Bigfoot Biomedical, a medtech firm based mostly in California, has developed the Bigfoot Unity System, a diabetes administration expertise for sufferers on a number of every day injection remedy. The system makes use of steady glucose monitoring information and physician suggestions to offer insulin dose suggestions, serving to sufferers to keep away from uncertainty.
The corporate argues that sort 2 diabetes sufferers have been traditionally underserved by the medtech business, partly as a result of such sufferers sometimes are usually older at prognosis, and maybe much less inclined to undertake new applied sciences. This contrasts with sort 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 last spoke with Bigfoot Biomedical CMO Red Maxwell in March 2020. Now, we discuss with Jeffrey Brewer, CEO and co-founder at Bigfoot Biomedical, to make amends for how the expertise and discipline has progressed.
Conn Hastings, Medgadget: Please give us an summary of the challenges these with sort 2 diabetes face in managing their blood glucose ranges each day.
Jeffrey Brewer, Bigfoot Biomedical: Successfully managing glucose ranges is commonly very difficult for individuals with insulin-requiring diabetes, particularly these with sort 2 given they’ve fewer instruments designed for them in comparison with these with sort 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 equivalent to these are troublesome and time-consuming for individuals with each sort 1 and sort 2 diabetes. Traditionally, individuals 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 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 attributable to fears of affected person miscalculations and insulin stacking.
Over time, excessive glucose ranges can result in extreme issues equivalent to kidney failure, heart problems, nerve harm and blindness. Individuals with sort 2 have been going through these challenges with too few instruments and assets, 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 sort 1 diabetes? In that case, why does this disparity exist?
Jeffrey Brewer: Individuals with sort 2 diabetes signify 90-95% of the whole 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 sort 2. They’ve been woefully underserved by the health-tech business which has centered its innovation on “energy customers” with sort 1.
The rationale this disparity exists largely stems from the truth that individuals with sort 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 must be. The perceived severity of sort 1 additionally encourages individuals to undertake expertise that helps their insulin administration. Insulin pumps for instance, are virtually solely utilized by individuals with sort 1. If you take a look at the sort 2 inhabitants, the affected person journey is vastly completely different. They’re virtually at all times identified later in life and usually 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 frame. It may be laborious for individuals with sort 2 to get into the swing of issues, particularly when the training curve is paired with the unfamiliarity of sophisticated expertise.
Individuals with sort 2 are normally 45+ years outdated. They’re much less prone to undertake expertise of any sort in comparison with youthful individuals with sort 1, particularly expertise for a illness they aren’t immensely conversant in. Due to this, many medical machine corporations have prioritized innovation for the sort 1 inhabitants, regardless of the upper prevalence of sort 2. Disruption in diabetes tech for individuals with sort 2 is lengthy overdue. 75% of individuals with diabetes are usually not reaching their diabetes care objectives – that’s an issue. Individuals 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 appropriate this disparity?
Jeffrey Brewer: We’re taking an unconventional method to delivering easy, linked, and complete options for many who have been ignored 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 every day injection (MDI) remedy to get an insulin dose advice, 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 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 observe of dose instances and dose suggestions, each 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 sort 2 aren’t misunderstood and below 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 individuals with Sort 1 or Sort 2 diabetes on MDI remedy that immediately integrates CGM information to offer an insulin dose advice. The dose, which is predicated upon directions from the individual’s well being care supplier, is displayed immediately on proprietary, linked good caps of the individual’s disposable insulin pens.
The system options good 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 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 evaluation 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 individuals with diabetes to grasp 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 supplies 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 supplies reminders for probably missed long-acting insulin doses, designed to extend the probability that customers by no means miss a dose, and supplies notifications for when an individual’s glucose degree is just too low.
This differs from the standard method of manually figuring out insulin doses and attempting to recollect if you took your final dose. With Bigfoot Unity, there is no such thing as a guide information entry. The good 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 essential to adherence, and Bigfoot Unity was designed to provide clear steerage 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 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 believe 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 appears to be like like, what their challenges are and the way we are able to assist these challenges. For individuals with sort 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 grasp and take possession of their illness by way of the assist of expertise that removes the sensation of isolation that so usually 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 reside the lives they select.
Hyperlink: Bigfoot Biomedical homepage…
Flashbacks: Bigfoot Biomedical for More Accurate Insulin Dosing: Interview with CMO Red Maxwell; Bigfoot Biomedical’s Diabetes Management System Going on Trial;
