It's a New Year's tradition here at the 'Mine to look ahead at the new technology and tools we expect to see coming down the pike in the year ahead.
Even before the calendar rolled over, we knew 2017 would be a big year -- with the market launch this Spring of the first-ever hybrid closed loop system from Medtronic. This ushers in a new era of Artificial Pancreas tech, and that's just one of the exciting developments we can expect this year.
We've been listening to earnings calls and talking with company execs, industry insiders and PR teams to get a sense of what else is on the horizon, compiled in the following report.
'Artificial Pancreas' Systems
Medtronic's Minimed 670G: Approved by the FDA in September 2016, this "hybrid closed loop" will be a first-of-its-kind system that can adjust insulin delivery accord to CGM values to keep users as close as possible to a set target of 120 mg/dL. The device itself will have a vertical design format with color screen. While it unfortunately doesn't accommodate data-sharing (!), the Minimed 670G uses the new Guardian 3 CGM sensor that MedT claims has improved accuracy and reliability. The system is set up to communicate directly with the Bayer Contour Link 2.4 fingerstick meter that Ascensia introduced in 2016, allowing for remote bolusing from the meter. Read our full coverage for more details on the 670G. In terms of launch date, so far Medtronic has only said "early 2017."
Tandem's First-Gen Automated Insulin Delivery (AID): Makers of the t:slim insulin pump have plans to get their own first-generation closed loop system to market by end of 2017. This one will feature the Predictive Low Glucose Suspend (PLGS) that in many ways mirrors what the MedT system will have first. The Tandem Diabetes Care pipeline site maps out the current state of affairs and what the company plans to roll out over the next few years.
Other APs: Yes, we're also watching numerous other exciting closed loop projects -- Bigfoot, iLET, and more -- but don't expect much to materialize on those in 2017 beyond just continued R&D.
Beyond its closed loop work (or maybe overlapping, depending on whom you ask), Medtronic tells us they're working on a "holistic" approach that will connect CGM, mobile apps and data analytics together into one package. Spokeswoman Pam Reese says this about what to expect in 2017:
Stand-Alone CGM: "Our first step will be a stand-alone CGM system that provides people on insulin injections with access to real-time data from a sensor right to their smartphone. The system will also have customizable text alerts enabling care partners to receive high and low glucose alerts on their phones. In addition, the systems will have the option of automatically linking daily uploaded sensor information to CareLink Professional software, giving healthcare providers the data they need to support care for people with diabetes and make therapy adjustments, as needed. This would give clinicians much more granular data on glucose trends, helping them see new patterns that can help them better optimize therapy for people with diabetes."
Sugar.IQ App: "An example of how this data could be leveraged comes from our work with IBM Watson Health to develop a first-of-its-kind cognitive app that helps to detect important patterns and trends for people living with diabetes. The Sugar.IQ app will use IBM Watson analytics to find patterns in diabetes data and offers real-time, actionable and personalized insights when they matter so that people with diabetes can have more freedom to simply enjoy life. The app will provide individualized guidance in understanding and managing daily diabetes management decisions by bringing relevant diabetes data and insights into a single platform."
We weren't able to ascertain specific timelines for either of these new tools, but we're hoping to hear more by the time the ADA's annual meeting rolls around in June.
An innovation leader, Dexcom has been working to commercialize a handful of exciting new tools. The first three have already been submitted to the FDA, while we expect to see the fourth bullet point filed with FDA in the coming months:
- Touchscreen receiver: this is pitched as an upgraded version of what’s currently offered in the Dexcom Receiver and will improve on durability and speaker issues.
- New one-button insertion device: expected at some point mid-year. From prototype images we've seen, it appears to resemble the Medtronic Enlite sensor inserter that can be operated with one hand.
- Reduced-size G5 transmitter: will be more compact than the current G5 and even smaller than the previous G4 model.
- Next-generation G6 sensor: thanks to the exciting Dosing Claim that Dexcom received from FDA in December, the company's planned 2016 filing of this new sensor was delayed, but this will hopefully happen in early 2017, with a potential launch by year's end. The G6 will be a true leap forward in CGM tech with 10 days of wear instead of the current 7, only one daily calibration required instead of two, and improved accuracy and reliability. Given how quickly the FDA has moved on D-tech in recent years, we're optimistic!
Abbott Freestyle Libre
We expect Abbott's novel FreeStyle Libre Flash Glucose Monitoring (FGM) tech to finally make its way to the U.S. during 2017. This system combines fingerstick testing and existing CGM (continuous glucose monitoring) with a splash of non-invasive tech. That is, it consists of a little round white sensor worn on the skin, and a "receiver" that looks similar to a handheld PDM, which you wave over the sensor to wirelessly pick up glucose readings.
You can do this as much or as little as you might want, making it a potential way to eliminate the need for expensive test strips without committing to a full CGM device if you wish.
Abbott received FDA clearance on the professional version of Libre for doctor's offices earlier in 2016, and the company filed its submission for the personal home version in 2016. So, it's only a matter of time... And the patient community is psyched for this!
Vibe Plus: That's the new name of the next-gen pump from JnJ, as the company has taken Animas out of the name and appears to be consolidating everything under the OneTouch brand. The FDA approved this on Dec. 16, only about six months after the regulatory submission!
