We're just returning home from the biggest diabetes conference of the year, and as always, our feet and minds are winding down from overdrive. The huge annual ADA conference never ceases to be overwhelming -- held in a major conference center spanning several blocks of city space (the meeting alternates between coasts), with no less than eight presentation tracks taking place simultaneously over five days, and a sprawling exhibit hall.
This year, roughly 16,000 scientists, physicians, and other healthcare professionals converged on the San Diego Convention Center between June 9-13 for the 77th Scientific Sessions. There were also more than 200 media folk in attendance (including us 'Mine editors and other patient bloggers), and that in part prompted one of the biggest stories to come from this gi-normous annual conference addressing new research and treatments in diabetes care.
Despite its pride in embracing social media (event nametags even touted the #2017ADA hashtag), the ADA has held on tightly to its policy banning attendees from sharing photos publicly. But this year, a huge Twitter storm erupted to "fight the power" and push for openness so that doctors and patients unable to attend can also hear and learn what's happening. The initiative was almost immediately successful, with ADA conceding they need to rethink their policies for next year. Ummm, yup... Those "Please delete this tweet" messages from the @AmDiabetesAssn feed need to cease and desist!
Moving on, here's our "reporter's notebook" of some themes we picked up on and product and technology news from the show floor:
Transparency, Beyond A1C, etc.
There was a lot of talk about transparency this year, in regards to Access and Affordability, and also re: conflicts of interest in the relationships between Pharma and healthcare providers and non-profits. In a session on Saturday, one presenter even called out doctors in the audience, asking "Who here isn't influenced by giveaways and lunches?" Which was met with uncomfortable chuckles. There was also recognition of patients feeling out of the loop on advancements and decisions that affect them (somewhat ironic given the photo ban issue).
Speaking of access and affordability, have you heard about Blink Health? This newly formed NY-based startup provides deep discounts on prescription drugs like never before, with 40% off Eli Lilly meds. Believe it or not, they're actually offering $10M worth of FREE type 2 medications for a year, or until the money runs out -- the three most prescribed T2 drugs metformin, glipizide, and pioglitazone. VERY COOL. Naturally, their red and white booth at ADA was buzzing! Note that we just read yesterday they've cut ties with Express Scripts, apparently because the PBM was not fully committed to offering patients the lowest insulin prices possible.
At ADA overall, we noticed many presenters and attendees taking on the language of “Beyond A1C,” i.e. talking much more about Time in Range as a meaningful measure, and how that can and should be standardized in some way. The next FDA meeting on #BeyondA1C is planned for July 21, 2017, btw.
On the tech side, we also noticed a lot of buzz about new smart insulin pens and insulin dosing apps -- both bolus calculators and titration apps hitting the market (more on that below).
A Subdued Exhibit Hall
In comparison to years past, the Exhibit Hall was certainly quieter, with fewer games, flashy “theaters” and swag giveaways (although One Drop was giving away their slick new meters!)
To be clear, the expansive exhibit hall still features hundreds of booths – from Big Pharma “mega-booth” spreads (where fresh custom cappuccino is on tap) to rows and rows of smaller booths featuring non-profits and “peripheral” exhibitors showing skin creams and orthotic shoes. You can still get your A1C tested on-site (if you don’t mind waiting in line behind a bunch of non-D doctors), and watch colorful product videos or attend an enthusiastic live tutorial in a “Product Theater” area with a booming mic. This year, Medtronic and Novo's Tresiba display were utilizing Virtual Reality to offer first-hand glimpses of their offerings.
But by comparison, it's much less of a party atmosphere than it used to be, which from a patient POV is actually a good thing.
OneTouch Via - Approved
Big news came in the days just before the conference, as JnJ LifeScan's OneTouch learned they had snagged FDA clearance for its meal bolus-only patch pump, the OneTouch Via! (formerly Calibra) They learned of the FDA 510(k) clearance on Wednesday June 7, and in the following two days created a big orange oval sticker for their Exhibit Hall signage saying "Just cleared!"
This is the ultra-slim skin-colored patch pump that's 3-day wear and can hold up to 200 units. It includes side buttons so you can dose without the controller, even through clothing.
