The start of a new year is a time when many of us in the Diabetes Community get especially curious about what latest and greatest new tech tools we'll be able to get our hands on soon. It's never easy to get straight answers on this, when you're relying on company execs, sales and PR people, and regulatory officials who can't talk specifics or make guarantees.
On Jan. 6, the FDA released much-anticipated draft guidelines for glucose meter standards in the U.S. that will call for tighter accuracy on blood glucose monitoring systems (BGMS). Instead of most blood sugar results having to be within +/- 20% of the true lab value, the proposed guidelines would say this:
- For meters obtaining 510(k) approval and sold over-the-counter: 95% of all blood sugar results should be within +/- 15%
- For meters used in professional hospital settings and clinics, the proposed guidance calls for even tighter accuracy: +/- 10% for BG results at or above 70 mg/dL and within +/- 7% for results lower than that
Meter accuracy has of course been the hot topic this past year and the patient-led initiative known as Strip Safely has really brought this whole issue to the forefront of the FDA and industry's attention. So, it's good to see 2014 starting out strong here.
The proposed guidance actually comes about eight months after a revised ISO standard got international approval in May 2013, the first update to that in a decade but something the FDA isn't required to follow. Interestingly, the FDA now appears to be calling for even tighter standards than those in the revised ISO guidelines. This is 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 last year:
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"I would say it is more stringent in some places and similar in others. We are not planning to recognize the new ISO document for several reasons, including that it did not go far enough to improve performance in the hypoglycemic range. We really tried to make sure our guidances didn't conflict with ISO, though (i.e., if you do what is in our guidance, you would also meet ISO, but not the reverse) because companies need to meet ISO requirements for marketing in some other countries."
FDA's draft guidance is now open for public comment through April 7, and everyone -- from industry, doctors and PWDs who use these meters -- are encouraged to offer thoughts on what they like or don't like about the new proposed standards. You can leave comments on the OTC meter accuracy document here, and on the professional meter standards here. Once public comment closes, there's no telling how long it might take the federal agency to finalize rules, but hopefully we'll see that happen within 2014!
We also heard this week that Delaware-based startup LabStyle Innovations have submitted for FDA for 510(k) approval of its little wireless Dario meter that 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 one bite-sized device, which plugs into the audio jack of your smartphone or tablet and communicates with a phone app. The meter's been launched overseas, so hopefully we will see it available to PWDs (people with diabetes) here in the States before long.
Aside from those headline-grabbing news nuggets, we're excited about the possibilities on tap for 2014. No, we don't have a crystal ball (even if that's kind of how I think my CGM works sometimes...), but we've between talking to companies and checking in on products already in the works, and have a number of items on our D-tech radar to share:
This is the integrated Animas insulin pump and Dexcom G4 Platinum, which you may remember was filed with the FDA back in April 2013. We were really hoping this could have hit the market by now, but we learned last fall that Animas was doing some more human factor and related testing at the FDA's request... and although 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 or so we'll finally have access to the long-awaited Animas Vibe that's been available in Europe since 2011.
Speaking of JnJ Diabetes...
We're still waiting to hear exactly when the LifeScan/OneTouch VerioSync glucose meter will actually be available after getting the FDA nod of approval last February. We and several others in the Diabetes Online Community have been able to get one to initially review, but the company's being coy on sales availability except to say it's expected by the end of the first quarter (see also: end of March). UPDATE: On Jan. 13, the VerioSync is now available for purchase to those using iOS devices here in the States.
Yes, we can't wait for this one! It's pretty much a docking station, but this device would be a way for Dexcom G4 data to be transmitted to the cloud and then sent to up to five different smartphones or tablets. This will allow parents, spouses, doctors or others to view real-time CGM results when the PWD wearing the CGM is in a different location (even across continents!). This Share device made its way to the regulatory review arena last July, and we're hoping that the FDA signs off on it soon. With the agency issuing mhealth guidelines in September 2013, there's even more reason to be optimistic that this could be coming sooner rather than later in 2014.
CGM Approval for Kids
Many are waiting to hear that these devices are approved for children with diabetes. Both Dexcom and Medtronic (with its September 2013-approved 530G system) are working diligently toward this, hopefully making good headway this year. Dexcom's already asked FDA for pediatric approval (as of Feb. 2013), so it seems likely we'll see the G4 get pediatric approval first (cross your fingers!). Medtronic is still gathering data on this, since kids weren't included in their initial clinical trials and the company got a finger-wag from the FDA to make this happen as soon as possible. So we hope to at least see a regulatory filing for MedT CGM pediatric use sometime this year.
