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 day by day injection remedy. The system makes use of steady glucose monitoring knowledge and physician suggestions to offer 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, partially as a result of such sufferers sometimes are usually 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 offer technological options to assist such sufferers to handle their illness extra successfully.
Medgadget final spoke with Bigfoot Biomedical CMO Purple 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 area has progressed.
Conn Hastings, Medgadget: Please give us an outline of the challenges these with kind 2 diabetes face in managing their blood glucose ranges daily.
Jeffrey Brewer, Bigfoot Biomedical: Successfully managing glucose ranges is usually very difficult for individuals 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 might probably all be very complicated and overwhelming. Challenges and actions corresponding to these are troublesome and time-consuming for individuals with each kind 1 and kind 2 diabetes. Traditionally, individuals on a number of day by day injections have had few options obtainable to alleviate the burden of those challenges.
One other problem confronted is suboptimal insulin use both by way of missed or mistimed insulin dosing. We additionally see limitations in glucose administration as a result of suppliers are reluctant to instruct correction dosing as a result of fears of affected person miscalculations and insulin stacking.
Over time, excessive glucose ranges can result in extreme problems corresponding to kidney failure, heart problems, nerve harm and blindness. Individuals with kind 2 have been dealing with these challenges with too few instruments and sources, and have been underserved for much too lengthy. It’s one thing that Bigfoot Biomedical is decided 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: Individuals with kind 2 diabetes symbolize 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 individuals with kind 2. They’ve been woefully underserved by the health-tech business which has targeted its innovation on “energy customers” with kind 1.
The explanation this disparity exists largely stems from the truth that individuals with kind 1 are identified as youngsters 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 should be. The perceived severity of kind 1 additionally encourages individuals to undertake know-how that helps their insulin administration. Insulin pumps for instance, are nearly completely utilized by individuals with kind 1. While you have a look at the kind 2 inhabitants, the affected person journey is vastly completely different. They’re nearly all the time identified later in life and customarily haven’t been raised with an understanding of the seriousness of diabetes, or the abilities to handle it. It’s a sophisticated situation that could be very obscure and handle in a brief time period. It may be laborious for individuals with kind 2 to get into the swing of issues, particularly when the educational curve is paired with the unfamiliarity of difficult know-how.
Individuals with kind 2 are normally 45+ years previous. They’re much less more likely to undertake know-how of any sort in comparison with youthful individuals with kind 1, particularly know-how for a illness they aren’t immensely accustomed to. Due to this, many medical gadget firms have prioritized innovation for the kind 1 inhabitants, regardless of the upper prevalence of kind 2. Disruption in diabetes tech for individuals with kind 2 is lengthy overdue. 75% of individuals with diabetes are usually not attaining their diabetes care objectives – that’s an issue. Individuals on a number of day by day injection remedy want higher entry to instruments that would assist them higher handle their diabetes.
Medgadget: How is Bigfoot Biomedical working to assist right this disparity?
Jeffrey Brewer: We’re taking an unconventional method to delivering easy, related, and complete options for many who have been neglected by diabetes innovation, and we’re doing it with our Bigfoot Unity System.
Bigfoot Unity permits, for the primary time, individuals on a number of day by day injection (MDI) remedy to get an insulin dose advice, on-demand, based mostly on steady glucose monitoring (CGM) knowledge and their physician’s directions – serving to to take the anxious guesswork out of day by day insulin dose administration.
We all know that episodic, quarterly physician visits and A1C checks could make it troublesome for individuals with diabetes to really feel “all in” and absolutely supported on their diabetes administration journey. With Bigfoot Unity, individuals have an easy-to-use resolution that helps them carry on monitor of dose occasions and dose suggestions, every day. Similar to with any big-picture plan, that’s the way you obtain outcomes – by constantly taking the small steps to get there. We’re in it with them for the lengthy haul, as a result of at Bigfoot, individuals with kind 2 aren’t misunderstood and beneath supported.
Medgadget: Please give us an outline 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 resolution for individuals with Sort 1 or Sort 2 diabetes on MDI remedy that instantly integrates CGM knowledge to offer an insulin dose advice. The dose, which relies upon directions from the individual’s well being care supplier, is displayed instantly on proprietary, related sensible caps of the individual’s disposable insulin pens.
The system options sensible pen caps appropriate with a complete checklist 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 offer present glucose data and insulin dose suggestions.
The CGM and dosing knowledge is uploaded routinely to the Bigfoot Clinic Hub, a safe, cloud-based hub that allows healthcare professionals to assessment well being knowledge and supply proactive, personalised care to their sufferers.
While you mix these parts, you get a complete resolution that’s simple for individuals with diabetes to know and observe.
Medgadget: How does the system assist Sort II sufferers to handle their situation? How does it enhance on ‘conventional’ approaches?
Jeffrey Brewer: Bigfoot Unity offers real-time insulin dose suggestions based mostly on present CGM readings and doctor directions. It takes the anxious guesswork out of day by day insulin administration. It additionally offers reminders for doubtlessly missed long-acting insulin doses, designed to extend the probability that customers by no means miss a dose, and offers notifications for when an individual’s glucose degree is simply too low.
This differs from the normal method of manually figuring out insulin doses and attempting to recollect whenever you took your final dose. With Bigfoot Unity, there is no such thing as a handbook knowledge entry. The sensible caps seamlessly combine the Freestyle Libre 2 CGM sensor, permitting individuals with diabetes to simply decide their healthcare skilled’s advice based mostly on their present glucose readings from their CGM or Blood Glucose Meter. Simplicity is vital to adherence, and Bigfoot Unity was designed to provide clear steering on how a lot to take and when, so individuals with diabetes can get again to utilizing their time and vitality 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 increase entry so extra individuals with insulin-requiring diabetes can take management of their diabetes with a complete, easy, and holistic resolution.
Medgadget: The place do you see diabetes administration going sooner or later? How will Bigfoot Biomedical contribute to this?
Jeffrey Brewer: I feel it’s crucial that innovators specializing in diabetes administration meet individuals the place they’re at. We have to perceive what their day-to-day seems to be like, what their challenges are and the way we will assist these challenges. For individuals 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 firms see this hole, and extra individuals with diabetes are empowered to know and take possession of their illness by way of the assist of know-how that removes the sensation of isolation that so typically stems from diabetes administration.
Bigfoot Biomedical was constructed to vary the paradigm of take care of diabetes. In the present day, we’re taking unconventional approaches and making daring strikes to supply holistic, built-in options with the purpose to simplify and enhance take care of individuals with diabetes. As time goes on, our contributions will proceed to broaden to satisfy our mission. We’ll by no means cease relentlessly striving to free individuals 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 Purple Maxwell; Bigfoot Biomedical’s Diabetes Administration System Occurring Trial;