Can Medtronic Retake Automated Pump Market?
With true artificial pancreas and more accurate sensors, Medtronic has the potential to resume leadership of the closed-loop pump market
I’ve been a Medtronic customer since I switched from MDI to an insulin pump in 2014. At the time, their integrated pump and CGM system was far more appealing to me than any other options on the market.
When they launched their automated hybrid-closed loop system a few years later, I was equally excited to upgrade to the more user-friendly, waterproof pump and more advanced CGM. Even though I never planned to use my pump in auto mode, it was exciting to be part of that first wave of truly advanced diabetes tech.
Tandem/Dexcom Now Lead Market
Even as a lifelong Medtronic patron, it is hard for me to feel the same excitement about the company that I did six years ago.
Not only has Tandem launched its own automated system with better features and a more user-friendly interface, but they were doing it with Dexcom, a calibration-free CGM sensor that is more accurate and longer-lasting than Medtronic’s Guardian sensor.
Tandem isn’t the only one entering the hybrid-closed loop market this year, either. Insulet’s Omnipod Horizon will soon be offering its own automated system that also integrates with Dexcom’s auto mode algorithm.
- Much like the 670g, none of these other looping systems offer tight enough control for diabetics who can achieve an A1C below 6.5 on their own.
- But Dexcom’s superior sensor tech is almost worth switching to in and of itself. And in fact, I was seriously considering it as the year began.
Medtronic Product Pipeline
I have learned that Medtronic is gearing up to launch a series of new products over the next two years. I am once again feeling a bit excited about what the company has to offer.
Medtronic’s Upcoming 780g Advanced Hybrid Closed Loop System
The first product set to be released is Medtronic’s answer to the superior algorithm used in the Dexcom compatible automated pump systems.
Much like the current 670g system, this advanced hybrid closed loop (AHCL) will use predictive values from the integrated sensor to adjust basal rates to keep blood sugar stable. But unlike the 670g (and much more like the Dexcom loop) this system will also be able to deliver corrections for missed meal boluses or undercalculated carb ratios.
Importantly, and unlike anything currently on the market, the AHCL system will target a goal blood sugar of 100 mmol/l rather than the current 120 mmol/l of the 670g and 110 mmol/l of the Tandem system.
Medtronic hopes this system will increase time-in-range from about 72% for current systems to 80%.
Both of these factors would seem to make the new 780g system a better choice for people with diabetes who already have fairly tight control on their own.
The AHCL system will also have Bluetooth capabilities, making it possible to read and control the pump via a phone app.
The 780g has just wrapped up clinical trials and results are set to be released in July. Medtronic expects to release this new product in the second half of 2020.
Medtronic’s Upcoming Personalized Closed Loop System
The second product in development is the Personalized Closed Loop (PCL).
Like all current auto-mode enabled systems, this one will adjust basal rates based on predicted CGM values.
Unlike anything available on the market today, the Medtronic PCL will also have the capability to give automated boluses for meals, effectively eliminating the need for carb counting.
It will also be able to self-correct for times of high activity without users needing to set a manual temporary basal rate.
With these features, the PCL has the potential to become the first true artificial pancreas system and would likely have a huge impact on the quality of life for millions of people living with type 1 diabetes.
In addition to greatly reducing the burden of diabetes management, the PCL system is set up to achieve greater than 85% time spent in range.
It will also allow the user to set customizable blood sugar goals.
Both of these factors mean the PCL has the potential to be useful to all T1Ds, even those who achieve near-normal blood sugar levels on their own.
Like the 780g system, this one will be Bluetooth enabled and compatible with a phone app.
The PCL system has received the FDA’s Breakthrough Device designation, which will allow Medtronic to move the product through the approval process more quickly than traditional devices. The company hopes to have the system available to patients as early as 2021.
Improving Sensor Technology
The success of both of these new automated systems relies heavily on the next generation of Medtronic CGM sensors.
The first to be released will be the GS3 sensor which is currently undergoing FDA approval to be marketed as non-adjunctive, which means that treatment decisions can be made based on the readings given by the CGM.
- This is a big improvement on the current Guardian sensor which requires users to check their blood sugar on a BG meter before making treatment decisions.
- The Dexcom G5 received a similar non-adjunctive designation back in 2016.
- The GS3 is expected to be available later this year.
Fewer Daily Calibrations
Like the current generation Guardian sensor, the GS3 will still require multiple daily calibrations. However, Medtronic hopes to reduce this drawback with the release of the Zeus sensor in 2021.
- The GS3, like Guardian, will be a 7-day wear sensor, but it will only require finger-stick calibrations on the first day of use.
- While this still does not achieve the “calibration-free” designation of Dexcom’s latest sensor, it is a huge improvement over the current recommended three to four calibrations a day for the Guardian sensor.
Following the release of Zeus, Medtronic hopes to simplify its sensor even further by offering a disposable form that will be released under the name Synergy.
- In addition to only requiring once-per-day calibrations, it will also be half the size, easier to insert, and will not need over-taping such as the current models require.
- The Synergy disposable sensor is expected to be released in 2022.
Increased Infusion Set Wear Time
Looking to the Future
While it is impossible to say if these products will live up to the hype, it is promising to see companies continuing to improve upon current diabetes technology.
And for me, personally, the potential to get to use a true artificial pancreas that eliminates the need to carb count while reducing burdens like finger-sticks is enough to keep me brand-loyal for a few more years.
Or, at least until the next company comes out with something even better.