August 5-8, 2015; New Orleans, LA – Full Report – Draft

Executive Highlights

This report features our full coverage from the American Association of Diabetes Educators 42nd Annual Meeting (AADE 2015) held in New Orleans, LA from August 5-8. This year’s meeting saw a rebound in attendance after a dip last year: ~3,000 attendees vs. ~2,500 who attended in 2014 (Orlando) and ~3,000 who attended in 2013 (Philadelphia) and 2012 (Indianapolis) – that said, Orlando was probably lower since it is among the least favorite conference towns for many health professionals as we’ve heard over the years. Where there was a meaningful change was in the number of exhibitors – this year, just 160 exhibitors were in New Orleans, representing a 20% decline from the 199 companies and organizations in 2014; this is the second consecutive year AADE has seen a double-digit drop in booths, perhaps a signal that there continues to be fewer and fewer industry resource available and perhaps a change in perspective on the effectiveness of the model - we certainly saw directionally the same movement in the more subdued showing at ADA 2015.

This year’s five-day AADE agenda (including pre-conference events) featured over 100 breakout sessions, corporate symposia, and product theaters, not to mention a host of other presentations. Highlights from the meeting included an update on the JDRF’s ongoing research efforts from Dr. Aaron Kowalski (that required two overflow rooms!), a compelling lecture on the future of technology in healthcare from highly-regarded HHS Chief Technology Officer Ms. Susannah Fox, and clarity on how CVOT findings can be translated into clinical practice from Dr. Jennifer Green (Duke University, Durham, NC). We also heard from Dr. Steven Russell, who provided an update on Bionic Pancreas progress with glucagon, and type 1 diabetes patient Mr. Eric Fenar, who offered passionate commentary on how Sanofi/MannKind’s Afrezza has changed his life. We already can’t wait till next year – August 12-15 in sunny San Diego!

Below, we have divided our coverage into five categories: (i) Diabetes Technology; (ii) Diabetes Drugs; (iii) Social Media and Mobile Health; (iv) Additional Topics; and (v) Exhibit Hall.

Diabetes Technology

Master Class

Automating Glycemic Control in Diabetes Mellitus With a Bionic Pancreas

Steven Russell, MD, PhD (Massachusetts General Hospital, Boston, MA)

Dr. Steven Russell provided a comprehensive overview of the Bionic Pancreas (attended by ~1,000 educators!), sharing the same goal as Dr. Damiano shared at FFL to commercialize the team’s new dual-chamber, integrated iLet device in late 2018-early 2019. The team is crowdsourcing the funding to complete development of the iLet fully integrated bionic pancreas device (they have raised an impressive $1.5 million to date, but are still $2 million shy of their needs). Most notably, Dr. Russell presented never-before-seen results from a two-week, placebo-controlled, double-blind glucagon-only study in patients with type 1 diabetes (n=20) – this was a very cool study design that had patients self-administer their own insulin, but blinded to automated glucagon or placebo delivery. Results demonstrated an impressive 74% reduction (p<0.0001) in hypoglycemia with glucagon vs. placebo administration, and no change to mean blood glucose (mean: 154 mg/dl vs. 152 mg/dl). The data continues to validate the addition of glucagon in the closed-loop setting, and we look forward to the glycemic target study that will begin on Monday at MGH (directly comparing insulin-only to insulin+glucagon at various algorithm glycemic targets). During Q&A, Dr. Russell provided the first ballpark estimate of the upfront cost of the Bionic Pancreas we have heard: ~$10,000. He cautioned that this was a very loose ballpark, and the team’s goal is to minimize costs and ensure they do not balloon too far greater than the current cost of insulin pump plus CGM. Dr. Russell received thunderous applause during at least five different points of this talk, and was mobbed by an eager group of about ~40 educators after wrapping up! More detailed results are below, and you can see pictures of the iLet here.

Bionic Pancreas Study Timeline
Set point study at Stanford (insulin-only)	August 2015-October 2015
Set point study at MGH (insulin-only vs. bi-hormonal)	August 2015- October 2016
Human Factors Study and Bionic Pancreas Bridging Study (testing integrated device)	2Q16-3Q16
Pivotal Study	Starting late 2016-Early 2017 (~18 months to completion)
Review of PMA by FDA	4Q17-3Q18
Commercial Launch	Late 2018/Early 2019

• Looking ahead, the team hopes to start its pivotal study in late 2016-early 2017, with FDA submission slated for 2018 and commercial launch in “late 2018-early 2019.” Two Bionic Pancreas pre-pivotal glycemic target studies are still on track to run in 2015 and early 2016; the MGH study (insulin-only vs. bi-hormonal) will begin on Monday and wrap up in October 2016, while the Stanford study (insulin-only) will start this month and run through October.
  
  • As a reminder, these studies will titrate the aggressiveness of the Bionic Pancreas’ algorithm, and test it in both insulin-only and insulin+glucagon configurations. The target blood glucose levels will be 100 mg/dl, 115 mg/dl, and 130 mg/dl.
• For the pivotal study, Dr. Russell suggested that the team is crowd-sourcing its funding for development of the iLet. The team has raised $1.5 million to date, but needs $2 million to complete the device developement. As a reminder, the team received a “fundable” score on the major NIH artificial pancreas grant initiative, but it sounds like they are not banking on funding solely coming from this program. To our knowledge, the awardees have still not been announced.
  
  • As a reminder, Dr. Ed Damiano unveiled the iLet at Friends for Life last month – the team’s own custom-built, dual-chamber, prototype pump and user interface for a fully integrated commercial version of the Bionic Pancreas. The still-prototype, integrated device is about the size of an iPhone 6, about 2.5 times as thick, uses a resistive touchscreen (a bit hard to press in this prototype version, similar to how the Abbott Libre touch-screen buttons are a bit hard to press – at least compared to the iPhone), includes built-in Dexcom and algorithm integration, and separate pump chambers for pre-filled insulin and glucagon cartridges. The iLet’s user interface was designed by the Tidepool team and was very user friendly in our run through it in the FFL Exhibit Hall. The hope is ultimately to improve the device by making it smaller and enhancing the touchscreen over the next nine months – ideally, it will resemble the iPhone 3 in screen size (~30% smaller) and use a capacitive touchscreen e-ink display (similar to the Amazon Kindle).
• For the first time, Dr. Russell presented results from the team’s placebo-controlled, double-blind, glucagon-only study in patients with type 1 diabetes (n=20). Patients wore a Bionic Pancreas at home for 14 days that administered glucagon-only on seven of those days vs. placebo-only on seven of those days, interspersed in random order (insulin was self-regulated). Patients were not restricted in their daily activities and were blinded to which days they were on glucagon vs. placebo, which Dr. Russell noted was effective (i.e., patients were not able to distinguish glucagon from placebo treatment). Additionally, patients were remote-monitored for safety and were contacted only if the subject had a glucose less than 50 mg/dl for more than 15 minutes or if there was a technical problem with the bionic pancreas that did not resolve on its own within 15 minutes.
  
  • Results demonstrated that glucagon administration reduced hypoglycemia exposure (area over the curve and less than 60 mg/dl) by 74% (p<0.0001) relative to placebo administration without affecting mean blood glucose (mean: 154 mg/dl vs. 152 mg/dl, respectively). Time spent in hypoglycemia (<60 mg/dl) was reduced from 4.7% to 1.2% for the entire day, also a 74% reduction. Furthermore, during the night, the improvement was even more striking – 5.4% time spent <60 mg/dl vs. 0.5% (a 91% improvement – wow!). These results continue to validate the addition of glucagon as effective in minimizing hypoglycemia, and we look forward to the upcoming head-to-head insulin-only vs. insulin+glucagon data that will emerge in the MGH glycemic target study beginning next week.

Glucagon-only Time spent <60 mg/dl

	Day and Night	Night
Glucagon	1.2%	0.5%
Placebo	4.7%	5.4%
p-value	<0.0001	<0.0001

• Notably, improvement was NOT at the expense of hyperglycemia, as time spent >180 mg/dl and time spent >250 mg/dl were not significantly different – 28% (glucagon) vs. 29% (placebo) (p=0.4) and 9% (glucagon) vs. 9% (placebo) (p=0.5), respectively. See below.

Glucagon-only Time-in-Range

	70-180 mg/dl	% >180 mg/dl	% >250 mg/dl
Glucagon	69%	28%	9%
Placebo	62%	29%	9%
p-value	0.0009	0.5	0.4

• Dr. Russell stressed that the Bionic Pancreas did not deliver excessive glucagon (~0.48 mg/day – on par with previous studies) and noted that there were no differences in self-reported nausea or insulin dose. The team continues to show strong data, and we absolutely cannot wait to see the head-to-head results – how much value will glucagon add over insulin alone? The other big question is the effects of chronic glucagon exposure, particularly if the Xeris glucagon moves ahead.
• Dr. Russell again shared the latest interim results from the Bionic Pancreas multicenter study (first shown at AACE 2015), which were very consistent with prior and ongoing results: Average glucose has been 141 mg/dl (estimated A1c of 6.5%) on the Bionic Pancreas vs. 162 mg/dl (7.3% estimated A1c) on usual care. Time spent in hypoglycemia (<60 mg/dl) was reduced by more than two-thirds: 0.6% on the Bionic Pancreas vs. 1.9% on usual care. In addition, the Bionic Pancreas did not deliver more insulin than usual care [0.63 units/kg/day usual care vs. 0.66 units/kg/day BP] nor was there excessive glucagon usage (~0.51 mg/day bionic pancreas).
  
  • Notably, Dr. Russell stratified the multicenter data in a new way to emphasize the improvement in “time in clinically relevant ranges.” Needless to say, the data are very strong (especially in hypoglycemia) where Dr. Russell noted that the 0.1% time spent <50 mg/dl and 0.6% time spent <60mg/dl correlates with roughly 1.4 minutes and 8.6 minute per day, respectively. From a patient perspective, it’s remarkable to think about less than 10 minutes of hypoglycemia a day... now that’s something we can all get behind.

Time in Clinical Relevant Ranges

	Usual Care	Bionic Pancreas	p-value
% <50 mg/dl	0.6	0.1	<0.0001
% <60 mg/dl	1.9	0.6	<0.0001
% 70-180 mg/dl	62	78	<0.0001
% >180 mg/dl	34	20	<0.0001
% >250 mg/dl	11	4	<0.001

• During Q&A, Dr. Russell provided the first ballpark estimate of the upfront cost of the Bionic Pancreas we have heard: $10,000. He cautioned that this was a very loose ballpark, noting more broadly, that the team’s goal was to minimize costs and ensure that they do not balloon too far greater than the current cost of an insulin pump plus CGM. Of course, the disposable costs will be higher (dual infusion set, glucagon + insulin) though Dr. Russell was adamant that the device would be a net long-run reduction of cost for patients and payers – not to mention a huge reduction in the immeasurable mental burden of diabetes. Certainly, it’s going to be challenging for payers to weigh all the options, and there are many unknowns at this point (e.g., what will stabilized glucagon cost?)
• An emotional Q&A (see the full transcript below) featured more than a few highlights. We bring you the most quotable quotes below.
  
  • “I have two grandkids with diabetes. I think this is the greatest thing since sliced bread. I think it is just AMAZING.” – An educator
  • “I think that as a scientist I get caught up a lot in the numbers. But we do understand that one of the biggest parts of this is the human piece and allowing people to spend a lot less time and energy worrying about diabetes control.” – Dr. Russell
  • “People would eat things in our study that they normally wouldn’t eat. They would tweet pictures of what they were eating. I was tempted to respond: “You know, you can still get type 2!” But you totally understand that urge to break free after being under the thumb of this damned disease.” – Dr. Russell
  • “You’re giving a lot of people their lives back. My patients have all the latest technology but still struggle with ups and down. The big key is to live a life without having all that stuff to think about. It’s just too much!” – An educator
  • “A recent study looked at the cost of just severe hypoglycemia visits to the hospital and the total cost to US was ~$1.3 billion. Now you add in DKA and complications and we’re talking about really staggering costs. Our argument to payers – and I think it is compelling – is that we can give all of your patients an A1c less than 7% while at the same time reducing hypoglycemia. What is that worth?!” – Dr. Russell
  • “I think we could be looking at the elimination of complications. That would be a big deal for me.” – Dr. Russell

Questions and Answers

Q: I’ve been waiting for this for about 22.5 years. I’ve been pumping for 15 years. I’m still hesitant about infusion sets though. Is this relying on the fact that you have two infusion sets?

A: No, it’s a single infusion set. Two cannula – one for insulin and one for glucagon. I think we’ll be using a 0.6 mm steel cannula. The advantage of steel is that they can’t kink and would be very had to pull out one without the other. In addition to that, the system can sense if the insulin or glucagon it’s giving you are not effective and that will trigger an alarm. So essentially, the Bionic Pancreas will notice if it’s giving you insulin but your glucose is increasing, and it will let you know.

Q: I just want to say THANK YOU for your work!!! [Thunderous applause]

A: I have to say thank you to everyone with type 1 diabetes and all the healthcare providers – such as those in this room – because the support we’ve gotten has been incredible.

Q: Will the next study use the new device?

A: The Set-point Study will use the old device. The new iLet is not quite ready for human stidies. We’re aiming to build a smaller version of the device. We’re still refining the device. It has to go through the IDE process at the FDA. There is a tremendous amount of testing to make sure it is safe to use in outpatient clinical trials. In the middle of next year, we’ll use it in the bridging study, where we test the device in a small number of people. That will be in a small number of sites before we rolling out full scale at end of 2016.

Q: Can you explain how glucagon has been stabilized?

A: The folks at Xeris will better answer that. However, I can tell you that the glucagon is formulated in non-aqueous solution. It’s the water that makes glucagon fibrillate. In this non-aqueous form, it’s very stable for two years at room temperature.

Q: My question is about type 2 patients. Could the Bionic Pancreas be used in this population?

