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Tim Dunn 2018 Transcript




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Freed: This is Steve Freed and we’re here at the 78th Scientific Sessions of the American Diabetes Association. And we have with us a very special guest, Tim Dunn, who’s Global Clinical Affairs for Abbott Diabetes. And Abbott is now involved with CGM, an exciting new product that’s really changing the way people look at diabetes, treat diabetes, and it has to do with just so many aspects, even emotional aspects of — every aspect of diabetes, so we’re going to talk about that. So, maybe you can give us a little bit about the data that Abbott is presenting here at ADA on their FreeStyle Libre and why it’s meaningful to patients.

 

Dunn: Great. Yeah, we’re really pleased; we’re presenting seven late breaking abstracts here at the conference, and really extending information about how the FreeStyle Libre system is really being engaged with the patients and really developing a lot of benefits to a broad range of patients. We really are committed to improving the system and making sure that it really delivers benefits to the patients who are really wanting a way to monitor their glucose, be aware of how they need to be managing their disease but also be freed from some of the hassles associated with diabetes management in the past, particularly routine finger-sticks. And so, the main topics we’ll be showing here are an expansion of our real world data, so we have access to voluntary uploads of the device, and our first presentation of that involved about 50,000 people’s readers. And now. here at the conference we’re up to over 250,000 readers. And even with this broader expanded data set we’re still seeing very similar patterns. namely that people are using a lot, they are scanning and checking their glucose a lot. And then also, those who scan more are associated with better glucose levels; more time in target, less time in hypoglycemia. So, that’s one big theme that we’re looking at. And another one is we obviously want to associate the better management and use of the device with long-term complications and so that’s through HbA1c markers. So, we have a meta analysis of 17 studies that is showing that when you look at these studies all in a group and analyze them for changes in HbA1c, we’re also demonstrating a significant drop of over a half percent of HbA1c across broad studies that included both type 1 and type 2 patients.

Another big focus for us has been to make CGM very affordable and accessible to people. And so, a new analysis showing here will be around the cost and the cost savings actually when you stack it up next to typical SMBG testing. So, one of the key highlights there is that compared to testing six times a day, which is sort of a range accepted by the ADA, they can save up to $120 per month using the FreeStyle Libre system instead. And then the final big area is those young adults and teenagers, that’s always been a historically difficult population to get engaged with glucose monitoring. And so, we do have a couple of studies that we’ve been able to look at or the investigators have been looking at in terms of the success with the system. And they’re again showing in this population, they are having good adoption and using the device and then also having benefits in terms of time and range and rejection of hypoglycemia.

Freed: And I’ll share a story with you that has a lot of impact when it comes to CGM. I was doing a presentation and I was out in the hall and one of the people there that were displaying products was a salesman who was selling insulin syringes. And we were talking about diabetes and he says, “Oh, I have diabetes,” and I said, “Gee, what was your blood sugar this morning?” And he said, “Well, I didn’t do it.” I said, “What was it yesterday?” and he said, “I didn’t do it yesterday.” I said, “When did you do it?” he says, “I do it once a day, every Thursday.” I said, “Why are you even checking your blood sugar?” One reading in 20 million seconds is meaningless, really it saves some money by not doing it. So, now you have a product basically– you have a type 2 patient, who doesn’t monitor as often as they should and that’s probably really most patients. And on top of that the doctors only tell to monitor their fasting blood sugars. They’ll eat whatever you want, just manage your fasting blood sugars with your basal insulin. And now, all of a sudden this drastic huge change. Now, they have a reading every few minutes if they want and they can see how their blood sugars are varied for their exercise, their emotional situations, their working situations. There’s so much more information that’s available to them now. How do patients react to that?

Dunn: It’s a good point that it reveals a lot more of the dynamics and complexity of the underlying glucose levels than typically people had seen either because they really weren’t testing very frequently or they tended to focus on the laboratory measurements that again aren’t going to reflect to the day-to-day or even hour-to-hour variability. We do try to encourage and educate patients around what their expectations should be and that they are going to see a lot more dynamics and ups and downs, then they might have been used to seeing with the finger-stick glucose. And then we’ve spent a lot of time focusing on how we present that data primarily for the clinician, but also for the patient in terms of summarizing it over the sensor, let’s say a week or two weeks of use of the device. And summarizing it in ways that we’ve gotten good feedback on, making sure people highlight the overall patterns, things they want to address in terms of highs and lows. And then, also specific instances particularly of low glucose and how to make sure those are attended to well. But it is an educational process for a lot of people to really be prepared for how much things can change depending on the different dynamics.

