Abstract
BACKGROUND: Diabetes is present in 10.5% of the US population and accounts for 14.3% of all office-based physician visits made by adults. Despite this established office-based approach, the disease and its adverse outcomes including glycemic control and clinical events tend to worsen over time. Available home technology now provides accurate, reliable data that can be transmitted directly to the electronic medical record. OBJECTIVE: This study aims to evaluate the impact of a virtual, home-based diabetes management program on clinical measures of diabetes control compared to usual care. METHODS: We evaluated glycemic control and other diabetes-related measures after 1 year in 763 patients with type 2 diabetes enrolled into a home-based digital medicine diabetes program and compared them to 794 patients matched for age, sex, race, BMI, hemoglobin A(1c) (HbA(1c)), creatinine, estimated glomerular filtration rate, and insulin use in a usual care group after 1 year. Digital medicine patients completed questionnaires online, received medication management and lifestyle recommendations from a clinical pharmacist or advanced practice provider and a health coach, and were asked to submit blood glucose readings using a commercially available Bluetooth-enabled glucose meter that transmitted data directly to the electronic medical record. RESULTS: After 1 year, usual care patients demonstrated no significant changes in HbA(1c) (mean 7.3, SE 1.7 to mean 7.3, SE 1.6; P=.41) or changes in the proportion of patients with HbA(1c)≥9.0 (n=117, 15% to n=113, 14%; P=.51). Digital medicine patients demonstrated improvements in HbA(1c) (mean 7.3, SE 1.5 to mean 6.9, SE 1.2; P<.001) and significant changes in the proportion of patients with HbA(1c)≥9.0 (n=107, 14% to n=49, 6%; P<.001), diabetes distress (n=198, 26% to n=122, 16%; P<.001), and hypoglycemic episodes (n=313, 41.1% to n=91, 11.9%; P<.001). CONCLUSIONS: A digital diabetes program is associated with significant improvement in glycemic control and other diabetes measures. The use of a virtual health intervention using connected devices was widely accepted across a broad range of ethnic diversity, ages, and levels of health literacy.