Bigfoot announces clearance of first-gen Bigfoot Unity™ Diabetes Management System (two connected pen caps, Abbott FreeStyle Libre 2 sensors, smartphone app); interview with CEO Jeffrey Brewer – May 10, 2021

1. The Bigfoot Unity System: first smart pen cap system cleared for use with disposable insulin pens (ages 12+); integrates FreeStyle Libre 2 data directly with pen cap

The Bigfoot Unity System is the first smart pen cap system for disposable insulin pens to receive FDA clearance. Indicated for people with type 1 or type 2 diabetes ages 12+ on multiple daily injections of insulin, the system first arrives in the Bigfoot Unity Welcome Kit with two smart pen caps (a white one for bolus/rapid-acting insulin pens and a black one for basal/long-acting insulin pens); two FreeStyle Libre 2 sensors; pen needles; and a back-up connected BGM (BGM readings transmit directly to the pen cap). The system is compatible with all major US brands of rapid-acting and long-acting disposable insulin pens (i.e., those from Lilly, Novo Nordisk, and Sanofi), which makes the system more flexible and accessible for patients switching between insulin brands. Bigfoot also shared with us plans to support future insulin pens from other manufacturers (e.g., Biocon).

Notably, Bigfoot’s smart pen caps are integrated with the FreeStyle Libre 2 system and the bolus smart pen cap is used to scan the FreeStyle Libre 2 sensor (i.e., rather than using a reader or phone app). After a user scans their CGM, the CGM value is automatically used to recommend  an insulin dose based on the person’s physician instructions, and the pen cap screen (see below) displays the user’s recommended bolus dose, along with their current CGM value and trend arrow. Because the Bigfoot Unity System displays the recommended dose, current CGM value, and trend arrow right on the pen cap, users do not have to use an app or other devices to access dosing support and their CGM data, which simplifies the insulin dosing process. For now, the bolus dose recommendation is done using the CGM value only, but a “smarter” calculator that takes trend arrow into account is in the works. When the user’s smartphone is in range, the pen cap also transmits CGM and insulin dose data via Bluetooth to the phone, where it is also uploaded to the cloud wirelessly. Overall, the goal of the system is to “help [MDI patients] answer the question, ‘How much insulin would my doctor recommend I take right now?’”

Below is a breakdown of notable features:

• The pen cap itself. Due to the different structures of insulin pens, Bigfoot designed different caps to match different pens (see the images below). While the pen caps are rechargeable and intended to last two years, patients can also exchange their pen caps as needed to match the insulin pen brand prescribed to them and covered by their insurance; Bigfoot estimated that ~30% of patients on MDI experience changes in their insulin brand on a regular basis. Rapid-acting white pen caps are designed to last a few weeks before needing to recharge, and the long-acting black pen caps are intended to last a month. The white-colored mealtime insulin pen cap is designed to remind users to bring that pen during the day, while the black-colored basal cap is designed to remind users to use that pen at night (when most basal insulin doses are delivered). Notably, users will be able to  upgrade the software on the pen remotely, which will be important as Bigfoot iterates on its initial product.

• The pen cap screen’s display. When not actively being used, the pen cap’s E-Ink screen displays the brand of insulin it matches (e.g., Humalog, Levemir) next to a single button. When a patient clicks the button, they can see the time of their last basal dose on the black long-acting pen cap and their last bolus dose and last CGM value and trend arrow on the white rapid-acting pen cap. When they use the white bolus pen cap to scan their FreeStyle Libre 2, they can see their current CGM information alongside a recommendation for whether or not to issue a correction bolus based on insulin on board and if so, how much to dose. The pen display also allows patients to easily access their provider-recommended meal doses, which depend on clinician-determined personalized settings and can be displayed by fixed dose, qualitative meal size (e.g., big, small, medium), or carbohydrate counting.

• Scanning the FreeStyle Libre 2 CGM using the smart pen cap. Bigfoot has enjoyed significant support from Abbott for many years and the rapid-acting pen cap includes NFC connectivity to scan Abbott’s FreeStyle Libre 2 sensor. This simplifies the process for patients and removes the step of using a separate reader or app to scan and access CGM data. It is also important that the system allows patients to access their current FreeStyle Libre 2 data on their pen cap and retrospective data on their phone because there is currently no phone app available for FreeStyle Libre 2 scanning and data review in the US. See more of our thoughts on this below in the competitive implications section.