*** UPDATE ***
On Feb. 3, the FDA approved the G4 for pediatric use in kids 2-17.
Novo's New "Smart" Pen
It was exciting to hear the news in August 2013 that Novo Nordisk received FDA 510(k) clearance for the NovoPen Echo, which would be the first insulin-delivery device of its kind here in the U.S. that not only doles out insulin in half units, but has a memory function that keeps track of injections and timing of doses. The small dosing increments are vital for kids and even some adults who are highly insulin-sensitive. And who wouldn't want a little extra help remembering if they actually took their insulin shot or forgot? Of course, this is a Novo device so it only makes sense that it's available only with Novolog insulin. On the fun side, the new pen device will offer all kinds of colorful skin designs 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. currently, but doesn't seem to have the States in its sights anytime soon.
*** UPDATE ***
On Jan. 21, the NovoPen Echo was released in the U.S.
This pump and CGM integration is also known as the t:sensor, as we learned in some recent news coverage. We're anxious to see Tandem ask for the FDA's OK on integrating with the Dexcom G4, something that was initially expected late last year but was delayed because of the California company's Initial Public Offering that happened Nov. 14. Sales reps were told to hold off on giving timelines about CGM integration, but Tandem assures us it's still a top priority for 2014 and the plan is to submit for FDA for approval ASAP. We also asked about device or software updates, 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 are committed to developing solutions for our patients that exceed their current 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 much easier than scrolling on other pumps." Yep, looking forward to seeing what 2014 has in store for the market's first Apple-esque insulin pump!
That Jewel Pump...
Remember the sleek-looking patch pump that first debuted in 2010 and we last updated you on in October 2012? This flat, oval-shaped patch pump will be detachable and usable for 7 days with 500 units of insulin; even smaller than the newest OmniPod generation; and will use new microfluidic MEMS (Micro-Electro Mechanical System) technology that's highly precise and puts all the brains of the pump into a tiny 2-gram microchip. Dr. Frederic Neftel, president and CEO of Switzerland-based Debiotech that makes the Jewel Pump, says most of 2013 was focused on finishing up clinical studies and getting development finalized. Now, he expects CE Mark approval by mid 2014 and potential FDA submission by year's end.
With news of the Dario meter being submitted for FDA review, there's also word of another "all-in-one" meter coming soon: the YoFiMeter, which is apparently being developed through a joint venture between Qualcomm and a San Diego startup called Gad Light (named after its creator Gad Shaanan). This isn't Qualcomm's first foray into the glucose monitoring world, as it's previously worked on the MyGlucoseHealth meter. But this YoFiMeter isn't related to that, according to Shaanan. He says the vision came from being surprised at the level of poor diabetes management tools for PWDs, and that his company could basically make D-Life easier and develop a line of products fitting into the "YoFiLife" umbrella. The first, being a meter.
Shaanan says this:
"The YoFiMeter is smaller and a bit thicker than an iPhone, and it has two cassettes inside: one with 20 test strips (half the length of a regular strip because you never touch them, other than to apply blood) and a cassette with 20 lancets. It has one button that activates the entire system, another that fires the lancet, and a third that disposes of the used strip. It has a touch color screen (as strange as it sounds, a novelty in the BGM world). And it has a sophisticated "recording device" built into the meter that does away with the need for any logbook. Basically, the meter automatically sends test results to the cloud, and the cell air time is integrated into the cost of the strip cassette so you don't need to subscribe with a carrier.
"We track your steps taken per day. We know how many strips and lancets are left in the meter, and we know how many cassettes you have left at home. We remind you that it is time to order more cassettes automatically. The BG results would be sent to the cloud for access via smartphone or tablet," he says. This tracking component is meant to address the needs of: parents with kids in school, elderly children with adult parents, diabetics that have a hard time being compliant, busy executives, soccer moms, construction workers who cannot just stop everything, find a table in a discreet location, unwrap their pouch and test."
