As per usual, the 2016 American Diabetes Association Scientific Sessions conference was... overwhelming. Set in super-humid New Orleans this year and peppered by thunderstorms that soaked hotel-hopping conference-goers, this annual gathering of over 16,000 healthcare professionals featured hundreds of oral presentations, corporate symposia and breakout meetings and thousands of research posters, not to mention the sprawling exhibit hall – this one with a warehouse-style ceiling and golden-hue lighting that gave the whole affair a cozier flare than most.
On Friday, we also hosted the 6th-ever DiabetesMine D-Data ExChange meeting, bringing together roughly 90 influencers at the cutting-edge of diabetes technology. More on that event soon.
Today, we present our annual overview of what sparked our interest on the expo floor, and in the face-to-face meetings we had with a number of companies present, in no particular order:
Trends & Personnel Changes
First off, a couple of trends we noticed:
There were a number of sessions and even a press briefing this year on the topic of “moving beyond A1C” for a stronger focus on patients’ quality of life. Wah-hooo! That was us shouting from the rooftops to see a scientific research spotlight on this absolutely essential predecessor to patients “succeeding” on any drug or treatment.
Along the same lines, a good endo friend of ours noted that this year’s ADA seemed to be “less glucose-centric,” meaning cardiovascular drugs and other non-A1C-focused treatments were more prominent.
A number of the established pharma and medical device companies were proudly touting how they’ve recently hired data and innovation experts to take their digital offerings to the next level. One big discussion back at the 2013 DiabetesMine Innovation Summit was the fact that these medical orgs had no core expertise in software / mobile computing / tech innovation, and to remedy that they ought to start hiring from outside their familiar territory. It’s exciting to see that happening now, with the likes of analytics expert Annika Jimenez as new Senior VP of Data for Dexcom, and award-winning product developer Adrian Chernoff as new Global Head of R&D and Innovation at JnJ Diabetes Care.
We also heard that Bob Ratner will be leaving his post as Chief Medical Officer of ADA after the 2017 ADA conference, taking place in San Diego. He’s been such a progressive thinker and great friend to the patient community – he will be missed!
On a brighter note, D-World veteran Paul Madden has stepped into the newly created ADA role of Director of Type 1 Diabetes (remember, ADA started out as an org solely for HCPs and has been traditionally T2-focused). We love the guy and can’t wait to see where he takes this new gig!
Yes, Afrezza inhaled insulin was in the house at #2016ADA with its own booth. Although the setup was not nearly as large and flashy as last year when they were still partners with Sanofi, a larger-than-life display of the Dreamboat inhaler certainly caught the eye.
We spent some time talking with MannKind Corp. CEO Matt Pfeffer and the company’s energetic new COO Matt Castagna about their ambitious plans for a (re)launch later this summer. They weren’t ready to disclose full details, but indicated they mean to go big once they have diabetes educators and their sales force trained and ready to call on customers.
Later at an evening reception, it was touching to see and hear the emotion in Pfeffer’s voice when he talked about his friendship with the late Al Mann, and how he promised the Afrezza inventor that he (Pfeffer) would give his all to help this revolutionary new drug to succeed.
More news on Afrezza to come soon. And if desired, read background on the whole inhaled insulin saga here.
Abbott Libre’s Pro Bro
The Abbott Diabetes Care booth was featuring their unique new Libre Flash glucose monitoring system that’s not yet available in the U.S. – albeit the “Pro” version for healthcare providers because that’s the one now pending PMA status with the FDA, so set to be launched first.
Libre is of course the “hybrid” system that consists of a little round sensor worn on the skin, and a handheld receiver that you just wave over the sensor to wirelessly pick up glucose data.
Anxiously awaited in the U.S., it’s been available in Europe since Fall 2014, and the company just launched both a smartphone app (developed by AirStrip Technologies) and compatibility with the Diasend platform for data-sharing capabilities with selected insulin pumps, blood glucose meters and activity trackers.