• Alarms and alerts. The Bigfoot Unity system has two real-time hypoglycemia thresholds alarms: a mandatory alarm at 55 mg/dl and an optional alarm at 70 mg/dl. The system also alerts users of potentially missed basal doses when more than 24 hours has elapsed since the last basal dose. Both the hypoglycemia alarms and the missed dose alerts are presented as phone notifications sent from the app. The system does not have predictive alarms or hyperglycemia alarms, nor alerts for potentially missed bolus doses.  Mr. Brewer argued that these were all intentional choices to avoid alarm fatigue, although we could certainly see value in having an optional alert for potentially missed bolus doses and for hyperglycemia given that those alarms could signal the need to dose insulin.

• The mobile app. On the Bigfoot Unity app, patients can view their retrospective CGM and insulin dosing data, view an event log of FreeStyle Libre scans and insulin injections, manage their devices (e.g., check when need to apply a new CGM, pair devices), and view and change settings, including the type of insulin currently being used and insulin dose settings (e.g., how the patient or their provider wants to categorize meal doses). Alarms are also sent via the app.

• Automatic, real-time data sharing with providers in the Bigfoot Clinic Hub. When data is sent to the cloud from the smartphone, it is automatically uploaded to a secure web portal, the Bigfoot Clinic Hub. In the portal, providers can access their Bigfoot Unity patients’ CGM and insulin dosing data, allowing them to remotely monitor patients and provide care and recommendations. This data sharing and remote monitoring portal is the basis for the Bigfoot Unity™ Diabetes Management Program, which is described below. We see automated data sharing with providers as a huge win for both patients and providers. We are thrilled to see data more easily getting into the hands of providers to support their patients both during visits and between visits. We’d argue that the next step for all diabetes technology companies is direct integration with electronic medical record (EMR) systems – while integrating data into a one-stop shops for those using particular technologies is a hugely important first step, we believe the ultimate goal is to integrate all data from all sources into EMR systems to simplify providers’ workstreams.

• A few contraindications, including one for ascorbic acid. The system is not intended for those requiring 0.5U dosing increments (e.g., small children), for those who take multiple daily injections of basal/long-acting insulin, and for those who take high doses of Vitamin C (more than 500 mg per day). This last contraindication on Vitamin C intake is presumably due to high doses of ascorbic acid’s documented interference with FreeStyle Libre 2’s accuracy.

2. Available in “select diabetes clinics beginning in spring 2021” as a monthly subscription service; “generally” covered by insurance; supports remote patient monitoring codes

The Bigfoot Unity System will become available in “select diabetes clinics beginning in spring 2021.” Presumably, Bigfoot eventually plans to roll out the program across the country and into primary care clinics – we believe endocrinologist systems will also be very interested in using it for their patients with T2D as well as people with T1D who don’t want to go the closed loop route or can’t afford it. Notably, the system is not available for direct purchase; instead, patients with diabetes will receive their system from their provider. The system follows a pay-as-you-go monthly subscription model with no upfront cost. While this, of course, poses some risk for Bigfoot if users try the system and discontinue use quickly; however, if discontinuation rates are low, having no upfront cost should attract a broader group of patients to the Bigfoot Unity Program by removing the cost barrier to entry. According to Bigfoot, the Bigfoot Unity Program “generally should be covered by insurance,” though co-pays will vary as do deductibles, of course, within the US. The prescription process seems fairly simple, as Bigfoot provides a web portal for providers to submit the patient information to Bigfoot. As a sidenote – we continue to be stymied by the fact that there still aren’t policies that make insulin free to anyone with diabetes. We do think that physician offices are very well suited to be able to point out Patient Access Programs to people with diabetes and we imagine that more could be in use if Unity takes off – the offices can also explain how to get cash pay costs for CGM where needed.

• To support rollout of Bigfoot Unity, the company announced a combined debt and equity raise of up to $57 million earlier this month. Back in June 2020, Bigfoot also closed a $55 million Series C, led by Abbott. In addition to the funding, Bigfoot has also added to its commercial team recently, with Mr. Berkley Nelson (previously Chief Growth Officer for Voluntis) hired as Senior Vice President, Mr. Tony Galliani (previously VP of Sales at Companion Medical) as VP of Sales, and Mr. Sam Auderer (previously Director of Commercial Offerings at Voluntis) as Director of Commercial Operations. Chief Medical Officer Dr. James Malone was also a very notable hire in mid-2020; he spent years in practice at the renowned Joslin Clinic and was at Lilly for well over a decade before joining Bigfoot.

