Although many attendees were heard grumbling that "nothing groundbreaking" came out of the annual ADA Conference this weekend, I spent most of my time there darting around the Expo for one-on-one meetings with company execs, and came home with a notebook full of juicy updates on what all the "players" are up to.

(Don't miss the Dexcom and Insulet updates! Spoiler alert: new & improved versions are being actively evaluated by FDA now)

Starting with the smaller players, here's what I learned:

VALERITAS

This company's super-simple patch pump, the Valeritas V-Go, is undergoing a small initial launch on the East Coast. Aimed at type 2 diabetics, the pump replaces daily injections with a once-a-day disposable pump that can be set to give doses in 20, 30, or 40 unit increments. So far, it's covered by Medicare part D and they're working on other health plans.

News nuggets from around the diabetes community

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.

closing banner

We like the form factor of this pump, but having a hard time imagining the big benefit to someone who only takes, say, four or fewer injections a day. Having to prefill and insert this pump every single day seems fussier than just taking out your insulin pen for a poke a few times a day...? We're just sayin'...

DANA DIABECARE

This company always has a large, colorful booth at ADA even though they're virtually unknown in the U.S. This year, they were showcasing their Dana pump with iPhone controller. Yes, it's an actual iPhone app that controls the pump! It looks very cool, but isn't anywhere close to getting approved in the U.S. If I got them right, they haven't even submitted for FDA approval since the agency is clearly blockading the notion of controlling an active medical device from a smartphone (some day our prince will come!)

We're told this company is very successful across Asia, China, Indonesia, Polland, Sweden, and in New Zealand — where they're proud to boast 50% of the pump market (which made me giggle — how big could that be anyway?)

DEXCOM

The Gen4 Dexcom is sleeker, faster, able to scale tall buildings!  OK, so that last bit refers to an expanded connectivity range of up to 20 feet, which is super-important for users like me who keep wandering out of range unwittingly. Grrr.

The new version will have a more accurate sensor and a brand new receiver that looks suspiciously like an iPod nano dipped in tar, as it is black all over, little scroll wheel and all.

Dexcom Gen4 is being evaluated at FDA now, and the company hopes to gain approval by the end of March (!)

New software is also being developed to make getting your data out and using/viewing it a better experience.

VP of Science and Technology Tom Peyser tells us a new study was just released, comparing the Dexcom Gen4 to Medtronic's new Enlite sensor, also not yet FDA approved.  The study, led by by Dr. Steven Russell, showed favorable results (details coming soon) for the Dexcom Gen4.

I also got a quick glimpse of the Dexcom Gen 5, which they're already working on! Whaddya think this one looks like?  Yup, can you say iPhone?

{side note: once again, Dexcom hit it out of the park by hosting the rockingest party at ADA! Which isn't just a party, they like to emphasize: it's also a fundraiser for ADA}

INSULET

Insulet was showing off its new, smaller Eros pod (awaiting FDA approval), which is 1/3 smaller and 25% lighter than the current pod.

"It's all about smaller, that is our story," says Peter Devlin, the company's head of commercial marketing.

But the new pod, when it comes out, will also be introduced with a whole new PDM model, which uses a new communication frequency. The form factor looks just like the current PDM, except that it is jet-black instead of blue. (What's up with this back-to-black trend? I thought we knew that patients like colors...?)

The other big change in the new PDM is a revamped IOB (insulin on board) function, that will now indicate meal bolus insulin still in your system instead of just showing corrections. As a long-time Omnipod fan and user myself, I say: hallelujah! The "mystery IOB function" has always been the one thing I didn't much like about this system.

Insulet is currently testing the new pod in seven Artificial Pancreas study sites around the world. Devlin tells me they are collecting patient data using something called the iDex, a combo of OmniPod and Dexcom (!). Focus of the research is "primary drivers in the algorithm" — aka trying to figure out the best way to control a combo system.

I asked them: what about a pod or other single-site device with a double cannula for glucose monitoring and insulin delivery?  "We're working on it," is all Devlin w(c)ould say.

MEDTRONIC

The company has just submitted their new and improved, smaller Enlite CGM sensor to FDA, so it's now being evaluated together with the Medtronic Veo, the advanced pumping system available in Europe that offers the low-glucose suspend (LGS) feature. LGS is potentially life-saving technology that can shut off insulin delivery automatically for two hours if the CGM detects a hypoglycemic event and the user doesn't respond to alarms.

The new Enlite sensor has "accuracy benefits," has only a 5-7 minute lag time over fingerstick tests, and the "insertion volume is 69% smaller," they tell me. Medtronic is hoping for a decision from the FDA within 12-18 months.

Concern on the part of FDA is two-fold, apparently:

  • They're worried about false claims that the Enlite sensor "cures hypoglycemia" — Medtronic has to be careful with their language so that patients won't hear the implied claim, "I won't get hypo using this pump."

"But people are already low when it shuts off, so it doesn't prevent hypos," noted Greg Meehan, VP and GM of the company's CGM business.

  • They're concerned about sensor accuracy that might make the automatic shut-off kick in unnecessarily.

"It gives you so many pre-alarms as you're starting to go low that it's impossible to ignore," Meehan says. "And there's a REALLY LOUD siren when it actually turns off. No way you are going to miss that!"

On the Artificial Pancreas front, Medtronic's big news is the dual sensing technology it is testing. It's pairing its current CGM sensor with optical sensor technology that came from its 2009 acquisition of PreciSence to improve reliability for use in a closed-loop system.