But in the ADA booth, all you could see was the Pro version of Libre, which we’re told is the same as the patient model, except the receiver is white instead of black and the screen is configured to show different info that’s more tailored to physicians’ needs. This version is “blinded” to patients, meaning only the provider can see the data. In fact, we’re told doctors can use one reader to connect with multiple sensors, to keep track of multiple patients simultaneously. We always prickle at the idea of blinded CGM, but apparently it’s a very useful tool for doctors to get real (not self-reported) data, especially from type 2 patients who may not take many fingerstick tests daily. This competes with Medtronic’s iPro professional CGM system.
btw, the Libre sensor is quarter-sized, and it can store up to 14 days data collected in 15-minute increments. It is approved only for wear on the back of the arm. Overseas PWDs who’ve reviewed it so far seem highly enthusiastic. Oh, and yes, the #WeAreNotWaiting hacking community has already gotten ahold of it, and published instructions for uploading Libre data to Nightscout.
Abbott was also showing off this "Know Your Sugar" campaign, made entirely out of sugar cubes, which certainly stopped most conference attendees in their tracks:
IBM Watson and Diabetes
This computing powerhouse made a big appearance at ADA, now partnering with various diabetes companies including JnJ, Medtronic, and Novo. Announced at the Scientific Sessions was a new partnership with the ADA to help build cognitive apps for doctors, researchers and patients – for which the two orgs have been analyzing 300,000 patient records to model outcomes so they can best help doctors and patients better manage D.
Also announced at ADA was an integration of IBM Watson tech with the Israeli-based startup HelpAround app, which connects PWDs locally to share emotional support or needed D-supplies or device help. IBM Watson will help analyze PWDs’ questions and requests in real-time, “assessing sentiment and tone and helping to identify frustrations, dissatisfaction and expressions of urgency.”
As to the Medtronic partnership announced in April 2015, the IBM Watson app expected later this summer now has a name: SugarWise! Remember that in January 2016 the two companies revealed Watson’s cognitive computing brain could predict hypo and hyperglycemia events up to three hours ahead. The new app will also offer coaching and guidance to PWDs to help avoid those events.
Medtronic's Artificial Pancreas Path
Our community’s largest pump-CGM manufacturer was all-abuzz about its latest science news: the pivotal trial data on its hybrid closed loop 670G. Medtronic plans to submit literally thousands of pages of documentation to the FDA soon, possibly by the end of this month. The hope is for FDA approval and commercialization next year – huge that it will be coming to the U.S. before anywhere else in the world!
The company is also developing a stand-alone CGM not connected to its insulin pumps – something we used to have in the Guardian but hasn’t been available since that product was pulled from market.
This future product, using the company's 4th generation sensor and transmitter, has actually been in the works for some time now, under the initial name Guardian Mobile. They were displaying it under glass, with a smartphone app that displays mmol-converted glucose readings for use in both Europe and America.
We’re told there will be two transmitter options going forward – one that talks to any sensor-augmented insulin pump and CGM device (!), and a different one if you only have the stand-alone CGM.
Say goodbye to the Enlite name. We hear MedT will call its future 5th generation sensor the Harmony and the pivotal trial will launch in the first half of 2017. Data presented on a poster offered a glimpse:
- 10-day wear time with a single calibration per day
- Bluetooth Low Energy integrated (removing the need for the separate receiver device like with the current keyfob-style Minimed Connect)
- Uses what’s dubbed “Fusion” tech in its proprietary algorithm allowing for better accuracy than with a single working electrode as currently exists
- Will have an improved adhesive backing to keep the sensor securely in place (replacing the current partial adhesive that leaves the seashell-shaped transmitter flopping)
- Redundant sensing ability to improve accuracy, reliability and product lifetime
- More intelligent diagnostics allowing for the sensor to better detect faults in CGM data
- Smartphone display with customizable alerts (TBD on whether iOS and Android at same time)
Insulet OmniPod Updates
Insulet of course has a new PDM (handheld controller) for its OmniPod tubeless pump system coming out soon. A prototype was on display again this year.
They were debuting their new logo (reminiscent of a Kodak slide carousel?) and new branding, along with new patient support resources, including:
- A Podder Community platform, including new presence on Facebook (myomnipod) and Twitter (@myomnipod)
- Initial release of their mobile app, featuring educational content and product reorder capabilities
The company is currently focusing heavily on outcomes studies, to provide the ammunition needed for CMS to eventually cover the OmniPod and private insurers to continue doing so. At ADA, they presented retrospective analyses of their patients with T1 and T2 diabetes showing positive outcomes.
