More than 15,000 scientists, physicians, and other healthcare professionals descended upon Boston for the annual ADA Scientific Sessions this year, the 75th anniversary of this gi-normous conference addressing new research in diabetes care and treatments.
This year’s science-fest featured more than 385 presentations and over 2,300 research posters, including 60 accompanied by “audio tours” attendees can listen to (holy museum visit experience!)
If you’ve never been to the ADA conference, let me just say it never ceases to be overwhelming –- despite perhaps less hullabaloo on the Expo floor than in previous years, when marketing budgets appeared to be no object. In a major conference center spanning several blocks of city space (the meeting alternates between coasts), no less than 8 different tracks take place simultaneously over 5 days. The expansive exhibit hall features hundreds of booths -– from “mega-booth” spreads from the Big Pharma leaders (where fresh cappuccino and frozen yogurt are on tap) to rows and rows of smaller booths featuring non-profits and “peripheral” exhibitors the likes of Colgate and Hawaiian Moon. You can get your A1C tested on-site (if you don’t mind waiting in line behind a bunch of non-D doctors), and you can watch flashy product videos or attend an enthusiastic live tutorial in a “Product Theater” area with a booming mic.
One whole expansive section of the exhibit hall is blocked off for the incredible maze of research posters, displayed on dividers that look like corporate cubby walls. As if all this weren’t enough, there seems to be no end to the pre-program company symposia (breakfast and dinner affairs), after-hours parties, receptions and meetups. For the Diabetes Online Community alone, there were special receptions this year organized by the ADA itself, Medtronic, Johnson & Johnson, Sanofi, Eil Lilly, and Novo Nordisk. Whew! I get worn out just explaining it.
So fitting that ADA hosted a Walking Challenge in which attendees could wear a tracking device (in red, of course) on the wrist to monitor how many steps they were taking. Mike managed to log more than 36,000 steps or the equivalent of 17+ miles over just four days!
We'll bring you our views of the "science" behind the Scientific Sessions later this week. As always, we like to focus first on what was new and exciting on the product / innovation front this year.
Medtronic had a landmark weekend with four news announcements, catapulting the insulin pump and CGM company into the spotlight.
On Friday, the company announced that it had gained FDA approval in mid-May of what it calls Minimed Connect, a new data-sharing system for its combo insulin pump and CGM. To use it, you need a small Uploader device that can be carried in the pocket or on a keychain (that black doohicky pictured between the pump and iPhone), which transmits real-time data from a Paradigm Revel or 530G pump with Enlite CGM sensor to the Minimed CareLink system online. This is facilitated through a smartphone app (currently only available for iPhone, but Android is coming soon) that also delivers preset text messages to loved ones or parents for Highs or Lows. (Here's the FDA documentation, btw).
We got to handle the lightweight uploader in the company's booth, and Mike (a Medtronic pumper) says he could definitely see himself easily clipping it to his keys.
The Uploader will cost $199 and be available starting in the Fall, with pre-ordering starting in July, says Medtronic spokeswoman Amanda Sheldon.
Tied in with that, Medtronic announced that it is partnering with both Samsung and Glooko. What this means is that the system will soon beam data directly to Samsung smartwatches (using a Linux-based Tizen OS). We have to admit the UI on that watch, with its curved face, does look pretty sweet! And soon Medtronic users will be able to view and share their data on the Glooko platform, which is huge -- especiallly for those who like the Medtronic devices but aren't fans of their proprietary software system, CareLink.
In (almost) bigger news, Medtronic announced that it is launching the first pivotal trial for its hybrid closed loop sytem (also referred to as the 670G), which is a pre-Artificial Pancreas that still requires some user intervention (i.e. not completely automated). This is BIG because it is the first-ever "pivotal trial" of closed loop technology conducted in the U.S. In reasearch, a "pivotal" trial is the final one providing evidence that a drug or device is ready for market. With this, Medtronic is paving the way for commercialization of an AP system soon!
The first patient has now been enrolled in that trial, which will recruit up to 150 people ages 14-75 from nine regions in the U.S. and one in Europe. The study will run through May 2016, and hopefully by the end of next year we'll see a filing with the FDA! More details on the trial can be found at ClinicalTrials.gov (identifier: NCT01857973).
Of course, before the closed loop hybrid makes its way to market, we hope to see U.S. availabilty of the Minimed 640G, with its predictive glucose suspend feature and (finally) a new, more smartphone-ish design. It was launched outside the U.S. earlier this year, and the clinical trial needed for FDA review is underway.
And that's not all. The company also announced a partnership with BD (Becton Dickinson) to bring patients the new FlowSmart infusion set that will have a teensy catheter with extra side port designed to improve insulin delivery and help prevent undetected occulusions. Interestingly, BD is the leading player in injection devices and needles but they've never before made an infusion set. The FlowSmart set announced last month will now be used in Medtronic pumps (and eventually closed loop systems) beginning in late 2017 or early 2018.
Props to Medtronic for a lot of exciting developments!
