Weâ€™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 â€” 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.
Moving on, hereâ€™s our â€œreporterâ€™s notebookâ€ 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 â€œWho here isnâ€™t influenced by giveaways and lunches?â€ 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, theyâ€™re actually offering $10M worth of FREE type 2 medications for a year, or until the money runs out â€” 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 theyâ€™ve cut ties with Express Scripts, apparently because the PBM was not fully committed to offering patients the lowest insulin prices possible.
On the tech side, we also noticed a lot of buzz about new smart insulin pens and insulin dosing apps â€” 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 â€œtheatersâ€ 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 â€“ from Big Pharma â€œmega-boothâ€ spreads (where fresh custom cappuccino is on tap) to rows and rows of smaller booths featuring non-profits and â€œperipheralâ€ exhibitors showing skin creams and orthotic shoes. You can still get your A1C tested on-site (if you donâ€™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 â€œProduct Theaterâ€ area with a booming mic. This year, Medtronic and Novoâ€™s Tresiba display were utilizing Virtual Reality to offer first-hand glimpses of their offerings.
But by comparison, itâ€™s much less of a party atmosphere than it used to be, which from a patient POV is actually a good thing.
OneTouch Via â€“ Approved
This is the ultra-slim skin-colored patch pump thatâ€™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 companyâ€™s still in the process of strategically evaluating its diabetes business lines â€” LifeScan, OneTouch, Animas, and Via â€” so nothing is finalized as to launch timing. But weâ€™re told the hope is end of 2017 at the latest, and weâ€™re also still awaiting word on whether the Animas Vibe Plus (their tubed pump integrated with the Dexcom CGM) will launch anytime soon.
Medtronicâ€™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 theyâ€™d be expanding the launch to everyone in their so-called â€œPriority Access Programâ€ 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 itâ€™s a healthcare professionalsâ€™ conference geared toward them.
Leading into this yearâ€™s ADA conference, Medtronic also announced that its Guardian 3 CGM sensor is now FDA-OKâ€™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
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
- itâ€™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 â€œsmaller than Abbott Libre, at worst 20% the size of that,â€ Sayer says. Wow!
If youâ€™re wondering whatâ€™s going on with Medicare coverage of Dexcom CGM, hereâ€™s the rub: CMS has mandated that Dexcom ship out to Medicare patients â€œeverything they would needâ€ 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 â€” 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. â€œLocked downâ€ 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 â€” 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 â€œinterim stepâ€ to their full Pump+CGM closed loop system controlled directly from a regular (non locked-down) smart phone that theyâ€™re calling OmniPod Horizon â€” 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. Theyâ€™ve even recruited a half-dozen members of the #OpenAPS DIY community to provide input. Horizon wonâ€™t likely hit market for another year- plus.
â€œBut why wait to give users the ability to use a phone as the receiver? Thatâ€™s an experience they want and we want to offer it as soon as possible,â€ 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 â€” so it shouldnâ€™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 theyâ€™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 â€“ 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 Dexcomâ€™s.
Their pump is a little rectangle with the top portion being the â€œbrainsâ€ 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 whatâ€™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. Theyâ€™re hoping to submit to FDA by the end of 2017 or early 2018 latest.
EOPatch â€“ is launching in its home country Korea this year, and in Europe and the U.S. next year, their reps tell us, although theyâ€™ve not yet submitted to FDA either. This oneâ€™s a small rectangle full-featured patch pump that visually resembles the V-Go.
And a new CGM provider out of China, POCTech â€“ touting its product with a brochure headline, â€œInnovative Leader of Diabetes Management.â€ Ahemâ€¦ this â€œme tooâ€ product brags about its â€œtiny softâ€ .3mm sensor and accuracy but doesnâ€™t seem to offer anything much unique.
In-Hospital Closed Loops
Just prior to the conference, T1DExchange announced investment in â€œbreakthrough startupâ€Admetsys, the first company to develop AP tech for hospital and surgical care. The official collaboration with Admetsys is part of T1D Exchangeâ€™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 Exchangeâ€™s inaugural Diabetes Innovation Challenge last fall.
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