Steve Freed — This is Steve Freed with Diabetes In Control and we’re here at the American Diabetes Association 77th scientific sessions 2017. And we’re here to present you some of really exciting interviews with some of the top endos from all across the world and we have with us a unique guest. Tell us a little bit about yourself and what you do.
Joel Goldsmith — My name is Joel Goldsmith. I lead Abbott Diabetes Care Digital Platforms Group, which is focused on software-based products and services, which are increasingly becoming important as one of the modern tools available to clinicians and patients to help manage and treat diabetes.
Steve Freed — How long have you been with Abbott?
Joel Goldsmith — Almost 10 years
Steve Freed — I don’t know if you’ll be able to answer this question, but Abbott was at the forefront of CGM before anybody. They bought a company and they had a product called Navigator. What happened to it?
Joel Goldsmith — The Feestyle Navigator story is an interesting one. It set the foundation for what we’ve introduced more recently with Freestyle Libre and freestyle Libre Pro. It certainly demonstrated to the clinical community that accuracy profile of are wired enzyme technology, which is the foundation to our sensing platform. That product embodiment wasn’t commercially viable for a number of reasons and so when we took a fresh look at a new product embodiment using that same core sensing technology, we really focused on a set of design principles, namely convenience, discretion, simplicity, affordability, and actionable information, and affordability was a big part of that because we know without making it accessible to a broad base of patients, it wasn’t going to be commercially viable and I think we’re now demonstrating that those attributes really live within Freestyle Libre and Freestyle Libre Pro because of the rapid adoption of those products.
Steve Freed — You mentioned Freestyle Libre and the Freestyle pro. A lot of people don’t even know what that is because it’s fairly new in the US. Can you explain what it is?
Joel Goldsmith — Freestyle Libre is currently under review in the U.S., but is available for use now in 35 countries, being used by over 300,000 patients for self-monitoring purposes and the simplest way to describe it is really delivering the known benefits of sensing but with a use model and a cost profile more similar to strips. So it’s being used as essentially as a replacement for strips for recurring self-monitoring without the pain and inconvenience that comes with strips. Freestyle Libre Pro is a sensor base system that’s designed for use by healthcare professionals. It enables an outpatient procedure. It’s based on the same hardware and software platform as Freestyle Libre, but it’s used really to characterize a patient’s glycemic profile so either to establish a baseline or to inform treatment changes when a patient is going from one treatment regimen to another or if a patient is experiencing adverse events or medical complications to really deeply understand with the root cause of those problems are. So, a common platform — one designed for recurring self-monitoring by patients, the other intended for use by professionals to enable an outpatient procedure.
Steve Freed — For the new one that hasn’t been approved yet, are you looking to maybe have that available this year sometime?
Joel Goldsmith –Yes, it’s currently under review by the FDA I can’t really comment on the expected timing of its availability but we’re hopeful that that will be soon.
Steve Freed — It is very interesting because CGM is probably going to replace blood glucose monitoring. It only makes sense that if you can get a reading every 3 to 5 minutes or 10 minutes even twice a day, it’s better than once a day in the morning. The physician has more information to deal with that patient whether postprandial medication time of day there’s so many variables that he doesn’t have the advantage of, so I think it’s going to actually replace and I’m sure you guys also think it’s going to replace, and that’s one of the reasons you sold your blood glucose monitoring to, I think it was Panasonic…
Joel Goldsmith –That actually wasn’t us. That was Bayer that you’re thinking of. ADC still has a thriving strip-based business also so, it’s a it’s a mix today of strip and sensor but what you’re referring to I think we all agree with that the early stages of a shift from strips to sensors and not that shift in itself is a pretty meaningful change and when you couple that with the shift from proprietary devices like traditional blood glucose monitors or the Freestyle Libre reader to commercially available consumer electronic devices, which are really becoming the preferred user interface, and then finally a shift from disconnected desktop application software to cloud-based services, those three things in combination are really positioning diabetes to take full advantage and realize the full potential of digital health.
Steve Freed – It’s interesting. I was speaking to a number of doctors. I asked almost all of them. I haven’t heard anything bad about CGM. Except for one doctor, who didn’t like your product. I talked to another doctor that loves your product and, you know, somehow this information may help you. The doctor is very well known. I won’t mention his name. He basically said he could never use a blinded program because having the information right in front of you, a patient can see that. Yeah, you can write down what you had a 10 in the afternoon, but people aren’t going to do that. They can actually see the changes and do things according to what’s happening. Then I spoke to a doctor who loves your product because he says you don’t want to give a CGM where people can see the results immediately. Down the road, yes, but in the beginning, I don’t want them to react to anything because people, from his experience, they overreact when they see readings and they forget about onboard insulin. So, it can be very dangerous to just give him a regular CGM where they see the results. This way I can slowly, gradually educate them on the information and then we can switch them over so you get both sides of the same story of why doctors like it or dislike it.
