First real-world experience with bigfoot unity: a 6-month retrospective analysis
Open accessAbstract
The Bigfoot Unity Diabetes Management System, a smart pen cap system cleared by the U.S. Food and Drug Administration in May 2021, incorporates continuous glucose monitoring data, real-time glycemic alerts, and clinician-directed dose recommendations. This study analyzed real-world clinical outcomes data for an initial cohort (n = 58, from 13 clinics) managing multiple daily injection insulin therapy using the pen cap system for 6 months. We examined glycemic control, including hypoglycemia events and interaction with and use of the pen cap system. In a cohort mainly consisting of adults with type 2 diabetes and an average age of 62 years, the results demonstrate close adherence to established glycemic targets, including a relatively short amount of time spent in the hypoglycemic range.
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The prospective 6-month study reported here showed similar results to 3-month data presented previously and similar glycemic control to a retrospective cohort using Bigfoot Unity.
“In general, the prospective 6-month study reported here showed similar results to 3-month data presented previously (35) and similar glycemic control to a retrospective cohort using Bigfoot Unity (34); here, the baseline HbA1c was higher (9.1% vs 8.4%), which may reflect health status or other demographic biases in those who consent to participate in an ongoing study vs those who do not (36).”
From Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis (2025) · cites this paper as [34]
In a subset of participants with baseline HbA1c ≥ 8%, the magnitude of the observed difference was larger (approximately 1.5%).
“Similar to other investigations (34, 37), in a subset of participants with suboptimal glycemic control (those with baseline HbA1c ≥ 8%), the magnitude of the observed difference was larger (approximately 1.5% here) which may reflect regression to the mean phenomenon.”
From Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis (2025) · cites this paper as [34]
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- Authors
- Baliga, B. S., Tillman, J. B., Olson, B., Vaughan, S., Sheikh, F. N., & Malone, J. K.
- Affiliations
- Texas Diabetes & Endocrinology (US)
- Bigfoot Biomedical (United States) (US)
- Corresponding author
- Tillman, John B.
- ORCID
- Tillman, John B.
- Venue
- Clinical Diabetes
- Publisher
- American Diabetes Association
- Published
- 2023-06-21
- Volume
- 41
- Issue
- 4
- Pages
- 539-548
- ISSN
- 0891-8929 (ISSN-L)
- 1945-4953
- PMC
- PMC10577513
- OpenAlex
- W4381510683
- Cited by
- 15
- References
- 31
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 2 · 2023: 2
- FWCI
- 3.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Diabetes (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Bigfoot Biomedical
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- continuous glucose monitoring, type 2 diabetes, glycemic control, hypoglycemia, dose recommendations, real-world outcomes, device adherence
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