Introduction & Objective: The Bigfoot Unity® System is an FDA-cleared smart pen cap system incorporating CGM data (Abbott FreeStyle Libre 2), real-time alerts, and clinician-directed insulin dose recommendations. The objective was to analyze real world, 6-month data for System users.
Methods: We conducted a per-protocol 6-month analysis (N=102) from the prospective, BURST study (NCT05088265). Participants completed baseline, adverse event and patient reported outcome surveys electronically. A1C data were from a home kit or electronic medical record.
Results: Median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic and 59% female. Mean A1C decreased from 9.1±1.7% at baseline to 8.0±1.2% at 6 months (mean difference -1.1%, 95%CI -1.4, -0.8; p<0.001). Six severe hypoglycemia events in 4 participants (none System related) and no DKA occurred. Diabetes Distress Scale scores decreased (mean difference -0.7, 95%CI -0.9, -0.5; p<0.001) and Hypoglycemia Confidence Scale scores increased (mean difference 0.4, 95%CI 0.2, 0.5; p<0.001) with System use (Table).
Conclusion: Glycemic improvement along with reduced diabetes distress and increased hypoglycemia confidence occurred using Bigfoot Unity for 6 months. The reduction in A1C occurred while meeting established hypoglycemia targets of <4 and <1% for percent time below 70 and 54 mg/dL, respectively.
J. Tillman: Employee; Abbott. R. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel. W.H. Polonsky: Research Support; Abbott Diagnostics, Dexcom, Inc. Consultant; Eli Lilly and Company, Sanofi. Advisory Panel; embecta. Consultant; Vertex Pharmaceuticals Incorporated. Advisory Panel; 9am Health. P. Calhoun: None. T.J. Mouse: Research Support; Bigfoot Biomedical, Inc., MannKind Corporation. R. Bailey: None. J. Jacoby: Employee; Bigfoot Biomedical, Inc., Beta Bionics, Inc., Sequel Med Tech. R. Nandan: Employee; Abbott, Bigfoot Biomedical, Inc. J.K. Malone: Employee; Bigfoot Biomedical, Inc., Abbott.
Abbott
