Abstract

Background: The Bigfoot Unity® System incorporates CGM data, real-time alerts, and clinician-directed dose recommendations. Clinicians use a web portal to view patient data remotely. Our objective was to analyze real world data from rural and urban subgroups. Methods: A 6-month retrospective analysis was done using a prespecified analysis plan for commercial users with ≥50% CGM data at 6 months (N=127, 24 clinics). A baseline A1C was obtained from clinic medical records (N=118). Glycemic and System engagement outcomes for those living in urban (N=102) and rural (N=25) zip codes were compared. Results: Most in urban and rural groups had T2D (82 v 84%); mean age was 65 and 61 years, respectively. Urban users had mean baseline A1C of 8.4±1.6% and 7.5±0.8% mean GMI at 6 months; rural users had baseline A1C of 8.5±1.9% and 6-month GMI of 7.2±0.8%. Subgroup outcomes are shown (Table). Using GMI as an A1C proxy, pairwise comparisons of 6 month GMI to baseline A1C in the overall cohort (N=118) show a 1.1±1.4% improvement (P <0.05). Discussion: Overall, both groups were primarily older adults with T2D using MDI and having suboptimal glycemic control before System use. Given concerns with disparity in diabetes management in rural areas, we evaluated rural and urban users of Bigfoot Unity. The rural cohort was small but data suggests that for both groups, using the System resulted in similar improved and durable glycemic control at 6 months. Disclosure J.Tillman: Employee; Bigfoot Biomedical, Inc. B.P.Olson: Employee; Bigfoot Biomedical, Inc. S.Vaughan: Employee; Bigfoot Biomedical, Inc. F.Sheikh: Employee; Bigfoot Biomedical, Inc. J.K.Malone: Employee; Bigfoot Biomedical, Inc. Funding Bigfoot Biomedical, Inc.

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