A: I think the Bionic Pancreas could have utility in insulin-dependent type 2 patients. In particular, I think there is a great need in older patients who may have challenges associated with visual acuity, memory, or dexterity. It’s becomes difficult for them to deal with complex insulin regimens. Many end up on basal-bolus therapy, which can be very challenging. I’m planning to write a grant to test exactly that. We think the Bionic Pancreas could be ideal for these individuals. In fact, we don’t think we’ll have to change anything about the system to make it work for people with type 2 diabetes. Some of our adolescents had tremendously high insulin needs, on par with people with type 2 diabetes. We think it’ll work for type 2 diabetes, but it hasn’t been tested in the population yet.

Q: Thank you for your work. Insulin was purified in 1922. And, before that, type 1 was a fatal illness. This could be a medical miracle.

A: There have been relatively few game-changing moments in blood glucose management since 1922. I would say that being able to measure blood glucose quickly is one. Other than that, the improvements have been largely incremental. I think the bionic pancreas could be something that fundamentally changes the way we manage diabetes. I don’t think I’ll need to see my type 1 patients every three months. I’ll miss them. [laughter] But you saw how much average blood glucose varied from day to day - hardly at all. Every day the average blood glucose was 140 mg/dl. What’s there to talk about? Nothing … at least not enough to talk about to justify seeing them every three months. Maybe we’ll see them less frequently, just to make sure that the promise of fewer complications is being realized. There is a lot of data on average glucose and complications. If you look at retinopathy, when you get down to an A1c of 6.5-7% then the risk of complications is not different than if you didn’t have diabetes. There’s a study from Sweden looking at patients who were controlled to an A1c of 7.5% from the time they were diagnosed and they never developed kidney disease. I think we could be looking at the elimination of complications. That would be a big deal for me.

Q: You may have discovered the biggest way to reduce healthcare costs for our patients with diabetes. The upfront cost may be expensive but look at the hospital costs. I have two grandkids with diabetes. I think this is the greatest thing since sliced bread. I think it is just AMAZING.

A: A: Thank you. But you’re pointing out something very important. In terms of the up-front cost, it won’t be much greater than current pumps and CGM. There will be a higher cost of disposables because of the dual cannula and the addition of glucagon. But I think those costs will pale relative to the cost of admissions for hypoglycemia. A recent study looked at the cost of just severe hypoglycemia visits to the hospital and the total cost to US was ~$1.3 billion. Now you add in DKA and complications and we’re talking about really staggering costs. Our argument to payers – and I think it is compelling – is that we can give all your patients an A1c less than 7% with very little hypoglycemia. What is that worth?! … Not that we’re going to charge that. [laughter] We’re going to try to keep it as low as possible. But over the long run, this should be tremendously cheaper for payers and patients. How do you put a price on gong to sleep and not having to worry as a patient or as a parent?

Q: Can you please give you a ballpark on the price?

A: Well, current pumps plus CGM are around $8,000. This might be $10,000. However, because the cost of disposable goods is higher, there will be some additional costs. We will use less glucagon than insulin, but if you assume the cost of glucagon is the same, then you have to double the cost of drug right there. However, I think a lot of this depends on volume. Right now, only a third of patients with type 1 diabetes use and insulin pump and even fewer (about 10%) use CGMs. These can be very helpful tools, but they still demand a lot of the patient. They can potentially have a significant impact on glycemic control, but only at the expense of much more effort and hassle for the patient. Many of the patients that I’ve tried to get on pump and CGMs have said it’s just not worth it to them. However, they also said that, when the Bionic Pancreas is available “then we’re talking!” I think we could expand the cohort of people that use diabetes technology quite a bit. I think this could make the business of diabetes technology more viable than it is right now. I would argue that in the long run, this will result in a net reduction of cost. But we need more data. And we need economic studies.

Q: Can you adjust people from their average blood glucose of 140 mg/dl?

A: The mean glucose varies with the person. We had one individual achieve averages of 117 mg/dl and very little hypoglycemia. So that particular individual ate few carbs and was very fit, despite being 77 years old. On the other hand, there are people who achieve a mean blood glucose of 150 mg/dl. For those people, that might be as good as the Bionic Pancreas can do for them. But for people who are lower, we’ll give them the option to raise the set point [from the default of 100 mg/dl] and they might still achieve a very good mean glucose with less insulin and glucagon usage and even less hypoglycemia than the very low amount we’ve seen in our studies to date. There may be some people where we can’t get lower than 150 mg/dl as an average. Maybe we could if they were better at announcing meals, but for some people a mean of 150 mg/dl is the best that we can do, but that is still an A1c less than 7%. Look, we’d love to get put out of business by a cure. But what the bionic pancreas can achieve is better than the current standard of care.

Q: Can you talk more about infusion sets and cannulas?

A: We like steel cannulas because they don’t kink. I have seen anecdotally people who have infusion set failures after a day or two. In our study, we have asked study subjects to switch infusion sets every two days. There is evidence that insulin administration becomes less effective after two days of the same set. I think it’s a good idea to change every two days. We haven’t done a study comparing teflon and steel sets, but steel is clearly less likely to kink. Another advantage for steel, as I mentioned earlier, is that when both cannulas are on the same adhesive patch, it is less likely that one cannula could be pulled out without the other also being pulled out. With flexible Teflon cannulas, it seems more likely that one could get pulled out without the other.

Q: Will you guys try for Medicare coverage?

A: Wow, that is tough. Obviously we would love to see everybody covered. In a perfect world, Medicare would make decisions solely based on what is best for beneficiaries and not on cost. I can tell from the laughter in the audience that there is some skepticism on that point. We will try really hard to get Medicare coverage. I know the JDRF is working to get CGM approved for Medicare patients and maybe the progress they make will help us. I think we’ll dramatically reduce costs, and that’s what Medicare understands.

Q: You’re giving a lot of people their lives back. My patients have all the latest technology but still struggle with ups and down. The big key to life is living without having all that stuff to think about. Because it’s too much!

A: Absolutely. I think that as a scientist I get caught up a lot in the numbers. But we do understand that one of the biggest parts of this is the human piece and allowing people to spend a lot less time and energy worrying about diabetes control. People would eat things in our study that they normally wouldn’t eat. They would tweet me pictures of what they were eating. I was tempted to respond back: “You know, you can still get type 2!” But you totally understand that urge to break free after being under the thumb of this damned disease.

Databetes

Doug Kanter (Databetes, Brooklyn, NY)

Mr. Doug Kanter provided attendees with a fascinating look at the power of data tracking and visualization. He shared his interest in applying actionable design to glucose data, an interest that led him to conduct a yearlong project in which tracked every blood sugar readings, insulin dose, meal and the majority of his activity data. Whoa! We knew of Mr. Kanter because of his work with Meal Memory but this was an entirely different – and personal – story. He shared data that provided an entirely new perspective on the entire “user experience” of being a patient with diabetes. We hear so often that there is huge value in applying information technology to diabetes – this was real world proof that technology-based solutions can inform health and behavior change. Indeed, Mr. Kanter achieved “the healthiest year” of his life, lowering his A1c nearly one point. (His A1c readings were 5.6%, 5.8%, 5.7% and 5.8% throughout the year.) The success story was not only inspiring but a striking reminder of the tremendous potential of digital health and, more importantly, the fact that we are BARELY scratching the surface of what is possible. Below, we share some of our most notable takeaways from Mr. Kanter’s presentation.

• As background, Mr. Kanter’s goal was to collect every data point that influenced his diabetes for the entirety of 2012. This meant keeping track of: (i) blood sugar readings; (ii) food (carb counts, meal descriptions, photos, Foursquare restaurant check-ins); (iii) exercise (used RunKeeper, a FitBit, Nike FuelBand, heart rate monitor); (iv) location information (OpenPaths data); (v) and insulin dosages. Wow!
• Self-tracking helped Mr. Kanter achieve the best diabetes control of his life – see below. His A1c readings were 5.6%, 5.8%, 5.7% and 5.8% throughout the year. He emphasized that combining medical and lifestyle data helped contextualize readings, making it easier to spot trends and react accordingly.

Improvement in Glycemic Control

• Mr. Kanter also plotted his blood glucose trend over the course of the entire year – a graph that we LOVED (see below). Mr. Kanter’s blood sugars were in range 52% of the year, though a deeper dive into the numbers shows a steady decline in the number of in-range (70-140 mg/dl) readings over the course of the year. January had the most in-range readings (63%), while December had the fewest (43%). In fact, December was the only month of the year where Mr. Kanter had more high readings above 140 mg/dL than in-range readings (46% vs. 43%). Imagine if everyone had this kind of data at their fingertips! This would make for some really valuable additional data for decision making on the diet and exercise front. 

Mr. Kanter’s Trends Throughout the Year

• It was not surprising to see how Mr. Kanter’s insulin levels correlated with his exercise. What WAS shocking was seeing how faithfully this could be tracked – see below! Mr. Kanter stressed that these are high-level trends that go unnoticed for 99.9% of patients. Indeed, the data speak to the potential for patients to connect the dots between behavior change and clinical results if data is appropriately utilized.
  
  • Mr. Kanter trained for and ran the Philadelphia Marathon during 2012. Fluctuations in exercise (shown using the circles at the bottom of the figure) nearly mirrored his insulin levels throughout the year.

Correlation between Insulin and Exercise

• Mr. Kanter printed a poster to visualize ALL of his blood glucose readings from the entire year. The image below shows 91,251 blood sugar readings from his CGM. Each colored line shows one day with January 1 is at the top and days progressing clockwise around the circle. Lines grow longer with more readings for that day. Blood sugars are color-coded and grouped based on the reading. In-range readings are white to make it easier to spot days where blood sugar control was not as good. High blood sugars are colder colors, while low blood sugars are warmer colors.

A Year of Diabetes Data

• As a reminder, Meal Memory is a meal-tracking app that is available on both Apple and Android devices. The app centers on taking a picture of a meal and prompting users to track pre/post-meal glucose values. The seamless integration of data from Apple Healthkit this February has enabled integration with Dexcom CGM data that automatically grabs four-hour glucose information around meals that make data collection easier and more useful for patients.

Tidepool

Brandon Arbiter (VP Product and Business Development, Tidepool, Palo Alto, CA)

Mr. Brandon Arbiter provided an inspirational overview of Tidepool’s efforts to empower the diabetes community. He opened by describing the inadequate state of current interoperability, distilling the field’s challenges into two points: (i) even if people are motivated to engage with their data, they can’t; and (ii) data is trapped in proprietary silos. Tidepool’s goal, of course, is overcome these hurdles by making it easier for patients and providers to access and view data and by building toward a diabetes app ecosystem. Indeed, Mr. Arbiter shared cautious optimism that we are at “the cusp of change” in making data more accessible and more patient-centered. We loved hearing his confidence and were impressed to see the response from educators – not only had they heard of Tidepool but it was clear [especially from the many “oohs” and “aahs”] that they were eager to jump on board. It’s not a secret that we are big fans of Tidepool’s visionary drive and non-competitive spirit, though it was evident at AADE that we were not alone.

Product Theater

Get Connected with the Latest ACCU-CHEK Technology

Jeremy Mangelson (Area Business Manager, Roche Diabetes Care, Indianapolis, US)

Roche has come to AADE 2015 with a strong marketing campaign for its new Accu-Chek Connect system (BGM and paired smartphone app with an FDA-cleared bolus calculator). After a big-deal showing in the opening day exhibit hall, the company backed up its effort with a packed product theater on Day #2. As expected, the Connect has been lauded as an important move toward more seamless, automatic, and hassle-free transfer of blood glucose data. Roche’s laudable aim is to reduce the patient and provider hassle in the downloading process by removing the need for manual data entry. As we’ve noted before, we think the highlight of the Connect system is the app that provides the convenience of insulin bolus advice on a smartphone. [We wish this wasn’t restricted to Connect users though …] The FDA clearance marks the software as the first mobile platform cleared for insulin-dosing recommendation and stands as big win for US insulin users on MDI (the vast majority of type 1s and 2s) who do not have access to bolus calculators on an insulin pump. We learned yesterday that the meter has already hit the shelves in some US Walgreens ahead of schedule. Walgreens, too, is integrating the meter into its rewards program, so that patients with the Walgreens mobile app can receive Walgreens points (that can be redeemed in store!) for testing their glucose. We love the move toward incentivizing healthy behavior! For more on the Connect system, please see our detailed report.

Diabetes Drugs

Breakout Sessions

From Research to Clinical Practice: Upcoming Advances in Diabetes Care

Aaron Kowalski, MD (JDRF, New York, NY)

Dr. Aaron Kowalski delivered a full update on JDRF’s research efforts, stating that this is the best year he has seen in terms of research progress in his ten years at the organization. The presentation, reminiscent of his outstanding talk at Friends For Life, drew a packed and enthusiastic crowd and touched upon a wide range of topics. Dr. Kowalski expressed disbelief over the lack of Medicare coverage for CGM and stressed that resolving this is JDRF’s top legislative priority for the year. He celebrated the role of AADE and others in the diabetes community in guiding the FDA’s thinking on the requirements for approving closed-loop systems; we hope to see similar advocacy efforts around topics such as the 2008 CV Guidance for diabetes drugs or a path to approval for drugs to treat prediabetes. On the closed loop, Dr. Kowalski reiterated his assertion that it is a matter of when, not if, a system will come to market. He also stressed that even imperfect first-wave products (e.g., hybrid or treat to range systems) can offer very meaningful benefits for patients. As in the past, he expressed some skepticism about bihormonal approaches – upcoming data (such as from the head-to-head Bionic Pancreas glycemic set point study slated to start this month) should provide more insight on this front. On the drug side, Dr. Kowalski offered positive commentary on Sanofi/MannKind’s Afrezza, noting that the anecdotal evidence in type 1 diabetes has been very positive – we are hopeful that this will eventually translate into better commercial performance after the relatively sluggish start for the product. He also reiterated his optimism about ViaCyte’s VC-01 cell encapsulation therapy, which the company recently announced will be moving into trials in Canada as well as the US, and the use of SGLT-2 inhibitors in type 1 diabetes despite the recent concerns about euglycemic DKA. Dr. Kowalski closed by highlighting JDRF’s efforts with the ADA and other organizations to redefine the FDA’s definition of early-stage type 1 diabetes to better incentivize companies to conduct prevention trials – this would be a huge win for the field. 