Meanwhile, the company's still in the process of strategically evaluating its diabetes business lines -- LifeScan, OneTouch, Animas, and Via -- so nothing is finalized as to launch timing. But we're told the hope is end of 2017 at the latest, and we're also still awaiting word on whether the Animas Vibe Plus (their tubed pump integrated with the Dexcom CGM) will launch anytime soon.
Medtronic's Big Win
In numerous sessions, Medtronic was the talk of the tech world given FDA approval of the Minimed 670G late last year, the first hybrid closed loop that automates basal delivery (you still must punch in meal boluses) in order to keep you at target of ~120mg/dL. The company has been rolling this device out gradually over the past few months, and just before ADA, announced they'd be expanding the launch to everyone in their so-called "Priority Access Program" and to the larger market by Fall.
Of course the 670G is a big milestone for Medtronic, and they were proudly showcasing the device with a massive display. They also had the blinded iPro2 professional CGM on display at ADA, since it's a healthcare professionals' conference geared toward them.
Leading into this year's ADA conference, Medtronic also announced that its Guardian 3 CGM sensor is now FDA-OK'd for use with the Minimed 630G launched last year, and not just with the new hybrid closed loop being launched now. The next-gen sensor also comes with labeling for a slightly younger age bracket, starting at age 14 instead of 16.
Dexcom Receiver & Pipeline
The company was showing off its new touchscreen receiver, expected to launch in the August-September timeframe.
Also on Friday just before ADA news hit that FDA approved the G5 Mobile app for Android, which had many enthused.
In a meeting with Dexcom execs, we learned that this leading CGM company has gone from 400 employees 6 years ago to over 2,000 employees currently. Their Gen 6 sensor trials are underway, and the specifics of this system are exciting:
- it will use new sensor membranes and a new algorithm for improved performance
- it will block acetaminophen, so patients can finally take Tylenol without messing up their readings (!)
- it will include a new transmitter and smaller, easier inserter device
- it's designed for 10-day wear, with very little calibration required: only 2 within the first 12 hours, and then one per day from then on
- the new sensor will be 30-40% smaller
- they hope to file with FDA by Q3 of this year, and launch in 2018
Regarding future technology, they are of course working with Animas, Tandem and OmniPod on closed-loop system configurations. CEO Kevin Sayer tells us their first product co-developed with Google will be aimed at doctors treating patients with type 2 diabetes. A tiny new sensor code-named Fusion will be "smaller than Abbott Libre, at worst 20% the size of that," Sayer says. Wow!
If you're wondering what's going on with Medicare coverage of Dexcom CGM, here's the rub: CMS has mandated that Dexcom ship out to Medicare patients "everything they would need" to use the product. Since calibrations with a fingerstick meter are required, that means Dexcom has to find a traditional meter company to partner with to actually ship meters and test strips in the package with their CGM. Kinda crazy, and definitely creating delays for the company and its customers!
Last not least, an announcement of Dexcom-Apple Watch integration was made at the recent Apple developers conference -- meaning the CGM data will be beamed directly to your watch. Once this launches, patients can not only ditch the traditional receiver, but could even leave their phones at home and just monitor BGs on their wrist. Cool.
OmniPod DASH & Horizon
Insulet was showing off its DASH platform, which is basically a locked-down Android device that will eventually replace the PDM (controller unit) for its tubeless insulin pump. "Locked down” means the device will have no other regular cellular capabilities or other apps available, nor will it have an integrated fingerstick glucose meter like the current PDM. It also means that users will basically be carrying around two smartphones -- a lot to schlep, possibly confusing, and both requiring charging. On the upside, it will bring the long-awaited phone-as-controller functionality that lets users bolus and otherwise control their pump from a smartphone touchscreen.
The company announced an agreement with Ascensia (formerly Bayer) to connect the Contour meter to DASH via Bluetooth, which will use the readings to calculate and deliver the appropriate insulin dose. Insulet is still hoping for an end-2017 launch, depending on FDA consideration.
The Insulet folks tell us that DASH is an "interim step" to their full Pump+CGM closed loop system controlled directly from a regular (non locked-down) smart phone that they're calling OmniPod Horizon -- which they were also displaying via larger posters. We know from presentations at our own #DData17 event on Friday that the company is working very closely with the patient community in designing the new UI. They've even recruited a half-dozen members of the #OpenAPS DIY community to provide input. Horizon won't likely hit market for another year-plus.