• The Bigfoot Unity Program automatically collects data to support Remote Physiologic Monitoring by providers – this should be a big deal as this becomes well understood by HCPs. This monitoring is reimbursable using existing CPT codes. To start, these codes include CPT code 99453 (one-time) and 99454 (billed every 30 days) for device set up and use. Providers could also file CPT codes 99457 and 99458 every 30 days for time spent interpreting glucose and insulin data. Importantly, all of these activities can be performed by a physician, qualified health clinical professional, or clinical staff. Alternatively, physicians and qualified health clinical professional can file the more commonly used 99091 code for provider time spent interpreting glucose and insulin data every 30 days. The Bigfoot Clinic Hub provides support to streamline the billing process by producing a document called a “Superbill.” The auto-generated Superbill documents the data collected by the Bigfoot Unity System and fills in information required for relevant CPT codes. We’ll be checking in across the field as to the significance of this and will report back – we know not all codes are well-understood or well-used and we believe Bigfoot should benefit from a greater focus on HCPs, specifically PCPs. We also believe the fact that so many patients are so far out of control is also something that will benefit Bigfoot – MDI is incredibly hard to do for so many patients on their own and there should be lots of areas of upside, even just some going from no insulin to basal only and some on basal only to MDI and some on MDI to smarter dosing (even changing this like timing of shots can have a massive impact on TIR – so can PWD having a better sense with CGM of the impact of food).

3. Competitive Implications: increased pressure on Medtronic’s InPen; Bigfoot Unity as potential stepping stone to AID

The Bigfoot Unity System is the second smart pen solution to come to market in the US and the first to support disposable insulin pens. The Bigfoot Unity System is coming to market at an opportune time for smart pens with the addressable MDI market estimated at 12X of insulin pumps, representing a sizeable opportunity from both a financial and public health perspective. In the US, Companion’s InPen, which was acquired by Medtronic in August 2020, has been the only significant player in the field for three years. However, given the size of the addressable market, we expect multiple players to be involved long-term. Just recently, Novo Nordisk launched two of its smart pen systems in Sweden and Lilly has made recent public announcements about its efforts in the area. It also appears Sanofi is developing smart pens as part of its digital health strategy.

• Medtronic’s InPen now has competition as the Bigfoot Unity System enters the US market. Medtronic’s smart pen efforts, so far, have centered around data integration with Medtronic’s Guardian CGM as well as concerted efforts to “close the loop” for MDI patients by leveraging AI algorithms, InPen, and future CGM technologies. Specifically, Medtronic has plans to integrate InPen with its AI-based food and activity tracking algorithms Nutrino and Klue. InPen continues to support data integration with Dexcom and Senseonics CGMs, in addition to Medtronic CGMs; however, the Bigfoot Unity System’s tight integration with the popular FreeStyle Libre 2 system could certainly be a driving factor for many patients. InPen also hosts its smart dose calculation on the smartphone app, rather than the connected pen itself. InPen is currently cleared for use by patients as young as 7 years old (patients under 7 can also use the system with adult supervision), while the Bigfoot Unity System is indicated for those 12+ years. Finally, while InPen is a durable insulin pen that uses insulin cartridges, the Bigfoot Unity System uses a pen cap for disposable insulin pens. Medtronic’s considerable marketing, name recognition, and payer muscle could also make a difference for some patients and providers. Regardless, the MDI market opportunity is massive and there is plenty of room for multiple viable players with differentiated offerings.

• Perhaps the “sleeping giants” of the connected pen landscape, major insulin manufacturers are also starting to build out their own connected hardware ecosystems. Novo Nordisk recently launched its NovoPen 6 and EchoPen Plus smart pen systems in Sweden and that launch will “soon be expanded to Western Europe and many other countries.” Though we have not heard plans from Novo for a US launch, the company almost certainly has plans to bring these reusable connected insulin pens to the US market. NovoPen 6 and Echo Plus received CE-Marking back in 2018, but Novo Nordisk encountered setbacks including a product recall that delayed initial launch. Eli Lilly and Sanofi have also both shared plans to develop and commercialize smart pen technology. Last month brought substantive updates on Lilly’s smart pen efforts when the company announced a collaboration and licensing agreement with Welldoc. Lilly aims to submit a pen attachment and insulin management app to the FDA “later this year,” with Welldoc’s help in building out the custom smartphone app solution. At the time, we also confirmed that the Lilly/Welldoc solution will also support automatic integration with Dexcom CGMs. Sanofi has been a bit less open about its smart pen strategy, but given the company’s remarks at JPM 2021, some sort of digital health strategy seems certain, such as building its own connected pens and titration apps as it suggested in September 2019. Sanofi already has data sharing partnerships with Abbott and the company’s December 2019 announcement that it would discontinue diabetes therapy R&D did not reflect its approach to digital, though we don’t know exact specifics.

