Background: In the US, approximately 10 million people with diabetes require insulin; the vast majority using MDI therapy. Diabetes is associated with sustained daily burdens due to complex, demanding, and often confusing self-care directives, which may be more pronounced with MDI. Bigfoot Unity is a unique, interconnected smart pen cap diabetes management system designed to address an unmet medical need to support MDI therapy, incorporating CGM data (Abbott FreeStyle Libre 2) , real-time alerts and clinician-directed dose recommendations.
Methods: The Bigfoot Unity System received FDA clearance in May 2021. We report a retrospective analysis on an initial cohort (N=49 at 11 clinics) with insulin-requiring diabetes managing MDI with Bigfoot Unity for 90 days. Deidentified data were evaluated to analyze glycemic metrics during use, and HbA1c obtained from medical records prior to use.
Results: Within the cohort, mean age was 60 years and 40 (82%) had T2D. The mean HbA1c prior to Bigfoot Unity use was 8.5±2.0% (N=43) . Mean GMI was 7.5±0.9% after 3 months use.
Discussion: These data show that for people using MDI with suboptimal glycemic control, using the Bigfoot Unity System has the potential for rapid and durable improvement in glycemic control. Considering the mean age of the cohort, results demonstrate close adherence to established glycemic targets including a short time spent in the hypoglycemia range. Further studies are planned to investigate this hypothesis.
B. Baliga: Speaker’s Bureau; Abbott Diabetes, Amarin Corporation, AstraZeneca, Bigfoot Biomedical, Inc., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intuity Medical, Inc., Merck & Co., Inc., Novo Nordisk, Stock/Shareholder; Amarin Corporation, Insulet Corporation, Merck & Co., Inc., Moderna, Inc., Senseonics. J. Tillman: Employee; Bigfoot Biomedical, Inc. B. P. Olson: Employee; Bigfoot Biomedical, Inc. S. Vaughan: Employee; Bigfoot Biomedical, Inc. F. Sheikh: Employee; Bigfoot Biomedical, Inc. J. K. Malone: Consultant; Eli Lilly and Company, Insulet Corporation, Thermalin Inc., Employee; Bigfoot Biomedical, Inc.