A new real-world study evaluating the Bigfoot Unity Diabetes Management System shows promising results for improving blood sugar control in patients with diabetes using multiple daily insulin injections (MDI). The study was published in the Journal of Clinical Endocrinology and Metabolism.

The system smoothly integrates continuous glucose monitoring (CGM) data with a smart insulin pen cap and mobile app. This allows for clinician-guided insulin dosing and real-time alerts.

The 6-month prospective analysis, part of the BURST study, included 102 participants, most of whom were older adults with type 2 diabetes (T2D). At baseline, the average glycated hemoglobin (HbA1c) was 9.1%. After six months of using the Bigfoot Unity System, the mean HbA1c dropped to 8.0%, a significant improvement of 1.1 percentage points (P < .001).

Alongside better HbA1c results, participants achieved a mean time-in-range (70–180 mg/dL) of 56%, with extremely low incidences of hypoglycemia: time spent below 70 mg/dL was only 1.0%, and below 54 mg/dL just 0.04%. No diabetic ketoacidosis (DKA) events occurred, and the six reported severe hypoglycemic episodes (in four participants) were unrelated to the system.