For updated coverage on the diabetes technology landscape, here is a look at what to expect during 2021.
The arrival of a new year always brings heightened hope for new advancements in diabetes tools and care. This year, the tech-spectations are especially high, as we’re on the cusp of seeing a boom in closed loop systems that partially automate insulin delivery (aka Artificial Pancreas tech).
Our team at the ‘Mine has been listening to industry earnings calls, talking with company insiders, and generally “reading the tea leaves” about what’s on the horizon. Here’s a roundup of what we expect to see materialize in diabetes technology in 2020, with some of our own insights and observations sprinkled in:
Tandem Diabetes Care
Control-IQ: FDA approval of this new tech from Tandem was the big end-of-year story for 2019. Control-IQ becomes the most advanced commercial closed loop system available. Tandem will be rolling it out starting in mid-January 2020, along with a new mobile app that will enable auto-uploads of diabetes device data to its t:connect web platform. We’re told that new features for that mobile app will be gradually unveiled starting in mid-2020, including data display and integration of other health data; eventually, they will offer full mobile phone control of the t:slim X2 insulin pump via the app! See our full coverage of Control-IQ here.
t:sport mini-pump: 2020 may also bring a new Tandem mini pump dubbed “t:sport.” It will be a hybrid of sorts, roughly half the size of the t:slim X2 pump and without any display screen at all. Notably, it would be the first patch pump style option beyond Omnipod and includes a side-button for a quick insulin dose from the device itself. The t:sport will have a stick-to-your-body adhesive part on the back, but would detach and also the t:slim’s trademark pigtail insulin tubing that attaches to the infusion set for insulin delivery. Now that Control-IQ is approved and being launched, Tandem is pushing forward on filing the t:sport for FDA review in mid-2020. The hope is to give customers a choice of how they want to use it: either via smartphone app, or a separate receiver device. The first FDA filing mid-year will center on the handheld receiver, while a later 2020 filing will focus on the mobile app control of the device. All of that depends on FDA decision-making, but we’re optimistic given Tandem’s success getting Control-IQ out the door.
Omnipod Horizon Closed Loop: Hoping for a commercial version of a closed loop system with a patch pump? This may very well be the year for Insulet Corp. to launch its official closed loop system called Omnipod Horizon.
In 2019, the insulin patch pump company launched its precursor Omnipod DASH version, and we also saw a Do-It-Yourself version of Loop emerge that’s compatible with the Omnipod tubeless pump. We’re excited to see an “official” version of this system with potential smartphone mobile app control hopefully coming soon this year. Insulet says it expects to file mid-year, with a hopeful approval and limited launch by end of 2020 and a full commercial launch in 2021.
Medtronic Diabetes Closed Loop
Advanced Hybrid Closed Loop (AHCL, or 780G): Announced around the ADA Scientific Sessions in June 2019, this next-gen “Advanced Hybrid Closed Loop (ACHL) system” will have the basic form factor of the company’s 6-series models with a vertical “modern” look, compared to the older models with a horizontal design that resembled 1980s pagers.
The 780G will use a new algorithm the company says is more accurate and reliable. It will provide automatic correction bolusing, will automatically adjust for missed meals, and allow an adjustable glucose target down to 100 mg/dL (compared to the 670G’s set target at 120 mg/dL). It also aims to achieve 80% user Time in Range compared to the existing 71% TIR shown in data on the 670G.
Importantly, this BLE-enabled pump-CGM combo will allow for remote software updating — as offered by Tandem’s t:slim X2 — so users won’t be required to buy a whole new device every time new features are launched. It will also have the built-in BLE necessary for data-sharing connectivity. Medtronic says they’ve already submitted the BLE-connected component of that device to the FDA. Clinical trials are ongoing (see here and here) and should wrap by mid-2020. The company’s initial target of April 2020 appears overly ambitious, since the 780G pivotal trial isn’t expected to complete until mid-year. Still, if Medtronic files this device, we could see it launch by the end of 2020.
Note, too: Previously, Medtronic had indicated it had plans to launch a BLE-enabled version of the 670G allowing for remote-sharing and data display via mobile app. However, MedT has now said that they are no longer planning for that connected 670G-version and will instead focus on bringing the 780G with built-in BLE to market ASAP.
Abbott Diabetes Care
Libre 2.0: We’re still waiting on this one after the company submitted it to regulators at the start of last year. This next-gen version of the FreeStyle Libre Flash Glucose Monitoring (FGM) system includes a little round disk-sized sensor worn on the arm that you scan with a receiver device to get glucose readings. The Libre 2.0 will bring optional alerts via Bluetooth Low Energy (BLE) that alarm if you’re out of range, to prompt you to do a fingerstick check to confirm an actual Low or High reading.
