All-in-One Automatic POGO Meter *Finally* Approved by FDA

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We honestly didn"t think this day would ever arrive.

But it"s finally happened: the FDA has approved the all-inclusive, automatic POGO glucose meter by California-based Intuity Medical that"s been in regulatory "purgatory" for a full six years.

This is the all-in-one meter with a multi-test strip cartridge and lancets built right in, promoted with a colorful swirl logo design. After several years of watching this company invest in flashy booth displays at the annual ADA Scientific Sessions despite being nowhere close to approval, we started joking that POGO had become a pipe dream that might never materialize. The FDA"s concerns focused on the built-in lancets, which the agency thought might be re-usable by multiple patients and therefore pose safety risks.

On April 26 of this year, at long last, the FDA gave the green light for this meter to be sold to patients. It"s the second all-inclusive meter to get regulatory approval in recent months, after the innovative smartphone-connected Dario meter by LabStyle Innovations that was approved in December and hit the market earlier this year.

Don"t get too excited yet, though. The POGO won"t be available until 2017 -- making it a full seven years from the time we first got a glimpse of this meter to when it will actually hit market. Leading up to that launch, Intuity plans to make improvements to make POGO more of a contender for success in the ever-competitive, highly-saturated glucose meter market.

They tell us they"lll be making it Bluetooth-enabled, more accessible to open-source data sharing platforms, and even sexier-looking by the time it"s available for people to buy.

We talked with Intuity Medical"s CEO Emory Anderson and Marketing Director Robin Gaffney recently about the loooong-awaited FDA clearance and what the company has planned.

Q&A with Intuity Medical on the POGO Meter

DM) Thanks for taking the time to talk, and congrats on finally get FDA approval for the POGO meter!

Intuity) We’re really proud of this accomplishment. When you do something that has never been done before, it takes time and is never easy. It took a lot of time and money along the way, and we’re very pleased to have now gotten to this point.

The length of time has actually helped us get closer with patients, understand their learnings and needs for POGO, and tell us how we can do better. Nine out of 10 patients in our focus groups told us they’d prefer to use POGO than their current meter, and we’re getting calls from all over the United States and people even showing up at the door of Intuity here trying to get a POGO now that it’s approved. The way they all speak about POGO is that they"ve always dreamed about (an all-in-one tool) that would greatly change their lives. That motivates us a lot and it helps us move to the next step of bringing this to patients.

What took so long?

We’ve seen changes in terms of what FDA looking for in products – particularly in terms of cleaning and disinfection on lancets, and also the changes in the desire for better accuracy. These have taken a while for FDA to implement. Couple that with a device like POGO that’s new to them, you’re naturally going to get a process that takes longer than traditional products. It’s been a changing time, and from the FDA perspective they have wanted better products, so the bar’s been set higher for all of us in this industry.

How did you respond to the call for accuracy improvements and lancet safety?

We did four pre-submission packages with them on our clinical trials, bench-testing, our software patterns, and our cleaning and disinfection. During each one of those the dialogue occurred relative to what was needed and desired for POGO to be cleared. It was helpful to understand their thinking.

Over this period of time, we moved to continuously improve POGO -- with a 15% instead of 20% accuracy standard and improvements in how the lancets were contained.

We also continued working with patients to refine the industrial design of POGO -- the size, shape and user interface, which is something that has been exceedingly well-received so didn’t need to be changed. A lot of the changes were under the hood.

Can you give us a quick snapshot of the POGO meter"s features, and what makes it "automatic"?

• POGO is about the size of an iPhone with an additional "bulge" in the front, has a screen backlight and port light near where the needle and strip are located.
• It uses two AAA batteries.
• It requires the smallest blood sample size on the market at .25 microliters.
• 10 individual test cartridges, each one containing a lancet and test strip inside.
• The user presses the power button, causing the cartridge to open and rotate to a new test position. That automatically provides a fresh needle and strip.
• The user puts their finger on the blue-lit test port and it senses the pressure and a short countdown appears.
• When the test is done, the lancet and strip do not come out. They stay within their single testing cell, which is retracted and disabled so it’s impossible to use again.
• After all the 10 tests are done, the whole cartridge comes out with the lancets and strips contained inside. There is a window that shows how many tests are left in the cartridge and when replacement is needed.
• The meter always shows how many tests remain, time and date -- even when the meter display is off.
• It"s paired with a data platform called Patterns, and by the time of launch have a mobile app and broader data-sharing capabilities (see below).

And those features where all what the FDA called for, as to a safe all-inclusive device?