• Dr. Kowalski noted that JDRF is working together with the Helmsley Charitable Trust (HCT) on fleshing out broad efforts in diabetes health policy to ensure new treatments are available/accessible to people with diabetes - and promised more details soon. We are eager to learn more, as both organizations are so highly regarded on the advocacy front.

Special Symposia

Inhaled Insulin – A Breath of Fresh Air for the Treatment of Diabetes

Timothy Gilbert, MD (Imperial Health, Lake Charles, LA) and Eric Fenar (Buffalo, NY)

Type 1 diabetes patient Mr. Eric Fenar offered passionate commentary on how Sanofi/MannKind’s Afrezza has changed his life. In the first half of the presentation, Dr. Timothy Gilbert emphasized Afrezza’s faster, more physiologic profile compared to injected rapid-acting insulins and attempted to educate the audience about common concerns like side effects, spirometry testing, and the size of the device. Mr. Fenar, introduced as the second Afrezza user in the US, then took the stage to offer an extremely enthusiastic endorsement of the product, at one point describing it as a “miracle drug” and “almost a smart insulin” (we agree with the latter since so few patients complain about hypoglycemia associated with it) He described the freedom he felt at no longer having to “chase highs” after a meal and instead watching his blood glucose fall within a matter of minutes. He also noted that he has not had a single unexplained low blood sugar since he began taking Afrezza. Mr. Fenar expressed frustration that the need for spirometry testing has presented such a hurdle, urging the audience to “please go out and buy” the device rather than forcing patients to see another provider and delay treatment for months. Notably, he suggested that Afrezza’s ultra-rapid action profile is a much stronger selling point for him than its inhalable administration. The companies have so far been unable to emphasize these advantages in promotional materials because Afrezza’s label does not currently include an ultra-rapid-acting claim – we think this would add a lot to uptake though aren’t sure what kind of trial will be needed to add that information. We found the Mr. Fenar’s comments similar to others who have used the product more extensively – that said, there is still plenty of “noise” around the challenges Afrezza has faced since its launch. Although the product has received very positive feedback from a small group of early adopters, it has struggled to make inroads in the broader diabetes community and we believe it hasn’t been marketed to nearly as many “front line” HCPs who could introduce it to insulin-naïve patients who have been out of control for some time. We will continue to look for improvement as we see continued grassroots support; it is impossible to know if administrative hurdles will ease, though we do think the broader rollout of the Afrezza COACH patient support program will be a positive if the appropriate resources are put into it.

• The diabetes educator community at AADE seemed to have significant reservations about Afrezza, which is unsurprising given negative press and the fact it hasn’t reached so many front line doctors – educators are already overburdened with administration. While inhaled insulin clearly has yet to gain mainstream acceptance, we do believe appropriate resources will help – how that will evolve is still certainly a question. In Q&A during an Afrezza product theater on the second day of the conference, educators questioned the difference between Afrezza and the failed inhaled insulin Exubera (which we thought was unfortunate reflection of how low awareness is – while Afrezza certainly has significant challenges, they are definitely significantly fewer in number than were Exubera’s) and expressed concerns about the pulmonary decline side effects.

Cardiovascular Safety of Antihyperglycemic Agents in Type 2 Diabetes: What Does Recent Clinical Trail Data Mean for Your Patients?

Jennifer Green, MD (Duke University, Durham, NC) and Curtis Triplitt, PharmD, CDE (University of Texas Health Science Center, San Antonio, TX)

Dr. Jennifer Green and Dr. Curtis Triplitt offered advice on how to translate recent CVOT results into clinical recommendations. Both speakers emphasized the need to clearly communicate the reassuring nature of neutral results to patients, who may be misled by headlines focusing on the studies’ failure to show superiority. The DPP-4 inhibitor/heart failure controversy was a major topic of discussion, with both speakers stressing the need to place the results in their proper context when making clinical decisions. Dr. Green expressed surprise at the heart failure signal and indicated that she remains perplexed by the divergent results in the three DPP-4 inhibitor trials. She believes that differences in the study populations or protocols, intrinsic differences between the agents, or statistical chance could all have been responsible for the outcome and encouraged providers to wait for updates from the FDA before making any major prescribing changes. For his part, Dr. Triplitt stressed that a significant heart failure signal was only seen as a secondary endpoint in one trial and that the overall safety profile of the DPP-4 inhibitor class remains very reassuring. Audience polls taken before and after the presentations illustrated both the challenge of translating such nuanced results into clinical practice and the value of education for HCPs. For example, on a bit of a surprising and depressing note, only 38% of attendees correctly identified SAVOR as the trial that showed an increase in heart failure hospitalization before the talk (34% picked TECOS), compared to 91% after the presentation. Similarly, only 6% of attendees rated their ability to communicate the CV safety of DPP-4 inhibitors and GLP-1 agonists as excellent prior to the talk, compared to 65% afterwards. We look forward to getting more perspective from key opinion leaders on how patients might be educated on possible cardioprotection and renal-protection – more conclusive results will be given on the former on September 17 at EASD.

Product Theater

Toujeo 300 Units/mL: An Alternate Insulin Option

Melissa Magwire, RN, CDE (Shawnee Mission Endocrinology & Diabetes, Shawnee Mission, KS)

A relatively well-attended Sanofi product theater on Toujeo (insulin glargine U300) featured several questions about the product’s differences vs. Lantus (insulin glargine U100). Ms. Melissa Magwire opened the session with a discussion on the barriers to initiating insulin in people with type 2 diabetes and then presented on Toujeo’s pharmacology, clinical data, and dosing and administration. Walking through different case studies, she demonstrated how to dose for a wide range of patients, from insulin-naïve patients to those on basal-bolus therapy. Ms. Magwire emphasized Toujeo’s smaller volume and compact depot size, pointing to its gradual release and steady state. During Q&A, attendees asked several questions regarding the differences between Lantus and Toujeo, as Ms. Magwire shared that there were no differences in skin irritations, weight gain, and injection site between the two insulins. Notably, upon being asked whether the company’s plan is to phase out Lantus, she responded that she “doesn’t think so” while acknowledging that she did not have the background to appropriately answer the question. Sanofi has made considerable efforts to position Toujeo as its new flagship basal insulin and is clearly relying on switches from Lantus as an important base for the product – during the company’s 2Q15 update, management noted that approximately 60% of patients new to Toujeo have switched from Lantus.

• The news flow for Toujeo continued today with the announcement of a launch in the UK. We will be curious to see how the pricing dynamics play out, particularly given the recent launch of Lilly’s Abasaglar/Basaglar (biosimilar insulin glargine). For more on this, please see our coverage of Sanofi’s 2Q15 update.

A Case Study in Treating Adult Patients with Type 2 Diabetes

Virginia Valentine, CDE, APRN (Sage Specialty Care, Albuquerque, NM)

In an early-morning Lilly-sponsored product theater on Trulicity (dulaglutide), Ms. Virginia Valentine called the product’s pen “the coolest injection delivery device there is.” In reviewing the drug and its clinical data from the AWARD studies, Ms. Valentine expressed enthusiasm for Trulicity, noting that the molecule of its once-weekly formulation is a “really thoughtful and creative molecule.” Also, while presenting the AWARD-5 data, she acknowledged the advantages of Januvia’s (sitaglipltin) oral delivery and safety, but was slightly critical of the drug’s efficacy commenting, “if it were effective, then we would love it!” However, she most excitedly commended the simplicity and painlessness of the Trulicity pen’s design – she pointed to its frosted needle (so patients can hardly see the needle, reducing anxiety) and its ability to inject quickly. Certainly, we would agree that especially for an injectable therapy, the design of the delivery device is critical for patient uptake and adherence.

Pre-conference Events

Phamacology Bootcamp

Susan Cornell, PharmD (Midwestern University Chicago, IL)

In this highly interactive pre-conference workshop, Dr. Susan Cornell provided a rundown of the current diabetes pharmacopeia. She began by reviewing the pathophysiology behind different types of diabetes, going beyond type 1 and type 2 to include type 1.5 (LADA), monogenic, and gestational diabetes. The bulk of the workshop consisted of a review of the major diabetes drug classes and a high level overview of their mechanisms, targets, and potential drawbacks. Attendees filled out a chart with the target organs, whether the drug affects fasting or prandial plasma glucose, the A1c lowering effect, the weight effect, the hypoglycemia risk, the cardiovascular benefit, and any side effects or other considerations for each drug class..Overall, the session was very focused on providing a basic mechanistic understanding underlying both disease and treatments in order to allow educators to recommend “rational” courses of therapy. Notably, it did include a bit of commentary on recent controversies in the diabetes drug arena, including the risk of euglycemic DKA with SGLT-2 inhibitors and pros and cons of Lilly’s novel basal insulin peglispro, which Dr. Cornell referred to as the “hottest” basal insulin on the horizon (though she did note its delayed submission timeline due to liver safety concerns).

• The workshop gave tips on recognizing signs of more unusual types of diabetes. Attendees were noticeably less familiar with LADA, monogenic, and gestational diabetes. Dr. Cornell explained the basic physiology of each, the diagnostic criteria, differences in disease progression, and signs to look for that indicate a patient’s diabetes may not be type 1 or type 2. We’re glad to see broader awareness of less common forms of diabetes and hope that it sparks better, more individualized and appropriate treatment for these patients.
• Dr. Cornell walked attendees through considerations involved in setting individual glucose targets. She recommended more stringent A1c targets (defined as “as close to normal as possible”) in patients with a shorter duration of diabetes, longer life expectancy, no significant cardiovascular disease, low risk of hypoglycemia, higher motivation, greater adherence, excellent self-care capabilities, and access to resources and a support system. Patients with a longer duration of diabetes, limited life expectancy, comorbidities and complications, and greater concern for hypoglycemia should have a less stringent A1c target at 8% or higher.
• Drug combinations should be “rational.” Workshop attendees were advised that when recommending a particular combination of therapies, they should pay attention to the mechanisms underlying each drug and make sure they target different tissue sites.
• The workshop covered 12 different pharmacotherapy options. The more common of these included metformin, thiazolidinediones (TZDs), sulfonylureas, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 agonists, and insulin.  The generally less commonly used alpha glucosidase inhibitors, dopamine agonists, bile acid sequestrants, amylin analogs/amylinomemtic agents were also reviewed. Dr. Cornell reviewed the mechanisms of action, effect on glucose, and side effects for each class.
  
  • Dr. Cornell listed a number of considerations involved in selecting a particular therapy. These include the patient’s remaining beta cell function, whether fasting or postprandial blood glucose is not at target, the degree of A1c-lowering effect required to achieve goal, the side effect profile and the patient’s tolerance, and any co-existing conditions.
  • Dr. Cornell discussed several key trade-offs for each drug class. Desired effects of any therapy include efficacy, protection of remaining beta cell function, cardiovascular benefit, and minimization of hypoglycemia risks, weight gain, and adverse effects. In order to best recommend a therapy, she explained that educators should understand where each drug class falls with regard to each of these effects. For each drug class, workshop attendees filled out a chart with the target organs, whether the drug affects fasting or prandial plasma glucose, the A1c lowering effect, the weight effect, the hypoglycemia risk, the cardiovascular benefit, and any side effects. Surprisingly, an important trade-off not mentioned in the workshop was cost, which often represents the limiting factor in the real world.
• The effect of different drug classes on weight drew much discussion. TZDs, sulfonylureas, and insulin were all noted as having a weight gain effect. On the other hand, GLP-1 agonists, amylinomimetics, SGLT-2 inhibitors, and metformin were applauded for their weight loss effects. To the surprise of many educators in the room, SGLT-2 inhibitors were revealed to have the largest effect on weight loss, even greater than that of GLP-1 agonists. This distinction was rationalized when Dr. Cornell reminded the audience of the SGLT-2 inhibitors’ mechanism of action – weight loss is a side effect of urinating out an excess 400 calories of glucose a day. We wonder about the potential for future obesity indications for SGLT-2 inhibitors – as one step in this direction, J&J is currently conducting an intriguing study investigating the effect of its SGLT-2 inhibitor Invokana (canagliflozin) in combination with phentermine on body weight and metabolism in patients with type 2 diabetes.
  
  • Euglycemic diabetic ketoacidosis (DKA) was briefly mentioned as a potential complication of SGLT-2 inhibitors. This is yet another indication of the rapidly increasing awareness of this issue since Dr. Anne Peters (USC, Los Angeles, CA) and Dr. John Buse (UNC, Chapel Hill, NC) and others first began drawing attention to it at the beginning of the year. Based on the evidence thus far, the risk appears to be manageable as long as providers are aware of it, particularly in type 2 diabetes. The risk/benefit profile in type 1 diabetes is less clear, though the several ongoing trials in that population should provide more conclusive data.
• Dr. Cornell stressed that the decision to begin insulin should be individually appropriate for patients and that educators should emphasize that starting insulin does not mean the patient will be on it indefinitely. For example, Dr. Cornell shared an anecdote of one of her patients who refused to go on insulin because she was a recovering drug addict and did not want to be in the presence of needles. On the flip side, Dr. Cornell extolled the benefits of insulin in patients at early stages of type 2 diabetes. To encourage patients to take this step and change the perception surrounding insulin, she suggested asking patients to try it for just one month.
• Insulin resistance was highlighted as a major challenge that concentrated insulins can help address. Dr. Cornell pointed out that when insulin resistance causes a patient to require more than 200 units/day of insulin, the sheer volume of a normal U-100 dose of insulin may pose challenges. The large size may make the dose too large for a single subcutaneous injection and increased injections may result in discomfort, poor adherence, and glycemic control. In addition, larger volume doses may not be absorbed as well as smaller volume doses. Concentrated insulins like Lilly’s Humulin U500 and Sanofi’s Toujeo (U300 insulin glargine) substantially alleviate these issues by providing the same dose in a smaller volume, of course. Dr. Cornell did note, however, that while Toujeo is administered through a simple dosing pen, U-500 currently does not have any approved pens and a dosing chart must be carefully used to ensure proper dosage with each injection. She also highlighted the long duration of action and ease of administration offered by both Toujeo and Novo Nordisk’s Tresiba (insulin degludec) – the two newest insulins on the horizon in the EU (though Tresiba isn’t approved here yet).
• Dr. Cornell referred to Lilly’s basal insulin peglispro (BIL) as the “hottest” basal insulin on the horizon. She deemed it “very promising” and was particularly excited about its potential weight loss effects. She did note its submission timeline delay due to liver safety concerns, which has prompted controversy when we have heard others discuss it at scientific meetings. As a reminder, phase 3 trials of peglispro in type 1 and type 2 diabetes demonstrated potentially worrying increases in liver ALT enzymes, liver fat, HDL, and triglycerides with peglispro, though the efficacy results were quite impressive (consistently superior A1c reductions and advantages on weight and nocturnal hypoglycemia vs. Lantus). Despite these advantages, we were a bit surprised to hear such a positive take, as we have heard other speakers take a more cautious tone since the delay was announced.

