We're officially conference-weary after running around the San Diego Convention Center for four days of ADA briefings, sessions, meet-ups and expo booth visits. We lugged home loads of material that will surely keep us post-happy here at the 'Mine for weeks. So what was super-new and hot? Spoiler Alert: Not all that much this year.
Our overall impression was that a lot of cool technologies we've already seen are stuck in the holding pen while FDA increasingly drags its feet on the approval process. Grrr.
Case-in-point: Intuity Medical's Pogo all-in-one meter including built-in lancing device and test strip cartridge. I believe this was the third year in a row we oggled the design in the company's booth, yet still nothing to market. It's just a glucose meter, for goodness sake — not some radical new therapy! *sigh*
Anyway, Intuity has had plenty of time to soup up their demo models. Check out this "race car" design:
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A New Square Patch Insulin Pump
TouchéMedical's new Bluetooth-enabled patch pump is supposedly the world's smallest and cheapest.
Also, weirdly, some of last year's hottest prototypes were glaring absent this year. No booth for Debiotech, for example, which wowed us with their Jewel patch pump last year.
Some new stuff we did learn about:
* A company now called Spring (formerly NiliMEDIX) is working on a new "hybrid patch pump" that's kind of wacky, in a good way. It's in development and so far only lightly described on their website, but we snapped a brochure pic, below. The part that attaches to your body will be a "cradle" that allows you to disconnect the "pod" portion (as with the Roche / Medingo Solo pump design). But here's the wacky part: you can also switch to wearing it as a tubed pump whenever you like, just by popping off the "pod" portion and plugging the infusion set right into the cradle connector. Wow!
- the remote control has an integrated glucose monitor
- you'll be able to bolus with or without the remote control
- you can suspend the pump at the push of a button
- the whole thing will be IPX 8 water-tight, which is BIG, and I'll tell you why...
Having taken another look at the Solo patch pump that Roche acquired from Medingo last year (which is still in the holding pen, btw), I discovered that it is NOT WATERPROOF. The Accu-Chek folks claim that in order to make it detachable, the device cannot be completely air sealed. Which means that the advantage of being able to disconnect is offset by the disadvantage that you are FORCED to remove it each time you shower, bathe, or swim. That's bad news, IMHO.
* On Friday, the folks at Spring submitted an application for European CE Mark approval of their "regular" Springâ„¢ Zone Insulin Delivery System, the updated version of their spring-driven insulin pump. We covered the details of this pump last year here.
As a reminder, once approved, the sporty-looking Spring would be the smallest tubed insulin pump on the market. Other advantages the company is touting are: that it doesn't use a motor, but rather draws energy from pressure created via a controlled-release mechanism — and this no-motor approach reportedly makes the system "virtually fail-proof" and very low-cost to manufacture. It also offers a highly sophisticated error sensing and alarm system.
Related to that last bit is the company's new SpringNow Universal Infusion Set, designed for the highest level of error protection. Its proprietary "Detach-Detect" mechanism actually triggers a blocking device that creates an occlusion in case any part of the infusion set base becomes detached from your body. It also features "high-transparency tubing (that) enables visual air-bubble detection." (Yes, I talked to them about the colored tubing idea, too!)
SpringNow is newly FDA approved, and compatible with all standard Luer Lock connectors (pretty much all pumps except Medtronics, which use their own proprietary connector.)
* Roche is also working on a system called the Accu-Chek Combo — a new competitor to the Animas Ping which uses Bluetooth technology to connect the meter and pump. What's special about the Combo is that you can control all pump features from the glucose meter, including basal rates and temp basals. You can also program in preset "add-ons" to your bolus calculations. For example, if you're dosing for a 45-gram-carb muffin and hit your preset "sick" rate, the system would automatically add 20% (or whatever increase you pre-programmed for "sick") to your bolus dose. Sweet! The Combo is not yet approved in the U.S., needless to say.
Roche has a few more pre-approval things up its sleeve, including the FastClix (pictured), an upgrade to the popular MutliClix lancing device, and the Accu-Check Aviva Expert, with a bolus calculator built into the glucose meter — designed for patients on shots. The Expert keeps track of boluses and insulin on board (IOB) too. That one's available in Europe already.
* CellNovo's new mobile-technology-enabled pump system was making a nice splash on display in that company's booth.
Earlier this year we published an in-depth conversation with the CEO, Bill McKeon. We were finally able to get an up-close and personal look at this quasi-patch pump. Why quasi? Because despite the fact that the pump can sit directly on your skin, there is still tubing to a set. In other words, it's almost like a patch pump that's attached to you with tubing.
There's a separate, wireless controller (the cool part that's got people excited), and you can choose to wear the reservoir "patch" portion either hanging off of long, standard tubing, or wear a velcro-like adhesive stuck to your body that will keep this portion in place. With the latter option, you would definitely be wearing two things stuck to your body.
Now, we at the 'Mine had a bit of a debate on this point. Allison, a long-time tubed pump user (Medtronic since 2000), is in favor of having a bit of tubing even if it means having a separate site, in case there's an issue with the insertion, or if the adhesive comes off. But I (Amy) thought it looked kind of like the worst of both worlds: you've got this tiny patch-like pump, but you still need tubing to use it, and your wear options are basically to tape it to your skin, or have it dangling off you with no good clip option that I could see.
CellNovo is still looking at a fall 2011 launch in Europe, but due to regulatory restraints at the FDA that have been discussed ad nauseum, the U.S. launch will be later — by late 2012 if they're lucky. Though at the rate the FDA is going, we wouldn't bet money on it...
* Two new type 2 drugs also seem quite hot.
Most drugs for people with type 2 focus on the obvious: the pancreas (producer of insulin) or the liver (producer of glucagon). But this new drug from the folks at Rhode-Island-based VeroScience is making an attempt at managing diabetes starting in the brain. Their theory is that it stands to reason that the control center of the body would have some kind of impact on diabetes. They found that people with diabetes have lower levels of dopamine (yep, that feel-good hormone), and that if they could turn it up in the morning, it could have a benefit for people with type 2 throughout the rest of the day. In their clinical trial, people on Cycloset vs. a placebo saw a 1% drop in A1C over a year, and it was shown to be safe for the heart.
The downside: the average dose is between 3.2 mg and 4.8 mg, but the tablets are .8 mg because Cycloset needs to be titrated at an average of one pill a week. That means that by the time you're at the average dose, you're taking anywhere from 4 to 6 pills. They're small, about the size of an Advil, but you have to take all of them at one time at breakfast. Seems like an awful lot to gulp down with your oatmeal every day, or...?
This is an entirely new class of drugs that will be hitting the market real soon, we hear. A subsidiary of Johnson & Johnson called Janssen is looking at using the kidney to flush out sugar from the body. What SGLT2's essentially do is force the body to rid itself of the glucose through the kidney, excreting it via urine. One woman at the booth likened these drugs to diuretics in that they use the kidneys to flush sugar. Patients will basically "pee out" the extra sugar. Sounds kind of weird, but apparently it is safe. Janssen's formulation is currently in clinical trials so the reps had sealed lips on any more info about it, but we'll be sure to share more as soon as we hear.
In addition, there were many briefings about data results in closed-loop research (we wish the reality were closer), and some very positive data reported on type 2 patients successfully using CGM systems.
And of course, there was lots of aggressive marketing going on. Like this:
Oh yes, they did.