We’ve heard the holdup has been the FDA considering whether to grant this device the
Dexcom is targeting a late 2020 initial launch of its next-gen G7 model, which has been in the works for several years as a collaboration with Verily (formerly Google Life Sciences). While details are still scant, Dexcom’s hinted at some big revisions to what the G7 will offer:
Extended Wear of 14-15 days: This adds four to five additional days compared to the current 10-day wear of the Dexcom G6. As with the G6, no fingerstick calibrations will be required.
Fully Disposable: Unlike Dexcom CGM models to date, the G7 will be fully-disposable, so you won’t have a separate transmitter with a three-month battery life. Instead, the sensor and transmitter will be fully integrated and once the sensor’s run is finished, you’ll dispose of the whole integrated unit.
Thinner: Dexcom says the G7 will be the thinnest generation of its CGM sensors yet, but the company hasn’t released any specific detail on measurements or design.
Decision-Support: While we haven’t seen this integrated yet into existing G6 tech, that’s still possible and will likely be weaved into the future G7. Dexcom has talked about this before, on wanting to expand CGM use for more type 2s as well as beyond those with diabetes. Given Dexcom’s acquisition of TypeZero and how that’s now in-house, it stands to reason we would see more software features like dosing assistance and interaction being included in the Dexcom CGM offerings as we move forward.
Dexcom hasn’t yet filed the G7 with FDA, but as of its Q3 earnings call in November 2019, they say they’re planning for a limited launch in late 2020 followed by a more broad commercial launch in 2021. The California company has been increasing its production capacity for the past year with G6, and says it’s paving the way for a smooth launch of its next-gen product.
Of course, the company is also working to address the server outage problems that came up twice in 2019 — once over the 2018-2019 new year holiday and a longer stretch over the Thanksgiving 2019 holiday weekend. CEO Kevin Sayer issued a YouTube apology for that toward year’s end, noting specifically that engineers are accelerating a plan to implement in-app notifications in case of any data-sharing outages in the future. Dexcom says it’s also planning to update the company website with a landing page showing 24/7 system functionality updates.
Eversense Implantable CGM
Mobile App: As of late 2019, this 90-day implantable CGM from Senseonics now has a “dosing claim” from FDA — meaning that along with Abbott Libre and Dexcom, it doesn’t require fingerstick calibrations to confirm readings before dosing insulin or making other treatment decisions. Strangely, the company’s new mobile app still requires two calibrations per day to ensure continuous accuracy over the 90-day sensor life, but “the new app also allows flexibility with your calibration times,” Senseonics says.
Longer Wear: We’re waiting on word about U.S. availability of a longer-wear 180-day sensor (available outside the USA as Eversense XL). This means users only need to have it implanted and replaced every six months, compared to every three months as is currently the case. Senseonics says it expects regulatory approval soon with an anticipated launch in 2020.
Bluetooth Connectivity for Afrezza
Hello, BluHale! MannKind Corp., makers of Afrezza inhaled insulin, tell us they’ll be launching a BluHale Pro in 2020, specifically for healthcare providers. This add-on adapter will allow the Afrezza inhaler device to feature connectivity.
While it won’t include dosing data initially, the BluHale Pro will monitor inhalation technique for doctors to use in training new patients. The unit is compatible with Android, iPhone and Microsoft devices. It flashes a green light if the Afrezza is inhaled properly and a red light if not. Doctors can view the tracked data on these instances and then offer their patients advice on how to best use Afrezza. BluHale will eventually be able to track and share dosing data as well.
MannKind’s CEO Michael Castagna says they also plan to start their Phase 3 pediatric trial soon, which is the last step before pursuing regulatory OK for Afrezza use in children.
Xeris Glucagon Pen
Gvoke HypoPen: In Fall 2019, Chicago-based Xeris got FDA approval for the world’s first ready-to-use stable liquid glucagon emergency pen, like an EpiPen for diabetes rescue. But the company opted to launch its prefilled syringe option first, before the single-use HypoPen — which is now expected in July 2020.
The much-anticipated auto-injector version contains a 6mm needle, but you’ll never see the needle, as the pen is self-contained for quick one-time use and disposal. In stark contrast to existing glucagon kits, it’s an easy two-step process to use: just pull off the red cap and push the Gvoke HypoPen down on the skin for five seconds, until the window turns red. That’s it! Then the pen auto-retracts and locks so it can’t be used again. The non-insurance cash price will be $280 per injector, same as the pre-filled syringe.
