New Diabetes Technology: What to Expect in 2022
As we look to what's ahead in new diabetes technology for 2022, many may experience a sense of déjà vu. After all, much of what we'd anticipated for 2021 was delayed because of the continuing global pandemic (much like the year before). That means a lot of the forecast for the year ahead resembles what had initially been on tap a year earlier.
Still, it's exciting to look at new innovations anticipated to literally change the face of daily diabetes management — from new insulin pens and pumps, to CGMs, and smart closed loop tech, 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 2022, with some of our own insights and observations sprinkled in.
Tandem Diabetes Care
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 been approved by the Food and Drug Administration (FDA) for use in diabetes devices. That's about to change.
Mobile bolusing by phone
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.
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 (aka insulin dosing) via mobile app for the existing t:slim X2 insulin pump platform and beyond.
The company had filed its expanded mobile app functionality with the FDA in late 2020, but the pandemic delays meant we didn't see that approval come in 2021 as many had hoped. [Tandem announced on Feb. 16, 2022 that it had received FDA clearance for the remote bolusing by mobile app for iOS and Android smartphones, with an expected launch in Summer 2022.]
This also 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.
Tandem Mobi (formerly t:sport)
The new mini-pump with smartphone control that was known initially by the prototype name "t:sport" is now publicly known as Tandem Mobi. Here's what we know about the design based on the company's first-ever R&D Day in December 2021:
- roughly 50 percent of the t:slim X2 size
- a hybrid mini-pump that has both a short, 4-inch tubing with the trademark “pigtail” connector that goes to an infusion set as well as adhesive on the back to stick onto the body — so it can be worn either way
- will hold 200 units of insulin in the cartridge
- has no display screen at all
- will be operated solely by an iOS or Android smartphone app
- allows for wireless charging
- has a bolus button on the side of the device
- compatible with the latest “iCGM” devices like the Dexcom G6
- has an embedded Automated Insulin Delivery (AID) algorithm to be compatible with Tandem Control-IQ features
- compatible with current Tandem infusion sets as well as a future 4-inch set in development
DiabetesMine got a first glimpse of an early prototype at the company’s San Diego headquarters in 2017. Tandem had planned to submit this device to the FDA in 2020, but the pandemic delayed the clinical trial, and it’s now waiting on the new mobile app with remote bolusing feature.
Tandem expects once it gets the FDA's OK on the mobile bolusing functionality, it will then finalize its Tandem Mobi plan and file that with regulators later in 2022. We may possibly see that approval and launch in '22, but it could be pushed to the following year.
Omnipod 5 tubeless system
Another holdover from the year before is the new Omnipod 5 tubeless insulin pump system, formerly known as Omnipod Horizon, from Massachusetts-based Insulet Corp. This will be the company's first closed loop system that automates insulin delivery based on CGM data.
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 insulin pods and mobile app. It will first be available to connect with the Dexcom CGM and later with Abbott’s FreeStyle Libre.
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 if you gave a compatible smartphone.
Omnipod 5 is another one that had been originally planned for 2020 but was delayed because of COVID-19. Insulet filed it with the agency on Dec. 23, 2020, but it didn't materialize by the end of 2021. However, many believe it will get FDA approval in the first half of 2022. [Omnipod 5's FDA clearance came on Jan. 27, 2022.]
Medtronic Diabetes technology
Minimed 780 and Guardian 4 CGM sensor
Many are also waiting for Medtronic's next-generation combo insulin pump and CGM sensor system, which will be the 780G — also known as the Advanced Hybrid Closed Loop (AHCL) system. This system will expand upon the foundation of Medtronic's 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 pump 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 CGM sensor (the Guardian 4), which will require just one calibration on the first day of wear and no further fingerstick tests beyond that (this sensor is also made for 7-day wear, same as their current model)
- provides automatic correction bolus delivery every 5 minutes to help keep users in an optimal blood glucose 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 of 120 mg/dL)
- offers different insulin action 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, right from the start, Medtronic has asked FDA regulators to OK this new system for adults and kids as young as 2 years old.
The company had planned to file the 780G for review soon after its investor update in late 2020, but that ended up being delayed until Feb. 23, 2021. Due to concerning FDA warnings about Medtronic's facilities and product development, the approval timeline and launch remains TBD.
Extended 7-day wear infusion set
Of course, Medtronic did get FDA clearance in July 2021 for its new extended-wear infusion set, designed to last more than twice as long as existing infusion sets that connect traditional tubed pumps to the body for insulin delivery. That means it can be worn on the body for up to 7 days — compared to existing sets that must be changed out every 2 or 3 days.
