With the arrival of a new year, our community is always eager to know what’s coming next in diabetes tools and technology.
Some of what we anticipated in 2020 was delayed because of the global pandemic and is now on tap for 2021.
Those and other innovations will bring anticipated features that will literally change the daily management of diabetes — from new insulin pens, pumps, and continuous glucose monitors (CGMs) to the smart closed loop tech also known as Artificial Pancreas or Automated Insulin Delivery (AID) systems.
Our DiabetesMine team has been listening to industry earnings calls, and talking with company insiders and other experts to compile this roundup of what’s expected to materialize in 2021, with some of our own insights and observations sprinkled in.
For the first time, people with diabetes (PWDs) will likely see technology giving us the ability to control our medical devices via mobile smartphone apps — including remote insulin dosing!
This functionality has been hinted at for many years but hasn’t yet made it into commercial FDA-approved diabetes devices. That is about to change.
“Once you have the ability to bolus remotely from a mobile app, there’s really no reason to take your pump out while you’re outside of your home,” Tandem Diabetes CEO John Sheridan said during that company’s investor update on Nov. 5, 2020. “That discretion is huge and I think people are very excited about it.”
Tandem’s mobile bolusing
Notably, Tandem Diabetes Care will likely be the first to cross the finish line in getting FDA clearance on a smartphone app that can be used to control an insulin delivery device.
The company had already filed its expanded mobile app functionality with the FDA by the end of 2020, according to investor updates.
With that added function, the newly designed t:connect app — launched in mid-2020 alongside Tandem’s Control-IQ system — will allow for remote bolusing via mobile app for the existing t:slim X2 pump platform and beyond.
This paves the way for Tandem’s future insulin pump technology, which promises the first new form factor since its original t:slim model first launched in 2012.
New t:sport mini-pump
Also from Tandem we expect to see the launch of a new pump internally dubbed the t:sport.
It’s a micro-pump hybrid of sorts, roughly half the size of the t:slim X2 pump and without any display screen at all. The t:sport will have an adhesive part, but also the t:slim’s trademark t:lock connector “pigtail” insulin tubing that attaches to the infusion set for insulin delivery.
Interestingly, the first iteration of this product will allow for complete control via the mobile app, and a later filing will be for a separate handheld receiver, for customers who prefer not to use smartphone app control.
DiabetesMine got first glimpses of the t:sport prototype at the company’s San Diego headquarters in 2017.
Tandem had planned to submit the t:sport to the FDA in 2020, but the pandemic delayed the clinical trial and submission. It’s now expected to be filed with FDA in late 2021, pushing the likely launch to either the end of 2021 or early 2022.
Also look forward to updates to Tandem’s Control-IQ algorithm that automates insulin delivery, likely with options for more personalized settings, at some point in 2021.
Omnipod 5 (formerly Horizon)
A second but just as notable new device expected in 2021 is the Omnipod 5, formerly known as the Omnipod Horizon, from Massachusetts-based Insulet Corp.
Like Tandem’s Control-IQ, Horizon is a closed loop system, aka Artificial Pancreas technology. It connects the Omnipod tubeless patch pump to a CGM via a smart algorithm, allowing for automatic insulin dosing adjustments.
It’s based on the Omnipod DASH platform launched in 2019 and uses the same pods and mobile app. It’ll first be available to connect with the Dexcom CGM and later with Abbott’s FreeStyle Libre.
Like Tandem’s new tech, this Omnipod 5 is also set to bring mobile app control and insulin dosing, eliminating the need to carry a separate Personal Diabetes Manager (PDM) around to control the Omnipod.
Omnipod 5 is another one that had been planned for 2020 but was delayed because of COVID-19. The Boston-area manufacturer Insulet said during its Nov. 4, 2020, investor update call that it had recently finished its pivotal trial and was finalizing FDA submission, in hopes of launching the new product in the first half of 2021.
There are a number of other exciting new products on the way. While these don’t yet offer remote control or bolusing from a smartphone, that functionality will likely become more common once the FDA signs off on it for Tandem and Insulet.
Medtronic 780G
Also known as the Advanced Hybrid Closed Loop (AHCL) system, Medtronic’s next-generation tech will expand upon the foundation of its first two iterations: the 670G and 770G. The latter already offers built-in Bluetooth for remote updating of the technology in the future.
