What an exciting few days here in California at the year's biggest diabetes conference!
Somehow it was just as exhausting as ever attending the ADA's 74th Scientific Sessions in my own backyard of San Francisco -- although despite the roughly 16,000 medical professionals and diabetes insiders converging here as we're told, the City didn't feel as overrun as it often does when ADA descends on other towns. And even the expansive Exhibit Hall was less enormous and quieter, with just about 120 exhibits this year, compared to 155 last year. Noticeably absent from the Expo floor were a few big D-industry players like Abbott Diabetes for the second year in a row, Roche Diabetes, and Bayer. Perhaps a sign of the cost-cutting times with the struggling glucose meter market?
That being said, there was a buzz of excitement in the many meetings, briefings, events and conversations going on around ADA -- especially related to the issues of data and device interoperability that is so close to our hearts. We plan to publish a report on our Friday D-Data ExChange event later this week. Huge thanks to the team at diabetes data startup Tidepool for co-hosting that event!
For now, suffice it to say the the do-it-yourself CGM in the Cloud solution called NightScout blew folks away, and we were privileged to host a sneak preview of Joslin Diabetes Center's new HypoMap tool, developed with Glooko, which was then officially debuted at ADA in a private event Sunday evening. This is an amazing use of app technology to help patients track and learn from their own hypoglycemic events, and share that learning with others to hopefully prevent severe hypos going forward. More on that later this week.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
Snail Uses Insulin to Poison Fish
New study shows these slow-moving creatures use toxic form of insulin to capture prey.
A New Square Patch Insulin Pump
Israeli company developing new reusable square insulin pump that has Bluetooth for smartphone communication.
So what was big coming out of ADA this year, from our POV? Here's a smattering of key news, in no particular order:
New Type 1 Guidelines & A1C Targets for Kids
Yesterday, the ADA made history by releasing its first-ever guidance statement specific to the management of type 1 diabetes, including a new hemoglobin A1C target for children.
The paper, championed by Dr. Anne Peters of USC, also gives evidence about the efficacy and safety of CGM (continuous glucose monitors) as "a useful tool to reduce hemoglobin A1c levels" all type 1 age groups (!) And as if that weren't enough, there is a whole section on recognizing the need for access to these tools by type 1 patients. "People with type 1 require more supplies and must monitor their blood glucose levels more often. This is not a one-size-fits-all disease, and it's important that we recognize that," Dr. Peters states.
(Among other things, this does a lot toward differentiating diabetes types, which we find especially important at ADA Conference time -- when the mainstream media comes out en force to cover diabetes news, and doesn't always understand the topic as well as they could/should.)
So far the most talked-about and reported-on aspect of this type 1 position statement is the ADA changing its position for the first time in almost a decade on recommendations for A1C targets in type 1 children younger than 19, stating they should now strive for an A1C level lower than 7.5%. Their previous recommendations were as high as 8.5% for kids 6 or younger, 8.0% for children 6-12 years old, and 7.5% for adolescents.
ADA is stressing that the original guidelines were set too loosely (i.e. too high) due to fear of hypoglycemia, and that the 2005-enacted guidance was based on the most current science at the time -- including DCCT results, but without access to the huge amount of CGM data we have now. With all of that new science under our belts, ADA now wants to encourage tighter control. During a press conference that Mike attended, the group spearheading the new position emphasized that this new 7.5 target is just that -- a "target." It's meant to be guidance for endos and HCPs to use in crafting and individualizing D-care plans for each child, since you know... YDMV.
In one sense, the new lower target scares us a little, since we've heard of cases where parents get so fixated on achieving a low A1C that they get militant with their diabetic kids. Not good. We adults with type 1 sure know how it feels to be considered failures if we don't maintain an A1C of under 7%. Personally, if my A1C is slightly above that target, but I am NOT having frequent hypoglycemia, I consider myself in good shape.
