervention A participants will be enrolled in a virtual DSMES program consisting of approved diabetes education materials, biweekly DSMES sessions, and a fingerstick glucometer device. Intervention B participants will be provided a CGM device and brief education on its use for diabetes monitoring. This study will help determine which of these evidence-based interventions is more effective in helping rural southern US individuals with diabetes manage their condition. Should a public health program be developed to help rural southern US Type 2 diabetics manage their condition, the findings from this study would offer a foundation of evidence to assist health systems and policy makers in choosing the best possible interventions for this high-risk population.