This new tech will keep 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 has many new features:
- works with Medtronic’s next-generation Zeus CGM sensor, which will require just one calibration on the first day of wear and no further fingersticks beyond that (this sensor is also 7-day wear, same as their current model)
- provides automatic correction bolus delivery every 5 minutes to help keep users in an optimal range and to automatically adjust for missed meal doses
- has an adjustable glucose target between 100 to 120 mg/dL (compared to the 670G’s fixed target at 120 mg/dL)
- offers different insulin duration times, unlike other commercial closed loop systems available
- offers built-in Bluetooth necessary for data sharing and remote monitoring, as well as remote software updates so users won’t be required to buy a whole new device every time new features are launched (currently, only the Tandem t:slim X2 offers this remote updating capability)
Notably, Medtronic plans to ask FDA regulators to OK this new system for adults and kids as young as age 2 right from the start.
The company had planned to file the 780G for review soon after its investor update in late 2020, but that was delayed to early 2021; Medtronic confirmed on Feb. 23, 2021 that it had submitted this to the FDA. Depending on the regulatory approval time, this system may be ready for commercial launch within the year.
See this DiabetesMine report with more details on Medtronic’s diabetes pipeline.
Dexcom G7 CGM
This latest model of the Dexcom CGM is set to bring a significant form-factor change: a combined sensor and transmitter design.
Dexcom G7
In its latest investor updates, Dexcom said it plans to submit the G7 for FDA approval as soon as possible in 2021 and plans for a limited launch late in the year. They’ve also released the first images of the new G7, which are pretty spectacular!
Here are the details:
- Fully disposable: Unlike Dexcom CGM models to date, the G7 will be fully disposable. This means there will no longer be a separate transmitter with a 3-month battery life. Instead, the sensor and transmitter will be integrated, and once the sensor’s run is finished, you’ll dispose of the whole combined unit.
- Wear time: While it will start off at 10-day wear like the current G6 version, the G7 is designed to eventually support longer wear for up to 14 to 15 days. No fingerstick calibrations will be required.
- Thinner: Dexcom says the G7 will be the thinnest generation of its CGM sensors yet at 60 percent smaller.
- Decision support: Dexcom has talked a lot about wanting to integrate software features like dosing assistance and information and prompts that help users make better health choices based on their CGM readings. Given Dexcom’s acquisition of TypeZero Technologies in 2018, they seem to be on the path to providing a smart algorithm for this kind of user support. This should also help the company in its goal to expand CGM use for more people with type 2 diabetes, as well as for users without diabetes.
In recent investor updates, Dexcom CEO Kevin Sayer explained that the company plans to eventually have different versions of the G7 for different groups of users. For example, non-insulin using type 2s or general health consumers may prefer a much simpler interface than insulin-using type 1s who have experience with CGM tech and want all the bells and whistles.
Abbott FreeStyle Libre 3?
The FreeStyle Libre from Abbott Diabetes is known as a Flash Glucose Monitoring (FGM) system because it offers a “flash” of a glucose reading whenever you scan the sensor with the handheld receiver or smartphone app.
Since hitting the U.S. market in 2017, Abbott has continued to gradually roll out modifications and features. The Libre 2 became available in 2020, offering optional alerts for low and high blood sugars; we should see the newly-updated mobile app available in 2021.
Next up is the Libre 3, which elevates the tech to full-CGM functionality because it will no longer require any sensor scanning to provide real-time glucose readings.
Libre 3 generates real-time glucose reading every minute, displaying that result on the compatible mobile app on iPhone or Android. This continuous stream of data allows optional alerts for high and low blood sugars, along with glucose results. This is a big leap forward compared to Libre 2 that still requires a confirmation scan to get a numeric reading, and doesn’t offer any alerts.
Libre 3’s round, fully disposable sensor is also much smaller and thinner, the thickness of just two pennies (rather than two stacked quarters in earlier versions). Per Abbott, that is a more than 70 percent size reduction that uses 41 percent less plastic.
The Libre 3 received international approval in September 2020, and with a pivotal clinical trial completed in the United States, we’ll likely see the Libre 3 submitted to the FDA during 2021.
WaveForm Cascade CGM
This is the new tech developed by AgaMatrix-spinoff WaveForm Technologies that received European CE Mark approval in November 2019 and is making its way to the United States.
WaveForm’s Cascade CGM is a 15-day CGM sensor with a rechargeable square transmitter that communicates to both Android and iOS mobile apps via Bluetooth.