A New Insulin from Sanofi
Here comes Toujeo -- a new long-acting insulin from Sanofi. With Sanofi's market-leading Lantus insulin due to go off-patent soon, others could begin to replicate it. Toujeo seems to be Sanofi's answer to that, a new proprietary insulin that's shown in studies of type 2 patients to reduce the risk of low blood sugar events during the daytime by 15%, and overnight by 31% in just-completed Phase 3 trials. Wow!
This reduction in lows is attributed to Toujeo's "flatter and prolonged profile" of action. It has been submitted to FDA and is under review there. Once approved, it will be offered in a pen delivery device similar to Solostar, the company tells us. They expect launch in the first half of 2015.
You never need to look far to understand which oral type 2 drug is getting the most marketing hype at ADA: it's always the one plastered on the conference shuttle buses (which must cost a busload, too). This year, it was Janssen's SGLT2 drug Invokana, the first in that new class of drugs that allows PWDs to slough off excess glucose through their urine. The logo was on the sides of the buses and also covered the seats inside, just in case you missed the outside view.
Invokana had one of the larger, glitzier booths too, ironically including something that I called the "pee fountain" (looks like it, no?) The rep in the booth had no idea what I was talking about.
Meanwhile, competitor Islet Sciences was hyping new positive Phase 2 research on their upcoming SGLT2 product Remogliflozin, which they have dubbed "best in class" because "the chemical structure of Remogliflozin confers a shorter half-life (duration of action) than other SGLT2 inhibitors, allowing for a unique target product profile with combined efficacy and safety benefits superior to long-acting SGLT2 inhibitors." Their studies evaluated once-daily and twice-daily doses in type 2 patients. The twice-daily dose performed particularly well, lowering A1C 1.0-1.4% compared to the placebo in their studies. They'll be moving into Phase 3 clinical studies in the coming months.
Note that SGLT2 inhibitors seem to have potential for treating type 1s as well. Read our story on that here.
ITCA 650 from Boston-based Intarcia Therapeutics is a new injectable GLP-1 treatment for type 2s. But instead of daily or weekly injections, patients would simply get a tiny, matchstick-sized pump implanted under their skin once a year, which delivers daily doses of exenatide, the active ingredient in AstraZeneca's Byetta and Bydureon.
Really. Just once a year! So you can imagine the potential for "adherence." The company announced its Phase 3 trial results via a research poster presentation at ADA yesterday. Results showed a "sheer magnitude of positive clinical responses... (the drug) significantly lowered the blood sugar of patients with severe hyperglycemia in 6-month results. In the interim data, the 50 patients who reached week 13 averaged a 2.5% decrease in blood sugar, while the 39 who hit week 19 reported a 2.9% drop, and the 25 who got to 26 weeks posted a 3.2% mean reduction."
"Those are impressive marks considering Intarcia's enrolled population had blood A1C levels of between 10% and 12% despite diet, exercise and, for about 70% of the patients, the use of one or more oral diabetes medications," according to Fierce Biotech.
Sounds like a newbie with a ton of potential, so expect to hear the name "Intarcia" thrown around a lot in the D-world in the near future. The company expects to file for regulatory approval in 2016.
Pen Wars + Smart Pen Solutions
Also making a big splash was Novo Nordisk's new Levemir FlexTouch pen, an especially easy-to-use delivery method for this long-acting insulin. What makes FlexTouch different is that it does away with the traditional plunger-style dial that you squeeze down when dosing insulin, replacing it with a a simple button-press function; no need for extended finger-action or even two-handed insulin delivery.
You can dose up to 80 units and once it reaches the 0-mark, you hear a click to signal that the dose is complete. Users can choose from the NovoFine cap or the new NovoTwist that's designed to seal both ends of the needle once you're done and ready to dispose. And remember how you're only supposed to keep insulin pens out of the fridge for use for about a month? Well, this FlexTouch lasts an additional two weeks for up to 42 days from the time you start using it.
