New Diabetes Tech on The Horizon: What’s Coming by Mid-2017 in the US?
By Adam Brown
By Lynn Kennedy, Ava Runge, and Adam Brown
What Abbott, Dexcom, LifeScan, Medtronic, Tandem, and others are bringing to make diabetes easier and less burdensome
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We’re living in the most exciting time ever in diabetes technology, and a slew of soon-to-launch products are going to subtract hassle from living with diabetes – fewer injections and fingersticks, less math, less data overload, less pain, and less worry. Equally important, most emerging technology shows excellent potential to improve glucose outcomes that matter, among them hypoglycemia, time-in-range, hyperglycemia, and A1c.
Curious what’s coming? Read on for a summary of the insulin delivery and glucose monitoring devices expected to launch in the US by mid-2017 or earlier, based on the most recent company timelines (listed chronologically). This list is not fully comprehensive, but does cover the major device launches expected. A more detailed description of each device follows further below.
New Insulin Delivery Devices
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Tandem’s t:slim X2 Insulin Pump – October-December 2016. The latest Tandem pump will add a new Bluetooth radio and enable software updates to add future Dexcom G5 connectivity and automated insulin delivery algorithms.
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New Glucose Monitoring Devices and Software
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Abbott’s FreeStyle Libre Pro (very soon) and FreeStyle Libre (potentially in early 2017). The blinded (Pro) version of the no-fingersticks-needed, 14-day glucose sensor should come to the US imminently, enabling healthcare providers to better understand glucose patterns. Abbott says the real-time version that’s been available in Europe could potentially come out in early 2017 in the US.
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New Insulin Delivery Devices – Deep Dive
Tandem Diabetes Care
t:slim X2 Insulin Pump
(launch expected October-December 2016)
What’s new? The t:slim X2 is a new insulin pump nearly identical to the t:slim, with the addition of a new two-way Bluetooth radio and a manufacturing change. Most notably, the X2 Pump will be capable of online software updates, enabling users to add Dexcom G5 integration once it is approved (expected mid-2017). As Tandem’s automated insulin delivery algorithms receive approval, these will be able to be added to the X2 Pump at home – no need to pay an upgrade fee for new hardware or wait four years for a new pump (it has not yet been determined if there will be a charge for some advanced algorithms, although G5 integration will definitely be at no cost). Tandem expects to launch a predictive low glucose suspend algorithm by the end of 2017, with a treat-to-target automated insulin delivery algorithm (also known as hybrid closed loop) to follow in 2018.
An upgrade program will enable current t:slim and t:slim G4 users to transition to the next-gen t:slim X2 Pump starting later this year. Read more here.
Medtronic
MiniMed Pro Infusion Set with BD FlowSmart technology
(US launch expected approximately late 2016)
What’s new? Medtronic’s new infusion set boasts BD’s FlowSmart technology, which adds a new side opening to the catheter to help insulin flow better. Having two openings for insulin to flow through helps prevent silent occlusions and flow interruptions, which can cause high blood sugars but go unnoticed. The set also has some key user experience changes, including the smallest insertion needle on the market, a sliding shield that covers the needle and contains it after insertion (preventing accidental needlesticks), and a multi-position connector that allows patients to connect tubing to the on-body set in eight different positions (no need to line it up).
LifeScan
OneTouch Via
(US launch expected early 2017)
What’s new? The bolus-only insulin delivery patch, OneTouch Via offers a discreet, wearable, on-demand option for mealtime insulin delivery for people with type 1 and type 2 diabetes. The very slim plastic device (two inches long, one inch wide, and a quarter inch thick) is worn on the skin for up to three days, holding up to 200 units of fast-acting insulin (Humalog, Novolog). Excitement about the OneTouch Via focuses on ease of use and increased discreetness: dispensed in two-unit increments, the small device is mechanically operated by pressing simultaneously on two small buttons – possible even through clothing. Read more here.
