Memorandum

Bigfoot Unity submitted to FDA last month for 510(k) clearance; interview with Bigfoot CEO Jeffrey Brewer – August 13, 2020

Interview touches on designing for ease of use and simplicity, Time in Range, initiating on insulin, and more; Unity was submitted to the FDA last month

Just before ADA (on June 10, 2020), we had a chance to speak in a wide-ranging discussion with Bigfoot CEO Jeffrey Brewer – see below for excerpts from that conversation. Throughout the interview, we learned even more about the simplicity and usability of Bigfoot Unity, Bigfoot’s connected smart pen system. This comes at a good time, when we’re learning more about smart pens through Medtronic’s recent acquisition of Companion Medical. Mr. Brewer long ago prioritized smart pens over another closed loop system, and although Bigfoot will have both eventually, Medtronic’s move certainly reinforces the logic and strategy behind Mr. Brewer’s pivot in early 2019 (see “Bigfoot’s latest: the shift to focus on Unity, its smart pen MDI titration system” – June 6, 2019”). In an update yesterday with the Bigfoot Biomedical CEO, former JDRF CEO, and early tech Web 1.0 CEO (GoTo.com was sold to Yahoo! And Citysearch merged with Ticketmaster Online) Mr. Brewer emphasized, "We've always said that a design flaw, if there is one in Bigfoot Unity, is that it's too simple. Every other device is more complicated but, at the end of the day, we feel like a simpler, more accessible approach is what is so desperately needed in this industry." Bigfoot submitted the first-generation Bigfoot Unity system last month. We’re very excited to see the system hit the market and offer more routine for people with diabetes on insulin – it bundles together all the hardware and software components, i.e., FreeStyle Libre 2 sensors, Bigfoot’s smart pen caps for basal and rapid-acting insulins, pen needles, a backup BGM and supplies, a mobile app as well as “real-time decision support” on the pen cap displays. See the full discussion below, including Mr. Brewer’s thoughts on bringing technology into primary care, why many people with diabetes don’t currently care about data, why the big insulin manufacturers are partners rather than competitors in his view, and more.

On Submission and Launch for Bigfoot Unity

Kelly Close: Jeffrey, thank you for talking with us yet again. We’ve had so many valuable conversations with you over the years and I will always remember meeting you in late 2002, two weeks after your son was diagnosed with diabetes and two weeks after I started Close Concerns with John. You struck me as bold back then, up at the microphone, asking researchers the most succinct, well-thought out question of the five-minute Q&A slot. Today, we’re at virtual conferences, you’ve become a CEO of a closely-watched data and technology company, and it seems like you’re coming full circle since Web 1.0. I’m so glad you are in this fight with the whole ecosystem. Talk to us about Bigfoot, and maybe we can start with Bigfoot Unity, the result of your strategic pivot in 2019.

Jeffrey: Absolutely. Bigfoot Unity will be launched, hopefully, at the end of this year or certainly early next year; we submitted the 510(k) to the FDA in July. We’re really looking forward to realizing what has been a long journey of taking everything we know about life with diabetes and applying technology to help people live easier and safer with it. We're glad to be at this last step of review with the FDA, and then put the system in the hands of people with diabetes.

Kelly: Can you say anything more specific about [the submission]? This will be fascinating to see where FDA goes with a subscription.

Jeffrey: The submission of our comprehensive system came at the heels of FDA’s clearance of the Abbott FreesStyle Libre 2 iCGM. The FreeStyle Libre 2 is a central component of Bigfoot Unity.

Editor’s note: FreeStyle Libre 2 was cleared by the FDA as an iCGM two days after the interview – see our June 12 piece for more background.

Kelly: This has been exciting to see. Bigfoot and Abbott have had a long-standing partnership and you guys have been really patient, at both organizations.

Jeffrey: I think we've actually played a small role in helping the FDA understand the tremendous power of the Libre platform and how transformative it can be to help people with diabetes, how such a broader population can use it successfully. The Libre’s current rate of sales in the US and globally are tremendous because it’s the product that truly broadens the market and widens accessibility, and the new Libre 2 will be even better.

