Bigfoot Biomedical, a medtech firm based mostly in California, has developed the Bigfoot Unity System, a diabetes administration know-how for sufferers on a number of every day injection remedy. The system makes use of steady glucose monitoring information and physician suggestions to supply insulin dose suggestions, serving to sufferers to keep away from uncertainty.
The corporate argues that kind 2 diabetes sufferers have been traditionally underserved by the medtech business, partly as a result of such sufferers sometimes are typically older at analysis, and maybe much less inclined to undertake new applied sciences. This contrasts with kind 1 “energy customers” who’re extra conscious of the nuances of their illness at an early age and are higher disposed to undertake new applied sciences to assist handle it.
Bigfoot goals to supply technological options to assist such sufferers to handle their illness extra successfully.
Medgadget final spoke with Bigfoot Biomedical CMO Crimson Maxwell in March 2020. Now, we discuss with Jeffrey Brewer, CEO and co-founder at Bigfoot Biomedical, to make amends for how the know-how and discipline has progressed.
Conn Hastings, Medgadget: Please give us an summary of the challenges these with kind 2 diabetes face in managing their blood glucose ranges each day.
Jeffrey Brewer, Bigfoot Biomedical: Successfully managing glucose ranges is commonly very difficult for folks with insulin-requiring diabetes, particularly these with kind 2 given they’ve fewer instruments designed for them in comparison with these with kind 1. Checking blood glucose ranges, counting carbohydrates, calculating basal (long-acting) and bolus (rapid-acting) insulin injections, doing calculations at each meal – it will possibly all be very complicated and overwhelming. Challenges and actions akin to these are tough and time-consuming for folks with each kind 1 and kind 2 diabetes. Traditionally, folks on a number of every day injections have had few options obtainable to alleviate the burden of those challenges.
One other problem confronted is suboptimal insulin use both by means of missed or mistimed insulin dosing. We additionally see limitations in glucose administration as a result of suppliers are reluctant to instruct correction dosing attributable to fears of affected person miscalculations and insulin stacking.
Over time, excessive glucose ranges can result in extreme issues akin to kidney failure, heart problems, nerve harm and blindness. Folks with kind 2 have been dealing with these challenges with too few instruments and sources, and have been underserved for a lot too lengthy. It’s one thing that Bigfoot Biomedical is set to handle.
Medgadget: How are such sufferers underserved in contrast with these with kind 1 diabetes? If that’s the case, why does this disparity exist?
Jeffrey Brewer: Folks with kind 2 diabetes signify 90-95% of the whole diabetes inhabitants, and subsequently drive extra healthcare prices than the kind 1 inhabitants. But we nonetheless see an immense hole within the technological advances for folks with kind 2. They’ve been woefully underserved by the health-tech business which has centered its innovation on “energy customers” with kind 1.
The rationale this disparity exists largely stems from the truth that folks with kind 1 are identified as kids and should totally perceive the seriousness of diabetes at a younger age. They’ve a strong understanding of highs and lows, time in vary, and what actions to take to maintain ranges the place they have to be. The perceived severity of kind 1 additionally encourages folks to undertake know-how that helps their insulin administration. Insulin pumps for instance, are virtually completely utilized by folks with kind 1. If you have a look at the kind 2 inhabitants, the affected person journey is vastly completely different. They’re virtually at all times identified later in life and customarily haven’t been raised with an understanding of the seriousness of diabetes, or the talents to handle it. It’s a sophisticated situation that could be very obscure and handle in a brief time frame. It may be exhausting for folks with kind 2 to get into the swing of issues, particularly when the training curve is paired with the unfamiliarity of sophisticated know-how.
Folks with kind 2 are normally 45+ years outdated. They’re much less more likely to undertake know-how of any type in comparison with youthful folks with kind 1, particularly know-how for a illness they aren’t immensely aware of. Due to this, many medical gadget corporations have prioritized innovation for the kind 1 inhabitants, regardless of the upper prevalence of kind 2. Disruption in diabetes tech for folks with kind 2 is lengthy overdue. 75% of individuals with diabetes will not be attaining their diabetes care targets – that’s an issue. Folks on a number of every day injection remedy want higher entry to instruments that might assist them higher handle their diabetes.
Medgadget: How is Bigfoot Biomedical working to assist right this disparity?
Jeffrey Brewer: We’re taking an unconventional strategy to delivering easy, linked, and complete options for individuals who have been neglected by diabetes innovation, and we’re doing it with our Bigfoot Unity System.