• One obvious takeaway here is that growing uptake of CGM continues to enable data-driven optimization of insulin dosing. While much attention has been given to CGM enabling insulin pumps to become “smart” with automated insulin delivery algorithms, CGM has the same opportunity to enable better insulin titration for MDI users. As of 4Q20, Abbott had “nearly 3 million” FreeStyle Libre users worldwide with roughly 25% of sales coming from the US. Depending on the speed and scale of uptake for Bigfoot Unity, Bigfoot’s system could be a compelling reason to bring more MDI patients to the Abbott CGM ecosystem. Specifically, as the Bigfoot Unity System will be marketed to both type 1s and type 2s, this represents a significant opportunity for Abbott to continue expanding FreeStyle Libre 2 use among the type 2 population. We also imagine that uptake will go the other direction with current FreeStyle Libre 2 users on MDI transitioning to the Bigfoot Unity System for a more integrated diabetes management experience. From our perspective, Abbott’s partnership with Bigfoot fits nicely with the company’s commitment to FreeStyle Libre as a “mass market” product given that the majority of people with diabetes around the world rely on MDI therapy.

• Depending on the burden and glycemic outcomes achieved with MDI + connected pen + decision support systems, these connected pen systems could also serve as a gateway to AID systems for some patients. By integrating CGM data and providing patients with dose-decision support based on their doctor’s instructions, Bigfoot Unity is taking important steps toward “closing the loop” in regard to patients’ data, while still allowing them to manually inject insulin. In this space, Bigfoot may offer patients an alternative if they are reluctant about committing to pump-based AID therapy. It’s also possible that these systems could make people more comfortable with CGM and insulin dosing technology, ultimately helping them transition to a pump-based AID system. Notably, based on 4Q20 numbers pump manufacturers continue to see large growth from patients converting from MDI therapy. Specifically, Insulet reported “approximately 80%” of new patients coming from MDI therapy, compared to “about half” for Tandem. Throughout our communication with Bigfoot,  the company has continued to emphasize a mass market approach to target patients who want a more intermediate level of digitization and automation. Regardless, patients and providers will certainly appreciate having more options to select how much data and involvement they want in managing their diabetes.

4. Post-market trials to assess Time in Range; second-generation Bigfoot Unity to include automatic settings updates; Bigfoot Autonomy AID system expected “~2023”

With the first product cleared from Bigfoot, here’s a look ahead at some of the next steps for the company. Of course, for now, the focus will likely be on successfully rolling out the first-generation Bigfoot Unity System. For an interesting look back, take a look at our coverage from the initial formation of the company in December 2014 (then called SmartLoop), with Jeffrey Brewer (CEO), Bryan Mazlish (CTO), and Lane Desborough (Chief Engineer). The company’s focus has been on simplifying diabetes technology for people with diabetes from the start (see our interview in February 2015) and despite some delays, we’re excited to continue watching the company progress towards its mission.

• Bigfoot has plans to conduct post-market trials to assess glycemic outcomes and Time in Range associated with Bigfoot Unity System use. To date, we haven’t seen much outcomes data on any connected pen + CGM system, so we are interested to learn how its Bigfoot Unity System may help patients improve their glycemic control. We also imagine that real-world data may encourage more providers to work with Bigfoot and make the Bigfoot Unity System available to their patients.

• Looking ahead for Bigfoot Unity, future updates will bring more automation between providers and patients. Specifically, providers can currently view patient system settings in the Bigfoot Unity platform and make recommendations, but actual settings must be manually adjusted by patients. In the next iteration of the platform, providers will be able to update patient settings from the provider-facing Bigfoot Unity platform which will automatically and remotely transmit the new settings to a patient’s device (and then must be accepted by the patient) allowing for increased personalization and system adaptation. Prior updates from Bigfoot also indicated that the Bigfoot Unity system would have an automatic dose titration feature by “~2022” to automatically adjust the insulin dosing algorithm based on user’s actual results over time. It is possible these feature updates will occur together as part of a system upgrade and it is our understanding that they will require additional FDA submissions.

• Bigfoot has previously shared plans to launch the Bigfoot Autonomy hybrid closed-loop system in “~2023.” Bigfoot has not shared any product details or updated timelines, but Mr. Brewer has previously stated that the Bigfoot Unity system “will serve as the foundation” for Bigfoot Autonomy. The AID field is certainly hitting its stride right now and may be a much more competitive market when Bigfoot Autonomy launches in a few years.

• As Bigfoot has described Bigfoot Unity as a “platform,” our discussion with management suggested similar pen caps could be used for non-insulin diabetes injectables (e.g., GLP-1RAs). While these medications don’t present the same challenge in titration, we’d imagine providers and pharmaceutical companies would be interested in gathering data on how these medications are being used in the real-world. For now, there are no publicly disclosed timelines on these connected pen caps.