Kelly: Thank you, and for sure Abbott’s vision on global pricing.

Albert: Right on. Jeffrey, can you talk a little bit about what might go into the Bigfoot Unity submission? It sounds like there wasn't the need for a full-on clinical trial.

Jeffrey: We have conducted extensive human factors work. When we talk about the Bigfoot Unity system, it includes all of the different components, so the wholly connected system is inclusive of the Libre. It's inclusive of the smart pen caps for whichever insulin is being used, for the basal insulin, mealtime insulin. The system includes the software on the phone, even the cloud systems that are actually onboard. The initial settings, which are directed by the health care provider and then propagate those down to the smart pen caps. You can draw a circle around all of these elements and that's what's in this submission. The system is bundled and shipped with all of the different pieces, including a connected blood glucose meter and consumable supplies. We strove to deliver something complete.

In our testing within the human factors setting, we're not just testing the technology but also the onboarding of all of the components because this is an entire system you're being introduced to; it teaches you how to use the Libre. For somebody who's CGM naive, it walks them through the Bigfoot app on the smartphone, how to initiate CGM usage, how to  use and connect all of the different hardware components of the system, how BGM works if you're not using CGM, and then builds competencies and skills that help people be successful with multiple daily injection therapy. The onboarding and the tools for doing that onboarding is done in a wholly self-paced fashion. All of this process is part of the submission and part of the customer experience.

Kelly: We love the thinking that has gone into this. That’s a lot for us to ponder. What did you learn in early tech that has been impactful here?

Jeffrey: During the early days of the internet, I found that almost any business or process could be completely reimagined. Anything was possible. As Bigfoot delves into AI, connected technologies and telemedicine, I'm finding that that same sense of endless possibility exists in the diabetes world. I can't wait to deliver these innovations to folks with diabetes who need it now.

On Making Insulin Therapy Easier for Patients

Kelly: I’m wondering about your relationships within the ecosystem, particularly now that we’re seeing so much focus on insulin pricing that has been so impactful. It’s amazing that rebates are over 70% for the insulin manufacturers, as a sidenote, and I’m not sure most of the field realizes this. Please talk about what some of the implications for Bigfoot might be.

Jeffrey: Insulin pricing is obviously one of the challenges that people have in effectively using insulin therapy. I think biosimilars at some point soon will begin to really impact pricing. Expanded competition is an important part of the puzzle. We feel like we build on top of that by promoting market competition amongst insulins because the Bigfoot Unity system supports all of the different insulins that are going to be available for once a day basal and mealtime dosing. The switch-ability between insulin brands is an important part of our system’s overall design to accommodate the competition that is here today and that will come in the future.

New insulins, I think, are going to be very price disruptive, and we're going to try and help people take advantage of that to make sure that they're not locked into any particular brand. However, once you have access to affordable insulin, the next big challenge is the day-to-day decision making of how much insulin to take. That's fundamentally what we're doing is helping people have confidence by giving them the information they need to get the right dose to keep them safe. We want them to succeed in this insulin therapy which is such a big part of life for people with diabetes.

We’re trying to take people from data to action. What they really want is not what the CGM value is or what the glucose trend is; they want to know, “How much insulin do I take at any given point in time so I can be safe and healthy?” We’re trying to get them as far down that curve as possible.

People may be tempted to think about Bigfoot Unity as just a smart insulin pen cap. The beauty of the Bigfoot Unity system is that we're not any one thing. It’s not just CGM. It's not just dose time capture. It’s not any one aspect of the system. It's really all those things altogether, knitted together to be easy to use. This is everything that a person is provided with on day one. The overall experience also includes walking them through the onboarding and initiation of therapy.

You need to be able to give yourself insulin in a safe and effective way. That's part of the challenge and what the clinicians call adherence or compliance. We don't really use the term compliance or adherence internally because we think that's a way to blame people with diabetes. It’s on device makers for things not being easy enough. I've said many times before: People want to succeed. They want to be healthy, and they will do so if you make it easy for them to integrate it into their lives. If you ask them to do too much, then they trade off other things that they're demanded to do in their daily lives, whether it be family or job responsibilities or others. It seems like an obvious thing, but I think it's been really underappreciated by the people in the industry. Making technology so simple that it negates those trade-offs is one of the things I think we’re particularly sensitive to -- and that’s where we’ll make an impact.