Previously, the company told DiabetesMine that:
- the sensor and transmitter are worn on the body in a single compact form, about the size of a nickel
- this system employs a proprietary, enzyme-based electrochemical sensor that is virtually pain-free to insert and measures glucose levels via interstitial fluid like other CGMs
- the sensor will transmit glucose data wirelessly through its small, rechargeable transmitter to a smartphone app — providing up-to-the-minute feedback on glucose levels
The company has presented on this system at diabetes conferences and has publicly shared conceptual images and accuracy data. It clocks in at 11.9 percent MARD (standard measure of CGM accuracy), meaning it’s not as good as the latest CGM competitors but on par with most first-gen iterations.
A clinical trial began in May 2020 and is expected to be completed by mid-2021. WaveForm says it’s planning for a 2021 submission to FDA and hopeful launch here in the United States by year’s end.
After the exciting launch of Companion Medical’s InPen in 2020, a number of other new smart insulin pens with data connectivity are on the horizon.
Bigfoot Unity
There’s lots of buzz about Bigfoot Biomedical, the closed loop technology startup born out of the grassroots #WeAreNotWaiting diabetes DIY movement.
This company’s first product will be a unique system built around a proprietary connected insulin pen — instead of an insulin pump.
Called the Bigfoot Unity system and filed with the FDA in mid-2020, it connects the smart insulin pen with the FreeStyle Libre to automatically calculate and adjust insulin dosing.
Bigfoot will eventually move forward with its pump version known as Bigfoot Autonomy, using the base design of the former Asante Snap insulin pump it acquired years ago. The Autonomy pump-based system is slated for launch possibly in 2022 or 2023.
Lilly connected pen
We’re told that pharma giant Eli Lilly plans to launch a new connected smart pen system during the second half of 2021. This is a prefilled, disposable insulin pen intended to be the foundation of the company’s new pen-based digital platform.
For most of the past year, Lilly has been working with regulators on how the device will transmit insulin dosing data from the pen to a mobile app. Eventually, this will work with the Dexcom CGM, as the two companies just signed an agreement to that end. Other CGM partnerships will likely be built in as well.
Novo smart insulin pen?
New smart pens have been expected from Novo Nordisk for several years now. Their NovoPen 6 and kid-friendly Echo Plus models received European approval and were expected to launch in Europe in 2020, but now that all appears to be happening in 2021.
DiabetesMine queried a Novo spokesperson, but we were given no word on whether the NovoPen 6 and Echo Plus will hit the market in the United States this coming year.
Aside from those big-ticket items expected this year, a number of others are on the radar that will bring new options for the diabetes community.
Tidepool Loop
The free software and open-source data nonprofit Tidepool is building a key piece of a closed loop system, which brings together both the DIY work and FDA-regulated commercial side.
Based on the DIY homemade systems, this separate Tidepool Loop mobile app will work with the Dexcom CGM and Omnipod tubeless patch pump. It will be available on iOS initially.
We’ve learned the org filed with the FDA in a 2,000-page filing on Dec. 17, 2020!) and hopes to get regulatory approval in order to launch Tidepool Loop in 2021. Note that Tidepool updates its progress continuously on the org’s blog, so you can keep tabs there.
New glucagon rescue pen
HypoPal glucagon rescue pen
Made by Zealand Pharma, the HypoPal Rescue Pen is expected to clear the FDA on March 27, 2021, and launch later in the year. The biotech company submitted its new drug application for this new stable liquid formation called dasiglucagon to regulators in May 2020.
This ready-to-use rescue pen will be the third new-form glucagon approved in recent years, following the Baqsimi nasal glucagon from Eli Lilly and the Gvoke rescue pen and prefilled syringe by Xeris Pharmaceuticals.
In clinical trial research, a single dose of dasiglucagon with this rescue pen rapidly boosted glucose levels to a safe level within 10 to 15 minutes. Though there were slight side effects like nausea and vomiting common to all types of glucagon, there were no severe effects or other safety concerns.
This is significant because a version made specifically for use in infusion pumps is also in development, and closed loop tech startup Beta Bionics will be one of the first to use it in their upcoming iLet device.
The dual-chambered iLet will deliver both insulin and glucagon to treat both high and low blood sugars, paving the way for others to offer this in next-generation closed loop technology.
Bluetooth connectivity for Afrezza
MannKind Corp., makers of Afrezza inhaled insulin, continue to work on their BluHale data tracking device for the inhaler.
They have launched a version for healthcare providers called BluHale Pro that monitors inhalation technique for doctors to use in training new patients on Afrezza.
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.
The personal version of BluHale for patients will eventually be able to track and share dosing data as well. MannKind expects that will be filed with FDA in 2021 and hopefully launch during the year.