First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis

BALIGA, BANTWAL; Tillman, John B.; Olson, Byron J.; Vaughan, Sarah; Sheikh, Fazal; Malone, James

doi:10.2337/cd22-0126

Cited by 3 publications

(4 citation statements)

References 29 publications

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“…Notably, there are no large, multicenter randomized control trials comparing connected pens or pen caps to vial and syringes or disposable insulin pens. Across all study types, these early studies show that connected pen systems are linked to higher time in range ( 26 , 28 , 30 , 31 ), reductions in A1c ( 29 , 31 ), reductions in severe hypoglycemia ( 20 , 26 ), reductions in missed insulin doses ( 26 , 28 , 29 , 30 ), and are a source of cost savings compared to standard insulin injections (nonconnected insulin pens or syringes) ( 19 , 20 ). Eckberg et al demonstrated that each missed basal insulin dose was associated with poorer glycemic management ( 27 ), illustrating that the dosage reminders from connected pen systems alone have the potential to improve glycemic outcomes.…”

Section: Scientific Literaturementioning

confidence: 98%

“…Since then, eight clinical studies have been published ( Table 2 ). Of the eight studies included in Table 2 , three are based on Novo Nordisk’s NovoPen 6 ( 6 ), two investigate Medtronic’s InPen ( 20 , 28 ), two use the Insulclock pen ( 29 , 30 ), and one investigates Bigfoot’s Bigfoot Unity Diabetes Management System ( 31 ).…”

Section: Scientific Literaturementioning

confidence: 99%

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Advantages and disadvantages of connected insulin pens in diabetes management

Lingen,

Pikounis,

Bellini

et al. 2023

Endocrine Connections

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Insulin administration remains vital to the treatment of diabetes and although there have been advances in insulin delivery, evidence suggests that many people with diabetes on insulin therapy have suboptimal glycemic management. Recent advancements in insulin administration techniques include connected insulin devices, such as connected insulin pens and pen caps. In this review, we provide an overview of the literature on the use of connected insulin pens and pen caps to further elucidate the clinical benefits and drawbacks of these devices. We discuss the development of these devices, outlining the characteristics of insulin pens and pen caps with regulatory approvals. These devices have different features that can ease the burden of diabetes management, including automatic recording of insulin dose information, tracking of insulin-on-board, bolus calculators, and missed dose alerts. Despite the advantages of connected pens and pen caps, a small percentage of insulin users are currently using these devices, due to many factors, including lack of healthcare professional awareness, initial training for prescribers, and setup of the device. Overcoming these barriers and publishing more data demonstrating the glycemic outcomes associated with these systems could improve diabetes management for people living with diabetes. As healthcare systems become increasingly digital, connected insulin pens have the potential to allow a data-driven approach to diabetes management for people who are not interested in, cannot afford, or do not have intensive insulin regimens that might warrant use of insulin pumps or automated insulin delivery systems.

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Section: Scientific Literaturementioning

confidence: 98%

Section: Scientific Literaturementioning

confidence: 99%

Advantages and disadvantages of connected insulin pens in diabetes management

Lingen,

Pikounis,

Bellini

et al. 2023

Endocrine Connections

View full text Add to dashboard Cite

show abstract

“…(I) Waveform glucose monitoring technology-© WaveForm Technologies Inc. Wilsonville, OR, United States, all rights reserved; reference ( 144 ). (J) Smart insulin pen for personalized diabetes management-Copyright © 2023 American Diabetes Association, reference ( 145 ). (K) Tempo ™ personalized diabetes management platform consisting of a pen, Smart Button, App, and a smartphone-© Lilly Corporate Ctr., Indiana, United States, all rights reserved; reference ( 146 ).…”

Section: Wearable/implantable Wearable Biosensors In Continuous Gluco...mentioning

confidence: 99%

“…The Waveform cascade device is a 15-day CGM with a rechargeable transmitter approved in Europe in 2019, and communicates with a mobile app via Bluetooth with high accuracy ( Figure 5II, I ) ( 144 ). The Bigfoot Unity diabetes management system integrates a smart pen cap with the Freestyle Libre 3 to transmit insulin dosing information between the pen and mobile app ( Figure 5II, J ) ( 145 ). There are two versions of the pen cap, one for long-acting and the other for rapid-acting insulins.…”

Section: Wearable/implantable Wearable Biosensors In Continuous Gluco...mentioning

confidence: 99%

Approaches of wearable and implantable biosensor towards of developing in precision medicine

Ghazizadeh,

Naseri,

Deigner

et al. 2024

Front. Med.

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In the relentless pursuit of precision medicine, the intersection of cutting-edge technology and healthcare has given rise to a transformative era. At the forefront of this revolution stands the burgeoning field of wearable and implantable biosensors, promising a paradigm shift in how we monitor, analyze, and tailor medical interventions. As these miniature marvels seamlessly integrate with the human body, they weave a tapestry of real-time health data, offering unprecedented insights into individual physiological landscapes. This log embarks on a journey into the realm of wearable and implantable biosensors, where the convergence of biology and technology heralds a new dawn in personalized healthcare. Here, we explore the intricate web of innovations, challenges, and the immense potential these bioelectronics sentinels hold in sculpting the future of precision medicine.

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Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis

Tillman,

Beck,

Polonsky

et al. 2024

The Journal of Clinical Endocrinology &Amp; Metabolism

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Context The Bigfoot Unity Diabetes Management System integrates Abbott FreeStyle Libre 2 continuous glucose monitoring (CGM) data into a smart pen cap and mobile app enabling clinician-directed insulin dose recommendations and real-time alerts. Objective The 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). Methods We 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 event and other surveys electronically. Either at-home kit or electronic medical record glycated hemoglobin A1c (HbA1c) data were collected. Results Of 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% confidence interval -1.4 to -0.8, P < 0.001). At 6 months, time in range 70-180 mg/dL, time <70 mg/dL and <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. 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.

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First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis

Cited by 3 publications

References 29 publications

Advantages and disadvantages of connected insulin pens in diabetes management

Advantages and disadvantages of connected insulin pens in diabetes management

Approaches of wearable and implantable biosensor towards of developing in precision medicine

Observed Glycemic and Psychosocial Benefits in the Prospective Bigfoot Unity Real World Study: A 6-Month Analysis

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