With the arrival of a brand new 12 months, our neighborhood is all the time desirous to know what’s coming subsequent in diabetes instruments and know-how.
A few of what we anticipated in 2020 was delayed due to the worldwide pandemic and is now on faucet for 2021.
These and different improvements will convey anticipated options that may actually change the day by day administration of diabetes — from new insulin pens, pumps, and continuous glucose monitors (CGMs) to the good closed loop tech also known as Artificial Pancreas or Automated Insulin Supply (AID) methods.
Our DiabetesMine staff has been listening to trade earnings calls, and speaking with firm insiders and different specialists to compile this roundup of what’s anticipated to materialize in 2021, with a few of our personal insights and observations sprinkled in.
For the primary time, folks with diabetes (PWDs) will possible see know-how giving us the flexibility to regulate our medical gadgets by way of cell smartphone apps — together with distant insulin dosing!
This performance has been hinted at for a few years however hasn’t but made it into business FDA-approved diabetes gadgets. That’s about to vary.
“After getting the flexibility to bolus remotely from a cell app, there’s actually no purpose to take your pump out when you’re exterior of your own home,” Tandem Diabetes CEO John Sheridan stated throughout that firm’s investor replace on Nov. 5, 2020. “That discretion is large and I feel persons are very enthusiastic about it.”
Tandem’s cell bolusing
Notably, Tandem Diabetes Care will possible be the primary to cross the end line in getting FDA clearance on a smartphone app that can be utilized to regulate an insulin supply system.
The corporate had already filed its expanded cell app performance with the FDA by the tip of 2020, in keeping with investor updates.
With that added operate, the newly designed t:connect app — launched in mid-2020 alongside Tandem’s Control-IQ system — will permit for distant bolusing by way of cell app for the prevailing t:slim X2 pump platform and past.
This paves the way in which for Tandem’s future insulin pump know-how, which guarantees the primary new type issue since its unique t:slim mannequin first launched in 2012.
New t:sport mini-pump
Additionally from Tandem we count on to see the launch of a brand new pump internally dubbed the t:sport.
It’s a micro-pump hybrid of types, roughly half the dimensions of the t:slim X2 pump and with none show display screen in any respect. The t:sport could have an adhesive half, but in addition the t:slim’s trademark t:lock connector “pigtail” insulin tubing that attaches to the infusion set for insulin supply.
Curiously, the primary iteration of this product will permit for full management by way of the cell app, and a later submitting will probably be for a separate handheld receiver, for patrons preferring to not use smartphone app management.
DiabetesMine acquired first glimpses of the t:sport prototype on the firm’s San Diego headquarters in 2017.
Tandem had deliberate to submit the t:sport to the FDA in 2020, however the pandemic delayed the scientific trial and submission. It’s now anticipated to be filed with FDA in late 2021, pushing the possible launch to both the tip of 2021 or early 2022.
Additionally sit up for updates to Tandem’s Control-IQ algorithm that automates insulin supply, possible with choices for extra customized settings, in some unspecified time in the future in 2021.
Omnipod 5 (previously Horizon)
A second however simply as notable new system anticipated in 2021 is the Omnipod 5, previously often known as the Omnipod Horizon, from Massachusetts-based Insulet Corp.
Like Tandem’s Management-IQ, Horizon is a closed loop system, aka Artificial Pancreas technology. It connects the Omnipod tubeless patch pump to a CGM by way of a wise algorithm, permitting for automated insulin dosing changes.
It’s primarily based on the Omnipod DASH platform launched in 2019 and makes use of the identical pods and cell app. It’ll first be obtainable to attach with the Dexcom CGM and later with Abbott’s FreeStyle Libre.
Like Tandem’s new tech, this Omnipod 5 can also be set to convey cell app management and insulin dosing, eliminating the necessity to carry a separate Private Diabetes Supervisor (PDM) round to regulate the Omnipod.
Omnipod 5 is one other one which had been deliberate for 2020 however was delayed due to COVID-19. The Boston-area producer Insulet stated throughout its Nov. 4, 2020, investor replace name that it had just lately completed its pivotal trial and was finalizing FDA submission, in hopes of launching the brand new product within the first half of 2021.
There are a variety of different thrilling new merchandise on the way in which. Whereas these don’t but provide distant management or bolusing from a smartphone, that performance will possible turn into extra frequent as soon as the FDA indicators off on it for Tandem and Insulet.
Often known as the Advanced Hybrid Closed Loop (AHCL) system, Medtronic’s next-generation tech will develop upon the inspiration of its first two iterations: the 670G and 770G. The latter already affords built-in Bluetooth for distant updating of the know-how sooner or later.
This new tech will maintain the fundamental type issue of the corporate’s 6-series fashions with a vertical “fashionable” look, in comparison with the older fashions with a horizontal design that resembled Eighties pagers.
