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

Abstract

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.

Keywords: connected pen; continuous glucose monitor; multiple daily injections; real-world evidence; smart pen cap.

Figure 1.

Participant flow diagram. ^aFive (5) participants withdrew from the study prior to their 3-month window; 2 participants were no longer seeing the prescribing health care professional, no longer using the System and asked to be withdrawn; 2 simply stated they no longer wished to participate; and 1 participant was withdrawn due to death. ^bAs noted, 4 were not included in the analysis due to having 3-month data that was still pending at the time of the analysis. ^cOne (1) participant who died during follow-up was active in the study during their 3-month window but provided insufficient CGM/HbA_1c data to be analyzed in the expanded cohort. One (1) participant who died during follow-up provided sufficient CGM/HbA_1c to be analyzed in the expanded cohort but not the per protocol cohort. ^dThree (3) participants requested to withdraw prior to the 6-month window; 1 participant was no longer using the System as was no longer on multiple daily injections and asked to be withdrawn; 1 simply stated they no longer wished to participate; and 1 participant was no longer using the System due to lack of insurance coverage and asked to be withdrawn. ^eAs noted, 15 were not included in the analysis due to having 6-month data that was still pending at the time of the analysis.

Figure 2.

Glycated hemoglobin A1c (HbA_1c) and glucose management indicator (GMI) in the Per Protocol Cohort. A, Comparison of baseline HbA_1c and 3- and 6-month HbA_1c (left side of panel) along with GMI within the first 2 weeks and within the third and sixth month of use (right side of panel). The median timing of baseline HbA_1c prior to System start was 16 days. B, Comparison of baseline HbA_1c and 6-month HbA_1c within type 1 diabetes (T1D) and type 2 diabetes (T2D). C, Comparison of baseline HbA_1c and 6-month HbA_1c within baseline HbA_1c subgroups (those ≥ 8% vs < 8%). For panels A, B, and C, data represent mean and 95% CI; in panel A, the P value indicates that the HbA_1c at 3 and 6 months is statistically significantly different from the baseline HbA_1c.

Figure 3.

Time in ranges. Time in range, time above range, and time below range are shown for the overall per protocol cohort and within type 1 diabetes (T1D) and type 2 diabetes (T2D) subgroups, for the sixth month of System use. Data represent the mean percentage within each range.