... uh, the way they'd track physical activity and supplies is a little fuzzy, but we couldn't get any more detail on that, or on cost. In fact, details are tough to find on this meter, and it's a little odd that the only YoFiMeter site online at this time appears to have been set up for the Consumer Electronics Show happening in Las Vegas this week. But Shaanan says his hope is to get the meter to market in 2014. His team is wrapping up clinical trials and expects to file with the FDA in March, in hopes of getting market approval by the end of 2014. Of course, it sounds a little ambitious and is always dependent on the regulatory review process...
Roche Diabetes: Patch Pump & CGM?
We put inquiries out to Roche Diabetes Care about what may be on tap for 2014, especially given some of the hard times the Indianapolis company has seen recently... but sadly we didn't hear back. We're hoping that two lingering tech devices will make more progress this year: the Solo Micropump that Roche acquired from Medingo back in 2010, and the once-promised integration with Dexcom. There's been no update on that since early 2013 when Roche put CGM integration on hold. And there's also been nothing more to report on the Solo pump since mid-2012, when we learned that the FDA had approved an initial device for the U.S. but Roche wasn't going to sell it commercially because it didn't include an integrated blood sugar monitor of any sort, and therefore would be at a market disadvantage. There
was talk then of a 2013 introduction overseas of a combined CGM pump (with a built-in bolus calculator and ability to read CGM data), but there's been no word recently on where that stands or whether the Accu-Chek Combo system or Accu-Chek Insight insulin pump might be the basis for a new offering here in the States. Latest word from the EASD conference last fall: a possible European launch sometime in 2014, but given the delays on this to date, we're not holding our breaths.
*** UPDATE ***
After publication, we heard from Roche Diabetes Care about another new product they expect to hit the shelves in the coming months of 2014: the Accu-Chek Aviva Expert meter that got FDA approval in October 2013. This will be the first blood glucose meter system here in the States that includes an on-board insulin calculator -- so it will automate some of the calculations required for food and correction bolusing for PWDs not using insulin pumps! The Roche team tells it's expected to hit market by the first quarter of 2014.
We also didn't hear anything back from Medtronic, which has naturally been all caught up with the 530G approval these days. Sure, the 530G should start impacting the market and getting hooked up to more people in 2014, so that's something to note. But we were really hoping to hear more about the next phase: the next-generation Minimed 640G with glucose prediction capabilities, that was originally planned to launch in Europe in 2013, but ended up not making any headlines. We'll just have to see what happens next on that, perhaps with updates at some of the big diabetes conferences later this year (or possibly more detail will surface at the Medtronic Diabetes Advocates Forum happening this week)...
*** UPDATE ***
We also heard from Medtronic Diabetes after-the-fact, and they confirmed what we heard was said at the JP Morgan Healthcare conference in mid-January -- that the next-gen insulin pump and CGM with a predictive algorithm, was expected to see a European launch later in 2014, possibly in July. So, we'll keep our eyes peeled for that overseas!
Many eyes are on Afrezza inhalable insulin, which has been filed in the "pipedream category" for years but may be getting closer to becoming a reality after its creators at MannKind Corp. resubmitted a new drug application to the FDA in October. This isn't the first time the California company's gone to regulators, and twice before have been turned down (in 2010 and again in 2011), but maybe the third time will be a charm for the device that is named the Dreamboat Inhaler and fits in the palm of your hand -- as small as an asthma inhaler. Research seems promising and it looks to be best-suited for mealtime doses, where you'd get basal doses from an insulin pump or injection therapy with a quick-boost of the inhaled stuff to help stop any food-related blood sugar spikes. The FDA's expected to finish its review of Afrezza by mid-April 2014, so it's certainly possible that we could get access to this by year's end should regulators see enough data this time around.
Still no change from Abbott Diabetes Care when it comes to a potential launch of the Navigator 2 CGM in the States, so we're told. For its new Flash Glucose Monitoring next-gen sensing technology that was shown off at EASD this past fall, the company's still planning on CE Mark approval and a European launch this year. But sadly, there's nothing U.S.-specific on tap at this point. We're also still awaiting to hear anything more on who Insulet's mystery partner may be, in creating a future single-cannula OmniPod that would include not only insulin delivery but continuous glucose sensing... So, there's still lots to hope for.
We do expect more exciting news to materialize in the broad arena of diabetes and mobile health, especially following the FDA's final mhealth guidance release in fall. And of course we're keeping our eyes on interoperability and the many ongoing Artificial Pancreas trials.
We at the 'Mine like to call ourselves "skeptical optimists," so we're hoping that this year could be one that sees more progress than we've become accustomed to in the D-Community!