2902-LB: Real-World Experience with Bigfoot Unity: A Two-Year Retrospective Analysis

Introduction and Objective: The Bigfoot Unity System (System) is a smart pen cap system incorporating data from the FreeStyle Libre 2 Sensor and provides clinician-directed dose recommendations. The objective was to analyze real world 2-year data for a large cohort using the System for multiple daily injections (MDI). Methods: A retrospective analysis was performed using de-identified data for those using the System ≥50% of time in the 90 days prior to the 24 month period with a baseline A1C available from medical records (N=310). Safety data was derived from post-market surveillance Medical Device Reports (MDRs) to the FDA. Results: The mean age was 66.6 years and 88.1% had type 2 diabetes. Mean baseline A1C was 8.8±1.8%. Mean GMI improved similarly at 3, 6, 12 and 24 month time periods (Figure); with GMI of 7.5±0.9% at 24 months. Over the first 2 years of system use, long-acting insulin therapy settings were changed an average of 2.9 times per user. Rapid-acting insulin therapy settings were changed an average of 1.9 times per user. Ten (10) MDRs were reported from 7 persons; these included 4 serious injury reports (severe hypoglycemia) and 6 malfunctions (with no adverse events). None of the severe hypoglycemia events were related to the device. Conclusion: For this 2-year cohort, primarily older adults with insulin-requiring type 2 diabetes using MDI, System use for 3 through 24 months resulted in stable glycemic improvement. Therapy settings changes were relatively infrequent over the 2-year period. Disclosure J. Tillman: Employee; Current; Abbott Diabetes. S. Vaughan: Consultant; Current; Abbott Diabetes. B. Olson: Employee; Current; Abbott Diabetes. A. Bindal: Employee; Current; Abbott Diabetes. Funding Abbott Diabetes Care