5. Bigfoot Unity Product Images

Interview with Bigfoot CEO Jeffery Brewer

Kelly Close: Hello, Jeffery! Thank you so much for taking the time to speak with us today amid all the excitement that you and Bigfoot must be experiencing right now. What an exciting story! I don't know, Jeffrey, if you have one word that could sum up how you’re feeling to start us off? The field of diabetes as well as Bigfoot itself has been through so much throughout the pandemic, and we are so excited for you as the world shifts into deeper understanding about the importance of diabetes management.

Jeffrey Brewer: I’d say, “About time.” We're excited to get this across the finish line despite a frustrating pandemic. We're all so grateful to the FDA for being able to work with us when they have so much else going on. Their resources are greatly taxed and reallocated to a lot of COVID related activities. We feel fortunate that given the current environment, we received clearance for the Bigfoot Unity System as quickly as we did.

Kelly: Of course – we are so thrilled to speak with you today and have a number of questions, so why don’t we just kick things off.

Katie Mahoney: It's nice to meet you all, and to echo Kelly, we’re really excited about Bigfoot’s clearance and what it means for the space and for people with diabetes. What does this mean for people with insulin-requiring diabetes who are on MDI therapy?

Mr. Brewer: With the Bigfoot Unity System, we’re achieving some very key milestones in terms of innovative advancements for people with type 1 and type 2 diabetes on MDI insulin therapy by clearly, and in real time, helping answer the question, “How much insulin would my doctor recommend I take right now?”

The system is designed to help a broad population of people take the right amount of insulin at mealtime, take corrections consistently, but also not stack insulin. By supporting people to address these challenges, I believe the Bigfoot Unity System could be a game changer for a lot of people whose lives depend upon insulin.

It's also important to understand that we also help clinicians better serve their patients who are on MDI therapy; thus, we have two user groups. There are the people with diabetes – the Bigfoot Unity System is cleared for use by individuals aged 12 and up – and there's the clinicians who are treating those people.

Katie: Great. Who is this system more designed for? People with type 1 diabetes or type 2 diabetes? How would you expect the patient split between those with type 1 vs. type 2?

Mr. Brewer: We look at patients with insulin-requiring diabetes, whether they are type 1 or type 2, as a community. And, we know those who are either on, or could benefit from, multiple daily injection (MDI) therapy, have been underserved by diabetes innovation. These are patients wanting more support with their insulin dosing decisions -- those struggling with glycemic control, insulin dosing or those experiencing hypoglycemic unawareness. Importantly, this community of people who can be served by the Bigfoot Unity Program is broad -- ranging from those with type 1 diabetes not on insulin pumps to those with type 2 diabetes needing to intensify their insulin therapy.

When I think about the actual split of patients, my guess would be 60/40, type 2/type 1, because I think that's what the practices see in terms of MDI therapy across type 2 and type 1. Plus, with our focus on simplicity and ease of use, we think the Bigfoot Unity System could be especially helpful to those e type 2 patients needing to transition to correction and/or mealtime dosing and who could benefit from its dose-decision support.

Katie: Got it. Can you walk us through the system in terms of how a user is going to experience it and how they're going to engage with it?

Mr. Brewer: The Bigfoot Unity smart pen cap, which is compatible with their disposable insulin pen, is designed so that the user can get an insulin dose recommendation, on-demand, based on their current CGM data and their doctor’s instructions. It's very simple. The only thing you need to do is press the button on the pen cap and cycle through a few screens to get the information to help with the dosing decision. Then take the insulin as usual. The intuitive design means most anyone could use this.

For taking basal or long-acting insulin, we have a black pen cap for the user’s long-acting disposable insulin pen. Press the button and the pen cap is going to display when you last took a dose, keeping you from taking two doses accidentally, but just as importantly, keeping track of the time the last dose is given so that we can remind somebody if it’s been, say, 25 hours since the system last recorded a basal dose. Press the button again, it's going to display the long-acting insulin dose directed by your physician. That's the easy part of MDI therapy because you're taking a fixed dose of long-acting insulin at the same time every day.

The hard part is the rapid-acting insulin, and it’s often the reason many people with type 2 diabetes get stuck on long-acting basal therapy and never progress to MDI because it's more complicated. Here, we again make things simple for users. For rapid-acting insulin, the pen cap color is white to represent the one you carry around with you during the day and reduce confusion between the two pens [long-acting vs. rapid-acting].