Corporate Symposia

Who’s on First? What’s on Second? Identifying a Line-up of Newer Agents to Individualize Care for Your Patient with T2DM (Sponsored by AstraZeneca)

James Gavin, MD, PhD (Emory University School of Medicine, Atlanta, GA), Pablo Mora, MD, CDE (Diabetes America, Arlington, TX), Davida Krueger, MSN (Henry Ford Health System, Detroit, MI)

In the Q&A of an AZ-sponsored corporate symposium, Dr. James Gavin (Emory University, Atlanta, GA) noted that euglycemic DKA in SGLT-2 inhibitors is “rare and infrequent” and advised attendees to refrain from off-label use and check for ketones in patients who present with symptoms of “a sick type 1.” He pointed to an analysis of reported cases that indicated that many of these individuals were using SGLT-2 inhibitors off-label in type 1 diabetes and that those who had type 2 diabetes were in “some sort of compromised situation” (i.e. perioperative, hospitalized). Similarly, Dr. Gavin commented that companies who have looked at their pivotal data sets found that there were small numbers of DKA cases in the trials with SGLT-2 inhibitors and that some of these cases occurred in type 1 diabetes patients who were misdiagnosed. Regarding how to address this in clinical practice, he characterized the phenomenon as “rare and infrequent” but recommended that providers check for ketones in those presenting symptoms of “a sick type 1” even if blood glucose levels do not look especially high. He described the “perfect storm” as someone with type 1 diabetes who has low insulin levels, high glucagon levels, and a drive for free fatty acids from lipolysis. Ms. Davida Kruger (Henry Ford Health System, Detroit, MI) echoed Dr. Gavin’s sentiments, commenting that, “we’re checking ketones at levels that you would otherwise not expect” and stressing that she is “not using SGLT-2 inhibitors in type 1 until we figure this out.” The current consensus in the field seems to be that education for providers and patients is the most important priority and that at the very least, significant caution is warranted for providers continuing to use SGLT-2 inhibitors off-label in type 1 diabetes. We do imagine that the class’ benefits likely outweigh the risk of DKA in most patients with type 2 diabetes and in at least some with type 1 diabetes – ongoing trials in this population should provide a better sense of the overall risk/benefit profile.

Rumor Has It? Demystifying the Use of Basal Insulin in T2DM Management

Richard Pratley, MD (Florida Hospital Diabetes Institute, Orlando, FL) and Deborah Hinnen, CDE (University of Colorado Health System, Colorado Springs, CO)

We heard positive commentary on Lilly’s novel basal insulin peglispro at two evening corporate symposia. At a Novo Nordisk-sponsored event focused on basal insulin and GLP-1 agonists in type 2 diabetes, Dr. Richard Pratley noted that peglispro has demonstrated equal if not greater efficacy compared to Sanofi’s Lantus (insulin glargine) along with less hypoglycemia and weight loss rather than weight gain. At the Sanofi-sponsored corporate symposium on basal insulins, Ms. Deborah Hinnen grouped peglispro with other ultra-long-acting insulins U-300 insulin glargine (Sanofi’s Toujeo) and insulin degludec (Novo Nordisk’s Tresiba) in terms of its benefits over older basal insulins. Peglispro’s lower hypoglycemia rates and weight advantages were especially highlighted. We were surprised that neither presenter mentioned the liver safety concerns that led Lilly to significantly delay the submission timeline for peglispro in order to conduct additional studies. We have seen peglispro as a high-risk/high-reward candidate for some time, and while its efficacy in clinical trials has certainly been impressive, we imagine that the FDA’s fairly conservative perspective on safety for new diabetes drugs means that the product is unlikely to move through the regulatory process unscathed.

Social Media and Mobile Health

Keynote Address

The “E” is for Engagement

Susannah Fox (US Department of Human and Health Services, Washington, DC)

Ms. Susannah Fox delivered an inspiring keynote address, stressing that the next frontiers of technology in healthcare are to leverage peer-to-peer communication and to utilize patients’ sharing of experiences as another source of information for the healthcare community. In presenting the context of her title, she opened by emphasizing the potential of “e-patients,” those who are empowered, engaged, and educated. Ms. Fox walked attendees through three revolutions in technology: (i) the Internet; (ii) mobile technology; and (iii) social networking, presenting data from the Pew Research Center on the skyrocketing rates of use in these three areas. Using the metaphor of a funnel, she illustrated that before the Internet, clinical knowledge and expertise was held very tightly as patients only had access to a “filtered drip” while today, that funnel has “cracked open” with patients’ better access to clinician-level information. Importantly, she pointed out that these tools have now put us in an era in which we do not only have access to information, but we also have access to each other. In discussing the most recent revolution of social networking, she emphasized the breaking down of patients’ barriers to turn to a peer with the same condition, noting that people with chronic conditions especially look for this sort of connection. Moving forward, Ms. Fox additionally pointed to the potential for information to be brought into the healthcare system from the level of patients. As she presented research that seven out of 10 US adults track some aspect of health but then shared that 49% of these individuals “track in their heads,” Ms. Fox emphasized the need to have empathy for where people are in their limited technology use and that adoption can be slow even if technology is moving quickly. Concluding, she empowered educators to empower their own patients to listen and learn from others and to contribute to this learning system through technology. As the funnel has been opened to flow down to patients and caregivers, Ms. Fox ended illustrating a two-way “funnel” and noting that “the future we need to build” is to now also learn from patients and caregivers.

• Ms. Fox noted that in her experiences, the Department of Health and Human Services (HHS) has shown enthusiasm in focusing its work on patient-centered research. In the beginning of her address, she acknowledged that most of her presentation was based on her work at the Pew Research Center and did not necessarily reflect the view of the federal government (which was met with her laughter). However, she shared that during her interviews at the HHS, the department demonstrated strong interest in bringing patients more into its work and agreed with many of her goals to make patients more engaged and empowered in their healthcare.
• Importantly, she also briefly touched on the limitations that still exist within information access. She specifically highlighted the “pay wall” that many patients and caregivers hit when they are attempting to access information from scientific journals that require a subscription or fee. In addition, she noted that there are still many places that do not have Internet access or do not have adequate levels of digital literacy. Indeed, as powerful as technology is, we will need to be wary to not exacerbate any disparities as tools continue to rapidly advance.
• Through stories, Ms. Fox illustrated the potential of social networking to “bend the cost curve” through peer-to-peer learning in healthcare. She shared how a mother of a child with cystic fibrosis, after joining an online community group, learned that sedation was not needed for her child’s CT scan, which her provider approved. In addition, Ms. Fox provided the example of a caregiver tips website in which the wife of a wheelchair-bound man shared a fall prevention tip to many other caregivers. According to Ms. Fox, while on a micro level, both of these stories demonstrate the power of peer-to-peer learning in helping save costs for both the patient and the healthcare system in preventing costly operations or altogether removing unnecessary procedures. She noted that while social networking is “not going to give a treatment or diagnosis, it can help raise questions” that can ultimately reduce burden at both the individual and population level.
• She encouraged the audience to “imagine a mobile-only world,” as she shared that she predicts this will come in the next five to ten years. She cited data from the CDC that 43% of households are now mobile-only with no landlines, with young and/or low-income individuals as the biggest demographics within this population. Ms. Fox stressed that “the smartphone is their window” and that texting is the most common way to communicate, as she predicted that mobile devices will have an even larger presence in the near future than they do today.
• Ms. Fox also suggested providers ask their patients about any health tracking behaviors as she noted that her research shows that most people do not share this information with their clinicians. She pushed providers to not just ask patients “what’s the matter” but “what matters” in order to dig deeper into learning what kind of information empowers patients. Specifically, Ms. Fox also stressed attendees to “not just assume but look for data,” as she cited research showing that people over the age of 65 are the demographic group most likely to track health behaviors, even though their most common method is by hand. We would certainly agree that while technology will take much of the burden off of providers, the success of its use will continue to require some form of strong provider-patient communication.

Engaging Patients in Their Care Using Connected Health

Kamal Jethwani, MD (Massachusetts General Hospital, Boston, MA)

Dr. Kamal Jethwani gave a compelling talk on the potential for new healthcare technology to transform healthcare. He suggested that our society needs to reconsider the way we think about “wellness,” turning health from something patients think about only when they are sitting in a doctor's office to something they are actively engaged in on a daily basis. He shared his personal efforts to enable this transformation with Connected Health’s “Text2Move” program. The platform is designed to motivate patients to increase the number of steps they take per day using text messages and information about their willingness to change their behavior. As we heard throughout AADE, Dr. Jethwani stressed the potential to utilize mobile devices to influence health (considering the incredible penetration of smartphones in both developed and developing nations). Notably, he shared that participants using Text2Move have seen a >1.0% drop in A1c over six months. In his view, this is but one example of our ability to tailor care to individuals, improve outcomes, and ultimately reduce the burden on the healthcare system.

Master Class

Mobile Prescription Therapy - Opportunities for Educators to Improve Patient Engagement & Outcomes

Kathy Gold, RN, MSN, CDE (Diabetes Research & Wellness Foundation, Washington, DC)

Ms. Kathy Gold put into context the tremendous enthusiasm we have heard at AADE 2015 for the potential of digital health. She opened her lecture by reminding attendees what it means to live in this digital age of healthcare: e.g., ~43,000 health-related apps; 62% of smartphone users use a healthcare app; 500 million smartphone users projected in 2018. [Not that the reminder was necessarily needed; we’ve seen these numbers in some form of another at least FIVE times already at this conference – just a testament to the growing acknowledgement of the importance of digital health.] Ultimately, Ms. Gold suggested that mobile health solutions provide a way to improve outcomes without increasing costs by empowering patients to improve their own care. Indeed, she suggested that mobile solutions can address a number of the barriers to patient engagement: (i) limited access to providers; (ii) confusion about expectations; (iii) a lack of technology knowledge; (iv) limited resources; (v) and limited positive feedback. Mobile solutions, on the other hand, provide a “CDE on your shoulder” approach to care that can provide patients with 24/7 – “non-judgmental” – coaching messages that better mirror the real-time nature of diabetes.

MPT in an Academic Diabetes Center

Debra Nelson, MA, RN, CDE (University of Maryland Center for Diabetes and Endocrinology, MD)

Ms. Debra Nelson provided attendees with a valuable and tremendously enthusiastic introduction to Welldoc’s Bluestar mobile prescription therapy. Speaking from 18 months of experience educating patients on Bluestar, Ms. Nelson described the positive impact the technology has had in increasing the efficiency of her practice and addressing a number of the “real-world” challenges of diabetes, such as limited numeracy and a lack of access to care. Below, we bring you three of the most quotable quotes from her presentation:

• “Bluestar does what we need patients to do,” said Ms. Nelson. She lamented the number of times logbooks do not show up in the clinic because patients have forgotten them at home. Even when glucose data are available, she noted that they could be inaccurate or filled with gaps, making it difficult for providers to make informed clinical decisions. Indeed, she espoused the mobile connectivity as one of the biggest pluses of Bluestar since “patients ALWAYS have their phone.”
• “That feeling of ‘overwhelmingness’ and that you’re alone … well, you are not alone.” Speaking anecdotally, Ms. Nelson stressed that the real-time coaching and positive reinforcement of Bluestar do offer real support for patients. It helps reduce stress, helps manage the chronic burden of diabetes, and keeps patients motivated.
• “It’s really opening up a lot of doors to engage and stay in touch with patients. This is the kind of support my patients needs when I’m not there.” Huzzah! We certainly agree!

MPT in a Pharmacy Practice

John Motsko, RPh, CDE (Apple Discount Drugs, Salisbury, MD)

Mr. John Motsko’s broad overview of mobile prescription therapy reprised many of the benefits of mobile prescription therapy that we heard earlier in the session – convenience, patient empowerment, positive reinforcement – and was highlighted by recently published data on patient engagement from Welldoc’s Bluestar. The study (presented at ADA 2015) looked at 162 type 2 patients (baseline A1C: 8.9%) using Bluestar and demonstrated solid engagement and improvements in glycemic control for patients at three months – over half of users (54%) were still using Bluestar and median fasting glucose had declined from 156 mg/dl to 143 mg/dl. It is fantastic to see that RCT reductions in A1c actually map onto the real world. As a reminder, WellDoc has published two RCTs showing significant 1.2-1.4% reductions in A1c levels with its software – Quinn et al., Diabetes Care 2011 (1.9% in the WellDoc intervention group vs. 0.7% in the usual care group; p <0.001 over 12 months) and Quinn et al., DT&T 2008 (2% in the WellDoc group vs. 0.7% in the usual care group; p <0.02 over three months). Ultimately, we believe WellDoc’s educational and motivational feedback on every patient input is critical to helping patients feel like their efforts are worthwhile (i.e., real-time feedback is so much better than slaving away for three months manually logging glucose values, only to see a provider for 30 minutes [at best], get feedback at that point, and then return 90 days later). It’s nice to see that patients in the real world can appreciate these benefits. This empowerment is a critical element of successful long-term diabetes control, not to mention something we feel can move the needle and reduce the economic burden of diabetes on our healthcare system.