This new extended infusion set introduces changes to the tubing material and a redesigned connector to reduce the loss of preservatives, prevent tube occlusions (insulin clogs in pump tubing) and keep the insulin chemically and physically stable over time. Medtronic specifically points to a “novel and proprietary approach” that addresses insulin degradation, preservative loss, and occlusions — all things that can result in disrupted insulin delivery and therefore higher blood sugars.
The extended-wear set also has a more skin-friendly adhesive designed to allow longer, more comfortable wear on the body. The company reports that participants in a 100-person European study commented on the new infusion set being more comfortable compared to their previous infusion sets and saw this as a meaningful improvement that reduced the overall burden of insulin pump therapy.
Clinical data also shows that people using this new set might save 5 to 10 vials of insulin per year because it eliminates the many units of insulin currently wasted by the requirement to change out an infusion set every few days. Less frequent set changes also allow skin site locations to rest and heal, Medtronic points out.
Medtronic hasn't specified when this new extended-wear set will actually launch, but it will be in 2022, and the pricing details will be offered at that time.
This latest model of the Dexcom CGM is set to bring a significant form-factor change: a combined sensor and transmitter design.
Here are the G7 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, but that will remain optional.
- Thinner. The G7 will be 60 smaller, as the thinnest generation of Dexcom's CGM sensors yet.
- Shorter warm-up. Instead of taking two hours to warm up before displaying glucose data, the G7 will only have a 30-minute warm-up period.
- Different mobile app. With the G7, Dexcom will roll out a completely new app. The company's a bit vague on what this new version will entail, but they've pointed to different alarms and alerts as well as more Clarity data integrated directly onto the G7 app compared to past app designs. The company points out this new software platform will also allow it to more easily update apps as features are changed, and that Dexcom plans to automate more services like customer assistance and tech support.
- 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.
- Follow app. As to data-sharing, Dexcom notes that its Follow app will work with the G7 at the time of launch. Dexcom also plans to update the Follow app at a later time.
At the big JP Morgan healthcare conference in January 2022, Dexcom CEO Kevin Sayer presented pivotal data that it had submitted to the FDA. Notably, this latest technology outperformed the regulatory iCGM standards with better time-in-range performance of 93.3 percent compared to the FDA's standard of 87 percent. The way CGM technology is measured for accuracy is by a standard known as MARD, or Mean Absolute Relative Difference, and the G7 registered an 8.1 percent in children and 8/2 percent in adults.
"The results are much superior to G6 and any competitive product in the market," Sayer said at the JPM investor update. "We think it’s going to be a fabulous product across the board. It was very rewarding when we launched G6 to see how that changed the world. This product is going to do it again."
In recent investor updates, 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 advanced alarms and tracking features.
Dexcom filed the G7 with the FDA by the end of 2021. So most likely, we will see that approved before too long in 2022 and Dexcom will conduct an initial limited launch before eventually rolling the G7 out more broadly across the United States later in the year.
Eversense 180-day implantable
The next-generation version under development would allow for the same tiny sensor to be implanted for 180 days (or 6 months rather than 3). This version will also reduce the number of fingerstick calibrations needed down from two to just one per day, according to the company.
In September 2020, Senseonics asked the FDA to approve the 180-day wear version, but it's still TBD on getting approval. We may very well see this appear in 2022. [FDA approved the Eversense E3 on Feb. 11, 2022.]
Lilly’s Smart Tempo connected pen
The pharma giant Eli Lilly had planned to launch its new connected Tempo Smart Pen system during the second half of 2021, but that didn't happen and now it's expected in 2022.
Lilly is collaborating with Welldoc to integrate a new version of Welldoc's BlueStar app into what's known as Lilly's Tempo Personalized Diabetes Management Platform. The first version of that platform will be a data transfer module known as "Tempo Smart Button," which attaches to the top of a prefilled disposal insulin pen (Tempo Pen) initially approved in 2019.
The company submitted the Tempo Smart Button to the FDA in 2021, as did Welldoc with its new app. Those are still under FDA review and pending 510(k) clearance. The expectation is the system will get approval and launch in 2022.
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, this system has allowed PWDs to get a glucose reading whenever they want just by scanning the little white round sensor worn on the arm. The Libre 2 became available in 2020, offering optional alerts for low and high blood sugars. The mobile app was released in 2021, which eliminated the need to scan the sensor with the handheld reader.
Abbott confirmed with DiabetesMine that it filed the Libre 3 with the FDA in 2021, so it's certainly possible we might see the agency approve this latest version at some point in 2022.
But Libre 3 promises to elevate the tech to full-CGM functionality because it will no longer require any sensor scanning to provide real-time glucose readings. Instead, Libre 3 generates a 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.
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 and the technology now filed with FDA, we'll likely see the Libre 3 hit the market before too long.
Originally published at DiabetesMine in January 2022