The fact is, this is safer than a traditional meter from the standpoint that you don’t have any bloody needle or strip laying around or going into the trash can. There is no contact with the used supplies, and that makes it a safer product. After disposing a cartridge, you just pop in another one and it rotates, and the meter automatically senses how many tests are left and displays that on the upper left corner of the meter screen.

Was there any talk about making the cartridge bigger to accommodate more than just 10 tests?

What we’ve really tried to do in design is make this very portable, recognizing that patients need to be out and about. We tried to find the right combination with this integrated cartridge and number of tests, to still make this device portable without needing a bulky carry case. What we’ve accomplished with 10 tests per cartridge is a miniaturization that’s been a huge breakthrough.

We’re also sensitive to the desire for more strips... but among the patients we’ve talked to in the testing we’ve done, no one really had a problem with the 10-test cartridge.

What’s important in this space is to factor in the insurance reimbursement side. Most strips are prescribed and reimbursed in multiples of 50. So you need to have a format to meet that or you’re out of sequence with the payers and reimbursement.

So we package 5 cartridges (with 10 tests each) in what we call our mini Pringles can, and supply two of those a month to patients so that fits into the formula. As time goes on, we’ll look for more improvements to make the product better.

How exactly does POGO differ from the Dario all-inclusive meter that just launched?

We think of these as two totally different types of systems. If you look at POGO, we are the only one that’s truly automatic. All patients have to do is push a button to test their blood sugar; there is no fumbling with lancets or test strips, and then having to put the blood to the test strip. Dario plugs into an iPhone and requries more steps to use. We don’t see Dario in the same space, as it’s really more of a packaging design versus a technology breakthrough.

We also try to stay away from calling ourselves “all in one” because there are so many meters that describe themselves that way. Those are just attempts to reduce the amount of supplies patients have to carry around.

What will POGO cost for patients, and will it have insurance coverage?

We see the reductions occurring in the Medicare space with competitive bidding, and they seem to be comfortable with the price-point they’re paying to use commodity generic meters for Medicare. That doesn’t really line up with the tech advancements of what we’ve done. So, our focus when we launch will be with commercial health plans.

We do talk a lot about patient access, co-pays and price-points in those discussions. That’s what we are using to develop our launch plan and pricing strategy, but we’re not in a position yet to talk about that. We are looking at the right pricing and even models like Livongo, Omada Health and Dario uses with subscription models that have gained traction, but it’s still early for us and nothing has been decided at this time.

What are you doing now to prep for launch in 2017?

To launch a diabetes product in the United States takes a lot of capital. We have a very strong group of investors, but as we move to the next level we need to raise more money. The worst thing we can do is to launch a product where our data shows we’ll have huge demand, and then end up in a position where we don’t have enough capital to fill the demand. We also need to build out our commercial infrastructure, to make sure we’re not spread too thin and can’t adequately support our clients.

You mentioned planning to improve the product before launch. How can you make changes without going back to FDA?

There is now precedent for Bluetooth Low Energy connectivity to be stable for this technology, so it isn’t such a power-hog. The FDA is comfortable with that. We believe it’s straightforward and will be ready for launch.

Also, we have a good easy-to-read screen now, but we are taking a very serious look at adding a color display. The costs have come down dramatically, and adding color to our user interface will make it look nicer for the future.

Can you talk about your data platform called Patterns and data-sharing?

As mentioned, the product now uses a mini-USB you can attach to any home computer or physician’s computer to access a web-based program that will automatically load the software to boot up Patterns. Then, the patient has the ability to authorize people to share data with – kind of like how you “friend” people on Facebook. The POGO data is in the cloud and any authorized user can access it at anytime online. So the doctor can see the reports before the patient comes to the office. That’s Step One for POGO.

Step Two for POGO is getting to the mobile platform, which will be possible once we have Bluetooth. We’ll have an iOS and Android app for the data to automatically flow from POGO into those apps, and into Patterns as well as to other places in the cloud for sharing on Tidepool, Glooko, and other platforms. We are more Apple-esque than we are Microsoft-esque, in that our view is patient data should be able to go where the patient best can use it to maintain a better life and help control their diabetes.

With this approval, are you planning anything specific at the upcoming diabetes conferences like ADA Scientific Sessions?

We’ll be attending, but we don’t have any plans to exhibit at ADA. We’ve chosen that route because... there are people who thought this meter would never get cleared. Our view is that we"d prefer to under-promise and over-deliver. Everything we’re doing will be saved for a powerful launch next year. We don’t want to create expectations now, so we’re flying under the radar for now and then we’ll come out of stealth mode and be ready to launch.

Congrats, Intuity, on the long-awaited approval! We"re eager to see the first market-ready product in 2017.

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.

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