• Notably, we learned today that Welldoc recently released a novel update to the Bluestar platform that enables paired testing (e.g., before vs. after breakfast). This offers a great way for patients to connect the dots between behavior change and clinical results (e.g., a 15-minute walk actually reduces blood sugar!). Welldoc has done some outstanding work on the education front, and we salute the company for going beyond simply display of glucose values.
• As expected, the greatest improvements in glycemic control were seen in patients with the highest baseline A1c values. This is, of course, a tough group and an important one considering the number of patients not at goal.

Welldoc Population Data: Glycemic Improvement

Baseline A1c	Sample size	Change in A1c
<7%	19	0%
7-8%	24	-0.3%
>8%	56	-1.4%

• Impressively, patients remained engaged over the long run – nearly 50% remained engaged even > four months after initiating mobile therapy. Considering the number of digital products that are used for just two weeks before interest wanes, this adherence is notable to see.

Welldoc Population Data: Engagement

	1 month	2 months	3 months	4 months	> 4 months
Percentage of patients engaged	70%	59%	54%	49%	47%

• Engagement was seen across all age groups with higher-than-expected engagement in the >60 age group (and highest in the 50-59 age group!).

Welldoc Population Data: Stratified by Age

Age Group	Percentage of total users	Percentage of total engagements
<60 years old	27%	34%
50-59	43%	42%
40-49	20%	19%

Breakout Sessions

From Brochures to Apps: Evolving Strategies for Diabetes Education Resources in the 21st Century

Alexis Williams, MPH, MS & Betsy Rodriguez, MSN, CDE (Centers for Disease Control and Prevention, Atlanta, GA)

Ms. Alexis Williams and Betsy Rodriguez provided a valuable overview of the value of online resources in diabetes education. We heard tremendous enthusiasm for the future potential of digital health juxtaposed against skepticism regarding reliability, access, and privacy. Indeed, Ms. Williams conducted an informal survey of the room, asking what educators “love” and “hate” about online resources. Answers were instructive both in their content and their relative distribution – skewed toward factors that educators dislike. It was clear that there are many challenges to adoption, but also that digital health is coming whether we are prepared or not. In this case, speakers throughout the day reminded the audience that the leap of faith is not only inevitable but needed. Indeed, we believe that this is exactly where diabetes care must go in the future – toward solutions that can scale. As we heard today, there simply aren’t enough endocrinologists and primary care doctors to manage patients, and those available aren’t being compensated to interpret the slew of data now being generated. Digital solutions have the potential to make life easier for patients and providers and provide population level solutions that save the healthcare system money in the long run.

• Ms. Williams conducted a valuable survey of the room, asking what educators “love” and “hate” about digital health. Answers were instructive both in their content and their relative distribution – skewed toward factors that educators “hate.” Of course, it’s human nature to identify flaws, and we’d note that the audience was generally high on the potential of online resources. However, the answers were a strong reminder that there are clear challenges ahead of us as well as tremendous potential.

What do Educators “love” and “hate” about Online Resources

What do educators “love”	What do educators “hate”
The ability to self-monitor	The ability to self-monitor
“Quick and at your fingertips”	“Another thing I have to learn”
Online Communication	Questionable reliability
	Lack of privacy
	Lack of access – “If you’re poor, you’re out!”
	Lack of penetration – “Doctors won’t use it”

• Ms. Williams suggested that patients fall into two camps regarding online resources: “Cheerleaders” and “Skeptical Dogs.” Levity aside, we liked the distinction Ms. Williams drew: “Cheerleaders” are those that get excited about online resources vs. “Skeptical Dogs,” who do not accept anecdotal evidence and do not want to jump on the bandwagon without understand the impact on patient’s health. Based on an informal survey of the audience, we would estimate that educators were split ~50/50 between Cheerleaders and Skeptical Dogs.
  
  • While Ms. Williams admitted to being a Cheerleader, she acknowledged that skepticism of online resources is legitimate. Indeed, she lamented the fact that there are: (i) a small number of studies; (ii) few studies focused on high-risk populations; (iii) studies that are outdated by the time they are completed; and (iv) a lack of clarity on what behaviors studies should focus on.
• “Online resources are coming to you soon if they haven’t already [and] they are not limited to digital natives.” Ms. Williams shared that 87% of Americans use the internet; that ~75% of these users use social media; and that 64% of American have a smartphone. Furthermore, Ms. Williams noted that this trend toward social media is not limited to younger populations who have grown up with the internet – indeed, she shared that >50% of adults >65 years old are on Facebook.
  
  • We were somewhat surprised to learn that people with chronic diseases are less likely to use the internet relative to those without chronic disease – 72% of adult with chronic conditions vs. 89% of adults without. Indeed, this disparity holds true even when comparing for age, income, or education. The numbers speak to the need to understand the extent of online resource access before rushing to use these tools (though we’d note that ~75% of use is still relatively high!).
  • We were less surprised to learn that high-risk populations are more likely to be smartphone-dependent than low-risk populations. Ms. Williams shared data that 12% of African-Americans and 13% of Latinos are smartphone-dependent relative to only 4% of whites. Of course, this would seem to reflect the fact that high-risk population may not have the resources for multiple internet-accessible devices.
• Notably, Ms. Williams offered two notable resources for connecting with patients that we typically do not hear about: Pinterest and Google docs. She stressed the value of these two-way resources that allows patients and providers to engage with each other. We wonder whether provider Pinterest pages – in particular – could catch on in social media circles! We haven’t heard much about this to date, but can imagine that the visual organization of material could appeal to a lot of patients.

Social Media: All “Hands-On” Deck

Hope Warshaw, MMSc, RD, CDE (Hope Warshaw Associates, Alexandria, VA) and Ms. Melissa Dobbins, MS, RDN, CDE (CEO, Sound Bites Nutrition Communications, Chicago, IL)

A packed, Saturday-morning session underscored how social media has come on the scene in a TREMENDOUS way at AADE 2015. This interactive session led by Ms. Hope Warshaw and Ms. Melissa Dobbins provided educators an introduction to Facebook, Twitter, Instagram, and Pinterest before breaking into focus groups that helped attendees get set up on these various platforms. We were amazed to see how well attended this talk was – we were unable to find a seat in the first twenty rows because EVERY seat was taken. The interest speaks not only to the growing appreciation for social media in on-the-ground clinical practices but how far perspective on this field has come in the past year. Thinking back to AADE 2014, social media was discussed in terms of the challenges to adoption and convincing educators that online engagement was worthwhile. This year, many educators have come in armed with – at least – a basic understanding of social media and the belief that the benefits are worth the perceived risks. This was certainly reflected in this session with the focus on the actual realization of social media, providing hands-on support to get educators set up on online platforms. This was terrific to see – one of our favorite moments of the conference was seeing 500 educators taking selfies for their profile pictures : >. Ultimately, we are big believers that social media can play a role in more scalable, more cost-effective diabetes care delivery in coming years. It offers a solution to connect more intimately with patients, to learn what they are “really” thinking, and to tighten feedback loops. Clear challenges still remain – certainly in terms of privacy and the ethics of online interaction – though this is true for any virgin movement. Rather than allowing those fears to dwarf the potential, it’s great to see the enthusiasm and appreciation for the utility of social media.

• For anyone who is on social media, we hope you’re following diaTribe (Twitter: @diaTribeNews; Facebook: diaTribe) for real-time updates on everything diabetes!

Additional Topics

Keynote Address

Diabetes Prevention and All that Jazz

Ann Albright, RD, PhD (CDC, Atlanta, GA)

In her fun-filled musical keynote address, the esteemed Dr. Ann Albright presented on the National Diabetes Prevention Program (NDPP) and announced Weight Watchers and Jenny Craig as two new approved organizations. In discussing prevention, Dr. Albright noted that we often “find ourselves aligning behind one solution or the other,” debating between whether interventions should be at the individual or population level. Using a jazz band as the metaphor, she pointed out that the challenge is to reframe this discussion and understand how we can maximize both approaches – similar to how the individual contributions of a jazz band’s instruments can come together as a unit. Dr. Albright discussed the NDPP’s four core components (training, the recognition program, intervention sites, and PR/marketing) as she outlined various opportunities in which educators can be involved. On the payer front, she highlighted that the CDC is working with insurers and employers to ensure their continued link to the DPP and that the recognition program is key to this collaboration. Notably, Dr. Albright announced that just earlier that morning, the CDC had approved Weight Watchers and Jenny Craig as part of the DPP, which was met by giant rounds of applause – we agree that this has enormous potential in outreach with these two organizations’ commercial recognition.

• In addition, while discussing the importance of PR and marketing, Dr. Albright hinted towards a “big announcement” about a prediabetes awareness campaign coming in January 2016 that she encouraged attendees to engage in and share over social media. Regarding other population-wide strategies, she commented that the implementation of public health policies such as sugar-sweetened beverage taxation or the regulation of portion sizes has been limited due to the belief of restraints on freedom of choice. She pushed for more modeling studies on such policies, but noted that natural experiments are even better as she encouraged that examining such implementation can help pave the way for more effective policies. Similar to the energy we sensed from the rest of the audience, we have been inspired by Dr. Albright’s pioneering work in diabetes prevention (she was also awarded AADE’s Lifetime Achievement Award this year) as she has so gracefully and enthusiastically executed her vision of collaboration through the NDPP.

Master Class

Ready, Aim: Advocate for Diabetes!

Manny Hernandez (Livongo Health, Mountain View, CA) and Charles Macfarlane (AADE, Chicago, IL)

In AADE’s closing session, Mr. Manny Hernandez and AADE CEO Mr. Chuck Macfarlane led an inspiring and powerful master class on how educators can be involved in advocacy. Mr. Macfarlane stressed to attendees that their unique expertise and perspectives are important in spreading education and awareness, as he shared the quote, “if you don’t talk, somebody else is talking for you.” The master class also provided attendees the opportunity to discuss their own experiences with advocacy, as the hall was filled with round after round of applause as educators shared their advocacy work from the level of the patient to the employer to the government. In highlighting other venues educators can be involved, Mr. Hernandez reviewed the organizations involved in advocacy and the biggest ongoing issues requiring advocacy from the flaws of competitive bidding to the Access to Quality Diabetes Education Act of 2013 and 21^st Century Cures Act. Mr. Hernandez also reviewed past advocacy efforts, as we were excited to hear him highlight the diaTribe Foundation’s FDA-Patient Dialogue – see our coverage of the meeting and how we crashed the FDA’s server (!) in Closer Look and diaTribe. We were overall incredibly moved by the passion by both the speakers and the attendees throughout this master class as attendees clearly left New Orleans with a newfound energy as Mr. Macfarlane concluded with a clip from the movie Network, asking everyone to stand up and scream the film’s noted line, “I’m mad as hell, and I’m not going to take it anymore!” Talk about leaving AADE all “jazzed up!”

Pathophysiology of Prediabetes and Early Treatment Considerations

Katherine O’Neal, PharmD, MBA, BCACP, CDE (University of Oklahoma College of Pharmacy, Oklahoma City, OK) Jeremy Johnson, PharmD, BCACP, CDE (University of Oklahoma College of Pharmacy, Oklahoma City, OK)

In a well-attended master class on prediabetes, Dr. Katherine O’Neal presented on pharmacological options that can be used for early prediabetes treatment. After Dr. Jeremy Johnson (University of Oklahoma College of Pharmacy, Oklahoma City, OK) reviewed the pathophysiology of prediabetes and stressed the importance of intervening early, Dr. O’Neal dived into additional drug therapies that can be used for prediabetes treatment. In acknowledging ADA’s recommendations for metformin and lifestyle intervention, she reviewed the available data and advantages and limitations of: (i) TZDs; (ii) alpha glucosidase inhibitors; (iii) GLP-1 agonists; (iv) DPP-4 inhibitors; and (v) weight loss drugs. Specifically, while she noted that TZDs have the most evidence and support for use in prediabetes, Dr. O’Neal pointed to the side effects of weight gain and bone fracture as likely reasons that the drug class has not been recommended. In addition, she highlighted that evidence for the use of GLP-1 agonists in prediabetes is growing, noting the class’ weight loss but also the limitations of the class’ high costs. That’s limitations for now. Indeed, we were impressed by the prediabetes results from SCALE for Novo Nordisk’s Saxenda (liraglutide 3.0 mg) – see our coverage of the results as well as Novo Nordisk US President Mr. Jesper Høiland’s thoughts in our interview with him. Regarding DPP-4 inhibitors, Dr. O’Neal stated that the class has few supporting data with mostly case reports. We did find it notable though that she highlighted obesity drugs as potential treatment options, as she demonstrated positive data from orlistat and Vivus’ Qsymia (phentermine/topiramate). Although revenues from branded obesity pharmacotherapies are lower than expected, we have certainly seen some movement towards diabetes indications in these drugs. Overall, we think these drugs can also bring great potential in addressing early intervention needs for diabetes, especially since obesity so often precedes prediabetes and type 2 diabetes.