On the Market for Smart Pens

Albert: It feels like smart pens have been waiting to see big momentum in adoption and commercial uptake for a while now. Now that we've seen some momentum with Companion, is this the year that we really see smart pens start to see real uptake? And what do we need to see in the market to drag it out?

Jeffrey: I think having some sort of dose capture technology that measures when people are doing an insulin injection or captures the amount, that's an input to a potential solution. However, the solution that is going to drive this big momentum is one that delivers seamless and simple integration of the different components. I believe the Bigfoot system’s connectedness and completeness is what is going to be differentiated, and that really introduces the opportunity for scale. It just has to be simple -- simple to learn and use -- and usable in a way that makes it hard to misuse it.

The design needs to be accessible in a way that I don't think a lot of people in our industry are considering. Bigfoot Unity can have a tremendous impact on your ability to succeed in managing your diabetes. All the user needs to do is, literally, just wear the Libre and then do what it says on the smart pen cap. It’s that simple.

If you do that, you're basically doing exactly what your clinician wanted you to do in terms of how to dose insulin. Today, there is a big divergence in the translation between clinician instructions and how that gets done in the field; people are literally carrying around a piece of paper or looking at a screenshot and then trying to do math in their heads. We make it very easy for you to do what your doctor would want you to do in that circumstance.

Moreover, we’ll be capturing everything that happens as a result of that dose decisioning and are able to provide clinicians with that data. Literally, we can recommend how to adjust the settings over time. “Closing the loop,” so to speak, between the clinicians and the person with diabetes has to be, on the functional level, a step simpler. That’s what Bigfoot Unity aims to make possible.

On Data Sharing

Albert: I wanted to ask about your approach to sharing your data with others, whether that's sharing with other companies or even, like we've seen with Dexcom, opening that data up through an API (application programming interface).

Jeffrey: We have great ways for patients to take their data and do what they would like to do with it. That is something that everybody is entitled to. However, our research, for this particular population, indicates that the need to take data and interpret it in some other system does not rank anywhere in the top 10 needs for people with diabetes.

People are looking for simplicity. Without any work on the patient end, they have all their data captured and available for their health care provider. Patients are not interested in data. They're interested in what can be done with the data on their behalf, whether it's the clinician adding value to the interpretation of the data or whether it's algorithms working in the background to actually derive insights.

Most people just want to have diabetes be a smaller part of their lives. They want to have fewer steps. They want to think about it less. “Just give me the right answer to how much insulin I’m going to take, and let me know.” That's really the customer that we're going after. We'll provide data accessibility to people. I just don't see that as a big driver in terms of the motivation for the population.

On Helping BGM Users

Albert: We’re thinking a lot about the field and the changes. Your work at JDRF, where you identified so long ago the absolute relevance of the closed loop and how it wasn’t even CGM but the closed loop that matters – now looking at Tandem and Medtronic and closed loop growth and DIY and Loop – you were way ahead of your time! And, the vast majority of people with diabetes are still using BGM. Please talk about what you think about those are you doing for those people?

Jeffrey: Many people are lucky if they are even regularly using a BGM. The vast majority simply look at a plate and may be thinking “that looks like eight units” or “eight units worked yesterday, so I’ll do the same thing again today at lunch.” They have learned that you can give yourself a low dose of insulin and stay alive. Whatever comes 20 years from now, you're not dealing with. That's what we're competing with.

We’ve always thought that whatever it is you as a person with diabetes will give to managing the disease, we want to take that effort and leverage it to the greatest possible degree. We've always said we can't add steps. We have to actually subtract steps, or we have to at least keep it the same for people who are already following a very simple regimen.

