Say hello to a new diabetes device on the scene, promising "pain-free" blood draws that can be used on fingertips or other spots -- and that's designed to look more like a magic marker than a boring old medical device.
It's called the Genteel lancing device, named appropriately on the notion that it's supposed to be gentle on both the skin and the eyes. We got our hands on an early prototype and have quite a few details to share.
But first, here's how the Midland, Texas-based manufacturer describes it:
About the size of a permanent marker, and elegant in appearance, Genteel is a radically new concept in lancing that completely replaces the more-familiar industry-standard spring-loaded devices.
Genteel is ideal for anyone needing a drop of blood for occasional sampling, those testing on a regular basis, and anyone wanting to avoid the usual pain and anxiety of lancing. Finger sticks can be especially traumatic for those highly sensitive to lancing pain, especially for the very young and newly diagnosed. Now, with Genteel, elimination of discomfort, and the option to use alternate sites, can be a godsend, and strong encouragement and incentive to test as often as their doctor recommends, knowing it will now be a pain-free experience!
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Some basics about the Genteel, whose parts are described in detail on the website:
- Yes, it's the size of a magic marker at roughly six inches long with the plunger (officially, the "push shaft") sticking all the way out. You can hold use it one-handed, as long as you know what you're supposed to do.
- There's a clear see-through cap, not unlike the clear caps you find on other alternative site testers.
- Six colorful rubber circles called Contact Tips come with the Genteel, to put over the tip of the clear cap in order to cushion the impact of the lancet against your skin.
- To use it, you push a little button on the side to make the lancet plunge, keeping your finger over the little air hole on the button and also keeping the clear cap and tip firmly against your skin for up to 20 seconds. This allows their "vacuum technology" to suck out a little droplet of blood for use on your glucose test strip.
- And for those itching to know the technical details: it has a "lightening fast" lancing speed of .018 seconds, depth accuracy to within .005 inch, and using the rubbery contact tips and vacuum technology the Genteel eliminates contact with pain nerves and generates a vibration that's supposed to do away with discomfort and pain. The vacuum function also helps draw enough blood out of a shallower lancing site than with other products, helping to soothe nerves and prevent any post-lancing soreness.
Here's their clever marketing video aimed at children with diabetes:
Yes, both the video and the company's website toss around eye-roll-inducing phrases like "absolutely pain-free," "revolutionary," "radically new," and the exclamation-point-accentuated, "No More Ouch!" It was really tough to stop my eyes from rolling back in my head with all this hype.
Still, we were curious enough about the still-under-development Genteel lancer that we wanted to not only try it out ourselves, but get the backstory behind this new device.
The Genteel Story
We talked with Dr. Christopher Jacobs, the founder and creator and also engineering mind behind this lancing device, about what he envisions it will provide for PWDs (people with diabetes) and beyond, for those who might be in need of cholesterol panels, hormone profiles, or blood typing using home-testing kits.
There's no personal D-Connect here for Jacobs. Rather, the whole idea stems from conversations he had about a decade ago with a friend who had been diagnosed with type 1 as an adult many years before that. His T1 friend was griping about how he didn't like the finger-poking required to testing his blood sugars. With Jacobs' background in biomedical engineering and patent-development for automobile ignition systems and other medical equipment like pacemakers, that friend turned to him for help in an almost-joking manner.
"Chris, you're one of those genius-types, can't you do anything to help? My fingers hurt so much," Jacobs recalls his friend saying.
He took it from there, and created a prototype of the original Genteel about eight years ago that was the size of a squeezable ketchup bottle. But his friend pointed out it was just too bulky and impractical. If it could shrink to the size of a magic marker, there'd be huge interest. It took eight years of refining the concept, but Jacobs finally made it happen.
"This isn't a breakthrough in technology," Jacobs admits. "Really, it's been about refining this to a point where it's practical for the average person to use. I would say it's clever implementation of tried and true technology, all working in concert."
At first, I received a handmade model that I was told up front wouldn't look like the machine-made devices to come, but it would operate the same way. But that prototype literally fell apart in my hands after the first alternative site poke failed to draw any blood. I wasn't exactly reassured about the prospects, but didn't give up. A second prototype was sent out and arrived on my doorstep early this week, so I've been using this test-version since then.
While the device certainly doesn't knock my socks off, it does seem to do what it claims to, thus might be worth exploring if someone's in search of a more painless poker.
Here's my takeaway, based on an interview with Jacobs and a full day of using the Genteel.
- Kids know magic markers and, and just like the marketing video above says, the resemblance can make diabetes blood testing more fun. Adults may not have the same train of thought or need for that fun, but it's there if wanted.
- The Genteel instruments I used were prototypes, so they weren't colorful or customizable, but the mass-produced Genteel devices will be. They will even come packaged with a variety of stickers to dress up the product, we are told.