Breakout Sessions

Diabetic Kidney Disease

Edward Barnes, MD (Western University of Health Sciences, Pomona, CA)

Dr. Edward Barnes discussed the future of diabetic kidney disease and the benefits of an integrated approach to care. He spent a significant portion of his very engaging talk reviewing the pathophysiology of the disease (which he stressed begins long before it is typically diagnosed) and current strategies to address it. He then highlighted the long list of potential biomarkers that could help providers intervene at an earlier stage, focusing on KIM-1 and NGAL as two particularly promising options. He also referred to advances in proteomics that allow researchers to search for biomarkers only among the highest-yield options rather than examining every possibility. With regard to novel therapies for diabetic nephropathy, Dr. Barnes lamented the slow rate of progress (“a lot of these things I’ve been talking about for over two years and they haven’t moved”), but listed endothelin receptor antagonists (like AbbVie’s phase 3 atrasentan) and pyridoxamine as promising options. Perhaps the most inspiring part of Dr. Barnes’ talk was his overview of his institution’s integrated, team-based approach to diabetes care. Every patient who enters the system receives a comprehensive evaluation from a wide range of specialists on his or her first day, and progress is continuously tracked using the Diabetes Cross-Disciplinary Index, a scorecard on everything from glucose control to dental health to depression. The group has also initiated a program that pairs patients with first-year medical students who serve as health coaches throughout their four years of education. Dr. Barnes expressed hope that this model will be tested in other places and attract payer buy-in. We wholeheartedly agree – as one attendee summed it up, “this model should be the model.”

Glycemic Control for Patients with Cardiovascular Disease or at High Risk of Cardiovascular Disease: How Low Should We Go?

Pat Rafferty, PharmD, CDE (St. Louis College of Pharmacy, St. Louis, MO)

Dr. Pat Rafferty tackled the ever-vexing question of the relationship between glycemic control and cardiovascular outcomes. She focused in particular on the ACCORD mortality results, stressing that it was the patients who failed to respond to intensive therapy who were responsible for the increased mortality in the intensive group. Therefore, while she believes it is appropriate to take a more conservative approach for patients not responding to intensive therapy, she finds it troubling to see providers increasing A1c targets in patients who were previously meeting more stringent goals. In terms of potential explanations for the ACCORD results, she suggested that severe hypoglycemia alone cannot explain the increased mortality risk, as patients with multiple episodes were moved to the conventional group and only one death in the intensive arm was attributed to hypoglycemia. That said, she also acknowledged significant gaps in the available data – for example, clinics were not required to measure blood glucose at the time of death. Dr. Rafferty also suggested that there is no clear evidence that the specific medications used in ACCORD (i.e., sulfonylureas, insulin, TZDs) were responsible for the increased risk, as there is no data conclusively linking any of those classes to adverse CV outcomes. She seemed to lend the most credence to the possibility that the results were due to chance, noting that stopping a trial early increases the risk of false positive results and that there is currently no clear biological explanation for the findings. One possible biological explanation put forward in a recent analysis by authors including Dr. John Buse and Dr. Vivian Fonseca is that the excess mortality could have been due to a subgroup of “high glycators” – the theory is that falsely high A1c readings could have led these patients to undergo more intensive treatment than their actual blood glucose levels warranted, increasing their risk of hypoglycemia and mortality.

• While acknowledging that the existing data is complicated and perhaps contradictory, Dr. Emily Evans (LSU Health, Shreveport, LA) presented a practical guide to cardiovascular outcomes data for providers deciding between different therapies. She reviewed data on outcomes and surrogate markers for all AACE-recommended first- and second-line diabetes drug classes, ranging from insulin to GLP-1 agonists to alpha glucosidase inhibitors. She pointed out that educators are often a first line of information for patients before they speak to their doctors, so it’s important for educators to be up-to-date on cardiovascular benefits and risk considerations. Ultimately, she suggested that patients at high risk for cardiovascular disease consider a higher A1c goal and consider Takeda’s Actos (pioglitazone) and alpha-glucosidase inhibitors (both of which have data suggesting cardiovascular benefit) earlier in the course of therapy but avoid older sulfonylureas and GSK’s Avandia (rosiglitazone). Of course, pioglitazone and alpha-glucosidase inhibitors both carry significant baggage (including heart failure risk in pioglitazone’s case) that has led to declining popularity in recent years. While we continue to expect most ongoing outcomes trials of newer diabetes drug classes to produce neutral results, we hold out some hope that one of the SGLT-2 inhibitor or GLP-1 agonist studies may be able to demonstrate a benefit – that would certainly be an enormous win for patients.

Current State of DSMT Reimbursement and Health Reform

Patty Telgener (Emerson Consultants, Excelsior, MN)

Reimbursement expert Ms. Patty Telgener gave her annual highly awaited overview of the diabetes self-management training (DSMT) reimbursement landscape – the entirely packed room was a testament to the complexities and confusion surrounding reimbursement. She noted that the 2016 Medicare proposed payment rates came out in July, with no change in reimbursement rates for DSMT codes. This was viewed as a positive outcome by Ms. Telgener, who reminded the audience that the Medicare fee schedule for most services is actually going down. Furthermore, the use of the Medicare Sustainable Growth Rate was finally ended with the Medicare Access and CHIP Reauthorization Act of 2015, providing greater stability in future fee schedules by no longer including a looming threat of an across-the-board 25% fee reduction. The new Medicare policy surrounding “medically unlikely edits” were also highlighted – under this policy, there is a maximum number of hours of DSMT per patient per day that will be reimbursed (three hours of one-on-one sessions and six hours of group sessions) since sessions longer than those limits are deemed medically unnecessary. Ms. Telgener noted that she felt the limits were reasonable, since patients will likely have difficulty focusing for longer sessions anyway. On the prediabetes front, Ms. Telgener highlighted the new CPT code that will go into effect January 1, 2016 that allows for billing for prediabetes education and prevention – a big step forward, though, as she reminds us, not necessarily a guarantee that payers will actually pay for it. Ms. Telgener concluded by highlighting the effect of broader healthcare reforms on the diabetes field, particularly how the rise of accountable care organizations will shift the payment structure of healthcare away from fee-for-service and how competitive bidding processes may lower costs for patients but also limit choices.

The Diabetes Prevention Program

Joanna Craver (AADE, Chicago, IL)

Ms. Joanna Craver presented an overview of AADE’s Diabetes Prevention Program (DPP) before turning the session over to Ms. Raylene Foster (Metro Health – West Michigan, Grand Rapids, MI), Dr. Jay Shubrook (Touro University California, Vallejo, CA), and Ms. Marci Butcher (Montana Diabetes Program, Helena, MT) to discuss their individual experiences implementing DPP in their health systems. According to Ms. Craver’s progress update, as of 2015, there are 45 AADE DPP sites, over 200 classes have been conducted (which struck us as low at about four per site), and over 3,000 participants have gone through the program (this also struck us as relatively low at about 66 per site – we’d love to know more about the range) . Ms. Craver shared that though National DPP funding is set to expire in 2016, there are ongoing discussions of extending the program an additional year. Ms. Foster then took the podium and emphasized that when setting out to begin a DPP program from scratch, the “why” and “how” are most important. Dr. Shubrook shared his experience convincing employer insurance groups to pay for DPP for their employees and the health costs arguments that ultimately won them over. On the other end of the spectrum, Ms. Butcher described working with government payers – Montana Medicaid specifically – to fund their DPP program. We were especially touched when Ms. Butcher teared up while sharing a patient letter to his congressman describing the impact DPP has had on his life and ability to care for his ailing wife. As background, the AADE DPP program is a is a network of DPP sites within the National DPP program run by the CDC and uses the National DPP curriculum, though AADE adds value through technical assistance in starting, marketing, running, and reporting data on each program. Outcomes data is tracked through the CDC Diabetes Prevention Recognition Program (DPRP) – after 12 months of DPRP feedback, AADE DPP sites had on average 72% of participants enrolled based on a blood test, 92% of participants attending four or more sessions, and a mean body weight loss of 5.9%. We see AADE’s role within this program as critical to its success and we were glad to see so many speakers and attendees committed to the cause through this session.

• Prevention in the prediabetes population was positioned as an increasingly essential part of a diabetes educator’s role. Ms. Craver reminded participants that part of the reason the AADE pursued this partnership with the CDC is results from a 2012 survey that indicated 78% of AADE members are already working with people with prediabetes, making it clear that it made sense for the AADE as an organization to be in the prediabetes space. In 2015, the percentage of AADE members working with prediabetes patients was up to 80.5%, indicating to us that educators have critical leadership roles within prevention efforts, stressing their importance in alleviating the epidemic.
• According to Ms. Craver, the AADE is actively thinking about the transition process when National DPP funds are no longer available. She highlighted the need for collaboration between state health departments, employers, insurers, and administrators to create programs that are self-sustainable. She also mentioned that “How to Start Your Own DPP” will be part of AADE’s pre-conference sessions in the future, along with the existing “Building Your Diabetes Education Program” we saw yesterday.
• Ms. Foster told attendees that if they start a DPP program, they must keep in mind the “why.” The “why” will need to be explained to participants, administrators, employers, insurer groups, and colleagues. Some of the reasons Ms. Foster listed for her “why” included her health system’s stated community-focused mission, the desire to be a trailblazer for DPP in their area, the evidence-based impact of the DPP program, and the potential for participant quotes.
  
  • Ms. Foster also gave tips for key components to success in creating a DPP. These included building a strong base with at least two educators, setting up a good system (she highlighted the AADE support as especially useful for this), creating partnerships and building support with nurses and not the “decision-makers” first, using feedback to improve, and thinking about program sustainability.
• In conversations with employers about DPP coverage, Dr. Shubrook emphasized that employers respond to the numbers of healthcare costs. He shared that he tells employers that typically 11% of people with prediabetes develop type 2 diabetes in a year and translates that to a $1.3 billion savings over 10 years if Medicare implemented the DPP program and there were 37% fewer cases of new onset diabetes. During Q&A, Dr. Shubrook shared that one Ohio large employer saw healthcare cost reductions within 13 months.
• According to Dr. Shubrook, employer support encouraged higher participant attendance rates. He stated that employers had several different payment methods for their DPP benefits – some would pay for the entire program, some paid 80% and reimbursed the 20% paid by the participant if they completed the program, and some would pay for the program but would deduct the cost from the participant’s paycheck if his attendance dropped below 80% of classes. Regardless of the employer benefit scheme, attendance rates notably remained the same. Surprisingly, however, participants who paid for the program out-of-pock upfront were more likely to drop out. We wonder if the motivation of external support and accountability could account for these results.
• Ms. Butcher shared her experiences garnering Medicaid buy-in to the DPP program. She noted that Montana’s Medicaid program has been funding DPP for the state’s Medicaid population through a CMS Innovation Grant. Despite Montana’s DPP-enrolled Medicare patients being two times less likely to achieve the 7% weight loss goal, the state’s Medicaid program has been so impressed by the program that it is discussing continuing the program after CMS funding expires.
• Ms. Butcher encouraged advocacy through letters to congressmen to support government funding for DPP. In a touching moment, she shared a letter written by a DPP participant describing how he was better able to care for his sick wife because he had better health himself. She also shared a patient’s blunt statement that “This program should be implemented statewide! They waste money in government on some really dumb stuff. Why not do something that will benefit the public for once?” It was so great to hear such personal stories and patient perspectives on these efforts – sentiments that we rarely get to hear at these meetings.

Q: Marcy, you mentioned that you have 250+ telehealth sites. Are there any issues with reimbursements?

Ms. Butcher: That was 250+ patients that had been seen in telehealth, I don’t think we have 250 telehealth sites in all of Montana. In terms of reimbursement, Medicaid is reimbursing it, but Medicare nationally doesn’t pay for DPP yet. That’s what we’re working on. There’s a major effort to gather evidence to bring to Medicare to support reimbursement.

Q: In trying to sell the DPP program to employers, do you have experience in industry to help with engaging larger employers?

Dr. Shubrook: We currently have a pilot with one of the largest employers in Columbus, Ohio – a health system. So far they have been very successful in health costs. I’m not supposed to share this yet, but they started saving money at 13 months. We’re writing a paper on it.

Ms. Craver: There are also other publications about other employers who saved money.

Q: I have a question for Marcy. Do you have enough data to do comparisons between telehealth and other sites?

Ms. Butcher: We have. We’re getting the same weight loss results and risk reduction as in-person. And that has been published. Search TS Hardwell or Montana Diabetes Prevention Program and it should have a list of publications.

Comment: I work for the city of Santa Fe. We folded DPP into the wellness program for employees and then convinced the county to do the same thing. I’m going to see what we can do about getting our legislature to fund us.

Q: I work in the employer market, and I have done CDC DPP on site. I invited anyone who was at risk or was interested to join and for outcomes we did A1c before and after the program. How do choose which participants to open it up to and what outcomes do you measure?

Dr. Shubrook: It’s a tricky balance when it’s a benefit to not offer it to all people. At Ohio, we have a lot of programs so we could offer others. Employers generally want to open it up to any employee but that’s difficult when you have to report back data. We’ve done it a couple ways: we offer to all and report only those who are at risk in data or we do communities. Those who are not at risk can really help those who are at risk. To me that’s an important inclusion.

Ms. Foster: There’s not always an obvious answer in maneuvering that. When you’re starting to talk to an insurer or employer, there should be some black and white in how you’re going to handle that.

Hypoglycemia in Type 1 Diabetes - the Impact on Family Members

William Polonsky, PhD (Behavioral Diabetes Institute, San Diego, CA)

Dr. William Polonsky (Behavioral Diabetes Institute, San Diego, CA) provided an insightful perspective on the impact of hypoglycemia on family members of those with type 1 diabetes. Dr. Polonsky reported that family members of people with type 1 diabetes are typically much more worried about hypoglycemia than the person with type 1 diabetes him or herself. He presented data showing that 22% of family members reported experiencing distress with regard to hypoglycemia compared to only 12% of patients.  He argued that this is a huge problem that no one talks about and it needs to be addressed, as the negative effect on family members is clear. There is a need for solutions to help family members feel more confident about hypoglycemic events, including information about how to avoid severe lows and handle emergences when they arise. Notably, he cited CGM as a major advance that has improved confidence that hypoglycemia can be avoided, especially while sleeping or exercising. Dr. Polonsky thinks that of all the advances in diabetes care, this may be the greatest. We agree that in addition to its lifesaving potential, the technology can make an enormous difference in terms of peace of mind for loved ones – this is why we feel so strongly that the current lack of Medicare coverage for CGM is such an important issue on which to work. 