The Bigfoot Unity pen cap can actually interface directly with the Libre, and it doesn't require you to use your smartphone or enter the carbs that you consumed to capture the result. The system is designed to eliminate steps. Most people are not going to enter carbs into a calculator. People aren’t even going to take note of blood sugar unless it's easy to do. That's a different type of customer driving the kind of technologies we're dealing with here. Our focus is repackaging the technology in very simple ways that reduce those steps so people will actually use it. I think it simplifies things where you get the greatest benefit from the technology with having the most usability and scalability.

We've always said that a design flaw, if there is one in Bigfoot Unity, is that it's too simple. Every other device is more complicated but, at the end of the day, we feel like a simpler, more accessible approach is what is so desperately needed in this industry. If we make any mistake, it's going to be because we took features out. As an example, Bigfoot Unity has a low alarm, but not a high alarm. We did this on purpose, because we think that CGM high alarms, which are often misleading and actionable, are part of the reason people aren’t successful with CGM. They're part of the tipping point in terms of the cognitive and emotional load that disallows people from using technology.  We may find out that a high alarm is appropriate for our future and we’ll make that adjustment. We do, however, have a low alarm, because that knowledge is need to know and is actionable.

We get the same question about using different CGM sensors with Bigfoot Unity. Again, you might say, well, can you use a Dexcom? Can you use another glucose meter? Well, you could, but then it introduces a lot of complexity. There are things that you can do in a Libre in terms of directly interfacing with the sensor and pen cap that you can't do with the Dexcom sensor. Then there's just training people on how to switch back and forth between sensors. All of that is creating barriers in terms of accessibility and usability.

Every feature, every bit of variation that you choose to support, it all creates a proliferation of training scenarios and a failure scenario where if people don't do it properly they can actually end up putting themselves in danger. That's why a sensor that cannot be calibrated is so much better than one that doesn't need to be calibrated. If I don’t have to train somebody on an error that you can't make, that’s a win for everybody. That's the way we look at it. The features that have been pulled out represent that complexity that frankly just doesn’t carry its weight in terms of benefit to the patient or to the clinician or to the outcome.

On Making Technology Easier for Providers

Albert: Thank you. I think a lot of what we've been talking about is very focused on making things simple for patients, and that's obviously great. But, can you talk a little bit about how Bigfoot Unity might be more successful at getting diabetes tech into the primary care space looking more on the provider side?

Jeffrey: The first version of Bigfoot Unity, I think, is going to be a great tool for endocrinologists to participate in the care of people alongside primary care providers on the front lines. We had a clinical advisory board meeting about ten days ago with people like Drs. Irl Hirsch and Anne Peters. Anne referred to how difficult it is today to support a primary care provider in multiple daily injection prescriptions and optimizing that therapy. She said this will be the perfect tool because she'll be able to tell them precisely what to do and the changes to make. Because the tools are in the cloud, they’re accessible remotely and they’re shareable across different providers. Then, in subsequent versions, we will fully embed the algorithms and tests, so that we can automatically titrate insulin and change all the underlying parameters, that's going to be the fundamental enabler for primary care providers. They'll only need to prescribe it and monitor successful usage in terms of the clinical outcomes. How to dose insulin is a math problem, and it can be optimized based on validated data and validated algorithms. That's what we're going to be doing.

Kelly: I love that it's a math problem. Do you think they share that view?

Jefffrey: Most folks who have the ability to independently use the technology successfully and are able to change their own insulin dosing, is a small number. The support resources available today don’t allow for scale. It is bad and getting worse on a relative basis.

Kelly: Great, thank you. This is a lot to think about. Do you think it would be helpful to have more data on a population level, like about practices in terms of how their patients are doing?

Jeffrey: Yes. But it’s only useful if you have all the data for most all the people. That requires simple and scalable approaches that passively acquire and deliver the data to the cloud. That is the problem that has to be solved – that's the solution we’ve designed.

With Bigfoot Unity, every user action will be captured, whether it's CGM or BGM, insulin dose timing, etc. It will all get stored on the smart pen cap, then will go to the phone when the phone is available, then will go to the cloud when the phone has a signal. Everything will be captured all the time. That happens without anybody having to do anything. None of these different data threads can require a manual step if you want to ensure that the information gets to the cloud. If you have a well-designed system that's sufficiently integrated, this is a solvable problem, one that we're solving.

