A closed-loop system—commonly referred to as an artificial pancreas—could one day manage a user’s diabetes around the clock, eliminating the need for fingersticks, regular check-ins with a glucose monitor or manual adjustments to insulin doses based on meals or activity.
During a session at AdvaMed’s annual MedTech Conference in Boston this fall, when asked which areas of medtech are currently looking most exciting from an R&D perspective, Medtronic CEO Geoff Martha pinpointed the emerging concept of “technology ecosystems,” specifically highlighting those designed to simplify diabetes management.
Those ecosystems, he explained, comprise “sensors and delivery devices and algorithms and wearables that are all coming together to really put diabetes in the background for patients.”
Indeed, that type of closed-loop system—commonly referred to as an artificial pancreas—could one day manage a user’s diabetes around the clock, eliminating the need for calibrating fingersticks, regular check-ins on a glucose monitor or mobile app and manual adjustments to insulin doses based on food intake or activity.
An artificial pancreas from Martha’s own Medtronic, for example, became the first approved by the FDA in 2016 and combines the company’s glucose sensor and insulin pump technology with an algorithm trained to self-adjust insulin dosages every five minutes, based on the sensor’s readings. But the system still requires some work from users, who have to manage their own mealtime bolus doses and occasionally recalibrate the sensor.
The concept of a truly closed-loop system came to the forefront in 2022, as devicemakers doubled down on developing a broad swath of new and improved sensors, pumps and artificial intelligence algorithms that can communicate with one another, sans any human interaction.
With even more developments already on the horizon, 2023 could be the year that medtech makers finally close the diabetes management loop once and for all.
Staying in the loop
The opportunities for closed-loop technology ecosystems in medtech are “big,” Martha said during the AdvaMed panel, not least because of their ability to fill the gaps in care that were exposed by healthcare worker shortages throughout the COVID-19 pandemic.
“Technology is the path forward,” he said. “That digital intersection—especially with the proliferation of data and data analytics techniques like AI, machine learning, deep learning—that is really driving an inflection point in medtech.”
And diabetes tech makers are certainly on that path. Insulet kicked off 2022 with FDA clearance for its Omnipod 5 tubeless insulin pump, which can be combined with Dexcom’s continuous glucose monitors to form what’s known as a hybrid closed-loop system. The pump takes in blood sugar readings from the connected CGM every five minutes, which its algorithms use to predict glucose spikes up to an hour in advance and automatically adjust insulin dosages as needed.
But the Omnipod 5 isn’t yet completely hands-free: Users still have to manually adjust bolus insulin doses at mealtimes using a connected smartphone or Insulet-provided controller.
For its part, Dexcom, too, secured the FDA’s blessing this year for its latest diabetes tech. The G7 sensor—which landed the long-awaited nod earlier this month, after the company cleared some regulatory roadblocks—automatically sends regular blood sugar readings to a user’s smartphone, and its predictive algorithms can forecast potential hypoglycemic episodes about 20 minutes in advance, setting off a discreet alert for users to adjust their insulin dosages accordingly.
Falling almost exactly in the middle of the span between Insulet and Dexcom’s major FDA wins was one for Abbott. Like Dexcom’s CGM, the FreeStyle Libre 3 sensor eliminates the need for users to perform calibrating fingersticks to activate the system. It also sends minute-by-minute glucose readings to a connected smartphone app, where users can program alarms that’ll go off if their blood sugar leaves a specified range and where they can choose to share their data with doctors and caregivers.
Abbott’s sensor has been tapped to join a hybrid closed-loop system, too, this one rounded out by an insulin pump from Ypsomed and an algorithm from CamDiab, which together comprise the MyLife Loop automated insulin delivery system. The system scored its first authorization late last month in Germany. Using readings from either the FreeStyle Libre 3 or Dexcom’s G6 sensor, the algorithm and pump communicate with each other to adjust insulin levels without requiring any input from the user.
Eli Lilly, meanwhile, has built out an all-in-one platform that combines its own blood glucose monitor, prefilled insulin pens and TempoSmart mobile app, giving people with either Type 1 or Type 2 diabetes a single place to track all of their blood sugar and dosage data—though, since it’s based around a manual insulin delivery device, the platform doesn’t qualify as an artificial pancreas.
Interestingly, however, Lilly’s insulin pens connect to the platform using the recently FDA-cleared Tempo Smart Button, which attaches to the disposable devices to transmit their data via Bluetooth. Similar technology from Biocorp was cleared earlier this month, turning standard insulin pens from Sanofi, Novo Nordisk and Roche into smart, connected devices and therefore eliminating at least some of the work of manual diabetes management.
Cutting out the middleman
After making major strides toward the goal of a truly closed-loop system in 2022, diabetes tech developers are poised to inch even closer next year.
Medtronic and Tandem Diabetes Care, for two, are currently awaiting FDA clearance for their own revamped insulin pumps. Medtronic’s MiniMed 780G, which has already been cleared in dozens of other countries, is equipped with the hybrid closed-loop SmartGuard algorithm to automatically manage the pump’s output based on separate CGM readings. Tandem’s Mobi pump is on track to snag an FDA OK in the first half of 2023, CEO John Sheridan told investors in August, adding that the company is also in discussions with Dexcom and Abbott to connect their glucose sensors to the new pump.
In addition to pursuing clearance for the slimmed-down Mobi pump, Tandem is also in the process of adding another insulin delivery system to its portfolio. It offered up about $216 million at the end of this year to acquire AMF Medical, the Swiss maker of a patch pump for automated insulin delivery. The rechargeable Sigi device is meant to connect via Bluetooth to a user’s existing CGM device, smartphone and other controllers, and the acquisition is expected to close early next year—giving Tandem yet another route toward closing the diabetes management loop in 2023.
The aptly named Diabeloop is also circling closer to the closed-loop goal. In June, it announced the close of a 70 million euro series C funding round it said would be used to help prepare for U.S. commercialization of its flagship AI algorithm, which does the work of translating CGM readings into insulin pump commands. The system has already been CE marked for European sales, and Diabeloop has spent the last year carving out a space for itself in the U.S. market, too.
Meanwhile, in an interview with Fierce Medtech during the American Diabetes Association’s annual conference in June, Robert Vigersky, M.D., chief medical officer of Medtronic’s diabetes business, described the company’s plans to upgrade its already groundbreaking artificial pancreas system. It’s in the process of developing new algorithms that would be able to calculate mealtime bolus insulin without the user’s input; Vigersky said at the time that the first study results concerning those algorithms could arrive within a year.
But as those algorithms go through the testing process, Medtronic is already working on making them even smarter. Vigersky said the company is aiming to integrate into its closed-loop system with the gesture-tracking technology it acquired in its 2019 purchase of Klue, which is embedded in a smartwatch and can analyze hand and arm movements to determine when a user is eating and for how long.