Some key features: Still holds 200 units (as does the previous model), it's waterproof and is compatible with Glooko-Diasend data-sharing software. It doesn't have a meter remote as the Ping once did and you won't be able to update this device from home, but JnJ tells us "remote updating capability is an aspect that we are factoring into future generations." The Vibe Plus comes in 5 different colors (blue, black, silver, pink, and lime green) and has eight color skins to personalize the device.
A JnJ spokeswoman tells us they're still evaluating launch timing, and what will be offered as to upgrade programs.
OneTouch Via: Yep, this one (formerly called Calibra Finesse) is a wait-and-see after we didn't get it as expected during 2016. This is a bolus-only, wearable insulin patch device with a very flat profile that can be worn on the body for up to three days. It holds 200 units of fast-acting insulin and allows PWDs to take two-unit boluses by pushing buttons right on the patch, without the need for a separate controller unit. This patch pump alternative was FDA approved way back in 2010 for both T1 and T2 diabetes and eventually bought by J&J in 2012, but it never materialized and seemed to slip into oblivion... until now! Expect to see this by mid-year, assuming JnJ gets its ducks in a row to launch this product.
We expect to have first glimpses of the new OmniPod PDM, dubbed "DASH," by the summer when the annual ADA Scientific Sessions are held.
During a November investor day, Insulet detailed the new Bluetooth-enabled OmniPod it plans to debut later this year.
The tubeless pod will retain the same form factor, but will have Bluetooth Low Energy wireless capability built in to allow for communication with the new color touchscreen PDM. This will also allow for communication with any BT-enabled fingerstick meter, but that means the next-gen OmniPod DASH won't have a built-in FreeStyle glucose meter like the current Pods have -- which may be a big downside for many users who love this combo device.
On the bright side, the new BT-enabled Pod and PDM will be able to talk directly with a smartphone app so users can track features like Insulin on Board (IOB), dosing records, BGs, and CGM data both on the new PDM and on their smartphone screens. The new PDM sports an improved food database for logging carbs, and you can manually enter BG and other data using a nifty touchscreen wheel. The new touchscreen will be what Insulet says is a "locked down Android" device, one that's locked down so other cellular data won't interfere.
Thanks to its new X2 pump platform, Tandem is now offering able to offer remote updating users the ability to update their devices from home (without needing to upgrade and trade out devices, as is the current D-device model). This technology also readies their system for integrated with the Dexcom G5, which the company is expected to file with FDA soon, in hopes of a mid-2017 launch. Their combo system will also include the Predictive Low Glucose capability, and existing users will also be able to update their devices to allow that functionality once approved.
New Glucose Meters
We're expecting a number of meters to hit the market in 2017, but two in particular that stand out come from Ascensia (formerly Bayer) and Roche Diabetes Care -- both of which were announced over the past several months. We reported on the new Accu-Chek Guide meter expected sometime this year, which looks pretty much the same as their existing device but has some cool new features, including a spill-resistant test strip vial! We were also stoked to hear about the new Bluetooth-enabled Ascensia Contour Next ONE meter just recently approved, that links to an app to identify patterns and trends, expected to launch in 2017.
Of course, with the new Dexcom dosing claim where fingerstick tests are no longer so necessary for CGM users, and with the introduction of the FreeStyle Libre here in the States soon, we have to wonder just how long the traditional glucose monitor market will continue to grow...?
Smart Insulin Delivery Tech
A few months back, we reported on Becton Dickenson's analyst day when it announced two new innovations it has in the works:
Patch Pump for Type 2: This will be a fully disposable, three-day wear pump offering both basal and bolus dosing. Few details are available yet, but expect to see this at some point in Fiscal Year 2017.
Smart Pen Needle Technology: They're also talking about Bluetooth-enabled pen needles that allow for dosing data to be shared, as BD works to bring more interconnected diabetes management into its product portfolio. These in-development pen needles will work with all types of insulin pens, BD says.
And on that note...
- Contains computer chip technology built right into the base, including Bluetooth LE wireless capability
- Is refillable using either Lilly or Novo insulin cartridges (the only two types of insulin available in cartridges here in the U.S.)
- Includes a temperature sensor built into the pen that sets off an app alarm if the pen's temp dips below freezing or above body temperature, ensuring that your insulin is intact
- Collects users' data and transmits it to an app that contains a dose calculator, and also calculates real-time insulin on board (IOB)
- Smartphone app also allows users to set up reminders for meal and snack times, and if you haven’t dosed by the end of the set time window, the app will alarm
- Allows remote monitoring – users can set the app to automatically text message their dosing info to up to 5 people. This can include not only every insulin dose, but also BG and carb values (if entered manually) -- all compiled into a single text message
In late July 2016, the FDA cleared the InPen for ages 12 and older. Companion Medical’s co-founder and CEO Sean Saint says the San Diego company plans to launch this smart pen "sometime in 2017."
Without a doubt, a lot more is happening out there for 2017 on the research side, and on the advocacy front when it comes to important issues like Access and Affordability. As always, we'll do our best to keep you all in the loop!
So tell us, Diabetes Friends: What do you have your eyes on for 2017?