The idea of an all-in-one glucose meter that eliminates the need to carry around a bunch of separate D-supplies is so appealing! But in many respects it's like the mirage of water on the desert horizon that we can never reach.

Many companies have promised All-In-One Boxglucose meters with built-in lancets and test strips to make D-management all the easier for us PWDs (people with diabetes), but so far they've all been vaporware.

Recently, one of these all-inclusive device developers caught our eye in that it was named by MedCity News as a top company investors should be watching in the near future: Pepex Biomedical in St. Louis, MN, which is creating a line of glucose monitoring products that it believes will "change the game" for diabetes devices.

The company's not a new kid on the block; Pepex has been around since 2009 and for four years has been working on its all-inclusive meter platform called Trio.PepexTrio

Different than traditional meters that use a strip to measure blood from a lancet-pricked fingertip, the Trio actually won't draw any blood but will instead test the blood at the tissue source, the company says. The meter itself will be about the size of an iPhone, and you'll be able to snap on a slim, side-loaded disposable cartridge that houses a supply of plastic molded glucose test "chips" that consolidate a lancet and glucose checking technology in one piece.

Innovation 2015

Meter Magic

This is all based on Pepex's proprietary Conductive Composite Monofilaments (CCM) for detecting blood glucose levels -- electrochemical biosensors inside the cartridge that are composed of single strands of fiber about the diameter of a human hair.

While the company markets the cartridges as being able to hold "a week's worth of chips," there is no clear number at this time on how many that might entail.

Once the cartridge is used up, the user can detach it and dispose of it without ever having to handle the lancet needles or test chips directly. In other words: no fuss, no muss.

"This technology hasn't been used in diabetes and it will change the game for how we monitor glucose levels," Pepex chief financial officer Joseph Driver told us in a phone interview recently. "There's a lot of magic in putting this technology into any device, and that magic is what we have."PepexTrioMini

The same concept will be applied to future versions of the meter under development, such as the TrioMini, a little round meter with the cartridge hooking onto the back (see image), and the TrioTotal, that would actually integrate this all-inclusive meter with an insulin reservoir so that it becomes an insulin pump as well (!)

According to Pepex, the Trio meters will not only be easier to use but will also lead to improved meter accuracy simply because user-error wouldn't be as common with these products.

 

History & Ambitions

 

 

Driver tells us the CCM biosensor tech at the heart of the Trio products is something that dates back to the late 90s, when the Freestyle technology was being created; it's what became TheraSense products and eventually was bought by Abbott and added to the FreeStyle line. The CCM tech was put on hold for years, but eventually the researchers and product developers started looking at getting the technology to market, he says.

 

 

We had to wonder, if this tech is so great, why hasn't it been implemented before by a bigger diabetes device company? Once again, we asked diabetes tech expert Dr. Barry Ginsberg, a veteran expert on glucose management gadgets. He said there's no reason to think the CCM tech can't be accurate, as sensors based on composite metal tend to be more accurate than those using carbon electrodes.

 

 

But one thing to keep in mind is that glucose oxidizes and becomes an anaphylactic, meaning people might become allergic to them very quickly and that would have to be taken into account in the device development, Ginsberg said.

 

So, what's the timeline for the Trio meter? Driver told us they have a pretty ambitious plan, hoping to file multiple 510(k) requestPepex Logos with the FDA by January and hopefully getting regulatory OK sometime in the middle of 2014. (Read: really?!). Pepex has manufacturing facilities in St. Louis and Arizona where the Trio products would be made, Driver says.

Once the initial Trio meter's approved and available, Pepex would gradually add other meters and technology as it's able, eventually getting to a point where they could look at adding the insulin reservoir, and possibly even integrating CGM (continuous glucose monitor) technology. Driver says the company is already talking to "one of the major players in insulin delivery" about an add-on device, and the addition would likely come in a third-generation product down the road.

Earlier this year, Pepex signed an agreement with Verizon Network to add mobile wireless technology into the Trio products and allow for mobile-to-mobile communication as well. Having that kind of communication is essential for any product going forward in this tech-savvy age, Driver said.

"It's exciting to be past the R&D phase and be so close to getting this to market," he said.