The white smart pen cap for your rapid-acting disposable insulin pen has the same general simplicity. Press the button on the pen cap, and it's going to tell you when you last took a dose and then give you the opportunity to interface directly with the glucose data source: the Freestyle Libre 2 sensor. The Bigfoot Unity smart pen cap allows the user to scan the sensor, after which the pen cap displays your current  glucose value, trend arrow and any recommended correction dose based upon your health care provider’s instructions. Press the button on the pen cap again and it will display your health care provider’s suggested meal insulin dose. The meal doses are customizable so, for example, it could show three different doses for small, medium, and large meals, which we believe will be a categorization that's going to be very popular with people with type 2 diabetes and even some people with type 1 diabetes. Or there can be fixed meal doses for breakfast, lunch and dinner, or carb buckets of, for example, 30, 60, and 90 grams. The user presses the button once more for the pen cap to display recommended doses that reflect the combined correction and meal doses. Very simple.

We use the phrase “dose recommendation” very intentionally because, ultimately, the patient is going to do what they want to do because they know more about their diabetes.

Our goal for the Bigfoot Unity System is to make it really simple for patients to translate what the clinician would have written down on a piece of paper in almost all other cases, and then can just follow those instructions. The final step is that the pen cap captures when that was done and starts the timer to track time between doses.

Katie: Can you expand on the timer a bit more? That’s so good to hear.

Mr. Brewer: The timer is really important because it helps with insulin stacking, which, as you know, is a big challenge, especially for people using CGMs. We have a simple way of dealing with that issue. First of all, the doctor-recommended corrections are displayed for you, but then we also track if there has been a recent dose recorded. Say, for instance, you come back an hour-and-a-half after taking a dose, pressing the button again, doing a scan, and getting another glucose reading. You still may be high because it takes insulin up to three or four hours to work. We know there's active insulin on board so then we do not recommend a correction dose. This is designed for simplicity, designed for ease of use, ease of training, limiting mistakes you can make. Truly your real time partner.

Katie: How is the Bigfoot Unity System compatible with all major US brands of disposable insulin pens?

Mr. Brewer: One of the big advantages of our system is that we're supporting all the different basal and bolus insulins from the major manufacturers, and we’re going to support additional pens as they come out, such as for future biosimilars. This is important because the research we've done shows that for a given clinician, about 30% of patients on MDI therapy get their insulin switched on them on a yearly basis. If you're on Novolog then the payer says, no, you must switch to Humalog, then Bigfoot is going to send you, at no additional charge, a new pen cap that fits your newly prescribed Humalog insulin pen. We think that this open system approach as regards to insulin is a really important differentiator.

Katie: What was the motivation for Bigfoot to go with a “smart cap” system versus a durable smart insulin pen?

Mr. Brewer: Three things were driving us to the smart cap solution. First, if you look at the current use of disposable insulin pens in the U.S., the vast majority of people taking insulin use disposable pens vs. reusable pens and this trend is growing. Second, knowing that the Bigfoot Unity smart pen caps work with all major U.S. disposable insulin pen brands certainly makes it simple for providers to start patients on the Bigfoot Unity System without changing their brand of insulin. Third is that we also want to support patients with their long-acting insulin dosing and enable providers to have this more comprehensive view of insulin dosing.

Katie: Great, and how about the Bigfoot Unity mobile app?

Mr. Brewer: The mobile app is where you can view retrospective glucose data and see the event log in terms of dose timing, sensor scans, and other events. It also gives you the opportunity to manage your devices: to go in and check when the sensor is due to expire and to make sure that any of the other devices are paired and robustly connected. There is also the settings section, which has all the settings for your particular type of insulin and your dose parameters set by your clinician.

In addition to retrospective data and settings, a key feature of the Bigfoot Unity app is providing hypoglycemia alerts. The app provides a very low glucose alert when the person’s glucose value falls below 55 mg/dl, as well as an optional low glucose alert when the glucose value falls below 70 mg/dl.

As I mentioned earlier, you don’t need the phone or the mobile app when you are making a dosing decision. Because all of the dosing information is displayed on the Bigfoot Unity smart pen cap, that’s all you need. There’s no entry of data at all. The smart pen cap is capturing the data and then uploading it to the cloud whenever WiFi or cellular signal is present.

Katie: A BGM is included, is that for backup BGM? How are patients intended to use that as part of the Bigfoot Unity system?

Mr. Brewer: A BGM is included with the Bigfoot Unity System and it’s also connected to the smart pen cap. If the patient or the clinician want to use the BGM instead of the FreeStyle Libre 2 sensor, they have that option. For the BGM, you just do the test, and the glucose value goes right to the pen cap where it’s displayed for the user. No transcribing the number. Our rule is no asking people to manage data because frankly, they don't do it, or they don’t do it consistently. Everything has to go to the phone and the cloud automatically. [Editor’s note – we’re very glad to hear this given variability in terms of affordability of sensors, even using the least costly system.]

