Bigfoot Biomedical, a medtech firm primarily based in California, has developed the Bigfoot Unity System, a diabetes administration expertise for sufferers on a number of each day injection remedy. The system makes use of steady glucose monitoring knowledge 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 trade, partly as a result of such sufferers usually are typically older at prognosis, 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 Pink Maxwell in March 2020. Now, we speak with Jeffrey Brewer, CEO and co-founder at Bigfoot Biomedical, to atone for how the expertise and area 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 day after day.
Jeffrey Brewer, Bigfoot Biomedical: Successfully managing glucose ranges is commonly 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 could possibly all be very advanced and overwhelming. Challenges and actions comparable to these are troublesome and time-consuming for individuals with each kind 1 and kind 2 diabetes. Traditionally, individuals on a number of each day injections have had few options accessible to alleviate the burden of those challenges.
One other problem confronted is suboptimal insulin use both by 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 consequence of fears of affected person miscalculations and insulin stacking.
Over time, excessive glucose ranges can result in extreme problems comparable to kidney failure, heart problems, nerve harm and blindness. Folks with kind 2 have been going through 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 characterize 90-95% of the full diabetes inhabitants, and subsequently drive extra healthcare prices than the sort 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 trade 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 recognized 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 expertise 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 sort 2 inhabitants, the affected person journey is vastly completely different. They’re nearly at all times recognized 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 an advanced situation that may be very obscure and handle in a brief time frame. It may be laborious for individuals with kind 2 to get into the swing of issues, particularly when the training curve is paired with the unfamiliarity of difficult expertise.
Folks with kind 2 are normally 45+ years previous. They’re much less prone to undertake expertise of any sort in comparison with youthful individuals with kind 1, particularly expertise for a illness they aren’t immensely conversant in. Due to this, many medical gadget corporations have prioritized innovation for the sort 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 aren’t attaining their diabetes care objectives – that’s an issue. Folks on a number of each 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, related, and complete options for many who have been missed 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 each day injection (MDI) remedy to get an insulin dose advice, on-demand, primarily based on steady glucose monitoring (CGM) knowledge and their physician’s directions – serving to to take the anxious guesswork out of each 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 totally supported on their diabetes administration journey. With Bigfoot Unity, individuals have an easy-to-use answer that helps them carry on monitor of dose instances and dose suggestions, every day. Identical 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 summary of the Bigfoot diabetes administration system and its elements.
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 individuals with Kind 1 or Kind 2 diabetes on MDI remedy that instantly integrates CGM knowledge to supply an insulin dose advice. The dose, which is predicated upon directions from the particular person’s well being care supplier, is displayed instantly on proprietary, related good caps of the particular person’s disposable insulin pens.
The system options good pen caps appropriate with a complete listing of commercially accessible 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 data and insulin dose suggestions.
The CGM and dosing knowledge is uploaded mechanically to the Bigfoot Clinic Hub, a safe, cloud-based hub that permits healthcare professionals to evaluation well being knowledge and supply proactive, personalised care to their sufferers.
While you mix these elements, you get a complete answer that’s straightforward for individuals with diabetes to know and observe.
Medgadget: How does the system assist Kind II sufferers to handle their situation? How does it enhance on ‘conventional’ approaches?
Jeffrey Brewer: Bigfoot Unity gives real-time insulin dose suggestions primarily based on present CGM readings and doctor directions. It takes the anxious guesswork out of each 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 simply too low.
This differs from the normal strategy of manually figuring out insulin doses and making an attempt to recollect whenever you took your final dose. With Bigfoot Unity, there isn’t any handbook knowledge entry. The good caps seamlessly combine the Freestyle Libre 2 CGM sensor, permitting individuals with diabetes to simply decide their healthcare skilled’s advice primarily based on their present glucose readings from their CGM or Blood Glucose Meter. Simplicity is essential 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 accessible at current?
Jeffrey Brewer: Bigfoot Unity is cleared by the FDA and accessible throughout the U.S. We’re actively working to develop entry so extra individuals 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 feel it’s important that innovators specializing in diabetes administration meet individuals the place they’re at. We have to perceive what their day-to-day seems like, what their challenges are and the way we will assist these challenges. For individuals with kind 2, there isn’t sufficient easy expertise to successfully assist them handle their situation in a manner that is smart. I see a future the place extra corporations see this hole, and extra individuals with diabetes are empowered to know and take possession of their illness by the assist of expertise that removes the sensation of isolation that so typically stems from diabetes administration.
Bigfoot Biomedical was constructed to alter the paradigm of look after diabetes. Right this moment, we’re taking unconventional approaches and making daring strikes to supply holistic, built-in options with the aim to simplify and enhance look after individuals 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 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 Pink Maxwell; Bigfoot Biomedical’s Diabetes Administration System Happening Trial;