Freed: The A1C is the gold standard in this industry for now at least. And it’s really an important number. I call it the quality of life number. I tell patients all the time that that number will determine when you’re going to live or die. It determines your risk factor for Alzheimer’s, for heart disease, for cancer because when your A1C is elevated, your immune system is completely screwed up and you’re more susceptible to every disease known to man. So, with your new product, the Libre, we’re getting more information. Does it have a tendency to lower A1Cs which is the gold standard, that it can actually be treated not as a monitor but as a treatment? I mean, it’s a whole different philosophy.

Dunn: It is, yeah. I mean, it’s a tool that’s been well adopted. For example, both of our original randomized control trials showed that people made adjustments immediately. As soon as they were able to see the data, they were able to primarily react to hypoglycemia and fix the excessive hypoglycemia they had. And then we have been seeing improvements in time in range, and improvements in glucose variability. And we’re still focused on HbA1c, that’s why this meta analysis we have is really putting that together, showing that people are able to lower their long risk by managing the day-to-day fluctuations, having access to it and getting a better understanding of how they might address that.

Freed: It’s kind of neat that it’s really the patient that’s lowering their A1C with the knowledge from the glucose monitor, the CGM. Yet, it’s still treated as a product and not as a treatment per se.

Dunn: Yeah. I mean, you’re right. We see it as a tool that patients need and the whole set of tools and skills they need for successful management. I guess, one thing I think about is how often people do typically check their glucose. What we’re seeing is people — whatever level of testing; most of them in our studies aren’t once a week, like you mentioned, but more on two to five per day. They typically check two or three times more often than whenever they came on it. And it’s sort of saying they have a need and they have an interest to look and understand it. But before they had easy quick access, it wasn’t a big hassle, it just was too difficult to get it. But once they get it, then they are using it and they are being able to make adjustments. That they already know and have the right skills, they just didn’t have the right data.

Freed: What is the significance of the real world data for this patient population?

Dunn: To me, it’s really showing how the findings we’re getting in our clinical trials match or a lineup and support the findings we’ve had in our clinical trials. And that even as we expand the data across a larger population that we’re still seeing the same types of trends. That it is typical for people to, again, to check very often with their glucose. And then, those that are checking more often are able to make the adjustments or integrate into their diabetes management to have less variability, less time in hypoglycemia, lower average values. And so, I think that’s an ongoing theme that’s just making people understand that worldwide today we’re seeing people checking their glucose 13 times per day with the system. That’s an unheard of number of finger-sticks.

Freed: Obviously the cost involved, and it’s more expensive if I went to the drugstore and bought a blood glucose monitor in 50 strips; it’s obviously going to be more expensive than that. So, how do you address that?

Dunn: Well, we do have programs in place. In terms of reimbursement, it is covered. It is currently the only factory calibrated system available through the Medicare system, so that’s an ongoing area of focus. Plus we do also support that, again, with one of our posters is focused on what is the health care cost saving or what’s the cost savings that then can translate to health care systems understanding the value of the system, of the FreeStyle Libre system, to help patients get better control. And it is an ongoing area of focus for us of making sure it accessible and affordable for patients.

Freed: So, you’ve shown that over the long period of time, it’s actually less expensive than checking five to ten times a day.

Dunn: Exactly.

Freed: So, they can actually save money and they can improve their health.

Dunn: Right.

Freed: So, what’s going to happen to your FreeStyle blood glucose monitors in the future?

Dunn: The traditional strip-base monitors? Well, we do see our future as being based around sensors. We’re going to — the strips have a role today and we see that playing out, but at the same time we do see sensors being the next generation of where people can really get good access to their glucose.

Freed: Now, you’ve had this technology years before anybody else in the industry, I think it was the Navigators.

Dunn: That’s right.

Freed: And yet you tried to get FDA approval for maybe something that wasn’t going to happen. Looking back, would you have changed what you were asking for from the FDA?

Dunn: I mean, you’re right there’s a long history of this technology. I mean, the original patents around the wired enzyme technology which is really the core different technologies in the FreeStyle Libre system was also in the FreeStyle Navigator system. It was originally created in the mid-90s. And so, we’ve had this long development process that has taken hundreds of people’s effort, thousands perhaps. And I think looking back, it’s always easy to think how you might have done things differently. But I do think it was necessary for us to go through the Navigator experience to really get some key learnings around what kind of performance was necessary for patients, what kind of price was acceptable, and what kind of manufacturing capability we needed and how to do that. And it really set the stage for then to the big evolution to FreeStyle Libre in terms of the factory calibration, the system, and more affordable cost, and ease of use, real focus on that.