Insulet / OmniPod
This happens to be the 10-year anniversary for Insulet and the Pod, so the Boston-area company splurged on two Exhibit Hall booths -- one showing off its history (40 million Pods made to date!) and showcasing their data-sharing partnerships with Glooko and Tidepool, and the other a straight-up product display showing off the current product and previewing their next-gen PDM.
(Ironically, Tandem Diabetes’ booth was sandwiched between the two Insulet booths. Wow, who organized that, we wonder…?)
Regarding the new PDM, it looks pretty awesome; the design is so iPhone-ish, in fact, that you may get it mixed up with the real thing. The big changes are:
- color touchscreen with super-easy swipe navigation
- a home screen that is “action-oriented” with just three main command bars
- IOB (insulin on board) displayed on the lock screen
- contains the carb database from Calorie King, with tons of info on common packaged and restaurant foods
- allows 0% temp basal periods (which they say is big for pediatric use)
- there’s even an illustration of a body on the PDM with markings to help you track your infusion sites, for good rotation
- it’s Bluetooth LE-enabled, allowing data sharing with the Dexcom and software and app partners
But, to keep the form factor slim, they’ve changed over to a lithium battery, so the new PDM will need to be plugged in (with a mini USB cable) and recharged every 4-5 days.
Yes, it will work with the existing pods, so no need to change out those supplies. But it wil be changing over to FreeStyle Lite test strips. Insulet execs tell us they plan to submit this new PDM for FDA review by the end of December 2015.
We also happened to overhear a conversation between one Insulet exec and a group of pediatric endos about the need for a "Find Your PDM" feature similar to those used to find your iPhone or car keys if you misplace them. Would that not be a great feature for the new PDM?! We hope they go for it.
In its booth, Dexcom was proudly touting its SHARE system with giant iPhones, smartwatches and G4 receivers displayed. The chatter was of course about how Dexcom submitted its direct-to-smartphone G5 system to FDA earlier in the year and is awaiting approval.
Just days before the conference, Dexcom had two exciting announcements: it has gained initial approval on an Android app for CGM data-sharing, and it has signed an agreement with closed loop startup Bigfoot Biomedical, allowing CGM data-sharing to be weaved into their future Artificial Pancreas system. This came just a week after Bigfoot acquired all the assets and design patents of the now-defunct Asante Snap pump.
On Friday at our DiabetesMine D-Data ExChange event, we also learned from Bigfoot CEO Jeffrey Brewer (a D-Dad and former JDRF leader) that the powerhouse startup is moving to Silicon Valley. That means the company will have access to the 45,000 square foot former home of Asante, as well as its manufacturing facilities.
Although this big sign greeted attendees at the main entrance to the Exhibit hall, there wasn’t as much buzz about Sanofi’s Afrezza as you might expect, given that is one of the most exciting new treatment options recently FDA-approved and launched (it’s the first commercially viable non-invasive insulin, for God’s sake!)
Frankly, I was expecting Afrezza to be the drug plastered all over the convention shuttle buses this year, but nope, that seemed to be mostly Invokana again, like last year.
Afrezza was covered in a “Product Theater” on Saturday morning. This was a very, dry medical introduction of the drug, that due to regulations had to start with the long laundry list of possible risks and drawbacks. Although the session was a pretty packed house of about 180 doctors I’d guess, it certainly wasn't inspiring by any stretch of the imagination.
And it appears the only other presentation on Afrezza at this entire conference was a corporate-sponsored CME (continuing medical education) symposium held on Sunday evening. I would’ve loved to have been a fly on the wall at that one.
The "low profile" of Afrezza was corroborated by prominent endocrinologist Dr. Irl Hirsch when I bumped into him in the ADA speaker room. We shrugged our shoulders at each other over how Afrezza doesn’t seem to be getting a fair shake (see the LA Times article on same topic, and one analyst who remarks that the distraction of the ADA conference itself may be one reason that Afrezza prescriptions are coming in so slowly – how ironic!) Observers are holding their breaths to see how the upcoming consumer ad campaign affects Afrezza sales, it seems.
When I met with Sanofi execs, I was able to ask them directly, and was told there’ve been three barriers to Afrezza’s success so far:
- Physicians haven’t heard about inhalable insulin for several years (and lingering memories of the Exubera fiasco don’t help)
- The requirement for a pulmonary function test is a deterrent – doctors have to figure out where to refer patients for this, or decided to fork over the roughly $600 to get their own machine
- Reimbursement is a struggle, as Medicare and the other Payors already have one or more preferred rapid-acting insulin products on their formularies, so Afrezza is getting bumped to a lower tier (meaning not covered so much)
Sanofi does plan to begin a consumer advertising campaign towards the end of this year that will focus on digital and print, but no TV ads, according to Andrew Purcell, Head of the Diabetes Business Unit at Sanofi. They’re hoping to “demonstrate success” with the drug first, and also by then, the newly approved 12-unit cartridge will be available too (although personally I’d be more excited about a 2-unit option).
