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 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 trade, partially 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 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 compensate for how the know-how and subject has progressed.
Conn Hastings, Medgadget: Please give us an outline 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 usually 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 will probably all be very complicated and overwhelming. Challenges and actions resembling these are troublesome and time-consuming for individuals with each sort 1 and kind 2 diabetes. Traditionally, individuals on a number of day by day injections have had few options accessible 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 as a consequence of fears of affected person miscalculations and insulin stacking.
Over time, excessive glucose ranges can result in extreme problems resembling kidney failure, heart problems, nerve harm and blindness. Individuals with sort 2 have been dealing with 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? If that’s the case, why does this disparity exist?
Jeffrey Brewer: Individuals with sort 2 diabetes symbolize 90-95% of the overall 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 trade which has targeted its innovation on “energy customers” with sort 1.
The explanation this disparity exists largely stems from the truth that individuals with sort 1 are recognized as youngsters and should completely perceive the seriousness of diabetes at a younger age. They’ve a sturdy 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 sort 1 additionally encourages individuals to undertake know-how that helps their insulin administration. Insulin pumps for instance, are nearly completely utilized by individuals with sort 1. Once you take a look at the sort 2 inhabitants, the affected person journey is vastly completely different. They’re nearly all the time recognized later in life and usually haven’t been raised with an understanding of the seriousness of diabetes, or the talents to handle it. It’s a sophisticated situation that may be very obscure and handle in a brief time period. It may be onerous for individuals with sort 2 to get into the swing of issues, particularly when the training curve is paired with the unfamiliarity of difficult know-how.
Individuals with sort 2 are often 45+ years outdated. They’re much less prone to undertake know-how of any variety in comparison with youthful individuals with sort 1, particularly know-how for a illness they aren’t immensely accustomed to. Due to this, many medical system 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 should 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 strategy to delivering easy, related, and complete options for individuals who have been ignored by diabetes innovation, and we’re doing it with our Bigfoot Unity System.
Bigfoot Unity allows, 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) information 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 totally supported on their diabetes administration journey. With Bigfoot Unity, individuals have an easy-to-use resolution that helps them carry on observe of dose occasions and dose suggestions, every day. Identical 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, individuals with sort 2 aren’t misunderstood and underneath supported.
Medgadget: Please give us an outline 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 resolution for individuals with Kind 1 or Kind 2 diabetes on MDI remedy that straight integrates CGM information to offer an insulin dose advice. The dose, which is predicated upon directions from the particular person’s well being care supplier, is displayed straight on proprietary, related sensible caps of the particular person’s disposable insulin pens.
The system options sensible pen caps suitable with a complete checklist 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 offer present glucose data and insulin dose suggestions.
The CGM and dosing information is uploaded mechanically to the Bigfoot Clinic Hub, a safe, cloud-based hub that permits healthcare professionals to evaluate well being information and supply proactive, personalised care to their sufferers.
Once you mix these elements, you get a complete resolution 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 based mostly on present CGM readings and doctor directions. It takes the anxious guesswork out of day by day insulin administration. It additionally gives reminders for doubtlessly missed long-acting insulin doses, designed to extend the probability 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 if you took your final dose. With Bigfoot Unity, there isn’t a handbook information 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 offer 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 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 essential 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 help these challenges. For individuals with sort 2, there isn’t sufficient easy know-how to successfully assist them handle their situation in a method that is sensible. 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 means of the help 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 look after diabetes. At present, 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 dwell 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;