Freed: What about the use in younger population? What kind of studies?

Dunn: So, today in the US we’re still indicated down to 18 years old. But outside the US we have that indication down to four years old through and supported by an accuracy study in younger population. And then, as our posters — one of the posters shown here, it’s looking at both our impact study which was a type 1 diabetes study in looking at people under 24 in that study. And then also another study called Selfie that was younger teenagers, 13 to 24-year-olds. And so, we’ve seen really good adherence to the system, that was something that was recognized maybe 10 years ago in the JDRF CGM trials, but this age group, under 25, had difficulty using the system consistently. And that those who didn’t use it consistently, didn’t see the benefit, which seems rational. And what we’re seeing is that with the Libre they are using it consistently and then they are getting the benefit in terms of reduced hypoglycemia, improved time in range.

Freed: Now, it’s interesting. If a patient was to actually check his blood sugars 20 times a day and hand write it and bring it in to the doctor, right now they didn’t even look at the logs anymore.

Dunn: (Laugh) Right.

Freed: Technology has really changed that. Do you have any programs in place for — the family practitioner uses it, now the patient has all this information — well, information is great but if they don’t act upon that information, it’s completely useless. So, the purpose is to use this information, educate the patient. So, I would think it would take more time for the medical professional to educate their patient as to what it means when you eat a corned beef sandwich or a piece of corn, some egg foo young. Do you have any kind of software or programs in place to help the medical professional take that information and show how to use it properly to educate the patient?

Dunn: So, we support educational programs. In fact, we did have a grant session yesterday morning that was very focused on how to interpret the data both on the individual patient level and their thinking about it on a single day but also looking at patterns. And so, we’ve been an early supporter of the ambulatory glucose profile. It was developed by the International Diabetes Center and we’ve incorporated that into our reports and really promoted the consensus from the expert community of the diabetes professionals around how to integrate the data into decision-making, how to summarize it in a meaningful way. And I would say anecdotally, I think we were concerned there would be so much data that the discussion would be long or would be difficult, but what we’re seeing when they look at these summaries, it really highlights quickly the discussion topics for the doctor. And so, it actually makes the interaction higher quality, of discussing details that before they just didn’t have any visibility about it. So, I think everybody could use more time with their doctor but I think that they’re using it in a more efficient way when they’d have the data in front of them and that they can share the decision making about what is the problem we want to focus on and what can we do about it.

Freed: Technology changes rapidly at least in the field of diabetes and sensors. And I remember I had the Biographer or the GlucoWatch, I still have scars from. (Laughs) So, technology — I give them credit. They were the first.

Dunn: Yup.

Freed: Okay. And from that research and —

Dunn: I actually worked at that company too. (Laughs)

Freed: So, what’s in the pipeline for Abbott because your competition has it on an iPhone. It’s a little bit easier to use. And I just assume that yours will be on an iPhone too.

Dunn: Yeah. So, we do — outside the US, we do already have both Android and IOS, iPhone version of an app that can be used instead of the Reader, and so that’s a big step forward. And we also have a way for the second app to share date between caregivers and the patient. And so, that’s an area we want to keep focusing on. And we agree, we want it to be convenient and accessible to the patient obviously by not needing a Reader, that’s another item they don’t need to purchase. And so, that’s definitely on the horizon for things we want to focus on.

Freed: And the best way for a patient to learn more or to get it – it requires a prescription and it’s available in the pharmacies.

Dunn: Correct.

Freed: Most insurances cover it for all types of diabetes or just for type 2s, types 1s on insulin?

Dunn: My understanding is it’s all types of diabetes. It may vary by some of the insurance companies. And, yeah, getting more information: there’s a very good website where there can be some assistance around requesting prescriptions from the clinicians. Obviously talking to the clinician and getting a prescription and having it filled at the pharmacy is the best way to go.

Freed: Well, I think it’s really information that can change the way we look at diabetes. Came out of nowhere, basically. We’ve been using blood glucose monitors. I’d always thought they would be around forever.

Dunn: It’s had a good run. It’s been 30 years.

Freed: But I can see the demise of blood glucose monitors; why anybody would want to get a reading three times a day when I can get 50 readings and it doesn’t cost anymore?

Dunn: Right.

Freed: It doesn’t make sense that people would want to purchase a normal blood glucose monitor. And yet it takes up a lot of space on the pharmacy shelves, all the monitors.

Dunn: Right, right. Yeah.

Freed: And so, I see a change coming within a very short period of time.

Dunn: Yeah. We’re definitely looking forward to advancing the technology, expanding access for people, and making improvements as we get the feedback.