The start of a new year is a time when many of us at the Diabetes Community get. It is never easy to get direct answers on this, when you’re relying on sales company execs and PR people, and regulatory officers who make promises or can’t talk particulars.
But we did see a lot of diabetes product approvals and starts from 2013, and it appears we’re already off to a pretty newsworthy start here!
On Jan. 6, the FDA published much-anticipated draft guidelines for glucose meter standards in the U.S. which will call for better precision on blood glucose monitoring methods (BGMS). Instead of blood sugar results having to be within +/- 20 percent of their lab value that is Real, the proposed guidelines will say this:
- For meters obtaining 510(k) approval and marketed over-the-counter: 95 percent of blood sugar effects should be within +/- 15%
- For meters used in professional hospital settings and clinics, the suggested guidance calls for much tighter accuracy: +/- 10 percent for BG outcomes at or above 70 mg/dL and within +/- 7% for outcomes lower compared to
Meter accuracy has been the hot topic this past year and the patient-led initiative called Strip Safely has really brought this entire issue into the forefront of the FDA and industry’s interest. It’s good to see 2014 starting strong out here.
The proposed advice really comes about eight weeks after a revised ISO standard obtained global approval in May 2013, the first update to that in a decade but something the FDA is not required to follow along. The FDA now is apparently calling for tighter standards than those from the revised ISO guidelines. This is exactly what Dr. Courtney H. Lias, director of the FDA’s Division of Chemistry and Toxicology Devices, tells us about the proposed accuracy in comparison to what was adopted internationally annually:
“I’d say it is more stringent in some places and similar others. We aren’t planning to recognize the new ISO document for several reasons, including that it did not go far enough to increase performance in the range. We really tried to make sure our guidances did not conflict with ISO, though (i.e., if you do what’s in our advice, you would also fulfill ISO, but not the opposite) because companies need to meet ISO requirements for marketing in a few other nations.”
FDA’s draft advice is now open for public comment through April 7, and everybody — from business, physicians and PWDs using these meters — are invited to give thoughts on what they like or don’t like about the new proposed standards. You can leave comments on the, and about the . There is no telling how long it may take the federal agency to principles once public comment closes, but we will see that happen within 2014!
We also heard this week that Delaware-based startup LabStyle Innovationshave filed for FDA for 510(k) apexpertval of its small wireless Dario meter which we wrote about back in March. This all-in-one glucose meter about the size of a cigarette lighter will have the test strips and lancet poker all integrated into a single device, which communicates and plugs into the audio jack of your smartphone or tablet . The meter continues to be launched abroad, so hopefully we will see it accessible to PWDs (people with diabetes) here in the States before long.
Besides those news nuggets, we’re excited about the possibilities on tap for 2014. We don’t have a crystal ball (even if that’s sort of how I think my CGM works sometimes…), but we’ve between speaking to companies and assessing in on goods already in the works, and also have a number of things on our D-tech radar to share:
This is the integrated Animas insulin pump and Dexcom G4 Platinum, which you might remember was registered with the FDA back in April 2013. We were really expecting this could have hit the market by now, but we learned last fall that Animas was doing some more human variable and relevant testing at the FDA’s request… and even though Animas PR pros won’t tell us anything official, we’ve heard talk that the deadline for that filing is end of January. So hopefully by mid-year so we will eventually have access to the long-awaited Animas Vibe that’s been available in Europe because 2011.
Talking of JnJ Diabetes…
We are waiting to hear exactly when the LifeScan/OneTouch VerioSync glucose meter will actually be accessible after obtaining the FDA nod of approval last February. We and several others from the Diabetes Online Community have been able to get one to initially review, however the company’s being coy on earnings availability except to say it is expected at the end of their first quarter (see also: end of March). UPDATE: On Jan. 13, the VerioSync is now available for buy to those using iOS apparatus here in the States.
Yes, we can’t wait for this one! It is pretty much a docking station, however this device could be a means to get Dexcom G4 data to be transmitted into the cloud and then sent to up to five distinct smartphones or tablets. This will enable spouses, parents, physicians or others to view real-time CGM outcomes when the PWD wearing the CGM is at a different place (even across continents!) . Last July this Chat apparatus made its way into the regulatory inspection arena, and we’re hoping that it is signed off on by the FDA soon. Together with the bureau issuing mhealth guidelines at September 2013, there is more reason to be hopeful that this could be coming sooner rather than later in 2014.