Medtronic
MiniMed 670G/Enlite 3 Hybrid Closed Loop System
(US launch expected by April 2017; currently under FDA review)
What’s New? The MiniMed 670G is a hybrid closed loop system that uses glucose data obtained from a continuous glucose monitor (CGM) to adjust basal insulin delivery via pump. The system targets a blood glucose level of 120 mg/dl and will use an updated Enlite 3 sensor that is much more accurate. While it is not fully automated or hands-off – it still requires carb counting, manual bolus corrections, infusion set changes, sensor wear, and calibrations, etc. – it has already been shown to reduce burden while resulting in much less hypoglycemia (low blood glucose) and hyperglycemia (high blood glucose), especially overnight. In a study, most participants on the 670G system reported waking up around 120 mg/dl every morning with no overnight lows. Study data additionally showed: users saw a 0.5% decrease in A1c (from a starting level of 7.4%), including a 1% A1c improvement for those starting at over 7.5%. At the same time, users saw a dramatic 44% reduction in time spent in hypoglycemia (low blood glucose), greater time-in-range, and tighter glycemic control (less variation in blood glucose). The results were particularly strong overnight and in adolescents.
The 670G will follow on the heels of the just-released 630G, which uses the same pump platform but doesn’t have the hybrid closed loop component (read more here). Both devices bring long-awaited waterproofing, color screens, and remote meter bolusing.
Companion Medical
InPen
(launch expected in 2017)
What’s New? After recently securing FDA approval, Companion Medical’s sleek InPen, free of screens and buttons, is expected to launch sometime in the new year. The reusable, Bluetooth-enabled smart insulin pen – cleared for use with Novolog or Humalog – will automatically track insulin doses, sending data via Bluetooth to a paired smartphone app compatible with the iPhone and likely with Android devices. The apps will include a bolus calculator, automatic insulin-on-board tracking, dose history, and insulin temperature (if it gets too hot or cold, prompting the alarm) among the available data – finally bringing digital diabetes technologies to non-pump users!
New Glucose Monitoring Devices – Deep Dive
Abbott
FreeStyle Libre Pro (professional, blinded version)
(FDA approval expected very soon)
FreeStyle Libre Pro has been under FDA review for more than a year and approval is expected very soon. Libre Pro consists of a tiny glucose sensor (less than a quarter-inch long, about the thickness of a hair) worn under the skin for 14 days and connected to a water resistant, on-body patch slightly larger than the size of a quarter. This version is used to help healthcare providers and researchers track an individual’s blood glucose trends over a longer period of time. After applying Libre Pro in the doctor’s office, it is worn for two weeks, during which time the sensor automatically records glucose values every 15 minutes. There is no receiver and the wearer does not have to enter any fingersticks – the system is factory calibrated and collects data in the background. The sensor data can then be downloaded during a visit with a healthcare provider, allowing for discussion of glucose trends and changes in therapy.
FreeStyle Libre (consumer, real-time version)
(FDA submission expected in early 2017)
What’s New? The FreeStyle Libre Flash Glucose Monitoring System (real-time, consumer version) has been available in Europe for two years now, where over 125,000 people are using the device. The same sensor as described above is used, but it comes with a handheld reader device (or Android app) for viewing real-time data and trend information. The 14-day sensor does not require fingerstick calibrations – after putting it on the upper arm and waiting one hour, it begins reading glucose and trend information. Read our very detailed review from 2015 here.
One Drop
Premium service with unlimited strips
(US launch expected October 2016)
What’s New? One Drop recently announced the upcoming launch of One Drop Premium, a monthly subscription service for people with diabetes. For about $30-40 per month, users will receive access to unlimited test strips (One Drop delivers test strips based on usage), a Bluetooth-enabled blood glucose meter (One Drop Chrome), 24/7 in-app coaching from a Certified Diabetes Educator, and a personalized diabetes education program within the One Drop mobile app.
The One Drop Chrome meter is currently under FDA review and is expected to start shipping in October 2016. The Premium service will be offered on both Apple iOS and Android devices; the iOS app launched in April 2015, and One Drop Android is expected to launch by early October 2016. For more about the app, read past diaTribe coverage here.
