Observational studyThe Journal of clinical endocrinology and metabolism2025
Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis.
Observational study in The Journal of clinical endocrinology and metabolism, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05088265 (Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Prospective Real World Data Collection for the Bigfoot Unity Diabetes Management System
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Authors and funding
10 authors.
Funding
Abstract
contextThe Bigfoot Unity Diabetes Management System integrates Abbott FreeStyle Libre 2 continuous glucose monitoring (CGM) data into a smart insulin pen cap and mobile app, enabling clinician-directed insulin dose recommendations and real-time alerts.
objectiveThe objective was to analyze real-world 6-month glycemic control in a prospective study for individuals using the System for multiple daily insulin injections (MDI).
methodsWe conducted a 6-month analysis from the BURST study (NCT05088265) of individuals with type 1 or type 2 diabetes (T2D). Participants reported baseline demographics, adverse events, and other survey data electronically. Either at-home kit or electronic medical record glycated hemoglobin A1c (HbA1c) data were collected.
resultsOf 102 participants in the per protocol cohort, median age was 59 years, 87% had T2D, 42% used CGM previously, 62% were White non-Hispanic, and 59% female. Mean HbA1c decreased from 9.1 ± 1.7% at baseline to 8.0 ± 1.2% at 6 months (mean difference -1.1%, 95% CI -1.4 to -0.8, P < .001). At 6 months, time in range (70-180 mg/dL), time at < 70 mg/dL, and time at < 54 mg/dL were 56 ± 23%, 1.0 ± 1.4%, and 0.04 ± 0.14%, respectively. Six severe hypoglycemia events occurred in 4 participants (none System-related) and no diabetic ketoacidosis events occurred in the per protocol cohort.
conclusionIn this study primarily of older adults with T2D using MDI, durable glycemic improvement occurred using the System at 6 months, with the frequency of hypoglycemia being substantially below established targets of < 4% and < 1% for time below 70 and 54 mg/dL, respectively.
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Registered trials
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