Joel Goldsmith –Yeah, you’re highlighting the defining difference between the Freestyle Libre system that’s intended for use by patients and exposes that information to them whenever they want, wherever they want and Freestyle Libre Pro, that solution that’s designed for clinicians and we very deliberately kept that in a blinded format. And it’s for many of the reasons that you described, but it requires nothing of the patients. So, over the course of a 14-day wear period, they wear that sensor on the back of their upper arm, they don’t have to interact with it at all, there’s nothing to look at or interact with, and therefore they basically forget about it and they lived their daily life like they naturally would. Meanwhile, that sensor is collecting glucose data passively every 15 minutes and at the end of the 14-day wear cycle, all of the data that it’s been captured on that sensor can be downloaded and then analyzed retrospectively through a series of visualization techniques, including their ambulatory glucose profile, which is now part of a standardized glucose report based on a series of guidelines that have been published by AACE and that enables the clinician with the patient to understand the root cause of any issues that they’ve been experiencing and make a faster, informed treatment decision as they change from one treatment regimen to another. So, that was done very deliberately. The other thing that Freestyle Libre Pro system provides is essentially a trial wear experience for the patient. Now even though they didn’t have to interact with that sensor, they now know what it’s like to wear it. So, if they’re a good candidate for the Freestyle Libre system for recurring self-monitoring, now they know exactly what it’s like to wear that sensor so they can make an informed decision.
Steve Freed — Do you have to calibrate it?
Joel Goldsmith –No, it’s one of the defining differences between the Freestyle Libre sensor and other sensors that are available on the market. It’s factory calibrated, which means that from the time that applied to the body throughout the indicated wear period. They never have to take a finger prick for the purposes of calibrating the sensor.
Steve Freed — That’s a huge advantage. The less they have to do, the better it is because they already have too many things to do on a daily basis.
Joel Goldsmith –It takes us back to those original design principles that I mentioned. Convenience, simplicity, discretion, actionable information and affordability. Those first three are critical in getting people to actually use this. When you think about it, the act of taking a blood glucose measurement, it creates this really interesting paradox because people need to be testing more frequently in order to make informed decisions throughout the course of their day, but they have this built-in deterrent to doing that because every time they use a strip they’re inflicting pain on themselves, which is unnatural for most people. With a sensor, you don’t have to do that and because the way that the Freestyle Libre system works where you simply hold either a proprietary device known as the reader or now in 10 countries a mobile app that runs on an Android phone, you hold that in close proximity to the sensor. In a fraction of a second, you have current glucose, 8 hours of glucose history and a trend arrow indicating the way in which glucose is changing, rising or falling and which direction it’s going. Now there is no deterrent to testing more frequently and the proof of that is some of the real-world data that we published ATTD in February based off of real-world utilization by over 50,000 active Freestyle Libre users. I think it’s over 64 million data points represented and it showed on average users were scanning their sensor more than 16 times for a day, which to me is proof that not only are they interacting with that information much more regularly than they do with strips, but it’s done over a sustained period of time and that’s half the challenge is sustaining those positive behavior changes.
Steve Freed — How affordable is it
Joel Goldsmith –I mean it’s not available for use in the US yet. So pricing in the U.S. is not available.
Steve Freed – But the Pro, Is that affordable?
Joel Goldsmith –Yes, that’s also one of the things that make Freestyle Libre Pro unique compared to other solutions that are available is to start-up cost associated with it and because the sensors are fully disposable and therefore don’t have to be reclaimed by the clinic or cleaned or recharged, they can simply be disposed of after they’ve been used. It enables the clinic to have greater capacity to do more of these procedures. Likewise, the handheld device that is used to retrieve the data from used sensors, instead of it being a one-to-one relationship with the sensor, a single reader can be used across an unlimited number of sensors, both to start then and to retrieve data from used sensors.
Steve Freed — What about reimbursement. I understand it’s reimbursable. Obviously, for physicians, it’s going to take time to download it for whatever reason and to review it. So, is there a reimbursement for using the sensor, number one, and then, is there a reimbursement for looking at it and making decisions?