Competition

Of course, Pepex isn't the only company working to develop an all-inclusive device:

  • We told you earlier in the year about the Dario meter created by Israel-based LabStyle Innovations Corp. that has some creative marketing going, and is poised to unveil its combo meter over in Europe very soon. About the size of a cigarette lighter, Dario lets you turn your smartphone into an integrated glucose meter complete with strips, lancet poker, and phone app for data logging and sharing via connection to a smartphone's audio jack. The company says it's expecting CE Mark approval in Europe shortly, and once that happens they will "ramp up their efforts to achieve U.S. FDA clearance."
  • You may remember Finnish diabetes tech company Mendor, which created the all-inclusive Mendor Discreet meter that combines the lancet and a cartridge of 25 test strips all into one little box about the size of an iPhone. The Discreet is available in about 10 countries in Europe and the company expects to enter the remaining four during 2014. There's no current timeline on entering the U.S. market, and Mendor hasn't filed with the FDA, but that could also happen next year.

A few weeks ago I received a Mendor Discreet glucose meter* to sample. The meter arrived packaged with a sealed cartridge of test strips, tiny lancets, a small bottle of control solution, a data cable (for downloading data) into their software, Balance, and a CD with user instructions (along with paper set-up instructions). My first reaction when I took the meter out of its box was "It's much bigger than my glucometer." But when I thought about it for a minute I realized that it's actually smaller since there is no need to carry a case with strips and a lancing device.

Setting up the meter, which is encased in a transparent plastic protector, was easy enough. Once it's been loaded with a cartridge of 25 strips and a lancet, you are good to go. When you lift the protector, it automatically produces a test strip ready for use. The internal lancet device is also primed by the opening of the case.

- See more at: http://asweetlife.org/feature/convenient-blood-sugar-testing-the-mendor-all-in-one-glucose-meter/#sthash.trp6OhYT.dpuf

all- in-one glucose meter, the Mendor Discreet. What does all-in-one mean? It means that the meter, the lancing device, and a cartridge of 25 test strips are all part of one little box, approximately the size of an iphone.

A few weeks ago I received a Mendor Discreet glucose meter* to sample. The meter arrived packaged with a sealed cartridge of test strips, tiny lancets, a small bottle of control solution, a data cable (for downloading data) into their software, Balance, and a CD with user instructions (along with paper set-up instructions). My first reaction when I took the meter out of its box was "It's much bigger than my glucometer." But when I thought about it for a minute I realized that it's actually smaller since there is no need to carry a case with strips and a lancing device.

Setting up the meter, which is encased in a transparent plastic protector, was easy enough. Once it's been loaded with a cartridge of 25 strips and a lancet, you are good to go. When you lift the protector, it automatically produces a test strip ready for use. The internal lancet device is also primed by the opening of the case.

- See more at: http://asweetlife.org/feature/convenient-blood-sugar-testing-the-mendor-all-in-one-glucose-meter/#sthash.trp6OhYT.dpuf
  • And who can forget Intuity Medical and the Pogo (short for Press N Go), that has been on the horizon for years but hasn't yet seen the light of day in getting FDA approval? This past summer, we told you that Intuity has gotten caught up in the whole "lancet regulation" discussion the FDA's been focused on over concerns about patient safety. Intuity's spokeswoman Kelley Lipman tells us that they've presented data and demonstrations to the FDA, something that isn't typical but was needed to appease regulators' concerns and show how the Pogo's internal cartridge area can be removed and cleaned. The company is still hoping for regulatory approval as soon as possible.

So, the race is to see who can get their all-inclusive meter made and approved first in the U.S. So life as a PWD may get a little more convenient, as we'll have less stuff to carry around and hassle with.

On the market perspective, Ginsberg says: "It's sort of interesting. It's hard for a little company to survive, particularly now because with competitive bidding taking out a lot of your type 2s, everyone's fighting for the type 1s. Type 1s are half the market , but there are many fewer people and you have to work hard to reach those people."

Here's hoping that Trio and other combo devices appear on drugstore shelves soon... rather than disappearing like yet another diabetes mirage.

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

Disclaimer

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.