They also presented some data on their new Artificial Pancreas algorithm, licensed from Mode AGC in February. Their AP system is currently in a feasibility study using the algorithm and a next-gen Omnipod prototype, and they expect to start on-body trials for the system later this year.
Dexcom too noted that a huge focus right now is payment/cost issues, where outcomes data is key, as CMS won’t pay for an “adjunctive” sensor that’s for safety (backup checks) only. The company is pushing to obtain “non-adjunctive” classification at an FDA meeting in July.
In terms of the highly anticipated Dexcom Gen6, CEO Kevin Sayer says the FDA was impressed enough with their new 505 software and system accuracy that they encouraged Dexcom to submit this next-gen system soon, earlier than the company had planned.
Gen6 will be labelled for 10-day wear versus 7 days, and needs just one calibration per day. It will also block interference from acetaminophen – a big step forward in CGM tech. A new insertion system with thinner transmitter is part of the package too. A Gen6 patient study will kick off this summer, we’re told.
Mid-year, the company will file with FDA for approval a new phone app – basically an upgrade with some bug fixes – and their new, improved transmitter firmware to support an Android app.
And about that Google Verily partnership to develop future systems? The two companies are creating a new circular CGM sensor that will be “much smaller than Libre with a single-button-push insertion device,” we’re told. Wow!
By 2018, they expect to be launching that new product, initially for T2 patients with a disposable 14-day wear transmitter, paired with a different app, “more geared toward interim use, by the HCP or on your own,” Sayer tells us. He adds that a second-generation Google device may be out by 2020, “when we’ll merge our R&D with Google.” Wow x2!
Finally, they are working on upgrade programs made easy by being software-only. In the interim, shorter transmitter life (like 3 months with the G5) “allows easy fast upgrades since the improvements are built into that piece.”
JnJ OneTouch Via - “Don’t Call It a Patch
JnJ is quite excited about the impending early 2017 launch of the new OneTouch Via, which is actually not so new after all. It’s a slightly updated version of Calibra Medical’s early patch pump design Finesse, finally surfacing now after the company was acquired by JnJ in 2012. The product is aimed at type 2’s and type 1’s using injections at mealtimes.
JnJ insists this product constitutes a new category of “On-Demand Insulin Delivery” products, differentiated from “patch pumps” because those continuously deliver insulin (basal therapy), and are competing against full-featured pumps that are categorized for insurance purposes as durable medical equipment (DME).
Actually, Calibra never used the term “pump” either, because this extremely flat-profile skin-colored patch-ish thing delivers bolus doses only, simply by squeezing together the two buttons on its sides -- which can be done right through clothing. Miraculously, it contains a 200-unit insulin reservoir (how do they get all that insulin in?). Right now, each squeeze delivers a two-unit dose. They plan to add other dosing unit options in the future.
I was confused that the JnJ folks I spoke with about Via insisted it’s the first device of this kind, with virtually no competitors, when the existing Valeritas V-Go is referred to as a "disposable insulin delivery device.” That small patch one-day wear device holds one day's worth of fast-acting insulin, and does also deliver basal insulin at one of three fixed flat basal rates (20, 30, or 40 units). But otherwise it works the same as Via, with a button deliver two units per press to help cover meals.
Anyhoo, new OneTouch Via data unveiled at an ADA poster session on Saturday showed that both type 1 and type 2 PWDs using the product reported they missed fewer doses and felt less stress about dosing compared to shots, and that “physicians were more likely to recommend the… device to patients who are not at A1C goals or who are new to rapid-acting insulin therapy.”
Specifics of initial FDA classification of the OneTouch Via can be viewed here. The company plans to submit for final FDA approval in late 2016.
The other thing JnJ’s excited about is their aforementioned new hire Adrian Chernoff, an innovation guru whose show-stopping past credits include pioneering electric transportation tech now used by Tesla, designing robots to upgrade NASA’s medical service offerings, and being a lead “imagineer” designing rides for Disney parks.
He’s not at liberty to discuss the details of his big plans at JnJ yet, but simply says with confidence: “We’ll be first to do disruption in digital.”