On the Target Market for Unity

Kelly: It’s clear you really are trying to reach a broader audience. And we’re curious, for the people that you are trying to reach broadly, if you can make a general statement if you think that people are under dosing and what you think the impact this product will have on time in range for the population?

Jeffrey: I think Bigfoot Unity’s dose recommendation system is going to have a tremendous impact. I think that people by and large are under dosing because we look at A1cs, which are high. Most people are just under dosing as a strategy to not spend a lot of time on diabetes.

Frankly, my son does a lot better these days. He turned 25, and his prefrontal lobes lit up and now he wants to live past 30. So, he’s actually doing a lot better with his diabetes nowadays. But before, he would under dose. With that approach you don’t have to worry about hypoglycemia, and you're not going to go into ketoacidosis. We worried about what would happen in the future. Not to disrespect the younger people on this call, but I also was not thinking about the future very seriously in terms of my health when I was 18 years old. It is a big opportunity to help relieve the cognitive burden for people. I do believe that you can do this, and at the same time, have a tremendous impact to reduce hypoglycemic episodes and increase time in range. That's basically the definition of an outcome that you want to have.

I think there's a lot of low-hanging fruit. I mean, bringing somebody’s HbA1c from a 10% down to a 7.5% is just about getting them on mostly the right amount of insulin to where they don't feel unsafe and exposed to hypoglycemia. The research that Abbott has done resonates with that. They asked people, what is it about insulin that’s so demanding as a therapy? The answer is the worry of how much insulin to take at any given time. People take less because they're worried. They forget to do it at all or avoid doing it at all because they don't want to have to think about the potential ramifications if they make a dosing mistake.

Having to make a high-stakes, life-involving decision multiple times a day, every day of your life, it just wears you down. You find ways to avoid it and manage it but don't actually help to increase health and safety. But if you have a partner – and we think about ourselves as a partner-like Bigfoot Unity, telling you what to do so you can do better, that sense of support is fundamentally enabling in terms of quality of life.

Kelly: I know that you're so ambitious, one of the most ambitious people I've ever met, in terms of strategy, are you more excited about the number of people who you could persuade effectively and engage in reimagining that they could do better if they were on insulin, all those people who are not at A1c targets? Or are you more excited about all the people on insulin who don't actually have really good advice and aren't doing particularly well on insulin? There's so much opportunity.

Jeffrey: All the people who are on a basal insulin once a day are type two. I bet half of them should be on multiple daily injections. But that's a big step, it requires training and supporting a person so that they can safely dose insulin. Going from one dose, the same dose every day, to the complexity of mealtime and adjusting the corrections, that is such a big leap in terms of capabilities for the patient. We're basically saying we can take all of that training and support and completely offload it from the clinician.  The patient onboarding that occurs with Bigfoot Unity trains the patient for multiple daily injections as well as providing FreeStyle Libre 2, which is a CGM that’s very simple to use. Even the connected blood glucose monitor is simple in terms of how it integrates and relates to the steps in insulin dosing.

Moving people from basal once a day onto MDI, and then better supporting the millions of people on MDI in the US alone, both of these are very much within the addressable population for Bigfoot Unity. That step of going to insulin at all is a big step, and the step of going to MDI is a bigger step. That's why we think about things in terms of the continuum of solutions that are going to serve a broader audience.

Kelly: Just on that part, all across the spectrum, obviously, there are people who should be screened and who aren't being screened, there are people who should be diagnosed and aren’t being diagnosed, and then, they should get the opportunity to use professional CGM, so at least they and their health care teams can figure out what might they be thinking about.

Just because there's so many things to think about combining with basal insulin, and to think people will live much longer and take insulin for much longer if they come into it with less cardiovascular risk and kidney risk and all that. I know that's not like what you're doing exactly. But when you say it's a math problem, the whole lead up is a math problem. So, I'm just wondering about professional CGM and how you would see that as part of what you would be encouraging.