This is a direct competitor to Sanofi's Solostar pen for their leading long-acting Lantus insulin, and they weren't taking the big marketing push lying down. The two booths, next door to each other, literally had dueling giant pen displays. The Sanofi booth had two metal 8-foot models of the Lantus Solostar and Apridra insulin pens that you could pose next to!
While certainly convenient for users, none of the current insulin pens on the market offer the kind of dose tracking and data collection that patients get with an insulin pump. Naturally, some entrepreneurs have noticed that gap and are working on solutions.
We were pretty impressed with a clever little product called Bee from a Switzerland-based company called Vigilant. It's "the world's first bluetooth smart injection tracker connecting insulin pens to smartphones." It's basically a user-friendly electronic cap that fits most insulin pens on the market. You simply turn the dial to record your injection and it wirelessly transmits the data to mobile logbook app on your smartphone or tablet that can be easily accessed and shared with health care providers, friends and family. So unlike Timesulin, it does much more than just remind you whether or not you took your last injection. It actually provides the same type of high-tech data gathering and sharing that you'd get with a smart insulin pump. And this product is already FDA approved, believe it or not! They're just rolling out in the U.S., but you can sign up to pre-order here.
A small startup called Companion Medical -- still tiny and not anywhere close to exhibiting at ADA -- is also working on an exciting bluetooth-enabled smartpen solution with full data collection and sharing capabilities. More on that as they disclose more.
In other news on the pen front, we got word that BD is prepping for a consumer launch (at AADE in August) of its Autoshield Duo safety pen needles, that keep the needle completely covered before, during, and after dosing, so you never come in contact with the sharp at all. Great for kids, and adults too.
Tech / Collaboration News!
More evidence that we seem to be reaching a tipping point on diabetes innovation! Big pharma players Medtronic and Sanofi, whom we might never have expected to buddy up, have announced a new innovation collaboration. Details on what they'll develop are still unclear, but at a media roundtable, both companies indicated this alliance is a part of Medtronic's newly-formed Type 2 Division. They're planning "new and unique" devices, potentially along the lines of pre-filled cartridge devices or even patch pump tech (possibly competition to the Valeritas V-Go, the CeQur PaQ pump, or even the Lilly and Insulet U-500 OmniPod collaboration?).
While they claim this partnership is about open innovation, both companies currently push their proprietary software on patients in efforts to be the "total management solution," and neither has yet signed on to the #WeAreNotWaiting notion of open systems and customer choice. Their joint announcement talks about "improving the patient experience," so we can only cross our fingers for a truly open approach here...
More immediately heartening is the Dexcom and Insulet announcement that DexCom's new mobile app platform, currently under development, will integrate data from Insulet's OmniPod system. Woot for us wearers of both!! This makes history in being the first version of a mobile app capable of integrating glucose monitoring and pump data in a single data app display. According to the press release, "this event also marks the start of DexCom's open architecture approach to diabetes-related data which will include an 'approved by DexCom' indication to validate the authenticity of devices and apps integrating DexCom CGM data." Love it! btw, this announcement went over the wire on Friday, smack in the middle of our D-Data ExChange event -- so ideal to show real-time progress!
Meanwhile, on the ADA Exhibit Hall floor, Dexcom wasn't ignoring Medtronic's aggressive marketing grab at its customers -- that promo deal offering patients up to an $800 discount if they trade in their DexCom for a Medtronic 530G system. In order to get the full discount, patients are required to submit multimedia testimonials on why they chose the MedT system. Um... maybe they chose it due to the discount? We've still got a bad taste in our mouths from that offer, because it pushes patients to switch to a clearly inferior monitoring product, and at the same time asks them to be cheerleaders of that product, too, all in the name of affordability. Is this really in the interest of improving patients' lives?