Many are currently waiting to hear these devices are approved for kids with diabetes. The two Dexcom and Medtronic (with its September 2013-approved 530G system) are working diligently toward this, ideally making good headway this year. Dexcom’s already requested FDA for pediatric approval (as of Feb. 2013), therefore it appears likely we will see the G4 get pediatric approval first (cross your fingers!) . Since kids weren’t contained in their initial clinical trials, Medtronic is still gathering data on this and the company acquired a to make this happen whenever possible. So sometime this year, we expect to visit that a filing for MedT CGM use.
It was exciting to listen to the news in August 2013 which Novo Nordisk received FDA 510(k) clearance to its NovoPen Echo, that would be the very first insulin-delivery device of its kind here in the U.S. which not only doles out insulin at half components, but includes a memory function which keeps track of shots and timing of doses. The dosing increments are vital for some adults who are and kids. And who wouldn’t want a little help remembering if their insulin taken was really taken by them forgot? So that it only makes sense that it is available only with Novolog insulin obviously, this really is a Novo device. On the other hand, the new pen device will provide all kinds of skin layouts that are vibrant to help personalize the pens — so bonus points for style, there! The reminder function sounds sort of like the Timesulin device that’s available outside the U.S. now, but doesn’t appear to have the States in its sights anytime soon.
Tandem t:slim + CGM
This pump and CGM integration can also be referred to as the t:detector, as we learned in some recent news coverage. We are anxious to visit Tandem request the FDA’s OK on incorporating with the Dexcom G4, something which was initially expected late last year but was postponed due to the California company’s Initial Public Offering that occurred Nov. 14. Sales reps were advised to hold off on giving timelines but Tandem assures us it is still a top priority for 2014 and the plan would be to submit for FDA for approval ASAP. We asked about software or device upgrades, but Tandem’s also mum on that for now. As to meter-connectivity, Tandem’s “working on it,” company spokesman Steve Sabicer says. “Tandem knows how much the market wants an integrated meter, and we’re devoted to developing solutions for our patients that transcend their present user experience. As you know, each t:slim pump is shipped with a OneTouch Verio IQ blood glucose meter. Entering a BG value on the t:slim’s keypad is significantly simpler than scrolling on other pumps.” Yep, looking forward to seeing exactly what 2014 has in store for the market’s very first Apple-esque insulin pump!
Bear in mind the sleek-looking patch pump which first debuted in 2010 and we last updated you on in October 2012? This apartment, oval-shaped patch pump will be removable and usable for 2 times with 500 units of insulin; much more compact compared to the newest OmniPod production; also will use new microfluidic MEMS (Micro-Electro Mechanical System) technology that’s highly precise and puts all of the brains of the pump into a tiny 2-gram microchip. Dr. Frederic Neftel, president and CEO of Switzerland-based Debiotech which makes the Jewel Pump, says the majority of 2013 was focused on finishing clinical studies and getting development finalized. Now, he expects FDA entry by the end of year and CE Mark approval by 2014.
With news of the Dario meter being filed for FDA inspection, there is also word of yet another “all-in-one” meter coming soon: the YoFiMeter, that is apparently being created through a joint venture between Qualcomm plus a San Diego startup called Gad Light (named after its founder Gad Shaanan). This is not Qualcomm’s first foray into the glucose monitoring world, as it’s previously worked on the MyGlucoseHealth meter. But this YoFiMeter is not related based on Shaanan. He says the vision came from being amazed at the level of poor diabetes management tools for PWDs, which his company could basically make D-Life simpler and produce a line of products fitting into the “YoFiLife” umbrella. Initially, being a meter.
“The YoFiMeter is smaller and a bit thicker than an iPhone, and it has two cassettes indoors: one with 20 test strips (half the duration of a normal strip because you can’t ever touch them, besides to apply blood) and a cassette with 20 lancets. It has one button which activates yet another that fires the lancet the system, and a third which disposes of the used strip. It has a touch color screen (as odd as it sounds, a novelty at the BGM world). And it has a sophisticated “recording device” built into the meter which does away with the requirement for any logbook. Basically, the meter sends test results so that you don’t need to subscribe with a carrier and the mobile air time is integrated into the price of the strip tape.
“We track your steps taken daily. We know how many lancets and strips are left from the meter, and we all know cassettes you have left in your home. We remind you that it is time to purchase cassettes automatically. The BG results will be sent to the cloud to get access via tablet or smartphonecomputer,” he says. This tracking component is meant to tackle the needs of: parents with kids in college, elderly children with adult parents, diabetics which have a tough time being compliant, active executives, soccer moms, building employees who cannot just quit what, find a table at a discreet place, unwrap their pouch and test.”