Medtronic
Android MiniMed Connect
(launch in Fall 2016)
What’s New? After this launch, Anroid users will finally be able to use MiniMed Connect, which sends pump and CGM data via a “relay” device to a smartphone app using Bluetooth (the original 2015 FDA clearance was only for Apple devices). The “relay” device is about the size of a car key fob and can be recharged with USB. Caregivers with any type of phone can then receive alert notifications (low blood glucose, pump alarm, etc.).
mySugr
Accu-Chek Connect Integration
(US launch expected in Fall 2016)
What’s New? A partnership between mySugr and Roche Diabetes Care is bringing direct integration of Roche’s Accu-Chek Connect blood glucose meter to the popular diabetes tracking app – mySugr Logbook – used by nearly 800,000 people in over 50 countries on both Apple iOS and Android devices. After checking blood sugar with the Accu-Chek meter, data will automatically transfer to the mySugr app, no need for cables or manual entry. The best part? Users will receive the Bluetooth-enabled Accu-Check Connect meter and access to mySugr pro (normally $2.99 per month) for free. Read here for more information. [A mySugr and Abbott partnership recently went live, allowing Abbott FreeStyle Libre data to sync directly with the mySugr app; other data integration launches are expected in coming months – details to come].
In addition, a limited US launch of a new coaching feature went live in September 2016. For an introductory price of $19.99 per month ($39.99 ongoing), users have access to remote coaching services from certified diabetes educators like Gary Scheiner. The coaching leverages the extensive capabilities of mySugr Logbook, allowing users to share diabetes data and communicate electronically with coaches from anywhere. Watch the video here.
Medtronic
Sugar.IQ with Watson (formerly known as Medtronic/IBM Watson app, first-gen)
(launching late 2016)
What’s New? In April 2015, Medtronic announced a partnership with IBM and the Watson supercomputer (the same one that won Jeopardy) to leverage Medtronic’s expertise in diabetes and IBM Watson’s analytical and computational skills. Sugar.IQ, the first app product of their collaboration, will analyze data retrospectively to uncover blood glucose patterns and share insights. A future version of the app will add a hypoglycemia prediction feature to warn users of impending low blood sugars up to hours before they occur.
Dexcom
Touchscreen Receiver
(possible launch late 2016)
What’s New? This new receiver will be more durable (i.e., less susceptible to wear) and will offer a better user interface in line with the G5 mobile app. To address recent issues with receiver speaker malfunction, Dexcom has also received FDA approval for a more robust speaker component for the current receiver.
Android version of G5 Mobile
(US launch in late 2016 or early 2017; international launch in several markets in fall 2016)
What’s New? This new feature will (finally!) allow Android G5 users to see glucose trends on their phone screen, similar to Dexcom’s current app for Apple users.
One Button Insertion Device and 50% Smaller transmitter
(Possible launch in 2017)
What’s New? This will dramatically improve the process of inserting a CGM sensor (less painful and intimidating) and will decrease the amount of skin covered by the device.
Enhanced G5 mobile app
(possible launch in 2017)
What’s New? The enhanced G5 mobile app will be able to receive insulin dose data from other devices. This will allow users to better interpret their glucose trends and dosing based on insulin they already have “on board.”
(FDA discussions underway; no timing)
What’s New? Following the very positive July 21 FDA meeting in which an advisory panel voted in favor of a label update for G5 that would allow users to dose insulin based on the readings, Dexcom is now speaking with the FDA on the user and healthcare provider training and post-approval study needed. It is not clear when this will wrap up. Read more on the FDA panel vote here.
Medtronic
Guardian Connect mobile CGM with Enlite 3
(launch expected by April 2017; under FDA review)
Guardian Connect sends CGM data directly from an on-body transmitter to an iPhone app via Bluetooth – no pump or receiver required. It boasts the new, more accurate Enlite 3 sensor. This launch will open up Medtronic CGM technology to a wider audience, especially people not on insulin pumps.
Roche
Accu-Check Guide Blood Glucose Monitor
(US launch expected in 2017)
What’s New? Resembling Accu-Check Connect, the new Guide blood glucose monitor adds a spill-resistant strip vial (making it easy to remove one at a time; less contamination), a new – and reportedly more accurate – strip design, Bluetooth compatibility with the Connect Apple and Android apps (including an integrated insulin bolus advisor), and on-meter high and low glucose pattern detection. The new strip design boasts innovative chemistry that lessens effects of interfering molecules, temperature, and humidity.
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[Photo Credit: Adam Brown]
