Abstract #1402689: Real World Experience with Bigfoot Unity: A Six-Month Retrospective Analysis

Abstract

The Bigfoot Unity® Diabetes Management System is an FDA-cleared smart pen cap system incorporating continuous glucose monitoring (CGM; Abbott FreeStyle Libre 2) data, real-time alerts, and clinician-directed dose recommendations. The objective was to analyze real world, 6-month use data for those with insulin requiring diabetes using Bigfoot Unity for multiple daily injections (MDI). A retrospective analysis was performed using de-identified data and a prespecified analysis plan. A cohort with type 1 and type 2 diabetes (N=103 at 21 clinics) managing MDI with Bigfoot Unity for ≥180 days is reported. At least 50% of CGM data were required in the first 2 weeks and in the 6th month of System use. An HbA1c (A1C) prior to starting Bigfoot Unity was obtained from clinic medical records (N=96). The mean age was 63.8 years and 83.5% had type 2 diabetes. Mean A1C prior to Bigfoot Unity use was 8.4 ± 1.7% (N=96). Mean glucose management indicator (GMI) in the first 2 weeks of use and in the 6th month of use was 7.2 ± 0.8% and 7.4 ± 0.8% (N=103), respectively. Using GMI as a proxy for A1C, pairwise comparisons in N=96 with data available at baseline through 6 months use show an estimated improvement in glycemic control of 1.0 ± 1.5% (P < 0.05). TIR was 64.7 ± 20.5% and 62.2 ± 20.9% with time below 54 mg/dL of 0.1 ± 0.5% and 0.1 ± 0.3% at 2 weeks and in the 6th month of use, respectively. The average number of rapid-acting doses per day was 3.0 ± 1.1 and 2.4 ± 1.1 in the first 2 weeks, and 6th month of use, respectively. The average number of long-acting doses per week was 7.5 ± 2.9, and 6.8 ± 2.5 in the first 2 weeks and 6th month of use, respectively. These data indicate that for this cohort, consisting primarily of older adults with type 2 diabetes using MDI having suboptimal glycemic control, using the Bigfoot Unity System has the potential for rapid and durable glycemic improvement. Limitations include the retrospective analysis with no control group, relatively small sample size and lack of direct adverse event data. Also, A1Cs were available at baseline but not during System use, but strong correlation between A1C and GMI support our approach of using GMI as a proxy of A1C. Our findings of an average of 2.4 rapid-acting doses per day and an average of 6.8 long-acting doses per week in the 6th month suggest minimal missed injections overall. Considering the cohort’s older age, results demonstrate close adherence to established glycemic targets including a relatively short time spent in the hypoglycemia range; for example, mean time below 54 mg/dL of 0.1% is below established clinical guidelines of 1 percent.