We spent the weekend at the huge American Diabetes Association annual Scientific Sessions event in Chicago. Everybody who's anybody in D was there -- except Abbott and Bayer, who opted out of exhibiting this year ostensibly due to the hit that the blood glucose monitoring market is taking in the face of reimbursement overhaul.
- Upwards of 17,730 people attending overall (Monday morning's count)
- 14,570 scientists, physicians, and other HCPs
- 2,500 abstracts (papers presented)
- 2,000+ research posters
- 92 symposia
- 52 oral sessions
- 155 exhibitors showcasing meds, devices, and all manner of D-products
- 60% international attendance, versus just 40% U.S.
- 2 extra pairs of shoes (for Mike and I, as we ran like crazy around the Chicago convention center taking it all in)
First, the Fun Stuff:
On the expo floor, doctors were lining up "around the block," so to speak, to get their photos taken and imposed on the cover of Diabetes Forecast magazine, and to have caricatures drawn. But the sight that always makes us giggle most is dozens of doctors waiting in long lines for an On the Spot A1C Test -- like it was a ride at Disneyland!
Novo had the now-Team Novo Nordisk riders decked out in their spandex, of course, meeting and greeting visitors and showing off their bikes! We also caught a glimpse of NASCAR driver Ryan Reed, a fellow type 1, who stopped by on Sunday afternoon.
Sanofi's Medikidz D-comics booth had an actual team of live superheroes! And we snagged some copies of the free D-comic books they were handing out.
Mike also tried some "diabetic-friendly" pancakes made with corn and veggies right on the show floor, but wasn't a fan. These flapjacks were being given out as part of Merck's Taking Diabetes To Heart campaign.
Right outside the exhibit hall, the ADA had a huge live-tweet screen streaming all tweets using the event hashtag #2013ada! Many DOC'ers appeared there, and it was pretty interesting to watch the healthcare professionals take a puzzled look as they walked past.
It's actually impressive to see how social-media focused ADA has become, publishing streaming updates on twitter and Facebook, and even making select webinars and many ePosters accessible for free online, which broadens access to the entire D-Community, not just the "insiders" who attend this event. Props for that, ADA!
So what was big at this year's event? Aside from buzz about new oral type 2 drug Invokana and a couple of investigational new insulins in the pipeline (which we'll get to later this week), it was some exciting research looking back and forward.
A Huge Dia-versary!
Looking back, did you know that this year is the 30th anniversary of the landmark Diabetes Complications and Control Trials (DCCT), and the 20th anniversary of beginning the followup Epidemiology of Diabetes Interventions and Complications (EDIC) study? As most in the D-world likely know, the results of that NIH-funded DCCT trial laid out the first-ever scientific evidence that intense therapy -- lowering glucose and improving A1Cs -- actually reduced the risk of diabetes complications. A special symposium on the anniversary of this study was held, mostly as a tribute to the researchers and study participants, but some positive new findings were also revealed.
Two decades after the DCCT, researchers report that they're still keeping tabs on 95% of the original 1,441 type 1s who took part in the study, and they're still finding that with intensive glycemic control comes a dramatic reduction in D-complications. After about 18 years, researchers saw 50% lower prevalence of complications among the treatment group versus those using conventional therapy -- even though A1C levels were no different between the two groups. That means eye disease, kidney disease, cardiovascular issues, and other complications such as limited hand and shoulder flexibility have all decreased (!)
This research continues, and the next step for the EDIC study is to look at whether glycemic variability has any impact on complications, cognitive function affects, hearing impairment, gastric emptying, or the impact of residual C-peptide on A1C and complications.
Closing the Loop:
Funny to think that in the first few years I attended the huge ADA conference, there were still plenty of respectable folks who gaffed at the notion of a closed-loop system ever coming to be. "It's a pipedream!" they said with a chuckle. But no one's laughing now.
Progress on the artificial pancreas (AP) was a big theme at this year's conference, and at least 10 of the stand-out studies highlighted in press materials this year were about AP systems, highlighting work being done on this across the globe. This tells us that the top minds in D-research are honing in on developing an AP system that's useable in the real world.
Among the promising results on various future AP systems were:
- A closed-loop system that administered insulin every five minutes overnight helped patients with type 1 diabetes maintain "exceptionally high levels of normoglycemia (95 percent) with almost no episodes of hypoglycemia." Nice!
- A multi-center study tested the safety and efficacy of the MD-Logic artificial pancreas developed in Israel for four nights running in a patient's home setting, observing regular daily activities. They compared this system to more simple "sensor-augmented pump therapy" (without the fancy algorithms) and found that T1 patients using the AP experienced "significantly fewer and shorter episodes of hypoglycemia."
- Another study showed that a closed loop system produces better results for T1 patients overnight when it "does not control to a single glucose level, but rather a range of glucose targets," What?! So most of the other systems are chugging away trying to get you to exactly 100 mg/DL or some other magic number? Now that seems silly... It's much more logical to use Dr. Howard Zisser's "treat to range" concept.
- Indeed, one fully closed loop system was also tested by Dr. Zisser in Santa Barbara, CA, delivering insulin into the peritoneum (inside the abdomen) in order to cut down the delay usually experienced when insulin is given in the tissue under the skin, like through a conventional insulin pump. Results showed "good 24-hour control, including after large unannounced meals, with almost no hypoglycemia."
- A look at the bionic pancreas! This system requires only the patient's body weight to start closed loop glucose control, and then it "learns" as it goes about the wearer's daily insulin needs, and other patterns such as stress, diet, exercise, and changes in hormones. It was tested by both adults and kids, and automatically adapted to prior insulin needs. Researchers report that it achieved better than standards of care expectations in all age groups. Wow! Lindsay Wagner would be so proud.