• Dr. Polonsky presented data showing that 22% of family members reported experiencing distress with regard to hypoglycemia compared to 12% of patients themselves. He described this as a huge problem that no one worries or talks about, and one that needs to be addressed.
• He cited trauma as a leading cause of fear among partners, many of whom have seen their loved ones experience severe hypoglycemia and lack confidence in their ability to respond (r=0.44). He explained that patients often say, “I don’t know why my partner is so afraid, it isn’t a big deal,” while the partner vividly remembers the episodes and loses confidence. This is concerning as this fear is correlated with depressive symptoms (r=0.35), greater life stress (r=0.25), marital dissatisfaction (r=0.28), type 1 diabetes related relationship conflict (r=0.46), and insomnia.
• Family members’ hypoglycemia-related distress decreases when they feel more confident, whether through witnessing fewer severe lows, knowing that the person with type 1 diabetes has taken action to control blood sugar, having an agreement about their expected role in managing hypoglycemia, or feeling more confident that they can handle emergencies.
• Dr. Polonsky offered several solutions for managing distress, most of which are aimed at reducing the risk of severe hypoglycemia.
  
  • Pick a number at which the person with type 1 diabetes will take action so that they avoid severe lows.
  • Improve blood glucose estimations by guessing levels and writing them down before checking actual numbers. This could help the person with type 1 diabetes understand body cues better.
  • CGM can greatly improve confidence that hypoglycemia can be avoided, and can help partners sleep better (though alarm fatigue can be a significant issue in itself).
  • Encourage conversation between partners, with a focus on areas of responsibility.
  • Embrace new technologies, including apps that allow a person with type 1 diabetes to share blood glucose levels with family members, while maintaining appropriate boundaries.

Questions and Answers

Q: I am wondering if you have some ideas for us, three quick takeaways for share etiquette? I think it is going to be really important because this is new.

A: The person I have talked to the most about this is Kerri Sparling. She is writing about this in her blog, Six Until Me. She has been taking the lead and putting the word out around the country on these etiquette issues. She is asking people all around the world how they are dealing with these etiquette issues. I believe she has an article coming out about this soon. I am looking forward to reading more about what she has to say.

Q: I am really concerned about the explosion of share and the impact on mental health. I am worried about codependency and the effect on normalization. The parents will over manage. Any insights?

A: If you are seeing kids that age, I have seen way too many parents who ask if they should move with their kid to college. This happens so often. I politely say, no, you should not do that. It is understandable as they have spent years being in charge and so vigilant, and it is hard to give it up. I am thrilled and worried about the share platform at the same time. We need to convince Dexcom to do this. How do you provide intermittent data? But until we figure that out, I do not know what the answer is.

Q: I am a spouse of a type 1. I have no fear of handling the lows. What I do have a problem with is the beeping and the buzzing in the middle of the night. How does one who has become so desensitized and avoidant of the beeping and buzzing, keep from ignoring it long enough that a warning becomes an absolute emergency.

A: It is a growing discussion that we have had among colleagues. We have heard so many different hypotheses as to why the beeping doesn’t wake up a patient but it does wake up the partner. Part of it is that partners are the caregivers. You want to make sure your partner is OK so you are a bit more sensitive. I do not know if we have any great solutions but we do hear this a lot. We do not have variable volumes on the CGM, but we do on the share platforms which is very odd.

Q: I have a couple of patients with type 1 who have managed their diabetes well for many decades. Now that they are older, their management is slipping. We have to pull in family and it can be challenging. As an educator, we are treading new ground with this person. Patients are experiencing more hypoglycemic events, more driving when they shouldn’t be. I would be interested to hear your thoughts on this.

A: These are people who were raised in the time where it was best to keep their blood glucose as low as possible. The conversation should be to set glycemic goals that are higher. People may fight you on that but that is where I always start.

Providing Persons With Diabetes – Diabetes Self Management Education and Support: A Position Statement

Margaret Powers, PhD (International Diabetes Center, Minneapolis, MN), Linda Siminerio, PhD (University of Pittsburgh, Pittsburgh, PA), Melinda Maryniuk, RD, CDE (Joslin Diabetes Center, Boston MA), Joan Bardsley, MBA, RN, CDE (MedStar Health Research Institute, Hyattsville, MD)

In this presentation, the speakers provided background on the new ADA Diabetes Self-Management Education and Support (DSME/S) position statement, discussed the value of diabetes education, and described the education referral algorithm. Dr. Margaret Powers (International Diabetes Center, Minneapolis, MN) kicked off the session by showing the dismally low referral rates to diabetes educators, with only 6.8% of commercially insured individuals and 4% of Medicare participants newly diagnosed with type 2 diabetes referred to a diabetes educator within 12 months of diagnosis. Dr. Linda Siminerio then presented evidence from the DAWN study showing that there is a global gap between psychosocial support and support from the care system for people with diabetes and that access to DSME/S is effective in improving outcomes and is cost-saving. Ms. Melinda Maryniuk highlighted the critical times for education: new diagnosis of type 2 diabetes, annually, when complicating factors arise, and transitions. Ms. Joan Bardsley wrapped up the session with an overview of the DSME/S algorithm. She noted that one of the key takeaways from the process of developing the position statement was that physicians understood the need for diabetes education but were not sure what steps to take, so there was a need to create something simple that was easy to follow. The resulting algorithm provides evidence on the value of diabetes education, aligns the time for referral with critical times in a patient’s progression through diabetes, provides objective criteria for when to refer, and explains what to expect from a referral. We are glad to see this increased attention from the ADA to the far too often underappreciated role of diabetes educators in helping patients manage their disease – we can only hope that the next step will be improved reimbursement for their services.

Taking Diabetes to College: Tools at your Fingertips

Christina Roth, BA (College Diabetes Network, Boston, MA) and Tricia Rousseau, BA (College Diabetes Network, Boston, MA)

Christina Roth, Chief Executive Officer and Founder of CDN, and Ms. Tricia Rousseau, CDN student and 2015 CDN Summer Intern, discussed the various ways in which the College Diabetes Network (CDN) uses commonly available resources to support students starting and during college. These resources form what Ms. Roth referred to as an “ecosystem of tools” that can support young adults making the transition to a different kind of life. She walked the audience through the four primary ways CDN interacts with students: (i) in clinic; (ii) online; (iii) via CDN student membership; and (iv) through off campus events. She also outlined the numerous benefits of joining CDN, pointing out the benefits of peer support and an extensive job/internship/recruiting network. Ultimately, both speakers encouraged educators to point students CDN’s way and we were pleasantly surprised to see how much interest attendees showed. CDN’s chapter network encompasses over 85 campus based chapters throughout the United States, with the number of students per chapter ranging from 2-3 to over 50- with most averaging 12-18 students each. 

Questions and Answers

Q: For parents to participate, do their children need to be in network?

A: No. We wanted to provide a platform through which parents of college students can connect and support one another- particularly those whose students’ may not be at a time in their life where they want to reach out and connect with others. Resources for parents include:

• Online information
• Monthly Parent E-News to registered “CDN Parents”
• Facebook group for CDN Parents where parents can connect, support one another, and communicate directly with CDN staff.

Q: Are students concerned about their privacy with regards to parents?

A: No personal information is provided about anyone in the network unless the student gives staff explicit permission to release it, or provide it themselves upon introductions facilitated by CDN staff.

Q: How long does it take to get the program established on various campuses?

A: It completely depends on the campus – it can take anywhere from days to more than a year.

Q: What can doctors tell patients who are excited about their independence at college to help encourage them to join CDN?

A: Clinics and providers can contact CDN staff and receive free packets of CDN brochures and handouts which can be given to patients and their families. CDN encourages providers to use these materials, with the simply suggestion to reach out to CDN and register as a student with the network. Unfortunately, for many young adults, suggestions made by parents and providers can have the opposite effect so simply “planting the seed” is often the best course of action. 

Q: Do you have any data regarding whether the students that join the networks are more active in managing their condition?

A: We believe this to be the case, and have seen many students that join CDN show improvement as a result of the support of the program and their peers.

For more information on the College Diabetes Network (CDN) or its programs, visit their website or email them directly.

A Systematic Review of the Literature of the Effect of DSME on HbA1c for People with Type 2 Diabetes

Dawn Sherr, MS, RD, CDE, LDN (AADE, Chicago, IL) and Joan Bardsley, MBA, BSN, RN, CDE (MedStar Health Research Institute, Hyattsville, MD)

Ms. Dawn Sherr and Ms. Joan Bardsley provided a comprehensive overview of literature demonstrating the value of diabetes self-management education (DSME) in people with type 2 diabetes. The lecture stressed the number of studies that have shown an association between DSME and “clinically meaningful” reductions in A1c. Broadly, both speakers stressed that a team approach to DSME is more effective than individual care and that the ten-hour cutoff currently used by Medicare is not enough time for a program to be effective. We absolutely agree and applaud both Ms. Sherr and Ms. Bardsley for raising the level of conversation on this front. DSME is widely underappreciated – both among patients and providers – and we believe there is a real role for educators to play a role in more effective care. That said, this is not a new view, and we’d love to better understand the barriers and how AADE and other health professional organizations could address this in a more concrete way.  

Questions and Answers

Q: Diabetes educators are not listed in insurance coverage, so patients often do not know what to look for. What can be done about this?

A: This is a huge problem. At the moment, we are looking into partnerships with internal medicine groups and working on strategies to get referrals to diabetes educators.

Q: It is concerning to me that being a “certified diabetes educator” doesn’t “mean” something in the healthcare community.

A: We are working very hard with the CDE to get licensing in place.

Research Session

The CDE-Ambassador: A Novel Approach to Control Diabetes at the Primary Care Level Leads to Significant Improvement in GLycemic Control and Cardiovascular Risk Factors

Paresh Dandona, MD (University of Buffalo, Buffalo, NY)

Dr. Paresh Dandona presented positive results of a year-long retrospective study that examined glycemic control in patients in a primary care practice that integrated a certified diabetes educator ambassador (CDE-A). In the study, participants in the intervention group (n=100) were referred to the CDE-A by the internist over the course of the trial while the control group (n=45) was not referred to the CDE-A. Throughout the entire study, the overseeing endocrinologist (Dr. Dandona himself) did not see the patients while the CDE-A was mostly autonomous after an initial three-month training period and typically met with each of the participants twice during the study period. After six months, the intervention group saw a mean weight loss of 2.8 kg (6.2 lbs) (p<0.0001), a BMI reduction of 0.96 kg/m² (p<0.0001), and an impressive A1c reduction of 1.6% (p<0.0001). Systolic and diastolic blood pressure, LDL levels, and triglyceride levels also fell significantly (p=0.0004 to p=0.003). Dr. Dandona pointed out that no diabetes drug can claim that level of A1c reduction efficacy and that the development costs of new drugs can reach a billion dollars while the integration of a CDE-A would only cost a tiny fraction of that. While we’re certainly impressed by these results, we’re less sure about their reproducibility – clearly such amazing results involve an extremely effective, well-trained CDE who may not represent the average educator’s skillsets and tools. Indeed, Dr. Dandona mentioned that in his review of the literature on CDE interventions, the range of A1c improvement was generally 0.2%-0.5%. Notably, Dr. Dandona presented recent one-year follow-up data showing that the weight loss and BMI reductions were sustained but A1c had risen 0.5%, as he thus stressed that periodic reinforcement of diabetes education through cyclical visits may be most effective for long-term positive outcomes. Overall, although a small study, we found these results very strong, reminding us of the power of what a good diabetes education can do and the need to conduct further research on what does and does not make up an effective diabetes education implementation.

• Results in the subgroup of participants who had their diabetic regimen modified based on the CDE-A’s recommendations were even more impressive. Of the 100 patients within the intervention group, 52 participants had their regimen modified while 48 remained unchanged. The 52 participants with modified regimens were compared to 17 control participants whose regimens were also modified during the course of the study. The modified intervention group had a mean weight loss of 3.7 kg (8.2 lbs) (p<0.0001), a BMI reduction of 1.3 kg/m² (p<0.0001), and an even more impressive A1c reduction of 1.9% (p<0.0001) (compared to the modified control group’s mean A1c reduction of 0.4%).
• However, participants whose diabetic regimens were not modified continued to experience significant improvements in weight and A1c, as Dr. Dandona asserted that there is a clear regimen-independent benefit to CDE involvement. Specifically, in intervention participants whose regimens remained the same, mean weight loss was 1.9 kg (4.2 lbs) (p<0.001), mean BMI reduction was 0.6 kg/m² (p<0.002), and mean A1c reduction was 1.1% (p<0.001)..

Q: When you say the diabetes educator was under the guidance of an endocrinologist, what was guidance? Were they part of a team they learned from?

A: The guidance is simply this: first of all, the educator worked with us for a couple of months and got to know our clinical reflexes. Afterwards, she did it entirely on her own. From time to time, she would come to me to get approval for what she was going to do that was novel.

Q: Were there any newly diagnosed patients in your study and what type of people did you use in terms of income level?

A: There was a spectrum of diagnosis times and socioeconomic levels and insurance types.

Q: What kind of mechanisms do you use to get compliance?

A: She had a hammer and she would hit them over the head. [Laughter] No, as most of us know, it’s human persuasion. You’ve got to have authority and a tactical fashion so you can reach the whole spectrum of people.

Q: We’re employing CDEs in partnership with staff to achieve significant reductions in A1c. The primary care staff has partnered with us more than with endo. We’ve been fortunate to be using EMR to partner with the primary care providers and the patients. We’ve seen in the first two months a significant reduction in A1c in newly diagnosed patients. We were able to employ a bootcamp for primary care staff to learn the basics of diabetes care. Can you tell us about what knowledge deficits you saw in the primary care staff compared to the endo staff?