This alternative sensor is based on optical technology, as described in a recent report by ASweetLife.org: "It is injected into the upper layer of the skin and measures the amount of glucose binding to fluorescent receptors within the sensor. When glucose binds to the receptors, the receptors give off light that can be measured, quantified, and reported back in terms of glucose concentration. This optical means of quantifying glucose levels in the tissue would act as a second check for the existing sensor, and the two together could be read and correlated by the closed loop system to ensure accurate glucose inputs were being used by downstream algorithms."

The optical sensor system is still under development, but has already been tested in pigs and humans.

"We spent the last few years 'productizing' it. The chemistry is on the tip of the optical sensor. The optical sensor will continue to work even if the cannula of the first sensor is pulled out," says Rajiv Shah, senior engineering director at Medtronic.

Shah tells me the company needs about three years to move the product forward so it can be commercialized. Some may be skeptical that this sensing technology is viable at all.

"25 years ago I was told subcutaneous (current) sensing would never work," Shah says with a smile.

Meanwhile, algorithms are being developed to better understand the lag time, be able to deal with delays, understand system flaws and even consider individual medical history, which can be programmed in.

"Whatever algorithms do, they have to ensure safety," Shah says.

Finally, of course I had to ask Medtronic: why didn't they make their new MySentry CGM remote monitor compatible with their own stand-alone CGM product, the Guardian? It just seems crazy... There are several business reasons, apparently.

"MySentry started as research product... it was not intended to pair with the Guardian. We started work on it a number of years ago, and by the time we had the opportunity, we even wondered, should we launch it, or just wait to move to the next generation?" Meehan says. "We didn't expect to get FDA approval."

The company says they don't actually sell a very big volume of Guardian products on their own. Rather, most are sold as part of the integrated system with the Revel pump. They talked about a "short lifespan of the product" as they move to newer models. There will be no Guardian 2, they stated clearly.

"It's true: we've underserved the stand-alone CGM market. Our focus has been on the integrated system," Meehan admits.

Finally, I asked them about the recent spat with Regence Health in the Pacific Northwest. Apparently, a nasty fight over pricing levels caused Medtronic to break off relations with that insurance provider, leaving patients ostensibly in the lurch.

"We're referring patients to local distributors who can get them their pump supplies. No patients will be left out in the cold," says director of PR Amanda Sheldon. Maybe not, but that's got to be a pain, having to shift all your prescriptions and order history over to yet another layered organization, get your doctor in touch with them for prior authorization, etc., etc. It seems like it's always the patients left holding the bag when these things occur!

SANOFI

Physicians were lining up to see the big show about the new iBGStar meter that connects directly to an iPhone or iPod touch. I imagine it's an even bigger wow factor for doctors to see a glucose testing device — something historically considered part of their clinical turf — plugging into a mobile phone. What? You mean my patient might be yapping to her best friend, or playing Angry Birds while testing? No worries, docs, we already do 15 other things while testing anyway. Am I right, PWDs?

Since cell phones and consumer devices change so fast, the question came up about product lifecycle. What happens when newer versions of Apple products render the iBGStar outdated? "We expect a 15-month lifecycle on this product," said Dennis Urbaniak, VP of U.S. Diabetes at Sanofi. I guess that means lots of upgrading required for users.

In the realm of "advancing the scientific dialogue," Sanofi submitted no less than 150 research abstracts to this year's ADA, Urbaniak says. "And we're also working on a number of projects outside the convention center, for communities."

They actually did something really neat! On the Tuesday before the convention began (bringing over 16,000 visitors into town), the American Diabetes Association hosted a "Diabetes Day," supported by Sanofi U.S., for hospitality workers across the city, complete with a free FIT Clinic at Thomas Jefferson University, cooking class, diabetes education, and CDEs on hand to answer questions. The major of Philadelphia even made a proclamation in thanks. After all, the conference relied on about 51,000 hotel rooms (nights) over the course of the 5-day ADA Conference, I am told. That's a lot of cleaning, washing towels, and room service! The ADA plans to create an annual tradition of Diabetes Day programs for hospitality workers in the cities hosting Scientific Sessions each year.

Sanofi also supports the related Cities for Life program launched April 24 in Birminham, AL, which is a grassroots, community-based diabetes management program led by the American Academy of Family Physicians (AAFP). The program works with community groups to "create an environment that facilitates healthy lifestyles and diabetes management," and they'll be working with local "Patient Navigators" to help take it to other communities, Urbaniak says.

Sanofi is also a major supporter of the new Dribble to Stop Diabetes campaign — a very cool high-profile national multimedia campaign designed to encourage basketball fans to live an active, healthy lifestyle and raise D-awareness. The program was developed by The National Basketball Association (NBA), the Women's National Basketball Association (WNBA) and the NBA Development League, in collaboration with the American Diabetes Association. 

"We want to be a total diabetes company and we need to show we're serious about it," Urbaniak says.

One more part of "embracing the whole patient experience" is Sanofi's new website called "The DX," which culls a variety of information and articles about living with diabetes — working closely with a number of our fellow diabetes bloggers in the patient community.

They're adamant that it's not a promotional channel for the company, but rather "a way to promote good content about life with diabetes."

What about FDA regulation on social media? Weell.... the FDA is ridiculously overdue on issuing firm guidelines for Pharma companies, which can and have sometimes nevertheless been penalized by the agency for inappropriate use of social media channels.

"They may never (issue clear guidelines). Our approach has been if we do the right things with our approach today, we're not going to get in trouble later," Urbaniak says. His colleagues cite how a number of Pharma companies were compelled to shut down their Facebook pages after a ruling that the pages had to be open for comments.

Right... that would be the S word in social media.

And that's all for this round of updates, Folks.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.