Lilly Connected Pens, and More
New Connected Pen: In December 2019, the FDA approved Lilly’s prefilled, disposable insulin pen intended to be the foundation of their new pen-based connected digital platform. The company says it’s working closely with the FDA to determine regulatory requirements for additional components of the platform, including the attachment that will transmit insulin dosing data from the pen to a mobile app. Eventually, this will work with the Dexcom CGM (continuous glucose monitor), as the two companies just signed an agreement to that end. It will all be launched together once the FDA OKs the connected pen platform.
Lilly also tells us that at the upcoming ATTD conference happening in Madrid in late February, they’ll present research on “a potential mobile app that would provide personalized proactive guidance… around exercise.” That will be part of their “larger Connected Care program.”
Ultra-Rapid Lispro Insulin (uRLi): This is a new even-faster acting mealtime insulin. Recent clinical data shows that uRLi clocked in at 13 minutes compared to Humalog and other meal-time insulins that took as long as 27 minutes to start impacting glucose levels. It also reduced post-meal spikes more dramatically. Lilly submitted URLi to regulators in the US as well as Europe and Japan during 2019, and the Pharma giant is expecting regulatory approval in all three markets in 2020.
New Hybrid Patch Pump: Lilly’s hybrid closed-loop system remains in development, and the company plans to present early feasibility data on that soon. While we don’t expect to see this launched in 2020, we do expect to hear updates on development and early trials.
WaveForm Cascade CGM: WaveForm Technologies is a spin-off of device company AgaMatrix, and they’re developing a new CGM that will be filed with FDA in 2020, but it’s not expected to be available this year.
The device, which received CE Mark approval in November 2019, is a 14-day CGM sensor with a rechargeable square transmitter, that communicates to both Android and iOS mobile apps via Bluetooth. At a recent Diabetes Technology Society meeting, the company displayed a scientific poster showing conceptual images and accuracy data. At 11.9% MARD, it’s not as good as existing CGMs but on par with most first-gen iterations. U.S. clinical studies and overseas launch are expected in 2020, and WaveForm tells us they’re planning for a 2021 launch here in the States.
BD Patch Pump for T2: We’ve also been waiting for several years on this new fully disposable, three-day wear tubeless pump from Pharma giant BD. It will offer both basal and bolus dosing, holds 300 units, and has a reusable handheld controller with Bluetooth connectivity to a smartphone app.
BD has talked about the very simple pump design being more comparable to insulin injection therapy for people with type 2 diabetes, making it potentially a better option for those whose insurers will resist approving a full-featured traditional insulin pump. In an earnings call in August 2019, BD announced it had withdrawn its FDA application for this product, but then-CEO Victor Forlenza (who was replaced in Sept. 2019) still emphasized that BD was working on it with a third-party R&D partner and “remained committed” to the patch pump.
Tidepool Loop: The free software and open-source data non-profit Tidepool is building a closed loop system that brings together both the DIY world and FDA-regulated commercial side. While it’ll be based off the DIY Loop homemade systems, this separate Tidepool Loop mobile app will work with the Dexcom CGM and Omnipod tubeless patch pump, and be available on iOS initially. We’re told the org is working with regulators and doing clinical trial research in the first half of 2020, and plans to file with the FDA by year’s end. (FYI: Tidepool updates its progress on the org’s blog, so keep tabs on that too.)
Bigfoot Biomedical: Excitement remains about this #WeAreNotWaiting grassroots-born closed loop technology, but plans are a bit different than they were a year ago. The startup continues using the base design of the former Asante Snap insulin pump for their main product dubbed Bigfoot Autonomy, but before that we’re still hoping to see progress in 2020 on the connected pen version named Bigfoot Unity. At our recent DiabetesMine University event in November, CEO Jeffrey Brewer put a 2021 timeline on the first-gen Unity product with a next-gen version the following year. Though more recently, we’re hearing Bigfoot plans to file the Unity pen-version in late 2020 with a possible launch slated for end of the year, so we shall see. The Autonomy pump-based system is slated to follow, possibly in 2023.
Beta Bionics iLet: Many are excited about the “FDA breakthrough device designation” received by this closed loop tech company in December 2019, but we’re still at least a year or two away from seeing this product ready for launch. We’re expecting an insulin-only version to be available before we eventually get to the dual-hormone version with both insulin and glucagon inside the pump. See the 2019 DiabetesMine University preview of Beta Bionics system here.
Of course, all of the above innovations mean nothing if people can’t afford or get their hands on them. We are thankfully seeing incremental progress on affordability, but still have a long way to go in 2020 and beyond.
We at the ‘Mine like to call ourselves “skeptical optimists,” so we’re hoping this year can bring meaningful advancements, accessible to as many PWDs as possible.