Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis.

Context: The Bigfoot Unity Diabetes Management System integrates Abbott FreeStyle Libre 2 continuous glucose monitoring (CGM) data into a smart insulin pen cap and mobile app, enabling clinician-directed insulin dose recommendations and real-time alerts.

Objective: The objective was to analyze real-world 6-month glycemic control in a prospective study for individuals using the System for multiple daily insulin injections (MDI).

Methods: We conducted a 6-month analysis from the BURST study (NCT05088265) of individuals with type 1 or type 2 diabetes (T2D). Participants reported baseline demographics, adverse events, and other survey data electronically. Either at-home kit or electronic medical record glycated hemoglobin A1c (HbA1c) data were collected.

Results: Of 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female. Mean HbA1c decreased from 9.1 ± 1.7% at baseline to 8.0 ± 1.2% at 6 months (mean difference -1.1%, 95% CI -1.4 to -0.8, P < .001). At 6 months, time in range (70-180 mg/dL), time at < 70 mg/dL, and time at < 54 mg/dL were 56 ± 23%, 1.0 ± 1.4%, and 0.04 ± 0.14%, respectively. Six severe hypoglycemia events occurred in 4 participants (none System-related) and no diabetic ketoacidosis events occurred in the per protocol cohort.

Conclusion: In this study primarily of older adults with T2D using MDI, durable glycemic improvement occurred using the System at 6 months, with the frequency of hypoglycemia being substantially below established targets of < 4% and < 1% for time below 70 and 54 mg/dL, respectively.