It's no secret that type 2 diabetes is the biggest market for companies creating new D-devices.
But until recently, insulin pump manufacturers have focused almost solely on the type 1 population since we're the ones whose lives depend on taking insulin regularly, and many T2s who could benefit from insulin have nonetheless done their best to steer clear of it.
We actually know plenty of T2s who use traditional pumps or patch pumps already, but those devices aren't tailored specifically for the type 2 population.
Right now, the only T2-focused pump available is the V-Go made by New Jersey-based Valeritas. We told you about this rectangle-shaped patch pump before, as it's been on the market for almost two years now for those type 2s who want to replace daily injections with a once-a-day disposable pump that can give set boluses of 20-40 unit increments.
It seems Valeritas is ahead of the innovation curve, as we're currently detecting an explosion of new interest in creating insulin pumps aimed at those living with T2 diabetes.
We know of four other insulin pump companies turning their attention to this contingent of the Diabetes Community, and within the next couple of years there are likely to be many more options on the table.
This week marks the 7th Advanced Technologies and Treatments for Diabetes (ATTD) conference that runs from Wednesday through Friday, this year in Vienna, Austria. At that conference, a new patch pump for type 2s is being unveiled. Yes, we're talking about a new version of the cool-looking JewelPUMP first introduced a few years ago.
Switzerland-based Debiotech hasn't brought its full-featured JewelPUMP aimed at type 1s to market yet in either Europe or the States, but the company hopes that will happen later this year. Before that initial JewelPUMP gets to the market, though, Debiotech president and CEO Frederic Neftel says the company is already adding a type 2 pump -- dubbed the JewelPUMP 2 -- to their eventual product portfolio.
The new Jewel 2 version will mimic the main JewelPUMP, featuring: 7-day wear, thinner than than an OmniPod, no tubing and connected to a mini remote that allows for more discreet use. It's just going to be about 3mm thicker in order to hold more insulin -- 800 units rather than the 500 units planned for the initial patch pump. Neftel says the Jewel 2 will therefore be about the size of a first-generation OmniPod.
The mini remote control for both Jewel models will feature an integrated blood glucose monitor, meaning PWDs users won't have to actually look at the patch pump to bolus or set rates (like with OmniPod). Of course, these new pumps are designed to send your data to the cloud and enable you to access it online. The picture is just a mock-up, they tell us, but it's interesting how similar the Jewel 2 app appears to the Simon Game (frustration! remember that?).
A specific timeline for these pre-market products is always tough to come by, especially for devices like the Jewel that have been in the works for years... but Neftel hopes for a commercial launch in Europe within 2014, and a possible U.S. launch of the main JewelPUMP followed by the Jewel 2 in both countries sometime the following year.
We also told you last summer about the PaQ pump made by CeQur in Massachusetts, which has a 330-unit reservoir that lasts up to three days and is more full-featured with a wider range of preset basal rates than other T2 pump designs.
Cequr is also presenting at the ATTD event this week, and we chatted by phone with Dr. Jay Warner, the company's senior VP of commercialization. He said the company's continuing with clinical studies this year and in particular, doing a new evaluation by mid-year that will show the A1C impact from the PaQ patch pump. If all goes according to plan, Warner says we should see a European commercial launch in 2015 and in the U.S. "shortly after that."
Also, Insulet is working with Eli Lilly to create a new OmniPod model aimed at PWDs who use higher amounts of insulin each day. The product design would remain the same, but the Pod would be filled with the higher-powered U-500 insulin, which is five times the strength of regular U-100 insulin but so far hasn't been approved for use in any pump, patch or otherwise. There's been no hint of timelines on this offering, and Insulet's CFO Brian Roberts will only say the companies are "making good progress" on the device. But word on the street is that they hope for a 510(k) filing with the FDA later this year, and there may be more updates at the upcoming earnings call later in February.
We've also learned that Tandem Diabetes Care, too, is developing a version of its t:slim insulin pump that will carry larger amounts of insulin for those PWDs who need it. This new model will be called the t:flex.