Katie: And how about alerts?

Mr. Brewer: The Bigfoot Unity System provides continuous support with important reminders and alerts. The system notifies the user if they may have missed their usual long-acting insulin dose. And, the Bigfoot Unity app provides a very low glucose alert when a person’s glucose value falls below 55 mg/dl as well as an optional low glucose alert when the glucose value falls below 70 mg/dl.

We have a philosophy on alarms that they need to be actionable, so we only alarm when we know you need to do something. So, we’re really trying to be sensitive to the cognitive and emotional aspects of this. People have too many reminders about diabetes and they have to think too much about diabetes. So, whenever we can err on not thinking about it, especially with alarms, that’s what we’re going to do. We're really trying to find the right balance between your glycemic management and the cognitive and emotional load.

Katie: Regarding the smart pen caps, what is their battery life and total lifespan? Does the screen display E-ink?

Mr. Brewer: On average, the battery life is a couple of weeks for the Bigfoot Unity smart pen cap for the rapid-acting insulin pen because you use it all the time when you're scanning the sensor. It's at least a month and probably more for the long-acting pen cap. And we do have a charger, and they’re lithium-ion batteries. The caps are designed to last at least two years. The screen display is an E-Ink screen, which is really cool. It's always going to show the insulin pen brand like Humalog or Novolog, even when it's off. So that's one of the cool things about the E-Ink screen, that it's going to have that continual visual affordance.

Katie: Got it. You’ve mentioned simplicity a few times, which is such a touchstone in diabetes; can you talk more about why is this so important?

Mr. Brewer: Simplicity and ease of use were our mantras when designing and putting the Bigfoot Unity System together. We wanted to make it for the most people, the most heterogeneous population: people with type 1 diabetes, people with type 2 diabetes, young, old, happy and familiar with technology or those who need some help. There are a lot of solutions out there that can create complications with more settings and more switches.  Those complex solutions are great for certain types of users. Certain types of people want that and demand it. The Bigfoot Unity System is for everybody else. We think it's going to be a very important part of the market in that respect.

Kelly: You said the Bigfoot Unity System has two users – patients and providers. How do you think about the provider as a user? It’s great to hear they will have such a specific focus and will be in touch with Bigfoot directly – we know there are many times that coding can be used but isn’t, sometimes because HCPs aren’t aware of coding changes. 

Mr. Brewer: The provider is a key user of the system primarily through the holistic Bigfoot Unity Diabetes Management Program, which has a larger footprint of capabilities. The program includes the technology to help clinicians manage their MDI patient population through the Bigfoot Clinic Hub web portal. The data that the Bigfoot Unity System automatically collects through the smart pen caps and the FreeStyle Libre 2 sensor along with the BGM values upload to the Clinic Hub. This data supports Remote Physiologic Monitoring, or RPM, by physicians. It’s an important point because clinics can use existing CPT codes for RPM so they can be reimbursed for the supplies delivered to the patient and their time delivering proactive, remote care.

Hanna Gutow: Why is the automatic collection of data for Remote Physiologic Monitoring important to physicians?

Mr. Brewer: We’re trying to help people to get more proactive care and the reimbursement necessary for doctors to be able to deliver that care.

Currently, our health system is set up so that if you have an acute problem, you go in, and you get it addressed and then you go away until you have another problem. That's why you go to the doctor. This idea of proactive care, the sort of tracking you across time doesn't really exist unless you have these tools to track populations and to be reimbursed for doing so. This is a big problem today – you have data that may be generated by patients if they're wearing the CGM or if they're using the insulin pump, but then the doctors may not be looking at it and actually using it in order to help that patient on a month-by-month basis.

There are existing CPT codes for Remote Physiologic Monitoring that enable providers to get reimbursed for their time providing proactive, remote care. There's a value-based element to these codes. They're incentivizing the clinician to actually look at the data on a monthly basis. These codes help bring into reality this better proactive care, meaning I have devices that help me dose insulin, those devices are smart, they capture data, they give it to clinicians, clinicians can use it on a monthly basis to tune my settings. We’re excited that the Bigfoot Unity System provides that automatic collection of data for Remote Physiologic Monitoring by physicians.  

Hanna: How does Bigfoot plan to approach reimbursement and pricing in terms of making Unity accessible to people with diabetes?

Mr. Brewer: The Bigfoot Unity System is not available for purchase on its own. It is part of the Bigfoot Unity Program which is provided through the patient’s diabetes clinician or endocrinologist. Importantly, there are no upfront costs for the Bigfoot Unity Program to patients or providers. The program is delivered instead as a monthly subscription service. The program is eligible for insurance coverage and generally should be covered by insurance although copays will vary.

