Milpitas, Calif., June 21, 2023 – Bigfoot Biomedical (Bigfoot), a leader in developing simple and easy-to-use tools for people with insulin-requiring diabetes, today announced the publication of a six-month retrospective analysis of real-world use data of the Bigfoot Unity® System in the American Diabetes Association's (ADA) journal, Clinical Diabetes. In this initial 58-person cohort, results demonstrate the potential of the Bigfoot Unity System to support rapid and durable improvement in glucose control in people with diabetes who use multiple daily injections of insulin. 

“Even with access to CGM data and counsel from their healthcare teams, people living with diabetes still struggle with knowing how much insulin to take when they are about to give themselves a dose,” said Bantwal S. Baliga, MD, East Alabama Endocrinology, PC, lead author of the manuscript. “The majority of people in the analysis had previous experience with CGM, so the data suggest that recommendations from the patient’s provider displayed right on the insulin pen cap contribute to the observed improvement in glycemic control.”

Study Method and Overview: 

The Bigfoot Unity System is an FDA-cleared system that turns continuous glucose monitoring (CGM) data into insulin dosing recommendations displayed right on the smart pen cap for people using multiple daily injection therapy. The retrospective analysis initially looked at 75 Bigfoot Unity System users across 13 clinics who had used the system for six months. A cohort of 58 users qualified for the prespecified real-world clinical outcomes analysis as they had at least 50 percent of CGM data within the first two weeks and in the sixth month of System use. The average age of participants included in the analysis was 62 years old, and 84.5 percent had type 2 diabetes. Most individuals had used CGM previously (76 percent), while nearly all were new to using smart insulin pens (96 percent) and diabetes apps (93 percent). 

A baseline HbA1c prior to starting use of the System was obtained from clinic medical records for 51 patients. Per the prespecified outcomes analysis, glucose management indicator (GMI) was used as a proxy for HbA1c after patients started using the System. 

Limitations of the reported results include the retrospective nature of the analysis, small sample size, lack of HbA1c during System use, lack of a control group, and self-reported adverse event data. 

Results: 

In a paired analysis of data from 50 individuals who had available baseline HbA1c and GMI values at each of the defined time periods, the cohort had a mean starting HbA1c of 8.3 percent and a mean GMI of 7.3 percent after six months of System use. Although not a direct HbA1c comparison, studies have shown that GMI is a reasonable proxy for HbA1c¹ and every 1.0 percent reduction in HbA1c can reduce microvascular complications by up to 40 percent.² In the analysis, those with higher baseline HbA1c, on average, had the largest decrease to mean GMI, while those with lower baseline HbA1c had smaller changes. 

Additional data included in this publication: 

• 36 users with prior CGM experience had a mean baseline HbA1c of 8.2 percent and GMI at six months of 7.3 percent, while 12 users with no prior CGM experience had a mean baseline HbA1c of 9.0 percent and GMI at six months of 7.1 percent.
• Time spent with low glucose and very low glucose (1.4 percent and 0.2 percent, respectively) at the 6-month period was below established treatment guidelines of 4 percent and 1 percent.³
• Mean two-hour postprandial (post-meal) glucose fell within ADA guidelines of <180 mg/dL, suggesting the importance of displaying clinician-directed meal and correction dose recommendations.⁴
• Two adverse events unrelated to System use were identified (hyperglycemia of unknown severity and a cardiac event resulting in death), neither of which occurred within the cohort of 58 patients meeting the CGM analysis criteria. 

Given that the majority of patients in this cohort were not new to using CGM but were new to using smart technology for pens and support apps, this analysis suggests that patient engagement with the Bigfoot Unity System and HCP-directed meal and correction dose recommendations may contribute to improved glycemic control. 

Bigfoot will have three posters and a product theater at the American Diabetes Association 83rd Annual Scientific Sessions. 

About The Bigfoot Unity System

The Bigfoot Unity system includes Freestyle Libre 2 CGM, sensors, a white pen cap for rapid-acting insulin, a black pen cap for long-acting insulin, pen needles, a BG meter, test strips, and a mobile app.

The Bigfoot Unity System helps people with diabetes answer the seemingly simple but very challenging question of “How much insulin do I take right now?” By making it straightforward for people with diabetes to follow their healthcare team’s dosing instructions, Bigfoot Unity supports providers to prescribe personalized insulin dosing through a program that is covered by most insurance and fits easily into the provider’s workflow. 

About Bigfoot Biomedical, Inc.:

Bigfoot Biomedical (Bigfoot), headquartered in Milpitas, California, was founded by a team of people with personal connections to type 1 and type 2 diabetes. Bigfoot aims to free people from the burdens of living with insulin-requiring diabetes, improve access, and support health care professionals in optimizing diabetes care. Bigfoot is an unconventional company taking an unconventional approach. Unlike others, Bigfoot looks at insulin therapy holistically, and utilizes services, support, and novel business models. The company partners with healthcare professionals to deliver simple, connected, and comprehensive solutions for the large number of people who have been overlooked by diabetes innovation. Learn more at www.bigfootbiomedical.com and by following us on LinkedIn, Twitter, Instagram, and Facebook.

Bigfoot and Bigfoot Unity are trademarks or registered trademarks of Bigfoot Biomedical, Inc. in the United States of America and other various jurisdictions. All rights reserved.

Media Contact:
Jessica Stebing
Account Director, Health+Commerce
(260) 336 6202
jstebing@healthandcommerce.com 

^[1] Bergenstal RM, Beck RW, Close KL, et al. Glucose management indicator  (GMI): a new term for estimating A1C from continuous glucose monitoring.  Diabetes Care 2018;41(11):2275-80

^[2] Nathan DM; DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care. 2014;37(1):9-16. doi: 10.2337/dc13-2112. PMID: 24356592; PMCID: PMC3867999.

^[3] Battelino T, et al. Diabetes Care 2019;42(8):1593-603.

^[4] American Diabetes Association. Diabetes Care. 2022;45(Suppl 1):S83-S96.