Those of us in the U.S. sometimes feel as though our Diabetes Community friends across the pond get all the coolest gadgets and medications before we do Stateside.
A preview of highlights at this year’s big diabetes shindig, the Annual Meeting of the European Association for the Study of Diabetes (EASD), reinforced that feeling but brings a whole lot of excitement, since we are getting a glimpse into the future of what’s to come.
The EASD is already going full speed in Berlin, Germany, having kicked off Monday and running through the end of this week. You can catch some tweet-coverage at @EASDnews and the hashtag #EASD2012. And though our ‘Mine team isn’t there in person, we’re watching and will provide updates as we’re able.
Sure, in many ways this event is like the American Diabetes Association’s Scientific Sessions, but EASD actually draws in about 18,000 people (more than the ADA!), possibly because D-innovators from all over the world are aware that the latest and greatest advancements tend to hit Europe-first (thanks, FDA…).
The EASD organization itself has more than 7,000 members spanning about 110 countries, and its Annual Meeting has been held in a different European country each fall since 2001.
Here are some announcements from the current meeting that caught our eye:
A Shiny Patch Pump Jewel
Anyone remember the futuristic patch pump called the Jewel? You might remember it debuting back in 2010 American Diabetes Association’s Scientific Sessions.
Smaller than the Omnipod (even the next generation expected in the U.S. soon), a key aspect of this flat oval shaped patch pump is that it’s detachable! It uses new microfluidic MEMS (Micro-Electro Mechanical System) technology that’s more precise and puts all the brains of the pump into a tiny 2-gram microchip.
You control the pump via a smartphone application that runs on Android, and its developers provide a telephone that can function as a medical device; it has a pump mode that disables the calling and email functions. Aside from all that cool 21st century stuff, it has all the basic non patch pump features we’ve come to expect, like bolus calculator, food database, tagging, etc.
So what’s new with the Jewel Pump being showcased at this year’s EASD?
We talked by phone recently with Dr. Frederic Neftel, president and CEO of Switzerland-based Debiotech, makers of the Jewel Pump. He says originally, they expected the Jewel to hit the U.S. market in 2011. But after meeting with the FDA and getting more guidance on rules and clinical trial requirements, they’ve been busy working to tweak and improve their product concept.
Neftel says they’re now in the phase of polishing off a “final product” designed for seven-day use, rather than the six days previously planned. And it will hold 500 units of insulin instead of 400 units.
But that weeklong wear doesn’t mean we’d be confined to one infusion site; because the insulin-reservoir portion is detachable, the infusion set could be pulled off and replaced in a new spot every two or three days without needing to refill the reservoir, Neftel said. The device has a built-in “anti-air bubble” design, addressing a concern that traditional pump users often have when filling reservoirs (raising my hand!).
The Jewel’s smartphone-receiver has a bolus wizard, and a glucometer built in, using a new more accurate strip they’re designing called the GlucoStrip (which would be accurate within +/- 15% across the BG-level board, better than what the FDA currently requires).
What if you forget the phone-receiver? No worries. Another new feature is two buttons built into the sides of the patch pump, allowing for quick bolusing ranging from a tiny tenth of one unit to a full unit of insulin.
Security is another area Debiotech has addressed, adding an extra chip for lock-out that Neftel says is the same kind U.S. President Barack Obama uses in his Blackberry! Basically, that extra measure makes this more tamper and hacker-proof (something that came to the forefront of DOC concern after the recent pump hacking debacle!).
The Jewel also has a vibration and beep alert mechanism, an insulin temperature sensor and water immersion sensor, as well as early occlusion detection at .01 units rather than most durable pumps that only alert 3 units — possibly allowing a PWD to get an alert within 12 minutes of an occlusion rather than several hours later, depending on how much insulin is used.
While the Jewel Pump’s initial version will not be integrated with a continuous glucose monitor (CGM), Neftel said the next generation likely would be and they’re working with Dexcom’s Gen4 sensor in clinical trials. He said the company is also developing separate software to interface with the iPhone and other smartphones.