Jeffrey: I think regular full-time CGM is going to be the answer, not episodic professional CGM. The cost of a Libre is so competitive. As long as the tools exist to translate data to action at point-of-patient, it's just going to be worth it in terms of the value delivered to a patient of the clinic. To be able to use technology to facilitate the relationship between clinician and patient, to asynchronously update insulin dosing therapy parameters, I think these benefits will more than justify the cost of CGM.

I do think that you're right, actually, accelerating people on to insulin therapy has many benefits that are proven. People are going to do better in terms of complications development over the longer term, but insulin dosing is hard and complex and dangerous today. We're going to try and attack those specific things: less expertise required to support the transition to insulin therapy, less engagement required from the standpoint of the patient to make the therapy successful, and then very clear, tangible outcomes that we can demonstrate because we're capturing all of the outcomes data that show the therapy is working.

On Reimbursement and Building on CGM

Kelly: I was so struck this year at JPMorgan, hearing [CMS Administrator] Dr. Seema Verma talk. As far as the ecosystem goes, we believe now is the moment to be thinking about prevention and preparedness way more. Prevention of severe hypoglycemia, prevention of cardiovascular disease, prevention of kidney disease, prevention of the wrong A1c, prevention of out of whack time in range and all of that. I really did hear her say prevention, a lot. I’m not as sure about how much she meant it. For sure, one sentence she said was really troubling. She said, “I watch every dime that goes out of CMS every week.”

Related to this, I just wondered if you have any advice for the field about CGM. A lot of type 2 people who aren't on it. According to President Trump, there are 3.3 million people on insulin on Medicare. And our CGM adoption numbers are still very low on type 2. We hear from some HCPs, “It’s such a pain, they won’t get the CGM, there are so many restrictions.” But, it sounds like that you really view that as a core fundamental piece for reducing barriers for people and them doing better and living longer. And, I’m not sure if Dr. Verma receives insights like the ones you’re sharing, on this.”

Jeffrey: I think she has a lot of short-term and long-term objectives, a very difficult environment. I think that we're just focused on taking tools that are reimbursed, making them more accessible, and tying those usages to outcomes. If you can do that, then the reimbursement is going to take care of itself, and it helps if those things are already reimbursed. What we’re essentially doing is we're taking CGM, and we're making it into a decision support tool. We’re not intermediating it through a person’s brain and interpreting numbers and actually layering on physiologic curves and all that stuff, rather just taking it as far toward dosing advice as it can be. We're really building on CGM. It’s CGM plus, in a way. That's a framework that people understand, it already has reimbursement. This is going to be very useful to us as we’re going out to the marketplace.

I think it's where the broken link in the chain is today. You give CGM to people and they don't necessarily do better. You're giving them data and that data has all sorts of side effects. It actually depresses them sometimes, the exact opposite of the empowerment we hope. Shovelling data to people makes them think more about the disease, more about complications down the road. That’s why the abandonment rate for CGM is still very high.  Maybe not everybody is as numerate as some CGM users or don't do the math as well as most CGM users. When you add all those things together, you have a lot of people who are not great candidates for CGM as it exists today. I think what we're doing is going beyond the CGM and saying this is amazing data, but it's our job to take it and turn it into actionable advice.

Kelly: Yes, actionable advice. Fantastic, this is what the field wants, no matter what all our collective starting points. What do you see happening with making CGM simpler and more accessible to people? What do you see in the next five years in terms of penetration for CGM and related outcomes?

Jeffrey: I think this [CGM] is going to transform the world of diabetes for a very large number of people. And whereas automated insulin delivery systems can transform the lives of a small number of people, bringing CGM to MDI with decision support is going to be a step function larger group. I think it's going to be building on the success the industry has already had to date and, fundamentally, enabling the technology for access and scale. I have very big expectations for what Bigfoot’s contribution to that will be, but there's plenty of room for a lot of different solutions. Up until now, everyone talks about the percentage of T1Ds that have insulin pumps, and that basically ignores the two thirds of T1Ds that are not on insulin pumps or use CGM. Then you look at the T2D basal-bolus, and CGM is very underutilized. Then, you look at the people who are on basal who should be on basal-bolus, there's a very large population. There's just a huge opportunity for solutions that scale, are accessible, affordable and take the burden of data management from the patient and onto the technology.