"But why wait to give users the ability to use a phone as the receiver? That's an experience they want and we want to offer it as soon as possible," says Alissa Heizler-Mendoza, senior director of advocacy at Insulet.
In related news, Insulet is investing $150 million to open a new manufacturing plant in Massachusetts, creating at least 200 jobs and accelerating their production capability. Great to see this company thriving!
They say imitation is the sincerest form of flattery -- so it shouldn't surprise us that there were at least two Asian companies displaying patch pump+CGM systems with phone app/controllers that mimic the OmniPod Horizon pairing (shown under glass because they're not yet FDA approved). Both have a patch pump with 200 unit capacity, a CGM sensor with 7-day wear, controlled from a phone with a data app with cloud-based storage and sharing functionality:
Medtrum – had the biggest booth and seems to be furthest along. Their so-called P6 system, which we reported on in-depth last summer, consists of a disposable patch pump and a sensor that looks suspiciously similar to Dexcom’s.
Their pump is a little rectangle with the top portion being the “brains” and the insulin reservoir below. Unlike OmniPod, this two-part design allows users to actually disconnect for a period during sports or swimming and then reconnect, since the controller portion is what’s attached to the adhesive. The China-based company has already launched in Germany, France, and the UK, and will soon be hitting Turkey, Sweden and Italy, they tell us. They’re hoping to submit to FDA by the end of 2017 or early 2018 latest.
EOPatch – is launching in its home country Korea this year, and in Europe and the U.S. next year, their reps tell us, although they’ve not yet submitted to FDA either. This one’s a small rectangle full-featured patch pump that visually resembles the V-Go.
And a new CGM provider out of China, POCTech – touting its product with a brochure headline, “Innovative Leader of Diabetes Management.” Ahem… this “me too” product brags about its “tiny soft” .3mm sensor and accuracy but doesn’t seem to offer anything much unique.
In-Hospital Closed Loops
Just prior to the conference, T1DExchange announced investment in "breakthrough startup"Admetsys, the first company to develop AP tech for hospital and surgical care. The official collaboration with Admetsys is part of T1D Exchange’s multi-million-dollar initiative to support the development and delivery of Automated Insulin Delivery (AID) systems. Using Ademtsys, hospital staff can more effectively control blood glucose levels and alleviate some of the stresses (and errors!) associated with diabetic care while patients are hospitalized. Admetsys was actually a finalist and award winner in T1D Exchange’s inaugural Diabetes Innovation Challenge last fall.
Another company tackling a closed loop system for hospitals is Glytec, which also had a well-visited booth on the expo floor. They just unveiled a set of case studies showing millions in hospital cost savings with improved glucose control -- not to mention the benefits for patients. They also just announced a partnership with AgaMatrix to create a cloud-based diabetes management platform for in-clinic settings; AgaMatrix will be integrating their Jazz Wireless Bluetoothmeter with Glytec's FDA-cleared Glucommander software for evidence-based insulin dosing decision support. (Disclaimer: 'Mine editor Amy Tenderich sits on their Advisory Board, alongside Dr. Steve Edelman, Dr. Bruce Bode and others.)
This is all good news for improving the notoriously bad diabetes management in hospitals. You can read more about both of these companies' technology in our previous review here.
Non-Invasive Testing That Works
One of the most exciting things we saw on the expo floor was a company called DiabetOmics out of Oregon, which is poised to soon launch a new non-invasive BG control test and two "point-of-care" diagnostic tools that could change diabetes treatment!
The first is Glucema, a saliva test that measures your average glucose readings over the past 1-2 weeks. It's a little stick that collects a drop of saliva and provides an immediate result. It connects to a handheld reader device that records results and can transfer them to mobile devices, and an app that can track results and also the patient's insulin doses and other parameters, and provide "alerts for critical readings and adverse outcomes." TBD on exactly how the app works, but this non-invasive test -- with study results to back its accuracy -- looks pretty exciting!