Here's Dexcom's tongue-in-cheek "counter offer" to HCPs at ADA, featuring CEO Terry Gregg:
On a more academic note, the well-respected Joslin Diabetes Center just announced a new Joslin Institute for Translational Technology (JITT), with early support from both Dexcom and Tandem Diabetes. With this move, Joslin would like to become the hub and clearinghouse for new diabetes mHealth innovations. We love that a legacy institution like this is changing with the times, and wish them all the luck in signing industry on for new collaborations that lead to faster improvements in tech tools for us PWDs.
One of the few truly new gadgets we saw at ADA was iHealth Labs tiny new iHealth Align glucose meter. Now FDA cleared at the end of May, it's about the size of a quarter and plugs right into an Apple or Android smartphone. The only drawback is that it doesn't display the blood sugar result directly on the meter, since that's how the company shrunk the size, so the only way you can see your BG reading is to plug it in. It uses the same cloud-based companion app as iHealth's previous product, the so-called Wireless Smart Gluco-Monitoring System, which we reviewed before and will remain on the market as a "higher end Bluetooth-connected option." The little iHealth Align meter will retail for $16.95, compared to $29.95 for the former system.
Additionally, iHealth made news by dropping the cost of its test strips for both devices to $12.50 for a box of 50 strips ($0.25 a piece), about a quarter of the price of many name brand strips. They've also announced plans to integrate all their devices with Apple HealthKit -- which is cool, but begs the question of how Apple will handle the integration with FDA regulated medical devices, discussed in our recent HealthKit post.
And China-based San MediTech was displaying their eye-catching CGM system, which we're told will be submitted for FDA review by end of the year. This rounded-edge rectangle sensor with a little circle in the center is slightly bigger in size than the current Dexcom G4 sensor, but a little thinner and very lightweight. Their new sensor will last up to 10 days, compared to the existing dime-size sensor that lasts up to 8 days, which has CE Mark approval and is available outside the U.S. The new version will use the new low-energy Bluetooth 4 tech and connect only to the Android platform, at least at first. Later they have plans to connect to other glucose monitoring tech we might be using in the cloud. The Receiver with this new system looks kind of like the old-school Abbott Freestyle Navigator CGM that was discontinued. Finally, they were also showing a clinical-use sensor that is round and had the company letters SMT colorfully imposed on it.
Bionic News, Tandem t:dual
One of most exciting device news bits came from a session covering the latest research on the Bionic Pancreas being developed by Boston-based researchers Ed Damiano and Steven Russell. They presented their study results showing that the insulin-pump CGM system with a glucagon formula indeed works better than an insulin pump alone. And on Monday, they began home use trials for people in the Boston area.
With that, we saw some exciting images of the Tandem t:dual, which is being developed as part of a JDRF partnership and involves a dual-hormone pump that would allow for insulin and another drug like glucagon or Symlin to be delivered simultaneously. We caught a first glimpse of what that new device could ultimately look like, with two pigtail tubes coming out of the double-cartridge t:slim that would be a bit thicker than the current insulin pump. Still, it's early in the R&D process and may not look exactly like this image when it eventually hits market. See also: this quality Bloomberg post on the Bionic Pancreas progress from yesterday's ADA presentation.
Also during some of the sessions on closed loop systems and D-tech, slides were shown giving previews of what some of the exciting new devices under development may look like, including the predictive Medtronic 640G model (maybe available overseas by year's end?) From what we could tell on the slides, the 640G would certainly look different than the traditional Minimed pump style we're used to -- it may stand vertical instead of horizontal, and have a scroll wheel instead of the push buttons. And there was a more colorful CGM graph from what we've become used to. Along with that, we saw images of the Guardian 2 link Transmitter and the Enlite 3 sensor that would both be a bit smaller than what's on the market now.
Update: Following our report, we actually came across a Medtronic investor call presentation from June 5 where MedT's executive VP and president of the Diabetes Group, Hooman Hakami, actually released visuals of the upcoming D-tech we can expect. Here's two of those slides, as seen here:
We should note that at ADA, no timeline updates were given on future products: not on the integration of Tandem's t:slim insulin pump and the Dexcom G4 (although we know the companies plan to file with FDA soon in the coming months), nor on the much-anticipated Dexcom SHARE docking station and Animas Vibe insulin pump that are still be reviewed by regulators.
