Last week marked the big European Association for the Study of Diabetes (EASD) taking place this year in Barcelona, Spain. Like the annual American Diabetes Association's Scientific Sessions, this gathering draws thousands from the scientific, medical and research spheres to talk about diabetes advances.
We unfortunately weren't able to make it to Barcelona ourselves (boo!), but have been watching the news announcements closely. Plus, one of our 2013 Patient Voices Contest winners who happens to live in Germany was on hand looking around for us.
It seems that two big conversation-starters at this conference both involved regulatory aspects for the medical and diabetes device world.
First, European lawmakers made news when they voted to tighten up medical device standards, more in the direction of the U.S. FDA approach -- an interesting development, as many of us Stateside have often noted how much quicker products seem to appear overseas. Not everyone thinks these stricter regulations will serve to protect patients, however, including the EASD organization itself.
Meanwhile, this overseas conference was apparently buzzing with talk about the FDA's final mobile app guidelines that were published on the first day of the EASD meeting. This was one of the biggest topics of conversation happening, we're told.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
State of the Union: It's Time to Cure Diabetes
President launching new precision medicine initiative to better treat, cure diseases like diabetes.
'Robotic Pancreas' Appears On American Idol
Carlos Santana's nephew Adam Lasher shows off Dexcom G4 during live performance.
We'll have to wait and see how these two regulatory changes impact the diabetes device world, but in the meantime here's a roundup of some cool news from this year's EASD meeting (not an exhaustive report, but some of the stuff that caught our eye):
Artificial Pancreas Using Inhaled Insulin!
We were excited to hear about the first-ever successful Artificial Pancreas clinical research trial employing ultra rapid-acting inhaled insulin. Yes, this is the Santa Barbara-based study we mentioned previously, funded by the JDRF and conducted by Sansum Diabetes Research Institute and the University of California Santa Barbara (UCSB). Principal investigator Dr. Howard Zisser presented results at EASD.
This research used system including an OmniPod, Dexcom CGM (the Seven Plus before, and now the FDA-approved G4 Platinum), and MannKind Corp's inhaled insulin Afrezza that is still experimental but could soon be submitted for U.S. regulatory review. Sansum is the only site to date testing this very fast inhalable insulin in an AP system to curtail postprandial blood glucose levels (i.e. it's being used for meal-time boluses). The Afrezza is and would be used in combination with a regular basal and bolus system, allowing a PWD to get a small boost of insulin that wouldn't cover a whole meal, but would serve to "balance out postprandial spikes." This research project has actually been underway for five years, and at this point has included 10 patients so far, Zisser says.
This video gives us a pretty cool glimpse into the AP system and what this research is all about:
"This study addresses one of the big questions in diabetes research, which is, 'How do we manage meals with the artificial pancreas?'" Zisser tells us. "Our preliminary results on the artificial pancreas working with the administration of mealtime ultra-fast-acting inhaled insulin are most promising. It's very straightforward to load the inhaler device and take the insulin. There's no needle involved and the small dose of inhaled insulin prevents the blood glucose from uprising very quickly just after eating or falling too fast an hour or two later. In this way, the subcutaneous insulin being supplied by the artificial pancreas' pump has the chance to actually work better."
Results are incredibly encouraging, Zisser says. A PWD using inhaled insulin might only see a BG spike of 20 mg/dL compared to a 60-point spike without the ultra fast-acting insulin, data shows. Zisser says these results also illustrate the effectiveness that Afrezza could have for any type 1 on a traditional pump or multiple daily injections (MDI), and also for type 2s.
The research is ongoing, but Zisser says his group is now in the data analysis phase and he hopes to finalize results and publish early next year. They'll keep doing more focused clinical trials to determine just how effective this inhaled insulin might be, possibly with other AP designs to see if anything works better.
We're excited to see how this unfolds, because inhaled insulin looks like it may be a reality for us soon after all!
Abbott's Flash, without Fingerstick Pokes
We heard Abbott Diabetes Care was showing off its next-gen, still investigational sensing technology called Flash Glucose Monitoring -- which is non-invasive! This new Flash system would use a small sensor that would be worn on the arm for up to 14 days and would use a "small reader" to scan the sensor for glucose readings. Details of the exact form factor are sketchy, but how cool does that sound?!
The idea is that this device would provide a person's Ambulatory Glucose Profile (AGP), which is a "visual snapshot of the PWD's typical day of blood sugars, trends and patterns." Abbott tells us this Flash Glucose Monitoring concept is still in clinical trials and the results will determine the timeline, but the company expects CE Mark approval and launch in Europe by the end of 2014.
Note that we just published a review of Abbott's Freestyle Navigator II continuous glucose monitor (CGM) that's only available outside the U.S., and the company still isn't saying whether that CGM device will ever be brought back to the States. But we're crossing our (pocked) fingers that this new non-invasive product makes the leap!
