117-LB: Impact of Bigfoot Unity Integrated CGM on HbA1c

Introduction: Continuous glucose monitoring (CGM) is a preferred method of glucose monitoring. Bigfoot Unity Diabetes Management is an integrated CGM (iCGM) system that incorporates remote patient monitoring with a mobile app, smart pen caps, and CGM via Libre Freestyle 2 sensors. Smart pen caps attach to rapid-acting and long-acting insulin pens and sync with patients’ CGM sensors to provide insulin dose recommendations based on the health care provider's (HCP) instructions. The smart pen caps also allow patients to view their last insulin dose and receive alerts for possible missed doses. The mobile app allows patients to review their HCP's instructions and receive critical alerts. Likewise, HCP can more closely track data to guide clinical assessments and plans.

Objectives: Examine the efficacy of the Bigfoot Unity system in improving glycemic control.

Methods: Baseline HbA1c values were obtained from 91 patients enrolled in the iCGM system and compared with Glucose Management Indicators (GMI), or estimated future HbA1c, after at least 30 days of iCGM use.

Results: Patients were in the target blood glucose range 59.9% of the time with low incidences (0.01%) of very low blood glucose. Patients’ mean baseline HbA1c was 8.87% (SD 1.91). After at least 30 days of iCGM, patients’ mean GMI was 7.55%, (SD 1.02) indicating a statistically significant mean difference of 1.32%, (95% CI 0.86 to 1.79%, p <0. 0001).

Conclusions: Use of Bigfoot Unity improves HbA1c.