Meanwhile, Sanofi was making a big splash about their new long-acting insulin Toujeo, with a smoother profile and even less incidence of hypoglycemia than their market-leader Lantus. They were presenting a lot of positive data on Toujeo, which comes in a Solostar pen similar to that for Lantus, but tweaked especially for this product to carry 450 units. And the big deal is that they’re rolling out a new coaching program (Toujeo COACH), in which patients get one-on-one training and optional followup calls and emails from a nurse or CDE. Nice! Who doesn’t love a little hand-holding with a new diabetes tool? We heard the company just announced extending this COACH program to Afrezza too -- much-need, and cool! Meanwhile, they assure us they are not abandoning Lantus, for doctors and patients who remain loyal to that drug.
From Around the Exhibit Hall
As we've noticed before, the scope of the Exhibit Hall seemed smaller than in past years. Yet the numbers tell a different story: 136 vendors compared to 120 last year, but 155 the prior year. Conspicuously absent in 2015 were Roche Diabetes and Abbott Diabetes, who presumably determined that exhibiting here is not worth their money anymore.
But we did hear some tidbits about both companies around the conference and even at our own D-Data ExChange on Friday.
Roche: Details aren't fully fleshed out, but we understand that Roche plans to launch a new meter in August that will be the first of its kind in setting a standard for interoperability. Sounds intriguing...
Abbott: Word was that Abbott is "very excited" about its FreeStyle Libre FGM (Flash Glucose Monitoring) system now available overseas, and many believe it won't be long at all before Abbott brings that to the States. Actually, the clinical study just wrapped up this Spring, so the regulatory filing should be just about to happen.
Diabetes App Security: We learned that Dr. David Klonoff, founder of the Diabetes Technology Society, will be spearheading a new Cyber Security Workgroup to look at the safety and security of mobile apps for diabetes. We hear it’s endorsed by CMS, the FDA, and Homeland Security. Wow! More on that soon.
The pump companies were making a big tadoo about pump therapy for type 2s, as apparently more doctors are thinking more about it these days. In case you’re wondering, Medtronic didn’t have any new products on that front; the sign is just marketing.
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Tandem’s new t:flex pump, on the other hand, holds 480 units and IS actually designed for type 2’s who need more insulin. It could also be useful for adolescents who need more insulin due to puberty hormones, we understand, although it’s not yet FDA approved for that.
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This is the truly smart insulin pen being developed by my friends at Companion Medical, now receiving investor money from Eli Lilly. The pen has built-in computer chip smarts that track your dosing just the way an insulin pump does, and you access that info on the companion app via BLE bluetooth. It offers dosing calculations and reminders as well. We'll be having a closer look at it soon.
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My good friend and renowned Joslin endocrinologist Dr. Richard Jackson says this new LDL cholesterol-lowering drug, PCSK9 from Sanofi and Regeneron, “works amazing.” Otherwise known as alirocumab (trade name Praluent), it was just approved by FDA on Tuesday, and the target population is patients who can't tolerate statins, mainly due to side effects.
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This company, San Meditech, had a whole pagoda set up to show off their low-cost, Bluetooth-enabled CGM that's taking off in China. Not yet available in the U.S., it has the potential to be mass produced for cheap, which gives it the makings of disruptive technology that could sweep the market. Only time will tell...
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This brand new device from Nuerometrix called Quell works to reduce the pain of neuropathy, sciatica and other chronic pain through neural pulses. It was recently FDA approved and just beginning to hit the market as an amazing new drug-free option for pain relief. More on this one soon.
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Real People Using Technology
It’s noteworthy that in the many sessions, there appeared to be a LOT more content this year around how to use technology successfully to help patients with their self-care. There were even several sessions that focused on patients’ use and perspectives on both diabetes devices and social media -- which was new territory for the ADA meeting! Among those were a session on Using Technology for Better Outcomes including DOC speaker Kelly Close; a session on Diabetes Devices & Technology – The Patient Experience, including DOC speaker Adam Brown; a session on Novel Technologies for Behavior Change including ePatient researcher Joyce Lee; Deb Greenwood of the AADE speaking on Use of Social Media for Patient Self-Management; and my own session on Leveraging Technology to Improve Diabetes Outcomes (I spoke on why social media community connections matter).
On top of that, this morning cellular-enabled meter company Telcare released a National Diabetes Awareness Index examining the costs and impacts of diabetes and technology options, along with how much the general public and PWDs actually know about these issues. Results show that 52% of Americans say they trust technology, with that number going up slightly to 57% when paired with the expertise of healthcare professionals. Results also show that 65% of people want doctors to incorporate technology into their health plans and 88% want access to real-time data for our D-management (no kidding!). Out of all those polled, people between the ages of 18 and 34 trust technology the most, and 55% of Millennials say they'd trust a health app over their doctor for advice.
As noted, we'll have a separate report coming very soon on some of the science presented at ADA 2015. So stay tuned, D-News fans!