The 780G has many new options:
- works with Medtronic’s next-generation Zeus CGM sensor, which would require only one calibration on the primary day of damage and no additional fingersticks past that (this sensor can also be 7-day put on, similar as their present mannequin)
- offers automated correction bolus supply each 5 minutes to assist maintain customers in an optimum vary and to mechanically regulate for missed meal doses
- has an adjustable glucose goal between 100 to 120 mg/dL (in comparison with the 670G’s fastened goal at 120 mg/dL)
- affords totally different insulin period occasions, in contrast to different business closed loop methods obtainable
- affords built-in Bluetooth mandatory for information sharing and distant monitoring, in addition to distant software program updates so customers gained’t be required to purchase an entire new system each time new options are launched (at the moment, solely the Tandem t:slim X2 affords this distant updating functionality)
Notably, Medtronic plans to ask FDA regulators to OK this new system for adults and youngsters as younger as age 2 proper from the beginning.
The corporate had deliberate to file the 780G for evaluation quickly after its investor replace in late 2020, however that was delayed to early 2021; Medtronic confirmed on Feb. 23, 2021 that it had submitted this to the FDA. Relying on the regulatory approval time, this technique could also be prepared for business launch inside the 12 months.
See this DiabetesMine report with extra particulars on Medtronic’s diabetes pipeline.
Dexcom G7 CGM
This newest mannequin of the Dexcom CGM is about to convey a big form-factor change: a mixed sensor and transmitter design.
In its newest investor updates, Dexcom stated it plans to submit the G7 for FDA approval as quickly as attainable in 2021 and plans for a restricted launch late within the 12 months. They’ve additionally launched the primary photos of the brand new G7, that are fairly spectacular!
Listed below are the small print:
- Absolutely disposable: Not like Dexcom CGM fashions up to now, the G7 will probably be totally disposable. This implies there’ll not be a separate transmitter with a 3-month battery life. As a substitute, the sensor and transmitter will probably be built-in, and as soon as the sensor’s run is completed, you’ll eliminate the entire mixed unit.
- Put on time: Whereas it would begin off at 10-day put on like the present G6 model, the G7 is designed to finally assist longer put on for as much as 14 to fifteen days. No fingerstick calibrations will probably be required.
- Thinner: Dexcom says the G7 would be the thinnest era of its CGM sensors but at 60 p.c smaller.
- Choice assist: Dexcom has talked rather a lot about desirous to combine software program options like dosing help and knowledge and prompts that assist customers make higher well being selections primarily based on their CGM readings. Given Dexcom’s acquisition of TypeZero Technologies in 2018, they appear to be on the trail to offering a wise algorithm for this type of consumer assist. This also needs to assist the corporate in its aim to develop CGM use for extra folks with kind 2 diabetes, in addition to for customers with out diabetes.
In current investor updates, Dexcom CEO Kevin Sayer defined that the corporate plans to finally have totally different variations of the G7 for various teams of customers. For instance, non-insulin utilizing kind 2s or common well being customers could choose a a lot less complicated interface than insulin-using kind 1s who’ve expertise with CGM tech and wish all of the bells and whistles.
Abbott FreeStyle Libre 3?
The FreeStyle Libre from Abbott Diabetes is called a
Since hitting the U.S. market in 2017, Abbott has continued to regularly roll out modifications and features. The Libre 2 grew to become obtainable in 2020, providing elective alerts for high and low blood sugars; we should always see the newly-updated cell app obtainable in 2021.
Subsequent up is the Libre 3, which elevates the tech to full-CGM performance as a result of it would not require any sensor scanning to offer real-time glucose readings.
Libre 3 generates real-time glucose studying each minute, displaying that outcome on the appropriate cell app on iPhone or Android. This steady stream of knowledge permits elective alerts for top and low blood sugars, together with glucose outcomes. It is a massive leap ahead in comparison with Libre 2 that also requires a affirmation scan to get a numeric studying, and doesn’t provide any alerts.
Libre 3’s spherical, totally disposable sensor can also be a lot smaller and thinner, the thickness of simply two pennies (quite than two stacked quarters in earlier variations). Per Abbott, that may be a greater than 70 p.c measurement discount that makes use of 41 p.c much less plastic.
WaveForm Cascade CGM
WaveForm’s Cascade CGM is a 15-day CGM sensor with a chargeable sq. transmitter that communicates to each Android and iOS cell apps by way of Bluetooth.