A med-financial report mentioned the t:flex late last year, and that article included even more exciting updates from Tandem: "In the pipeline is t:flex, a pump with a larger insulin capacity; and t:sensor, which integrates Tandem's slim technology with continuous glucose monitoring. The company has also partnered with the JDRF to develop t:dual, a two-chamber device that can deliver multiple hormones."
Again, tough to get details about products still under development, but here's what the company spokesfolks were willing to disclose about their t:flex plans so far:
The t:flex Insulin Pump, or t:flex, is designed for individuals who require more than 300 units of insulin over a typical three-day cycle, which will make it the largest reservoir size currently available. t:flex incorporates the same product platform, technology and user interface as t:slim, but will offer a 480-unit cartridge. Utilizing this larger cartridge, people who require large doses of insulin, such as teenage boys with type 1 diabetes and people with type 2 diabetes, will receive the advantages associated with insulin pump therapy without having to replace disposable insulin cartridges as frequently as required with a 300-unit cartridge.
In our market research, two-thirds of endocrinologists cited limited volume capacity as the number one barrier to pump adoption for their patients with type 1 diabetes who require large doses of insulin, or people with type 2 diabetes who require insulin. We believe that offering a 480-unit cartridge will address the typical insulin needs of a person with type 2 diabetes who is insulin-dependent. Our research has also shown that the appearance of traditional pumps is another deterrent to pump adoption. The t:flex cartridge extends out slightly on one side to accommodate the extra volume while maintaining all of the other benefits of t:slim, including its slim and sleek appearance. As a result, we believe t:flex provides us with an opportunity to expand the current insulin pump market.
We hope to hear more about this t:flex before long.
Need and Accessibility
So, there are a lot of options coming down the road for insulin delivery in the type 2 world. And from what we've heard, there's definitely a need.
Data presented at the ADA Scientific Sessions last summer showed that these T2 insulin pumps not only address the psychological and emotional barriers to insulin pumping for resistant PWDs, but they can decrease total daily units required and lead to an A1C reduction.
From that data, it was interesting to hear that one-third of type 2 PWDs using insulin reported often missing three meal-time insulin doses within a week, with the top reasons being that they're too busy or traveling. Whoa! One of the experts moderating the ADA panel discussion on this topic was Dr. David Harlan from the University of Massachusetts Medical School, who said he has high hopes that new pumps designed for type 2 patients "can help them get a handle on their diabetes quicker."
Of course, as more companies venture into this new territory, there's the lingering question of access and affordability -- a touchy topic with all the upheaval in healthcare reform among both MediCare/MediCaid and private insurers (who tend to follow suit on cost-cutting measures).
From CeQur, Warner explains that they're emphasizing studies that will illustrate A1C reductions with these T2 pumps, to help insurers see that the medical benefit is worth paying the upfront costs. He says using a simplified insulin pump (minus all the bells and whistles like bolus calculators and CGM integration) really isn't much different than using an insulin pen -- whose medical benefits have already been proven. It's just another way to get the insulin in at the right time, of course.
"These are simple, low-tech solutions that we want to make as accessible as possible," Warner said. "There's truly a need to free people up from daily injections, if that's what they need, and that is what we're all trying to provide."
But not everyone agrees. Notorious naysayer David Kliff of Diabetic Investor says, "That's the problem with all these patch pumps, they are not true insulin pumps. They aren't easy to learn and nowhere near as convenient as an insulin pen. Now if they were more cost effective than an insulin pen or vial and syringe that would be another story, but they're not."
On the academic side, pump expert Dr. Bruce Bode reports that 89% of type 2s already on insulin do not inject outside the home, and that a pump might prompt them to be more diligent because it's more discreet in social situations. Yet we hardly need research to tell us that lots of people are reluctant to wear a contraption attached to their body 24/7. So how many T2s would actually adopt these devices if they're available remains questionable. Bode concludes that more research needs to be done on which patients with type 2 would be the best candidates to succeed with a pump. After all, it's a huge swath of people we're talking about.
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