The first clinical studies with the Jewel began in April and just recently wrapped up in September, with 35 patients using the patch pump at seven diabetes centers in France. Clinical data on that study is being presented at EASD, and Neftel said the information is positive.
Neftel is tight-lipped about timelines and possible partnerships, but said the company is “talking with potential partners” here in the U.S. and abroad. He also said while it’s ultimately up to the regulatory agencies in dictating launch timelines, the plan is for them to wrap up results of their European studies and begin a second round of clinical studies here in the U.S. in early 2013. From there, filing for CE Mark and FDA approval would flow as they get those results.
In the meantime, Neftel said we can follow new material on the patch pump, including videos, their EASD posters and safety information, all to be posted later this week at www.jewelpump.com.
Also at EASD, Connecticut-based biopharm company Biodel Inc. will be presenting experimental data from its new “ultra-rapid-acting meal-time insulin,” which could not only be a key development in general for insulin-dependent PWDs, but also factor into progress of the Artificial Pancreas.
You may remember some recent news about Biodel, as it’s the company that received a two-year grant from the National Institutes of Health (NIH) to develop special glucagon that could be used in an insulin pump (or the Artificial Pancreas) to boost BGs quickly in the event of a hypo. The abstract being presented at the EASD is available online.
JDRF Backs Research, Infrastructure
Where there’s type 1 research happening, you can count on the JDRF being involved. The international organization funds more than $100 million in research each year in as many as 18 countries, and at this year’s EASD the JDRF stands behind more than 30 studies being presented. Everything ranging from new tools for studying and treating type 1, to prevention of the disease and also protecting or regenerating the insulin-producing beta cells in the pancreas. A news release says the new studies include:
- Beta cell imaging – Two studies looked at techniques for visualizing the insulin-producing beta cells still in the body. “Such capabilities, if perfected, would enable scientists to see and better understand how the cells are affected by the autoimmune response, contributing to efforts to halt their destruction and promote cell regeneration.” These studies were led by researchers at Uppsala University in Sweden and The Bartholin Institute in Copenhagen.
- Immune therapies – Researchers representing multiple academic institutions will present their latest data on different attempts to preserve beta cell function in people recently diagnosed with type 1. Three studies utilized different therapeutic agents, including the anti-CD3 agent Teplizumab, developed by Macrogenics and tested by a team from Yale University.
- Biomarkers – A team of JDRF-funded researchers from the Institute of Bioinformatics and Systems Biology in Munich will present findings looking at “metabolic signatures associated with auto-antibodies” (oh, science talk!), in an attempt to determine whether the presence of those signatures could show an elevated risk for type 1. Accurate biomarkers would enable scientists to more precisely target patients for clinical trials, as well as measure any potential therapeutic benefits.
Word is in addition to these research presentations and two workshops led by JDRF researchers, the organization will be announcing a partnership the with the Danish Diabetes Academy, a new program to develop the diabetes research infrastructure in Denmark that’s supported by the Novo Nordisk Foundation.
Roche Diabetes Care reports that only half of the European countries currently have introduced national diabetes plans, and it’s apparently similar on a global level. But even those “disease management programs built on evidence-based medicine” aren’t adequate, because they don’t “sufficiently break down (care) to an individual level so that it can impact the diabetes epidemic.”
Enter Roche’s new initiative called FOCUS: Diabetes, with the motto: “Patients. Perspectives. Progress.” This scientific media symposium got the EASD players together to talk about personalized diabetes management programs, along with some conclusions from a recently-published paper on the topic by Prof. Antonio Ceriello in Spain.
The symposium will also focus on first results from the ABACUS study (Automated Bolus Advisor Control and Usability Study), which looked at whether patients who tested their glucose more often gave more frequent insulin doses and therefore brought their A1C levels down (they did!). The idea of the FOCUS symposium is to get authorities to look closely at these studies, and start thinking about ways the results can be used to affect better everyday D-management with patients wherever they live.