U-Strip: A Weirder Insulin Patch
In yet another déjà vu experience, we couldn’t help doing a double-take at the funky-looking non-invasive insulin patch called U-Strip on display at ADA yet again.
First unveiled at ADA in 2012 by Pennsylvania-based Transdermal Specialties, the company is not giving up on this stick-on patch that delivers insulin through the skin using ultrasonic waves. Those waves apparently expand the pores, allowing the insulin to seep through the skin and into the blood stream. It’s designed for three-day wear and can deliver up to 8 units per hour.
They’ll be launching Phase 3 clinical trials shortly in the U.S., Korea, and Japan, we’re told… which should be exciting. But honestly, despite its no-needles advantage, we have very little faith that this product will take off, because:
- the patch is REALLY large, compared to the footprint of current patch pumps and sensors
- they’re apparently working to connect it to smartphones, but right now you need a separate controller device that is itself the size of a large-model smartphone
- the patch is currently WIRED to the controller. Yes, like a tubed pump. Huh?
And if that weren’t enough to make you suspicious the company doesn’t understand life-design considerations, they were showing off big colorful posters of this supposedly cool armband they’re making so you can wear the (big chunky) controller on your arm. Facing outwards, where you cannot see or reach the screen. Because… why??
Sanofi Goes for Gold
Sanofi Diabetes was out en force, presenting over 70 abstracts at ADA this year (!)
When we spoke with their leadership, they were proudly touting that for the fifth year in a row, the company sponsored a Community Hospitality Workers Program that offers diabetes education and screening to the thousands of locals who help host ADA attendees, along with a Primary Doctor’s Care Education program, bringing in local physicians to learn from all the expert endocrinologists in town.
In terms of drug pipeline, they were excited about the recent FDA 12-2 vote in favor of their new T2 injectable drug, a combo of basal insulin glargine and GLP-1 receptor agonist lixisenatide. Positive Phase 3 study results were unveiled at ADA.
Their new long-acting basal insulin Toujeo just hit the one-million prescription mark in the U.S. A higher concentration insulin with smooth curve of action, Toujeo comes in injection pen only, and execs tell us that the Coach program they’ve launched with this drug has helped drive acceptance. Sanofi states that 90% of the 5,900 endos in the U.S. they've targeeted for diabetes treatment have prescribed Toujeo vs. competing therapies, and over 28% of patients are enrolled in the Coach program.
Two studies presented at ADA showed positive results in patients using Toujeo, which Sanofi execs attribute to the fact that “when patients switch from Lantus, they’re not fearing hypos so much, so are not afraid to be a little more aggressive in their dosing.”
Interestingly, in the study that pitted Toujeo directly against Lantus in T1D patients – all using CGM – the end point was time in range rather than A1C. Bravo!
“Lantus has been the Gold Standard in diabetes care. We want Toujeo to move to become the new Gold Standard,” says Andrew Purcell, head of Sanofi’s diabetes business unit.
A pediatric study for Toujeo is being organized as well.
Ascensia Diabetes Rising
Ascensia Diabetes Care is the reincarnation of Bayer Diabetes Care after it was acquired by Panasonic at the start of 2016. Their Contour BG monitoring line is still going strong, and at ADA, the company was busy reintroducing itself with a new logo and bright purple and blue color scheme.
They were distributing a fact sheet about their new(ish) company that included:
- Ascensia will soon have more than 1,400 employees and operations in 38 countries around the world
- Products sold in more than 125 countries and used by approximately 10 million PWDs
- New CEO is Michael Kloss, former Global Head Diabetes Care for Bayer
We got word that the Contour Next ONE meter, coming soon, will be a new, easy-to-use Bluetooth-enabled meter paired with a smartphone app. It will use the existing Contour Next test strips.
Note that Ascensia has an international alliance in place with Medtronic "to work exclusively to develop innovative next generation diabetes management solutions for patients worldwide." They're also paired with consumer electronics giant Panasonic now -- but we couldn't get them to disclose any details of data solutions to come. Darn! The waiting is the hardest part...
In any case, we applaud their commitment to doubling down on entrepreneurship and innovation, and were happy to have them be part of this year's NOLA #DData16 event.