Joel Goldsmith –That’s one of the reasons why the Freestyle Libre Pro system has been adopted so quickly. In fact I think in the first six months of its existence it’s now become the number-one prescribed professional-use CGM system and it’s in part because reimbursement already existed for that procedure type. So, both for the placement of the sensor and its subsequent activation but also the download of the data once that sensors been used for up to 14 days. So there’s two different codes that are used to request reimbursement for those different operations within that procedure.
Steve Freed — What are the emerging trends within the CGM space that are going to transform diabetes management?
Joel Goldsmith — I think a lot of them revolve around those shifts that I described at the beginning. It starts with this shift from strip to sensor because the data acts as the fuel for everything that’s happening in digital health and a sensor enables that data to be acquired in an effortless way. The second of those two is from proprietary devices to connected consumer electronic products so now that you’re seeing a growing emergence of mobile medical apps running on popular devices, namely smartphones, that smartphone really acts in a couple meaningful ways. One, it’s a common development platform so that software can be developed in advance on a much faster time cycle but those devices tend to have a persistent connection to the Internet and the fact that they’re connected devices that data can be instantly and automatically uploaded to cloud-based services, which is the third major shift. Those cloud-based services act not only as essential data repository as a recording solution, but also as a gateway for that data to be shared with a growing number of apps, devices and other cloud-based services. So, those three things in combination advance the overall opportunity moving from script to sensor.
Steve Freed — The Libre Pro, because it’s blinded, would you say it’s more for the type 2 patient or the type one patient?
Joel Goldsmith –Because it’s used to establish a baseline or to help reveal the root cause of issues that might require a treatment change, it’s really broadly applicable, certainly to any patient who is on insulin and they are the ones that frequently might need to have a treatment adjustment, but we imagine that it could be applicable to anyone that’s been diagnosed with diabetes even eventually possibly as a way of detecting prediabetes.
Steve Freed – The AACE recently added the ambulatory glucose profile report to its recommendation. How does Abbott plan to address this recommendation?
Joel Goldsmith — We were one of the first companies to embrace AGP as a visualization technique. It’s been part of the application software that ships with the Freestyle Libre system in the Freestyle Libre Pro system from day one. So, we recognized it as a really effective clinical decision support tool and we’re thrilled that it’s now becoming a standard visualization technique so we fully intend to implement the new standardized glucose report based on those published AACE guidelines and we’re going to do that this year.
Steve Freed — Are you presenting anything here at the ADA this year as far as any studies or any abstracts?
Joel Goldsmith –I believe there are some studies and abstracts associated with the use of AGP in helping to sort of demonstrate how that’s being utilized in clinical practice and the effectiveness as a visualization tool.
Steve Freed — You mentioned AGP but we didn’t define that yet.
Joel Goldsmith — Ambulatory Glucose Profile and maybe you can show an example of that in your website that helps really expose what that technique does. Essentially it normalizes data over a defined period of time. Could be as little as 5 days, up to maybe 90 days and shows that the glucose variability.
Steve Freed — Being here, you’ve had a chance to meet a lot of different people. What has been the response from people using the Libre system?
Joel Goldsmith –Yeah, the product theater earlier today I think the response was overwhelming. It was a packed house that focused on Freestyle Libre Pro, which of course is available for use in the U.S. today but also sets the stage for the expected availability of the Freestyle Libre system because they are based on a common hardware and software platform so as far as I can tell that the response was extremely positive.
Steve Freed — For type twos that are not on insulin… Obviously for a person on insulin, it could be life and death certainly in helping to lower their blood sugars, having that kind of information. For type two who’s not on insulin, it’s mostly all about postprandial and nutrition, physical activity but probably 90% nutrition. What kind of benefits have you seen for type 2, the older patient as far as wearing this and having an educator or physician go through their food log and see this is what happens when you ate this, this is what happened to ate that? Are you seeing that take place?
Joel Goldsmith –I’m not sure if we have any published studies yet that specifically focus on that patient segment, but I can say with Freestyle Libre Pro it would designed with the clinician in mind to fit into their existing clinical workflow and to be broadly applicable at their discretion. iI some patients it might make sense to do that procedure type once a year simply to confirm that they’re baseline is still where it should be. In other instances, it might be up to 4 times a year, especially for patients who are experiencing recurring complications and need refinement to their treatment regimen so I think that a broad base of patients that it’s applicable to and each practice, depending on the composition of their patient population .will make those choices because the startup cost is so low for the clinic, it’s a great way for them to experiment with that and then judge for themselves which patient types it makes most sense to use it with.
Steve Freed — Thank you for your time.
Joel Goldsmith — My pleasure.
Steve Freed — I think was very informative and enjoy the rest of your time here.