Earlier this summer, we told you about the Valeritas V-Go system that is undergoing a small initial launch on the East Coast. We wanted to follow-up and give you a closer look at this product, which isn't what you might normally think of when you hear the term "insulin pump"; it represents a new breed of delivery device for the growing number of type 2 PWDs on insulin.
By D'Mine Columnist / Correspondent Wil Dubois
I stuck my utility knife into the seam, cut the seal, and gently wiggled the blade back and forth to loosen the cover.
Twathap! In a flash the pod exploded in my face. A large chunk struck my forehead. Another bounced off my chin. I heard other pieces ricochet off the walls, clink-clunking to the floor. Only the shell of the V-Go pump remained in my hand. Its innards were nowhere to be seen. What the ---?
The nurse who was helping me giggled, "Lucky thing we're not on the Bagdad Bomb Squad."
This was my first impression of the Valeritas V-Go, one of the new-kid-on-the-block insulin pumps designed for type 2 diabetics.
I can read press releases about the product and get a glimpse of the system online, and sure there's the whole using it aspect to tell people about... but I'm also a fan of looking under the hood of a new pump.
Well, curiosity killed the cat. But satisfaction brought it back. And this cat just had to see what was inside this 2010-approved pump. Now, if you've never dissected an OmniPod patch, I have. It's full of electronics: circuit boards, computer chips, wires, gears, antennas, batteries and more. It's quite an amazing device for something with a maximum life span the same as a fruit fly's. (Three days.)
But Valeritas' entry into the pump market is something entirely different. For one thing, it doesn't use electricity. For another thing, it isn't programmable. And it doesn't even use infusion sets or cannulas.
Is it even a pump at all? Well... Maybe. Sorta. Kinda. But not really. To their credit, while everyone else is calling the V-Go a patch pump, Valeritas isn't. They call it a "disposable insulin delivery device." And although it's new to the scene, if you were to create an evolutionary tree of insulin-delivery systems, you'd have to put it in-between pens and pumps.
The V-Go is a very small patch device that holds one day's worth of fast-acting insulin. It is pre-set to deliver one of three fixed and flat basal rates for that day (20, 30, or 40 units) and also provides a button that can deliver two units per press to help cover meals. The insulin gets into the body via a fixed steel needle about the size of a pen needle.
I never recovered enough of the pieces that went flying hither and yon to figure out how the Sam Hill it worked. But rather than finding clockwork-like gears, I found a big spring. And a clear, nasty, gooey, sticky, thick fluid. More on that later.
Who's It For?
The intended market for V-Go are type 2s who already need multiple daily injection (MDI) therapy: folks who are taking one or two basal shots per day via pens or syringes, and taking fast-acting insulin to cover every meal.
That's a lot of people. And with the number of type 2s potentially interested in pumping, the market for the V-Go could be very large indeed.
Using it is simple enough, assuming it's something you want to do.
You fill it with insulin and slap it on your bod. Every day. The V-Go is a one-day device, something that might seem ludicrous to type 1 pumpers who are used to changing pump sites every three to four days. That said, given the much higher volumes of insulin needed by type 2s, many type 2 pumpers on traditional pumps are changing sites and reservoirs every 48 hours as it is.
Filling a V-Go is a snap. It comes with a pod-filling device. Snap a pod in at one end, and insert a vial of insulin in the other. Push a lever a couple of times to fill the pod. Peel off the sticky back, slap the pod onto (clean) skin, and simply press a button to insert the needle and start the flow of insulin.
There's no controller to lose or leave behind. No batteries to change, charge, or fail. It's discreet in public, which is good. Using pens or syringes in public is a proven barrier that keeps many type 2s from using fast-acting insulin.
While V-Go is simple, it's also limited. Or is it? Really, it depends on what you compare it to. A flat-rate basal seems crazy to type 1 pumpers, who are used to multi-step basal programs. But consider who this is intended for. A flat basal rate is no different than a shot of basal insulin, and the constant delivery of fast-acting insulin may prove to give a smoother profile than a once or twice daily shot of Lantus or Levemir.
The two-unit-per-press meal delivery (while seemingly limited to us type 1s), suits the needs of the more insulin-resistant type 2 well. With insulin-to-carb ratios commonly at 1:5 and 1:8, rounding to the closest two units is precise enough.
But Will Anyone Use It?
Health insurance coverage for V-Go is already widespread, but mixed. Some plans recognize it as a fancy syringe and include it as a pharmacy benefit. Others classify it as a pump and lump it into the durable medical goods benefit. If you were using your wallet, a month's supply would set you back around 250 bucks. Not cheap, but a fraction of the cost of a month's worth of supplies for a traditional pump.
And of course, there's no pump to buy. With a traditional pump's retail price close to ten grand, this means that PWDs could try V-Go, and if they didn't like it, they wouldn't be out a mint.
So if out-of-pocket costs were equal (and for many people they will be), would type 2s want to use V-Go rather than pens and syringes? I'm putting my money on Valeritas. It's one "injection" a day instead of 4-5. Filling the pod and putting it on takes less than a minute. It's easy to learn and simple to use. Clicking a couple of buttons on the bod to cover a meal is faster and more discreet than using a pen.
I think docs will like it too, at least compared to conventional pumps. The training time and learning curves are both short; and the V-Go's fixed delivery makes follow-up visits simpler for the physician because there's no programming or adjustments.
The only downside I can see is that even the big V-Go may not be big enough. Some of my type 2 pumpers use 70-100 units per day in basal alone. I've got one guy who uses 120 units a day. He'd need three V-Go 40s on his body! That ain't gonna happen.
So What About Traditional Pumps for Type 2s?
We tend to think about insulin pumps as type 1 gear, but both traditional tethered pump and OmniPod patch pump use is increasing among type 2s.
While the clinical evidence for the effectiveness of pumps for type 2s is mixed, commercial health insurance plans have accepted that pump therapy for type 2s makes financial sense. A half dozen years ago, getting a pump approved for a type 2 was very difficult at best—and commonly completely impossible. Now most commercial plans cover pumps for type 2s who are already using basal/bolus therapy, although getting Medicare coverage is still proving to be a bit tricky.
Meanwhile, rumor has it that several pump companies are working on high-volume pumps for the type 2 market, and in Europe the Jewel holds 400 units, one of the largest pump reservoirs to date.
Postmortem: What Makes a V-Go Go?
The second time I dissected a V-Go pod (cats have nine lives), I did it under a heavy towel to contain the "explosion" and catch all the pieces. Like an NTSB crash investigator, this time, I was able to piece it all back together. The V-Go features an industrial-strength 6-inch dual spring that is forced into a one-and-a-half inch cavity in the pod. This creates pressure on a reservoir of liquid silicone-like fluid. The plunger that drives the insulin is pushed, not by a traditional push rod, but by this fluid. The flow of basal insulin seems to be controlled by the diameter of the delivery needle itself, which pierces the top of the insulin cartridge at the same moment it's inserted into the skin.
In a nutshell, the system is more hydraulic than mechanical. It functions on fluid dynamics. It's simple. Somewhat elegant. And for many type 2s, it may prove to be just what the doctor ordered. Literally and figuratively.
Especially if they can avoid dissecting it and making it explode.