Bigfoot Unity permits, for the primary time, folks on a number of every day injection (MDI) remedy to get an insulin dose suggestion, on-demand, based mostly on steady glucose monitoring (CGM) information and their physician’s directions – serving to to take the anxious guesswork out of every day insulin dose administration.
We all know that episodic, quarterly physician visits and A1C checks could make it tough for folks with diabetes to really feel “all in” and absolutely supported on their diabetes administration journey. With Bigfoot Unity, folks have an easy-to-use answer that helps them carry on monitor of dose occasions and dose suggestions, each day. Similar to with any big-picture plan, that’s the way you obtain outcomes – by persistently taking the small steps to get there. We’re in it with them for the lengthy haul, as a result of at Bigfoot, folks with kind 2 aren’t misunderstood and beneath supported.
Medgadget: Please give us an summary of the Bigfoot diabetes administration system and its parts.
Jeffrey Brewer: The Bigfoot Unity System, which is the centerpiece of our bigger Bigfoot Unity Program, is the primary and solely FDA-cleared answer for folks with Sort 1 or Sort 2 diabetes on MDI remedy that straight integrates CGM information to supply an insulin dose suggestion. The dose, which is predicated upon directions from the particular person’s well being care supplier, is displayed straight on proprietary, linked sensible caps of the particular person’s disposable insulin pens.
The system options sensible pen caps appropriate with a complete record of commercially obtainable disposable insulin pens for each long-acting and rapid-acting insulin. The pen caps combine seamlessly with the Freestyle Libre 2 CGM sensor to supply present glucose info and insulin dose suggestions.
The CGM and dosing information is uploaded mechanically to the Bigfoot Clinic Hub, a safe, cloud-based hub that allows healthcare professionals to assessment well being information and supply proactive, personalised care to their sufferers.
If you mix these parts, you get a complete answer that’s simple for folks with diabetes to grasp and comply with.
Medgadget: How does the system assist Sort II sufferers to handle their situation? How does it enhance on ‘conventional’ approaches?
Jeffrey Brewer: Bigfoot Unity gives real-time insulin dose suggestions based mostly on present CGM readings and doctor directions. It takes the anxious guesswork out of every day insulin administration. It additionally gives reminders for probably missed long-acting insulin doses, designed to extend the chance that customers by no means miss a dose, and gives notifications for when an individual’s glucose stage is just too low.
This differs from the standard strategy of manually figuring out insulin doses and making an attempt to recollect if you took your final dose. With Bigfoot Unity, there isn’t any guide information entry. The sensible caps seamlessly combine the Freestyle Libre 2 CGM sensor, permitting folks with diabetes to simply decide their healthcare skilled’s suggestion based mostly on their present glucose readings from their CGM or Blood Glucose Meter. Simplicity is essential to adherence, and Bigfoot Unity was designed to offer clear steerage on how a lot to take and when, so folks with diabetes can get again to utilizing their time and power doing the issues that matter most to them.
Medgadget: The place is the system obtainable at current?
Jeffrey Brewer: Bigfoot Unity is cleared by the FDA and obtainable throughout the U.S. We’re actively working to broaden entry so extra folks with insulin-requiring diabetes can take management of their diabetes with a complete, easy, and holistic answer.
Medgadget: The place do you see diabetes administration going sooner or later? How will Bigfoot Biomedical contribute to this?
Jeffrey Brewer: I believe it’s vital that innovators specializing in diabetes administration meet folks the place they’re at. We have to perceive what their day-to-day appears like, what their challenges are and the way we will assist these challenges. For folks with kind 2, there isn’t sufficient easy know-how to successfully assist them handle their situation in a means that is sensible. I see a future the place extra corporations see this hole, and extra folks with diabetes are empowered to grasp and take possession of their illness by means of the assist of know-how that removes the sensation of isolation that so typically stems from diabetes administration.
Bigfoot Biomedical was constructed to alter the paradigm of take care of diabetes. As we speak, we’re taking unconventional approaches and making daring strikes to supply holistic, built-in options with the aim to simplify and enhance take care of folks with diabetes. As time goes on, our contributions will proceed to broaden to meet our mission. We’ll by no means cease relentlessly striving to free folks with insulin-requiring diabetes to stay the lives they select.
Hyperlink: Bigfoot Biomedical homepage…
Flashbacks: Bigfoot Biomedical for Extra Correct Insulin Dosing: Interview with CMO Crimson Maxwell; Bigfoot Biomedical’s Diabetes Administration System Occurring Trial;