A: If I were to diagnose this issue in one word, it’s a lack of commitment. Once you’re committed, you do things. Right now, there’s a massive inertia. We don’t like to use term “non-compliance” – non-compliance is a term that is banned in my unit. [Applause]. If someone is non-compliant, maybe your advice was not worth complying to. You’ve got to make your advice worthwhile, you have to find the right partners to work with. I’m impressed by your results; that’s spectacular in the first two months and the primary care providers should respect that. I started the center in 1995, when I was the only attending. Now there are four. Since 1997, we’ve not had a single case of chronic diabetic foot, gangrene, or amputation. Since 2001, we have not had a case of end-stage renal failure. People ask what is the magic – there is no magic. We all have the same drugs and intelligence. It’s just commitment, the commitment to get things done.

Pre-conference Events

Building your Diabetes Education Program: Everything You Need to Know and More

Leslie Kolb, RN, BSN, MBA (AADE, Chicago, IL), Dawn Sherr, MS, RD, CDE, LDN (AADE, Chicago, IL), Patty Telgener, RN, MBA (Emerson Consultants, Excelsior, MN)

AADE hosted its half-day annual workshop on “Building Your Diabetes Education Program,” which provided practical guidance on successful design and implementation of diabetes education practices. The workshop opened with Ms. Leslie Kolb’s overview of the National Standards for Diabetes Self-Management in order to help educators navigate certification processes, stressing that ADA and AADE have similar standards and requirements. Other presentations touched on a wide range of issues, which included support on program cost and requirements, strategies to facilitate behavior change, documentation processes of running a program, and more. Similar to past years, this pre-conference event was very hands-on and practical, as educators frequently worked with each other on case studies and worksheets throughout the workshop.

Improving Outcomes for Women with Type 2 Diabetes: Individualizing Evidence-Based Care

Eileen Egan, CDE (Stony Brook University, Stony Brook, NY)

In an “Interactive Professor” session in the registration lobby, attendees could sit in on a recurring presentation video by Ms. Eileen Egan on how to individualize care for women with type 2 diabetes. Ms. Egan stressed the higher cardiovascular risks in women with type 2 diabetes compared to men as well as women’s higher prevalence of abdominal obesity and anxiety and depression. Walking through a case study, she reviewed various therapies in women vs. men, stressing women’s higher rates of adverse events with metformin and higher rates of hypoglycemia and bone fracture with TZDs. Interestingly, the video pointed to recent data that suggested that saxagliptin was associated with greater A1c reductions in older women (≥45 years old) vs. younger women while SGLT-2 inhibitors were suggested to have greater efficacy in younger women vs. older women.

Exhibit Hall

Abbott

We were pleased to see Abbott’s presence at the exhibit hall after the company’s absence at ADA. Located at toward the middle of the hall, Abbott’s booth featured its signature yellow panels and large, bright yellow circular banners reaching toward the ceiling. The center of the booth was taken up by a large bar, allowing attendees to refresh themselves with a drink and rest their legs. Abbott’s FreeStyle line of products were the focus of the booth – representatives highlighted Abbott’s FreeStyle Promise program that provides patients with “instant savings” on tests strips (as low as a $15 test strip co-pay per month) regardless of whether they are on formulary. As has been characteristic of recent US conference, reps were unable to comment on FreeStyle Libre. We learned at the company’s 2Q15 call that Abbott has submitted its FreeStyle Libre Pro system (retrospective, blinded) for regulatory approval in the US; launch is expected in approximately one year. There is still no US timing on the consumer version that is currently available in Europe, Israel, and many other places in the world.

AZ

The bulk of AZ’s booth was occupied by a very hip food truck (first introduced last spring – the truck was also at ADA) advertising the company’s Fit2Me diabetes support program. By comparison, there was less space devoted to its specific products, though Byetta (twice daily exenatide – said to be making a comeback), Bydureon (once weekly exenatide), and Farxiga (dapagliflozin) each had its own dedicated panel. The company also posted its smaller booth across the hall advertising “The Battling A1c Challenge,” a tough pop quiz on diabetes pathophysiology.

Bayer

Bayer returned to the exhibit hall after choosing not to put forth a booth at ADA. Tucked toward the middle of the hall, Bayer sported a good-sized exhibit, decked out in the company’s striking blue and white motif. Stations set against shimmering white curtains advertised the Contour Next system with a focus on the meter’s impressive accuracy – this is typical of Bayer booths! We tried to glean new insights on the upcoming pipeline or the divestiture to Panasonic, though reps were understandably tight-lipped (good on them!). As a reminder, Bayer sold its Diabetes Care business to Panasonic for ~€1.0 billion (~$1.2 billion) in June, and the closing of the transaction is still expected in 1Q16. Nevertheless, reps did guide us toward a wonderful Greek yogurt bar at the center of the booth (which we would highly recommend!).

BD

We spotted BD’s distinctive orange and blue colorway from across the exhibit hall. We were pleasantly surprised to see promotional material for the new infusion set, though no samples were on hand. Availability is still slated for 2016, consistent with the latest timing update from the Medtronic partnership announced at ADA. Posters highlighted the set’s FlowSmart technology (allowing insulin to flow out of the bottom and side of the catheter) and shared studies from ADA and ATTD on silent occlusion. Per usual, BD’s “Lipo Larry” dummy was spread out on an examination table, inviting attendees to feel the lipohypertrophy on Larry.

Dexcom

Dexcom’s modest booth focused on the new Dexcom G4 Platinum Share Receiver and paired iPhone and Apple Watch apps. Glass cases showed the technology up close (both Android and Apple versions), while reps explained the laudable problem that Dexcom hopes to solve – in a word, “integration.” Notably, there was no mention of Gen 5 in the booth, which is currently at the FDA. However, the booth did feature a new-to-us video of new Dexcom spokesperson Nick Jonas ... which was getting MORE than a few glances from curious booth-goers.

Diabetes Hands Foundation

The DHF booth was tucked away toward the side of the exhibit hall, though that did not stop many from finding the chest-high display table and checking out the full-length poster that explained the mission of the foundation. Representatives had their hands full fielding questions from visitors, but still took the time to welcome us along with our friends from diaTribe – indeed, the booth actually promoted diaTribe by directing educators to check out the “helpful” resources!

Insulet

Toward the rear of the hall, Insulet sported its classic white paneled booth with blue and green accents. The new touchscreen, Bluetooth-enabled PDM was disappointingly not on display. [We asked and it wasn’t even “hidden” like at ADA.] Notably, the representative we spoke with said that the plan is to file a 510(k) clearance “in 2016” – which would represent a delay relative to the most recent timeline for a filing by the end of this year – though we believe he misspoke or perhaps was referring to when Insulet expects launch. Indeed, the company confirmed this end of year guidance in its 2Q15 update last week (though did postpone its conference call.) As we understand it, the call remains unscheduled.

International Diabetes Center

The Center’s primary goal for AADE 2015 was to promote new educational materials for type 2 diabetes educators. This year’s booth, while relatively small, provided an impressive array of literature produced by the organization including books, informational pamphlets, and much more.

J&J/Animas

While Invokana was the focus of J&J’s exhibit, Animas still had a substantial presence in the far corner. Educators who stopped by the booth could receive stuffed foxes [We think they were foxes … the booth was too packed for us to get close enough to tell!] intended to aid in infusion set insertion demonstrations for the Animas Vibe insulin pump (it’s an educational tool). Of course, the integration with Dexcom’s G4 Platinum CGM was the main focus of the Animas side. Judging from the crowds, the marketing message was successful! It was perhaps a bit coincidental that Animas’ booth was just a little ways away from Tandem – given the latter’s coming CGM offering – though there was no verbal mention (or otherwise) of the other in either booth.

J&J/Janssen

J&J’s booth was split fairly evenly between Janssen and LifeScan/Animas sections. The Janssen section appeared to be marketing Invokana (canagliflozin) more as a package deal than an individual drug, with equal attention given to standalone Invokana, Invokamet (canagliflozin/metformin), and the CarePath patient support program. As at other recent conferences, the promotional materials focused heavily on access, advertising Invokana’s >80% commercial and Medicare access. Strong reimbursement has certainly boosted Invokana’s performance of late, as evidenced most recently by the product’s positive performance in 2Q15 relative to its competitors – also driving sales is the first-in-class that Janssen’s product had – as well as the growing popularity of SGLT-2s..

J&J/LifeScan

LifeScan built on its string of strong marketing performance, riding the momentum of ADA 2015 when it was the only one of the Big Four BGM companies that showed! The segment launched a new marketing campaign at ADA – “Every Touch is a step forward” – that aims to capitalize on the common association between “colors and numbers.” As we’ve seen in the OneTouch product line (VerioIQ, VerioSync), the meters have color indicators that accompany glucose readouts - red for hypoglycemia, green for in-range, blue for hyperglycemia – that anecdotally have been popular among patients and providers. The exhibit featured a number of videos and games to further build the association for attendees.

Lilly

Lilly’s booth occupied a substantial amount of real estate near the entrance to the exhibit hall. The Humalog U200 KwikPen was prominently featured, with promotional material emphasizing the flexibility and convenience offered by the pen. Lilly’s new GLP-1 agonist Trulicity (dulaglutide) also occupied a prominent position in the booth, with clinical trial data displayed on a large wall and several demonstration pens available. Representatives emphasized the drug’s non-inferiority vs. Novo Nordisk’s Victoza (liraglutide) in clinical trials and the convenience of the device compared to other once-weekly options. Lilly’s newest product, Glyxambi (empagliflozin/linagliptin), had a perhaps surprisingly understated presence, with a single panel positioned between the displays for SGLT-2 Jardiance (empagliflozin) and DPP-4 inhibitor Tradjenta (linagliptin).

Medtronic

Medtronic’s booth occupied prime real estate in the front corner of the exhibit hall, where the company showed off a new booth design – for the first time, the exhibit was divided into “Type 1,” “Type 2,” and “Connected Care” kiosks. Unfortunately, the redesign did not come with any new pipeline updates, though the latter section did feature a live look at the MiniMed Connect remote monitoring keychain device and paired iPhone/iPod touch app. Launch is still slated for this fall at a price of $199. As a reminder, we first got to demo the device at FFL.

Novo Nordisk

Novo Nordisk’s booth drew attendees in with the promise of delicious handcrafted espresso drinks and donated to AADE for every attendee who allowed their badge to be scanned. The booth itself devoted the bulk of floor space to Victoza (liraglutide), NovoLog (insulin aspart), and Levemir (insulin detemir). Each drug was given a large touchscreen and accompanying company representative who walked attendees through its usage, efficacy data, head-to-head comparison to competitors, and ways to keep up to date on any new information. Notably, Saxenda (liraglutide 3.0 mg) was not mentioned anywhere in the booth, despite Victoza’s screen emphasizing its weight loss efficacy data.

Roche

Like Abbott and Bayer, Roche was back on the exhibit hall floor after its absence from ADA. The company’s signature navy blue paneling arched over the booth (with new light purple accents this year), held up by what appeared to be blue, stick-figure-esque people. As expected, the booth focused on the company’s new Accu-Chek Connect System that not only consists of a BGM paired with a smartphone app but integrates a bolus calculator! We learned that the meter has already hit the shelves in some US Walgreens ahead of schedule; launch was originally scheduled for August 7. Great to hear that Roche hit its timeline here! Notably, Walgreens is integrating the meter into its rewards program, so that patients with the Connect and Walgreens mobile apps can receive Walgreens points (that can be redeemed in store!) for testing their glucose. Big-time kudos for the forward thinking on incentivizing healthy behavior! Of course, this is just the tip of the iceberg in this day and age, but it’s great to see the innovative thinking from both companies! At our end, Kelly, Adam, and Reed (our new development manager at The diaTribe Foundation) are all testing the Connect and expressing delight at various aspects – they’ll have more soon!  

Sanofi

Sanofi’s booth anchored the front left corner of the exhibit hall with its commanding large white booth. The greatest amount of signage, space, and attention was devoted to its new flagship product, Toujeo (insulin glargine U300), while the former flagship Lantus (insulin glargine) held a small corner on the interior of the booth. At the booth, a large cartoon played on the theme that patients may be able to go a whole weekend with only one pen of this concentrated insulin. Toujeo’s ease of use was also a take-home point – the booth provided new dosing calculators to determine dosage based on the patient’s body weight and the 1:1 dose conversion with Lantus and easy dosage pen were highlighted. Afrezza, Sanofi’s inhaled insulin marketed in parternship with Mannkind, also received significant floor space, with an enlarged model of the delivery device and representatives focused on explaining how the device is used. Surprisingly, Sanofi’s booth did not contain any information on its Toujeo and Afrezza COACH programs, but representatives were very enthusiastic about the programs’ ability to encourage patient adherence when asked.

T1D Exchange

The T1D Exchange booth stood to the side of the exhibit hall, featuring an open floor plan that allowed attendees to examine a variety of informational materials being presented. The booth also offered a chance for educators sign up on the database and create accounts with the T1D Exchange.

Tandem

Tandem’s characteristic wood paneled booth showcased the company’s newly approved t:flex, 480-unit pump. A rep confirmed that the device is shipping to patients, as we learned at ADA 2015. There were no new updates on the t:slim, though there is a lot of excitement on this front. Talks with the FDA have apparently been “positive,” and reps sounded optimistic looking to the future.

Type WE

The exhibit hall saw the launch of Type WE, a support program for partners and families of people with diabetes. Sponsored by the Diabetes Empowerment Foundation, led by the great Dr. Nicole Johnson, the program features a free online stress assessment tool and a number of online educational resources targeted towards caregivers. The program is part of the foundation's efforts to lessen the burden of diabetes in everyday life – for everyone touched by diabetes. We certainly applaud this effort to bring greater appreciation to the psychosocial burden of diabetes on caregivers – after all, where would we be without them!?

 

-- by Melissa An, Helen Gao, Varun Iyengar, Sarah Odeh, Emily Regier, and Kelly Close