- Now this is interesting! We all know that Glucagon is a highly unstable substance, which is why it has to be mixed up immediately prior to use. That makes it near impossible to plug into a lasting artificial pancreas system. One study out of Oregon found that an Indian spice (curcumin) could prevent Glucagon from degrading, "potentially allowing it to be used in a portable, two-chambered pump for up to three days." Actually, there are lots of folks working on ways to make glucagon stable, so it could be delivered in a pen, pump, or other quick delivery device.
The rest of this year's abstracts — and sessions and exhibitors too! — can be searched and viewed using ADA's comprehensive "Dashboard App" here.
There wasn't anything epic happening on this front, except for a fair amount of talk about the emerging insulin pump market for type 2s.
PaQ Pump: Joining with the Valeritas V-Go patch pump on the market is a new 3-day wearable insulin pump called the PaQ. Made by a five-year-old Swiss company called CeQur, this new patch pump is about the size of a computer mouse and delivers up to 110 units a day. CeQur obtained CE Mark approval in Europe back in November, and they're hoping to file with the FDA later this year.
PaQ differs from the V-Go in that has a 330-unit reservoir that lasts up to three days, whereas V-Go is one-day wear only (24 hours). PaQ is also more full-featured, with a wider range of preset basal rates.
In data presented during a product demonstration on broader insulin pumping for type 2s, CeQur presented data showing the PaQ not only addressed the psychological and emotional barriers to insulin pumping for type 2s, but it decreased total daily units required and led to an A1C reduction of .3% in the study samples.
Mike sat in on the presentation and was surprised to learn that the study shows a third of type 2 PWDs using insulin reported missing three meal-time insulin doses in a week (!). Main reasons are that they are too busy or traveling (?)
Panel moderator Dr. David Harlan from the University of Massachusetts Medical School said he has high hopes that PaQ and V-Go styled systems can increase the use of insulin pumps in type 2 patients, in order to help them get a handle on their diabetes quicker.
- Medtronic: No new products, but the company announced it's moving forward with its overnight artificial pancreas trial, joining many others as mentioned above. This Control-To-Target system will use the Medtronic Revel pump and CGM technology and an Android smartphone platform, and using algorithms to keep the 85 trial participants as close to a specific value, say 120 mg/dL, as possible. Weird (see above notes on Treat-to-Range.) Medtronic Diabetes VP of research and development John Mastrototaro also told us that while they're still waiting on FDA approval of the 530g system (known as the Veo overseas) with Low Glucose Suspend, they are already looking ahead to the next predictive CGM platform that will actually look different than most of the existing pump gens before it! The initial 530g product will likely be not be compatible with the mySentry, which is a drawback. But the next gen will. Medtronic is also working on a mobile version of mySentry, which they could only mention vaguely, but sounded a lot like a mini-version of the Dexcom Share coming soon.
- Dexcom: Speaking of the Dexcom Share that we reported on back in May, it was cool to finally see the device-under-development in person (under glass, of course!) at the company's display. And although the product is not approved for use in children in the U.S., it is overseas, so they had a whole section in their booth devoted to kids' wear. Dexcom CEO Terry Gregg shared that their plan is to file the new Share product with FDA by the summer's end, so hopefully by this time next year we'll hear some exciting news on that, followed of course by the new direct-to-smartphone Gen5 CGM!
- Tandem: All the rage last year, Tandem didn't have much glitter but its t:slim insulin pump was still the talk of convention as many are impressed with the iPod-ish look and how the device will become a part of the closed-loop future. At an evening event put on by Tandem, they hosted Dr. Steven Russell, who's working on a Bionic Pancreas Project with D-Dad and fellow Boston researcher Ed Damiano, to share updates on where that research stands. And fellow D-peep Kelly Close gave an emotional talk about her recent experience trial-testing that system in Boston.
- Intuity Medical: Ironically, this company was back AGAIN with the same tall, flashy booth they've had the last three or four years, displaying their all-in-one Pogo meter that has been held up for years by FDA (!) Why keep investing in a booth? No one had a sensible answer there. But we did learn that Intuity has done some serious lobbying to combat the FDA's concerns over the relative safety of a built-in lancet, that might be shareable and therefore not sanitary; they've actually pushed the FDA to take a closer look at lancets overall, to possibly reclassify them as Class II devices requiring FDA scrutiny. Everyone but Intuity seems to think this is a terrible waste of resources. The FDA public meeting on this is being held tomorrow if you're interested in commenting or getting involved.
Meanwhile, the Pogo people say they've added a talking component to their meter and expect to do more clinical studies this year, with "new hope" for FDA OK by next year's sessions in San Francisco.
- Dana Insulin Pump: The Korean-made Dana DiabecareR pump by SOOIL was designed by a longtime endo in that country and has been available overseas since 2010, but has never come to the U.S. We've seen this pump at ADA before, and it isn't earth-shatteringly appealing to the eye, but it's a "ubiquitous" pumping system that has a glucose meter built in, and works directly with an Android phone that functions as a remote. Company reps told us they plan to launch a new version of the Dana pump in Europe in September, and they seem very ambitious about trying to file for FDA approval Stateside in the next year.
We're filing these last two in the "believe it when we see it" file.
We also have more ADA 2013 updates for you coming soon... So, stay tuned!
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Huge thanks to my colleague Mike Hoskins for his diligent co-reporting!