… uh, how they’d track physical action and supplies is a little fuzzy, but we could not get any more detail about that, or on price. In fact, details are tough to locate on this meter, and it is a little strange that the only YoFiMeter site online now seems to have been put up for its Consumer Electronics Show occurring in Las Vegas this week. But Shaanan says his hope is to get the meter to advertise in 2014. His group is rolling up clinical trials and expects to record in hopes of getting market approval. Obviously, it sounds a bit ambitious and is always determined by the regulatory review procedure…
Roche Diabetes: Patch Vacuum & CGM?
We put queries out to Roche Diabetes Care on what might be on tap for 2014, especially given some of the challenging times the Indianapolis company has seen lately… but sadly we did not hear back. We are hoping two lingering tech apparatus will make more progress this year: the Solo Micropump which Roche gained from Medingo back in 2010, and the once-promised integration with Dexcom. There’s been no update on that because ancient 2013 when Roche put CGM integration on hold. And there’s also been nothing more to report about the Solo pump because mid-2012, when we learned the FDA had approved an initial device for its U.S. but Roche was not likely to market it commercially because it did not incorporate an integrated blood sugar track of any type, and so would be at a market disadvantage. There
Was talk then of a 2013 introduction abroad of a combined CGM pump (with an integrated bolus calculator and capacity to read CGM data), but there’s been no word lately on where that stands or whether the Accu-Chek Combo system or Accu-Chek Insight insulin pump may be the foundation for a new offering here from the States. Latest word from the EASD seminar final fall: a possible European launching sometime in 2014, but given the delays on this so far, we’re not holding our breaths.
Following publication, we heard from Roche Diabetes Care about a second new product they hope to hit the shelves in the forthcoming months of 2014: the Accu-Chek Aviva Expert meter that obtained FDA approval in October 2013. This will be the first blood glucose meter system here in the States which includes an insulin calculator — therefore it will automate a few of the calculations required for correction and food bolusing for PWDs not using insulin pumps! The Roche team tells it’s expected to hit market by 2014’s first quarter.
We also did not hear anything back from Medtronic, that has obviously been caught up together with the 530G approval these days. Sure the 530G ought to begin getting hooked up to people in 2014, so that’s something to notice and impacting the sector. But we were really expecting to hear more about the next stage: the next-generation Minimed 640G with glucose prediction capabilities, which was initially planned to launch in Europe at 2013, but ended up not making any headlines. We will just have to find out what happens alongside that, possibly with upgrades at a few of the big diabetes seminars later this year (or possibly more detail will surface at the Medtronic Diabetes Advocates Forum occurring this week)…
We also learned from Medtronic Diabetes after-the-fact, and they confirmed what we heard was mentioned at the JP Morgan Healthcare conference in mid-January — which the next-gen insulin pump and CGM with a predictive algorithm, was expected to observe a European launch later in 2014, possibly in July. Thus, we’ll keep our eyes!
Many eyes are on Afrezza inhalable insulin, that has been registered in the “pipedream class” for years but might be getting closer to becoming a reality after its creators at MannKind Corp. resubmitted a new drug application to the FDA in October. This is not the first time the California company’s gone to regulators, and twice before have been turned down (in 2010 and in 2011), but maybe the next time will be a charm for the system that is called the Dreamboat Inhaler and fits in the palm of your hand — as little as an asthma inhaler. Research appears promising and it seems to be best-suited for doses, in which you’d get basal doses from injection treatment or an insulin pump with a quick-boost of the stuff that is inhaled to help prevent any blood sugar spikes that are food-related. The FDA’s expected to finish its review of Afrezza by 2014, therefore it possible that people could get access to the by year’s end should regulators see data that was enough now around.
Still no change from Abbott Diabetes Care when it comes to a Possible launch of the Navigator two CGM from the States, so we’re told. For the Flash Glucose Monitoring next-gen sensing technologies which was shown off at EASD this past fall, the company’s still intending on CE Mark approval and a European launch this year. But sadly, there is nothing U.S.-specific on tap at this point. We are also still hoping to hear anything more about who Insulet’s mystery partner may be, in creating a future single-cannula OmniPod that will comprise not only insulin delivery but constant glucose sensing… Thus, there is still plenty to expect.
We at the ‘Mine like to call ourselves “skeptical optimists,” so we’re hoping that this year could be one which sees more progress than we’ve become accustomed to in the D-Community!
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