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. 2023 Fall;41(4):539-548.
doi: 10.2337/cd22-0126. Epub 2023 Jun 21.

First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis

Bantwal S Baliga  1 , John B Tillman  2 , Byron Olson  2 , Sarah Vaughan  2 , F Naureen Sheikh  2 , James K Malone  2
Affiliations

First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis

Bantwal S Baliga et al. Clin Diabetes. 2023 Fall.

Abstract

The Bigfoot Unity Diabetes Management System, a smart pen cap system cleared by the U.S. Food and Drug Administration in May 2021, incorporates continuous glucose monitoring data, real-time glycemic alerts, and clinician-directed dose recommendations. This study analyzed real-world clinical outcomes data for an initial cohort (n = 58, from 13 clinics) managing multiple daily injection insulin therapy using the pen cap system for 6 months. We examined glycemic control, including hypoglycemia events and interaction with and use of the pen cap system. In a cohort mainly consisting of adults with type 2 diabetes and an average age of 62 years, the results demonstrate close adherence to established glycemic targets, including a relatively short amount of time spent in the hypoglycemic range.

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Conflict of interest statement

B.S.B. has received consulting fees and is on a paid speakers bureau for Bigfoot Biomedical, Inc. J.B.T., B.O., S.V., and J.K.M. are employees of Bigfoot Biomedical, Inc. F.N.S. is a former employee of Bigfoot Biomedical, Inc.

Figures

FIGURE 1
FIGURE 1
GMI compared with baseline A1C. A: Pairwise comparisons of baseline A1C and GMI in the first 2 weeks, third month, and sixth month of use for the cohort with data available for each period (n = 50). B: Comparison of baseline A1C and GMI in the sixth month of use for baseline A1C subgroups (≥8% vs. <8%). For A and B, data represent mean and 95% CI; *GMI is significantly different (P <0.05) from baseline A1C using the Wilcoxon signed rank test. C: Change plot for baseline A1C to GMI in the sixth month. Lines reflect subgroups for various starting A1C levels based on 1-point increments. Data reflect those in the cohort with both parameters (n = 51). Line thickness reflects number of individuals in each A1C level.
FIGURE 2
FIGURE 2
Stacked bar chart for times in ranges for type 1 and type 2 diabetes subgroups. TIR, TAR, and TBR are shown by diabetes type for the sixth month of system use. Data represent the mean percentage within each range.
FIGURE 3
FIGURE 3
Preprandial and postprandial glucose. Preprandial and postprandial average glucose are shown for the third month of use when the system displayed an HCP-recommended correction dose versus when no correction was suggested (A). Similar preprandial and postprandial average glucose data are shown for the sixth month (B). In both A and B, data represent mean and 95% CI. *Difference in postprandial glucose from the preprandial glucose is statistically significant (P <0.05) using the paired t test.
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