Beforehand, the corporate advised DiabetesMine that:
- the sensor and transmitter are worn on the physique in a single compact type, concerning the measurement of a nickel
- this technique employs a proprietary, enzyme-based electrochemical sensor that’s just about pain-free to insert and measures glucose ranges by way of interstitial fluid like different CGMs
- the sensor will transmit glucose information wirelessly by way of its small, rechargeable transmitter to a smartphone app — offering up-to-the-minute suggestions on glucose ranges
The corporate has introduced on this technique at diabetes conferences and has publicly shared conceptual photos and accuracy information. It clocks in at 11.9 p.c
A clinical trial started in Might 2020 and is anticipated to be accomplished by mid-2021. WaveForm says it’s planning for a 2021 submission to FDA and hopeful launch right here in the USA by 12 months’s finish.
There’s numerous buzz about Bigfoot Biomedical, the closed loop know-how startup born out of the grassroots #WeAreNotWaiting diabetes DIY motion.
This firm’s first product will probably be a novel system constructed round a proprietary related insulin pen — as a substitute of an insulin pump.
Referred to as the Bigfoot Unity system and filed with the FDA in mid-2020, it connects the good insulin pen with the FreeStyle Libre to mechanically calculate and regulate insulin dosing.
Bigfoot will finally transfer ahead with its pump model often known as Bigfoot Autonomy, utilizing the bottom design of the former Asante Snap insulin pump it acquired years in the past. The Autonomy pump-based system is slated for launch probably in 2022 or 2023.
Lilly related pen
We’re advised that pharma large Eli Lilly plans to launch a brand new related good pen system throughout the second half of 2021. It is a prefilled, disposable insulin pen meant to be the inspiration of the corporate’s new pen-based digital platform.
For a lot of the previous 12 months, Lilly has been working with regulators on how the system will transmit insulin dosing information from the pen to a cell app. Ultimately, it will work with the Dexcom CGM, as the 2 firms just signed an agreement to that finish. Different CGM partnerships will possible be in-built as nicely.
Novo good insulin pen?
New good pens have been anticipated from Novo Nordisk for a number of years now. Their NovoPen 6 and kid-friendly Echo Plus fashions obtained European approval and have been anticipated to launch in Europe in 2020, however now that each one seems to be occurring in 2021.
DiabetesMine queried a Novo spokesperson, however we got no phrase on whether or not the NovoPen 6 and Echo Plus will hit the market in the USA this coming 12 months.
Apart from these big-ticket objects anticipated this 12 months, a variety of others are on the radar that may convey new choices for the diabetes neighborhood.
The free software program and open-source information nonprofit Tidepool is constructing a key piece of a closed loop system, which brings collectively each the DIY work and FDA-regulated business aspect.
Based mostly on the DIY do-it-yourself methods, this separate Tidepool Loop cell app will work with the Dexcom CGM and Omnipod tubeless patch pump. It will likely be obtainable on iOS initially.
We’ve discovered the org filed with the FDA in a 2,000-page submitting on Dec. 17, 2020!) and hopes to get regulatory approval to be able to launch Tidepool Loop in 2021. Word that Tidepool updates its progress repeatedly on the org’s blog, so you possibly can maintain tabs there.
New glucagon rescue pen
Made by Zealand Pharma, the HypoPal Rescue Pen is anticipated to clear the FDA on March 27, 2021, and launch later within the 12 months. The biotech firm submitted its new drug software for this new secure liquid formation known as dasiglucagon to regulators in Might 2020.
This ready-to-use rescue pen would be the third new-form glucagon authorized in recent times, following the Baqsimi nasal glucagon from Eli Lilly and the Gvoke rescue pen and prefilled syringe by Xeris Prescription drugs.
In clinical trial research, a single dose of dasiglucagon with this rescue pen quickly boosted glucose ranges to a secure degree inside 10 to fifteen minutes. Although there have been slight negative effects like nausea and vomiting frequent to all varieties of glucagon, there have been no extreme results or different security issues.
That is important as a result of a model made particularly to be used in infusion pumps can also be in improvement, and closed loop tech startup Beta Bionics will be one of the first to use it of their upcoming iLet system.
The twin-chambered iLet will ship each insulin and glucagon to deal with each excessive and low blood sugars, paving the way in which for others to supply this in next-generation closed loop know-how.
Bluetooth connectivity for Afrezza
MannKind Corp., makers of Afrezza inhaled insulin, proceed to work on their BluHale data tracking device for the inhaler.
They’ve launched a model for healthcare suppliers known as BluHale Professional that screens inhalation method for medical doctors to make use of in training new patients on Afrezza.
The unit is appropriate with Android, iPhone, and Microsoft gadgets. It flashes a inexperienced gentle if the Afrezza is inhaled correctly and a pink gentle if not. Docs can view the tracked information on these situations after which provide their sufferers recommendation on how one can finest use Afrezza.
The private model of BluHale for sufferers will finally be capable of observe and share dosing information as nicely. MannKind expects that will probably be filed with FDA in 2021 and hopefully launch throughout the 12 months.