The other two tests, which are also administered right in the clinic or physician's practice with no need to go to a lab, are:
Insudex, for early detection of type 1 diabetes and LADA (Latent Autoimmune Diabetes in Adults) -- a USB-stick-sized device that takes a fingerstick blood sample and provides results with 2-5 minutes. Those results show a variety of autobody levels including GAD and C-peptide that indicate T1D. Imagine, all those sophisticated results with just one drop of blood right in your doctor's office!
And finally Lumella - a similar test for detection of preeclampsia and gestational diabetes. Seriously, this could do away with the need for the traditional Oral Glucose Tolerance Test (OGTT) that requires drinking disgusting liquid and hanging around in a lab for hours. The company boasts high accuracy: "90% of subjects with a positive Lumella test in the first trimester will test positive with the OGTT at 24-28 weeks gestation."
All these are coming to market in early 2018, we're told.
More D-Tech to Watch!
* Bigfoot Biomedical - the closed-loop system developers have just acquired pen timer cap Timesulin, and its Bluetooth-enabled insulin pen dose capture technology. "The acquisition positions Bigfoot as the first company to simultaneously pursue insulin delivery solutions in both the insulin infusion pump and injection spaces. The addition of insulin pen dose capture technology will enable a future connected ecosystem... for insulin-requiring diabetes."
* Abbott Libre Flash CGM - there was a packed house in the Product Theater (detailed demo presentation) for the Abbott Libre Pro, the physician's blinded version of this revolutionary new type of continuous glucose monitor. No one quite knows -- or is telling -- why the holdup with FDA approval of the patient version, which was approved in Europe three years ago already. Needless to say we can hardly wait!
* Companion Medical's InPen - This reusable smart pen paired with an intuitive smartphone app is still ETA in 2017. There's a lot of excitement about bringing the coveted Bolus Wizard functionality of an insulin pump to pen users, as this device basically does the math for you, and allows you to gather data on your shots in the same way a pump user automatically has digital records of everything. The tagline is: "No more guesswork for MDI patients." Nice!
* Insulia from Voluntis - the first-ever FDA-cleared prescription basal insulin titration app for type 2 diabetes. Why is this exciting? Well, did you know that studies say 82% of T2 patients discontinue their Lantus or Levemir insulin treatment within 12 months? Insulia's companion app (Android or iOS) provides basal insulin dosing recommendations and educational messages based on blood glucose values for patients, and a web-based portal for doctors where they can configure personalized treatment plans based on the patient’s profile, prescription and BG targets. Insulia has also recently partnered with Livongo Health to bring this dosing support to users of that connected meter.
* DiabNEXT - lots of foot traffic in the booth of this new startup utilizing AI (Artificial Intelligence) to create a three-part system for tech-enabled diabetes care: a smart insulin pen cap called Clipsulin, compatible with all insulin pens; a data platform called GlucoNext, compatible with all glucometers; and a photo-based carb-counting tool called SmartCarbs, that really will be like the Shazam for Food, if and when it launches as envisioned. This China and Boston-based company won an innovation award at the Consumer Electronics Show (CES) in Las Vegas in January. Definitely one to watch!
* WellDoc Remade – remember this early text-based diabetes coaching service for type 2s? The company has completely revamped their offerings with thousands of coaching messages that cover treatment regimen, trending, and lifestyle insights. They also now offer a bolus dose calculator built into their “therapeutic products.” They currently have a small but devoted user base, but are hoping to expand greatly when their FDA-approved BlueStar app will be integrated into Samsung's new mobile health app starting this Fall.
* Remember also those Tru Metrix meters from Trividia? Well, they’ve launched a Bluetooth-connected meter called Tru Metrix Air (available at Walgreens and elsewhere) and are working with Glooko and Tidepool to offer data-sharing connectivity. “We’re open to working with a variety data partners,” the booth folks told us. “We’re starting here and hoping to build.” Hat tip: need instructions for pairing this meter with Glooko? Go here.
* Insupen needles out of Italy are hoping to give BD a run for their money with the tiniest pen needles ever. Somewhat surprisingly, given that the-smaller-the- gauge-the-larger-the-needle, their 33G version is already approved for sale in the U.S., while the larger 32G version is still pending FDA approval.
Thoughts? Questions? Additions?
Stay tuned for more of our coverage from this year's big diabetes conference, coming soon.