Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis
Main finding · HbA1c, baseline to 6 monthsResult — go to the resultMean difference −1.1 % 95% CI −1.4 to −0.8Authors' conclusion
In 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.
Study context
- Population
- Individuals with T1D or T2D using MDI; median age 59 years, 87% T2D, 42% prior continuous glucose monitoring (CGM) use, 62% White non-Hispanic, 59% femaleper protocol cohort
- Participants
- 102 individuals
- Exposure
- Hemoglobin A1c (HbA1c) at 6 months vs baseline with the Bigfoot Unity System
- Bigfoot Unity Systemn = 102
- Outcome
- Glycemic control (HbA1c)
- Follow-up
- 6 months
Methodological details6-month analysis of the BURST study, single-group, per protocol cohort
- 6-month analysis of the BURST study
- Single-group
- Per protocol cohort
Main finding
HbA1c, baseline to 6 months
Mean difference
−1.1 %
95% CI −1.4 to −0.8
P < 0.001
By group
6 monthsvs Baseline
mean difference −1.1 % (95% CI −1.4 to −0.8); P < 0.001
As reported in the abstract
Observational data: associations, not effects.
Further findings
CGM metrics: TIR (70-180 mg/dL), time <70 mg/dL, time <54 mg/dL · 6 months
- TIR (70-180 mg/dL)
- 56 ± 23%
- Time <70 mg/dL
- 1.0 ± 1.4%
- Time <54 mg/dL
- 0.04 ± 0.14%
Safety
- Severe hypoglycemia events (none System-related)
- 6 events in 4 participants
- DKA events
- 0
- Per protocol cohort
Original publication
Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis. J Clin Endocrinol Metab. Published 15 November 2024. doi:10.
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