Sanofi Meter Gives A1C
We were also intrigued by Sanofi's announcement of its new MyStar Extra meter that gives an estimated A1C value and also shows fasting glucose trends. This device isn't as pretty as the iBGStar and it's not an update to the one that fits into the iPhone, but it certainly has some unique data features. It's gotten CE Mark approval and is expected to be available for sale in Europe later this year. When will it come to the U.S.? Sanofi plans to bring it here "soon," spokeswoman Susan Brooks says, but she wasn't able to provide any other details, not event to say when they hope to file with the FDA. A fellow diabetes blogger from the UK who attended Sanofi's press briefing on the MyStar Extra also has a more detailed look at this, too!
Julia's Device Roundup
As it turns out, one of our 2013 DiabetesMine Patient Voices Contest winners, business economist Julia Neese, attended and offered some updates of her own on the device landscape. A German national and longtime type 1 who we're planning to introduce you to more officially soon, Julia says she used to attend diabetes conferences pretty regularly during her teen years, but lost interest thanks to a "lack of innovation" and her own struggles coping with diabetes. New tech advances have sparked her interest again more recently.
Julia says Roche Diagnostics is still talking about its Solo MicroPump but that's nowhere close to being launched. Latest word: possible European launch by the end of 2014, which we really have to take with a grain of salt as this has been pushed back a number of times since Roche bought the company Medingo in 2010. No one is holding their breath on this one.
Ypsomed, which distributes the Omnipod and other diabetes care products under its umbrella brand Mylife Diabetescare in Europe, attracted visitors with its bright green and white booth and oversized product dummies, Julia reports. "Whereas some companies didn't display a single physical product (such as Dexcom — though they have a great product to show with their G4 sensor and receiver!), Ypsomed's display tables full of devices to play with gave it a bit of an Apple store feeling." They were showing off the new smaller OmniPods that began shipping earlier this year. Of course, we know there have been distribution headaches in the States with this second-generation Pod release this year. But Insulet CFO Brian Roberts told us recently that all existing customers have pretty much received their upgraded Pods as of Oct. 1, so the supply issues from earlier this year should all be solved now.
Dexcom was showing off its anticipated Dexcom Share device -- at least in pictures -- that it submitted for FDA approval in late July. Also on tap: a flatter sensor, and improved customizable software. CEO Terry Gregg and COO Keven Sayer were both in attendance at EASD and according to Julia, they stated that they have "more innovations coming from Dexcom in the next two years than in the entire past 10 years." So, lots to look forward to!
Remember Cellnovo, the iPhone-ish patch pump that got CE Mark approval in September 2011 but has not yet made it to market? Well, progress continues on that. Julia reports that the UK-based company is planning for a UK launch in 2014, with other European countries to follow and a hope that the U.S. could get the device by 2016. A deal with California-based Flextronics early this year for manufacturing and design support shows the company is moving forward, and Julia says the product design itself remains unchanged from what we've reported before.
The Cellnovo patch pump is less ergo-dynamic than the familiar OmniPod thanks to its square, matchbox-style shape. Julia says likes the removable Velcro-like adhesive strip that lets you disconnect this patch pump and also likes how the injection site is outside but very close to the device. Basically, this would allow PWDs to take off the patch pump for a bit if they want -- particularly during sports activities. Julia is also a fan of the rechargeable aspect that makes it "green," and how you can just toss the infusion set and reservoir after the 3-day use.
Sadly, it only contains 150 units max compared to the 200 units in the OmniPod. That may be an issue for some users.
"The controller unit or handheld is the best I've seen so far," Julia reports. "It is definitely iphone-ish and less clumsy than the Omnipod's... It features a quite intuitive navigation menu and allows for comprehensive data capture. Neither being an avid logbook keeper nor a carb-counter so far, I find the touchscreen, navigation menu and pre-defined options very appealing. There are for example 150 specified food items you can choose from to add to your diary and you can also add personalized food items (photo and description) to the library. There are also many sports categories available to choose from and the activity meter built into the pump sends data on when and for how long you have been active. The missing CGM integration, however, is quite regrettable though the company acknowledges that this would be something to be considered for following releases."
We also spent some time combing through news releases and reports on the research side of the EASD meeting, and compiled a few "notables" worth sharing:
- Type 1s who have kids may live longer, according to a study presented at EASD. As you might expect, this means more for women than men, but it applies to all type 1 PWDs. Woot! Of course, then there's related data on how social deprivation factors into mortality for those of us with diabetes.
- Our type 2 friends are better off having a big breakfast rich in protein and fat, compared to smaller low-calorie breakfasts.
- Men with type 1 are are "better" at blood sugar control than women... (our own Mike says 'for real?! Maybe a European thing?')
- Lilly Diabetes showed off late-stage clinical data from its experimental once-weekly GLP-1 receptor dulaglutide, showing that it helps type 2s achieve better glycemic control compared to metformin.
So... Did you attend or hear about anything from this conference that caught your eye? We'd love to hear about it. And of course we're looking forward to what materializes in advance of the next EASD meeting, planned for Vienna, Austria, in September 2014.