But we did see a preview image of the integrated t:slim/Dex4 product, and also a slide on the still-in-development Roche CGM technology that will eventually weave their Accu-Chek Spirit pump into a patch pump design thanks to the 2010-acquisition of Medingo's Solo pump concept. The ADA staff was pretty serious about no photos being taken and shared publicly from these sessions, so sadly we aren't able to share those previews just yet.
Display Surprises + A1C When?
With the conference overlapping with the World Cup soccer match, a few island displays like Lilly and Dexcom had big screen TV areas where attendees could sit or stand to watch the games. And as always, there were a number of coffee and juice stands -- Mike says one came in handy as he went low on the show floor with no glucose tabs on hand!
We had to smile about the absence of a big display booth from Intuity Medical for the first time in years, which they seemed intent on investing in despite the fact that their all-in-one Pogo meter has been caught up in FDA purgatory for so very long. Yet we caught a glimpse of Pogo marketing banners on San Francisco street cars outside the convention center. What the ...?
Meanwhile Lilly had a pretty glamorous booth set up, trumpeting the company's history in the diabetes and insulin-making business. But we couldn't help scratching our heads when seeing their huge wall of 40 iPads creating a puzzle-like display of Lilly images. Sure, it was catchy and cool to look at, but it seemed over the top in this age of tightening R&D budgets and other cutbacks.
BD had a life-sized rubber dummy wearing a company shirt, which looked a bit like a corpse in the middle of their booth. Turns out they were doing live demos about how to recognize the lumpy skin condition known as lipohypertrophy that many of us longtime insulin users have experienced. This was actually tied to a recent study on the issue.
Of course, there were a number of other fun displays like Team Novo posing for pics and the ADA allowing you to pose for a photo to be super-imposed on the cover of Diabetes Forecast. Both at-home A1C device companies Bio-Rad and A1C Now had booths, too, and during the three days they each had at least 600 people who came by for tests -- including Mike, who ran into D-peep Kerri Sparling on the exhibit hall floor one afternoon and they had their A1C checked together.
btw, in case you were wondering what happened to that A1C Now home testing kit, formerly from Bayer; it did not entirely bite the dust. Rather, the product has been acquired by Indianapolis-based CHEK Diagnostics, and is currently available only in multi-packs for HCP offices. But the folks in their booth at ADA told us they're getting ready to rebrand it as a consumer product with a new name, and it will hopefully appear on shelves at Walgreens and Wal-Mart soon.
I can't help thinking how just a few short years ago, when I tried to gain access to ADA as a patient blogger, I was rebuffed as an oddity. Now for the first time in 2014, we had a whole contingent of diabetes bloggers not only running around the conference with press passes, but also being courted by both industry and ADA itself at receptions and tweet-ups. We've come a long way, Baby!
Not only that, but Patient Voices were present on the official conference program for the first time ever, in a Behavioral Medicine track on Sunday featuring leaders in the diabetes online community. Both Mike and I sat in on this session, as well as a large group of other bloggers, and chimed in where we could on the incredible value of peer support. The message to healthcare providers in the room was that patients need more than medical instructions! To succeed, we need camaraderie, reality checks, down-to-earth answers, and a channel for collective advocacy on a regular basis. That's what social media enables.
And in this exciting time when I hear numerous industry folks and policymakers recognizing that nothing's going to change in diabetes care without consumer pressure for those changes, I think Patient Voices need to be heard loud and clear at every type of diabetes, healthcare and pharmaceutical event there is!
To read more about the specifics of the Sunday ADA "Principles in the Diabetes Online Community" session, check out the hashtag #DOCatADA.
You can also check more of the live-tweeting from ADA by keying in the #2014ada hashtag. Stay tuned for more ADA reports coming here soon.