Background: The Bigfoot Unity® System is an FDA-cleared smart pen cap system incorporating CGM data (Abbott FreeStyle Libre 2), real-time alerts, and clinician-directed insulin dose recommendations. The objective was to analyze real world, 3-month data for System users.
Methods: We conducted a per-protocol 3-month interim analysis (N=54, 15 clinics) from the prospective, BURST study (NCT05088265). Participants reported baseline demographics and completed adverse event surveys every 2 weeks. For A1C data, an at-home kit or electronic medical record was used for baseline and 3-month values; CGM metrics were collected post System initiation.
Results: Most (85%) had T2D and median age was 57 years; 58% were Caucasian and 58% were female. Mean A1C decreased from 9.2±1.8% at baseline to 7.9±1.3% at 3 months (mean difference −1.2%, 95%CI −1.6 to −0.8, p<0.001). Four severe hypoglycemia events in 3 participants and 1 DKA occurred and were not related to the System. Percent time below range and other 3-month glycemic outcomes and System use data are shown (Table).
Discussion: In this cohort, consisting primarily of older adults with T2D using MDI and suboptimal glycemic control, durable glycemic improvement occurred using Bigfoot Unity at 3 months. The observed reduction in A1C in this older cohort does not compromise them in meeting established hypoglycemia targets of <4 and <1% for percent time below 70 and 54 mg/dL, respectively.
J.K.Malone: Employee; Bigfoot Biomedical, Inc. R.Beck: Consultant; Eli Lilly and Company, Novo Nordisk, Diasome, Insulet Corporation, Research Support; Tandem Diabetes Care, Inc., Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc., Medtronic, Ascensia Diabetes Care, Roche Diabetes Care, Eli Lilly and Company, Novo Nordisk. J.Tillman: Employee; Bigfoot Biomedical, Inc. P.Calhoun: None. T.J.Mouse: None. R.Bailey: None. B.P.Olson: Employee; Bigfoot Biomedical, Inc. S.Vaughan: Employee; Bigfoot Biomedical, Inc. F.Sheikh: Employee; Bigfoot Biomedical, Inc.
Bigfoot Biomedical, Inc.