- Yes, it does seem to be pain-free! When it hit my skin, whether that was a fingertip pad or my forearm or top of my leg, all I felt was a plunk and a little vibration. Actually, it almost feels like a little pinch as the blood's getting sucked up. Noticeable? Yes. Painful? Not at all. (Note that I wouldn't describe my regular lancing device as "painful" either -- noticeable in a slightly different way, but not with more pain).
- I used the Genteel for a total of 10 blood sugar checks while also comparing to results from my regular lancer and Dexcom G4 and didn't see any glaring discrepancies or lag-time (as alternate site testing is sometimes known for).
- You can use any mainstream lancet needle with a rounded base with the Genteel -- so no special proprietary needles necessary.
- Once you use it a few times, it's not complicated to figure out and seems to work just fine as long as you remember the various steps.
- After using the Genteel, it does leave a little round impression on the skin from the contact tip. It was a little annoying to me that this mark remained a few hours after testing. And a day after the blood tests, I could see little dot marks on my skin in each spot I'd tested. Isn't a key point of this whole thing supposed to be to avoiding those kinds of telltale signs of blood testing?
- It's bulky. Not as bulky as the original design the size of a ketchup bottle, but still bigger than most lancing devices on the market.
- And yes, you can use it one-handed, but the design isn't one that really lends itself to being discreet.
- Genteel is supposed to be kid-friendly and less intimidating, but honestly the look and feel is not; it's a pretty big device with a plunger reminiscent of syringes and needles. And the sound of the spring-loaded action is louder than most of the modern lancers I've used.
- Cost - there's a special pre-order offer on the website now of $99 until April 30, 2014, and after that the cost will go up to $129. This is pretty steep a price-tag for a device that one typically gets for free with a glucose meter -- and even though it's less than some of the now-defunct alternate site testing predecessors, it's still pretty pricey.
- I must repeat: it's bulky. A supposed benefit is that it's kind of "open-source," meaning you can use any type of rounded lancet in it. But that same logic doesn't apply to carrying it around, as it doesn't fit in most smaller carrying cases -- especially the one I've got for my USB-sized meter, a small vial of strips and a different lancing device that's the size of my pinky finger. As we know in diabetes, size matters when it comes to toting supplies around, and Genteel is even longer than some pencil-length lancers I've used in the past. Heck, even the Genteel's own case won't hold the instrument when it's completely put together and the pre-primed plunger is fully extended.
I'll be honest: I've had diabetes for a few decades and I come from a line of PWDs who don't have big issues with painful pricking of the fingers. So I knew going in that even if Genteel worked as promised, it wasn't going to be a game-changer for me. Sure, my fingertips are calloused on the pads where I stab myself often (usually with blunt lancets, since I don't change them very often). But despite the occasional "bruised ninja finger" here and there out of roughly 200 pokes per month, lancing issues hardly appear on my radar of things to be concerned about when it come to diabetes.
Kids are different, of course, and I get that it's a scary thing for the littlest of children to even think about having their fingers stabbed multiple times a day. Same for most newly diagnosed adults, I'm sure. So yes, the Genteel instrument probably has a lot of curb appeal in concept.
Keep in mind, though, that many others have made the "revolutionary pain-free" claim before, yet most of the products (and companies) eventually faded away. Some of these predecessors include the great Pelikan Sun, known as "the Cadillac of lancing systems," the Renew lancing device, and even more similar to this newest offering, the Microlet Vaculance and EZ-Vac that both used vacuum technology for alternative site blood sampling. Neither of those appears to be manufactured anymore but you can still find legacy products in some places online.
Of course, Genteel's Jacobs will tell you how this is unlike anything before it on the market. They have filed several patents on their technology, in fact six in the U.S. and 22 internationally. So despite what we've seen in the past, it is true that nothing there's nothing directly comparable to the Genteel right now. Whether that unique technology is enough to make it a success remains TBD.
Now this part came as a surprise: despite the company's assertion that the product will hit market in April, we learned that the Genteel team just filed in early March (!) for FDA regulatory review -- which is required since this will be a medical instrument. Legal minds on their team believe that since the Genteel device is designed to use pre-FDA-approved lancet needles, there won't be much delay in getting the agency's OK. Jacobs also told us the FDA's taken an initial look at the Genteel, and offered a "letter of intent" basically saying it will be OK'd.
Still... does the FDA ever move that fast on approvals? We were amazed by the company's confidence. In the meantime, they're taking pre-orders and more detail about the device can be found on the newly revamped Genteel website.
Personally, I'm not planning to buy one or change up my routine with the pinky-sized lancing device I use now. But that doesn't mean this won't be exactly what some PWDs and CWDs are looking for in pain-free poking devices.