On the Role for Insulin Manufacturers

Kelly: There's going to be so much value with insulin that could be seen see for large populations of people. Can you talk a bit about this and what opportunities for manufacturers might be?

Jeffrey: We have agreements with the big three manufacturers, Novo Nordisk, Sanofi, and Eli Lilly. They’ve all been helping us. They have provided us with specs so that our smart pen caps work with their disposable insulin pens down to the nth degree. They have supported us robustly because they want to sell more insulin, and Bigfoot support for branded insulin is good for that business.

Now, on the other hand, they have these efforts to try to do some dose-capture on their own; and, at some point, dose-capture will be table stakes for disposable insulin pens. Those days are a little ways off, but that will come. And we'll build on that. I mean, literally, Bigfoot’s smart pen cap could talk to the dose capture of a disposable insulin pen as easy as it communicates with the other components in our system.

Dose capturing will become a commodity resource for the marketplace. Bigfoot Unity is not dose capture. It is taking different data streams, bringing them together and making them useful in-real time and in a sustainable workflow to help people be safe and have easier lives.  So, in that sense I don't see them as competitors at all. They’re in the insulin business, and so their fundamental interests in that regard have led them to embrace us.

Kelly: I hope that you're right. So many more people could be helped by many organizations, as the ecosystems drives toward insulin use for the populations that will benefit, basal insulin, basal/GLP combos, rapid-acting insulin, and all of the types of insulins, and all people that could be helped more by the most appropriate transitions (to MDI, toward other forms of insulin delivery), and acceptable dosing and then optimal dosing for all those on insulin.  

Jeffrey: We have a lot to prove as Bigfoot and we have high aspirations. I'm just glad to have the opportunity to put our Bigfoot Unity system in the hands of people with diabetes and then let them and their clinicians decide whether it's useful. My bet is there’s going to be a big place in the market for Bigfoot Unity.

On What is Most Misunderstood About Bigfoot

Kelly: The last thing that we would ask is what do you think is most misunderstood about Bigfoot, or what's the one thing that you really want to convey to the people who you think don't know about Bigfoot yet?

Jeffrey: We’re not in the connected pen cap or the smart pen business. We’re defining a new category of solution that can’t be evaluated in a reductionist fashion. It's not the sum of its components. You can’t say, let's look at the dose capture, let’s look at the BGM, and let’s look at the CGM. All of these things are made to work together seamlessly, easy to set up, hard to misuse, and then graceful to integrate into the workflow of how people dose insulin. It’s all of that together, which delivers the value. That's a different way of thinking about it.

But the package itself is more digestible and scalable. The synergy of the different components has a unique value on top of any of the specific components. But, that’s hard to explain. When you experience it, I think it will be easy to see. But I’m not complaining. That’s the cost of being the first to do something; you have to prove it's worth doing.

Kelly: At diaTribe, we're really trying to think about how we can convey more about the importance of if you are on BGM. There are still so many ways to look at and use data and technology.

You’re right. If people haven't experienced it yet, and if their health care teams aren't asking for it yet, it's a little harder to explain. But I do think there is a real mission. The world is hearing people with diabetes deserve to be doing much, much better. There's a lot more people who want to help support that, and so, we're here to amplify what you guys have already started to do.

I really think it is key for the ecosystem is to understand more about Bigfoot’s history and what you have been investing in as a parent and ally of the field for so long, with your brainpower, with your genius, and with your massive successes in and around technology. Albert and the team and I thank you so much for spending this time speaking with us today.

Jeffrey: As I’ve said, we have a lot to prove yet, and we're happy to be able to have our opportunity. Thank you for all your amazing work and trying to advocate and highlight the need for better, simpler, more impactful diabetes technologies for a broader population of people.

 

--by Albert Cai and Kelly Close