AgaMatrix Jazzes On
In related glucose monitor product news, note that AgaMatrix was showing off its new Jazz Wireless 2 meter, that just got the FDA’s green light at the end of May. This one is particularly aesthetic, as is the companion AgaMatrix Diabetes Manager app.
There was a fair amount of buzz around the Intarcia Therapeutics booth, where reps were demonstrating their new implantable exenatide stick on life-size flesh dummies just realistically enough to make us non-med-school-grads a tad queasy.
This new GLP-1 treatment for type 2s was first shown at ADA last year. The way it works is that instead of daily or weekly injections, patients would simply get a tiny, matchstick-sized pump implanted under their skin that can be replaced after 3, 6 or 9 months, depending the patients' needs. It delivers daily doses of exenatide, the active ingredient in AstraZeneca's Byetta and Bydureon.
The system will be submitted for FDA approval later this year, under the new device brand name Medici Drug Delivery System (the drug, ITCA 650, has yet to be brand-named).
Naturally, this will do wonders for "adherence." Results of the company’s FREEDOM-2 trial presented at ADA were creating a lot of buzz: "After 52 weeks, ITCA 650 continued to produce between glycemic control and more weight loss than sitagliptin (Januvia), a popular therapy for T2 diabetes.”
Hello, Glutalor CGM
It’s a bird, it’s a plane… no, it’s actually the new CGM system called Glutalor iWel, from a Philadelphia-based company by the same name (superhero much?).
This one takes readings every 3 minutes, is designed for seven-day wear, connects to your iPhone or Android smartphone to display readouts and alarms, and sends data to its own Glutalor cloud platform for easy sharing with doctors. It boasts a smaller sensor profile at just ¼-inch vs. the one-inch profile of current products, and the insertion is completed with a simple button-press to the center of the oval.
Their first-generation model is already available in Europe and in use by 25,000 patients, and a newer version with functional improvements is under review, they tell us.
We again got déjà vu checking this one out, till it dawned on us that it looks EXACTLY like the CGM sensor that San Meditech of China was showing off the last two years at ADA (and mysteriously, theirs now looks different…?)
We remembered this was the one with potential to be mass-produced for cheap, giving it the makings of disruptive technology… IF it manages to take off in the U.S. market. The company does expect European CE Mark approval by year’s end and they're in the process of an FDA submission with hopes for approval by mid-2017.
Home A1C Testing, etc.
A1C Now has nine lives, apparently. It’s back!
After being pulled from market twice, this A1C home testing kit was recently acquired by Indianapolis-based PTS Diagnostics, which is marketing it anew through third-party distributors. There’s also an A1C Now+ professional version for fast and easy testing in doctors’ offices.
In addition, the company offers a test kit called CardioChek that allows for “quick, cost-efficient, and user-friendly methods to accurately determine lipid values.” It’s a handheld, battery-powered gadget that looks and works like a glucose meter. The endos on hand in the ADA booth seemed very enthusiastic, as this provides values and measurements using the same technology as clinical labs. CardioChek apparently competes with Colestech – but is more compact, works faster and requires less blood.
Diabetes Drug Notes
The new class of PCSK9 inhibitor drugs is showing some serious promise as a powerful way to treat high cholesterol, it seems.
There were flashy displays by Sanofi on is Praluent drug, and Repatha from Amgen – the latter with a bean bag game for doctors in its booth. This drug is an injection taken every two weeks, and our good friend Dr. Richard Jackson, formerly of Joslin, says this drug class “could be more impactful than statins -- and there are not many alternatives to statins for folks who can’t tolerate them.” These drugs are still new, and more expensive than statins but gaining attention.
Meanwhile, Jardiance, an SGLT-2 (“pee drug”) from Boehringer and Lilly is showing great results not only in lowering A1C, but also reducing cardiovascular events. Dr. Jackson says it’s not yet clear why. According to info in the booth, Jardiance is also showing good results among T1 patients. This was all being celebrated with some sort of Cricket game, it seems.
And we must note that AstraZeneca won our “most wild drug names” award with unpronounceable products titles including Farixya, Onglyza, Xigduo XR and Kobiglyze. Many of these are combo drugs for T2 patients, even if the names seem more geared at partying GenX’ers.
Whew -- a lot going on! Got additional questions about #2016ADA product news? Feel free to comment below or email us.