Hanna: Can you just share a little bit more on the payer coverage that you have right now?

Mr. Brewer: The beauty of the Bigfoot Unity Program is that there is coverage out of the gate for Remote Physiologic Monitoring (RPM) supplies and services, and the supplies included in the Bigfoot Unity Program qualify for existing codes that already have existing reimbursement when provided by the clinician for RPM services.

To qualify for the RPM code that covers the devices/supplies, your program has to include these things: (i) you have to be a cleared medical device regulated by the FDA; (ii) you have to be a prescription from a clinician; (iii) you have to wirelessly collect physiologic data and you need to do that passively, meaning no parameters get manually entered into a field, no cables get plugged in, and it just uploads automatically; and (iv) you're not reimbursed by another code.

The Bigfoot Unity Program meets these requirements and is designed to assist the clinician in providing RPM services. That's a very good place to be. It's not just for CMS, which initiated these codes and has really been an advocate for them, but also for private payers that have largely embraced them and are now supporting them.

Hanna: That’s terrific, particularly as private payers themselves have started looking more closely, it seems, at how people with diabetes in their systems are doing on diabetes management. Let’s dig into how providers interact with the Clinic Hub - how does that work?

Mr. Brewer: The Bigfoot Clinic Hub is a web portal specifically designed to support providers with their patient population using the Bigfoot Unity System. It includes a standard AGP, developed by Dr. Rich Bergenstal and the International Diabetes Center, which we adapted to our reports with some additional information in terms of adherence, for example, did they miss doses, and includes daily CGM profiles. The portal also shows the patient’s current insulin dose settings.

When they access Clinic Hub, the provider can choose to look at retrospective patient data in many different ways. For example, providers can sort by patients who may be experiencing high glucose or low glucose on a regular basis. If the provider determines that a change in the patient’s settings is needed, they can contact the person to quickly and easily make those changes.

Hanna: How does a provider or a clinic get started with the Bigfoot Unity program?

Mr. Brewer: First of all, I need to make clear we have a different commercial model as we enter into partnerships with endocrinology practices and diabetes clinics to deliver the Bigfoot Unity Program from that clinic to its patients. It's a different approach, and it is because we're so deeply partnering with the clinicians and the patients to enable a more scalable care.

So, let’s assume that a clinic has signed up for the Bigfoot Unity Program and they're starting to provide it to their patients. Once a clinic is signed up for the program, they will go into the Bigfoot Clinic Hub and enter the patient's information, including the settings: Which insulin are you prescribing? What are the ways you're prescribing it? Dosing for breakfast, lunch and dinner? This is all done digitally and then signed digitally by the clinician in the clinic that we're supporting. There's no piece of paper. Nobody has to go and call us. It’s just done.

So now the patient is prescribed by their provider and the next interaction will then be from Bigfoot directly to that person. We make it very streamlined and straightforward for the clinic because we're taking a lot off of their plate. The next step is for us to send the Bigfoot Unity Welcome Kit directly to the patient’s home. The kit includes what the patient needs to get started except their separately prescribed rapid- and long-acting disposable insulin pens.

Hanna: From home, how does the person learn how to use the Bigfoot Unity System?

Mr. Brewer: Bigfoot has an app-based training program to walk you through the set up with all the components in the Welcome Kit. One of our Bigfoot diabetes care and education specialist (formerly CDE, certified diabetes educator) meets with the patient in a Zoom remote session and supports them with what's happening on the app and what’s happening on the screen so that the patient receives full personal support. If they're inserting a FreeStyle Libre sensor for the first time, that's a big step for people, and they'll be supported through the first-time insertion of the sensor. There are also tools we’ve created to do a simulated usage on the screen to make sure all the basic concepts are understood in terms of how to use it.

So, the level of training provided by Bigfoot is very robust. We're striving to provide training on our devices and system so it is off of their radar and their responsibility list. Instead, the health care provider can focus on providing medical/therapeutic advice and determining therapy settings using the system that we have developed.

Hanna: Great. Thank you so much for all that information and all your insights. We so appreciate you taking the time to talk with us.

Mr. Brewer: A pleasure. Thank you for your attention and time. We can't wait to get the Bigfoot Unity System into the hands of people with diabetes.

Kelly: Thank you. You're doing the work in diabetes that is really challenging, helping people get to MDI and be on it successfully – I echo the team, thank you so enormously for this time that you’ve spent with us.

--by Hanna Gutow, Katie Mahoney, Albert Cai, and Kelly Close