968-P: Real-World Comparison of Younger and Older Cohorts Using the Bigfoot Unity System for Six Months

Abstract

Background: The Bigfoot Unity® System is an FDA-cleared smart pen cap system incorporating CGM data, real-time alerts, and clinician-directed dose recommendations. The objective was to analyze real world data from younger and older subgroups using the System for MDI. Methods: We conducted a 6-month retrospective analysis using deidentified data and a prespecified analysis plan for commercial users with ≥50% CGM data in the 6th month (N=127, 24 clinics). A baseline A1C was obtained from clinic medical records (N=118). Outcomes for those <65 (N=58) and ≥65 (N=69) years old were compared. Results: Most (83%) in each group had T2D; mean age in <65 and ≥65 groups was 54 and 73 years. Mean baseline A1C was 8.6±1.7% and 8.2±1.6% in the <65 and ≥65 groups; mean 6 month GMI was 7.5±0.9% and 7.3±0.8%, respectively. Glycemic outcomes and System use data are shown for age subgroups (Table). Using GMI as an A1C proxy, pairwise comparisons of GMI at 6 months to baseline A1C (N=118) show a 1.1±1.4% improvement overall (P<0.05). Discussion: The overall cohort consisted mostly of older T2D adults using MDI with suboptimal glycemic control. Given there may be concerns with older people adequately adopting and using new technology to manage diabetes, comparison with those younger highlights similar glycemic control and System engagement with Bigfoot Unity. Both groups demonstrate close adherence to established glycemic targets at 6 months. Disclosure S.Vaughan: Employee; Bigfoot Biomedical, Inc. J.Tillman: Employee; Bigfoot Biomedical, Inc. B.P.Olson: Employee; Bigfoot Biomedical, Inc. F.Sheikh: Employee; Bigfoot Biomedical, Inc. J.K.Malone: Employee; Bigfoot Biomedical, Inc. Funding Bigfoot Biomedical, Inc.