Insulet is developing an automated insulin delivery system that will be “completely different” than its competitors, Chief Medical Officer Trang Ly said in an interview after the American Diabetes Association’s Scientific Sessions.
The system, which Insulet calls “fully closed loop,” is for people with Type 2 diabetes and does not require carb-counting or insulin bolusing ahead of meals. Physicians also don’t need to program the starting settings, and dose titration is automated.
“With our system there’s no bolusing at all. There’s actually no bolus button. … It’s completely different to what Medtronic and Tandem and everyone else is working on,” Ly said. “There are no settings for anyone to enter.”
Insulet shared results of its Evolution 3 study of the planned system at the conference on Saturday. The study built on previous results the company shared at another diabetes conference in March.
While the Evolution 2 study was designed to test the system’s core algorithm, the Evolution 3 study tests the device’s starting conditions and auto-titration. The 36-person trial included adults with Type 2 diabetes taking insulin, the majority of whom were taking multiple daily injections, but a few people also used insulin pumps or basal insulin only.
Participants’ time in range, a measurement of how much of the day a person stays within a target blood glucose range, increased from 51% to 64%. Their total daily insulin was also reduced from 86 units to 58 units, with no weight gain.
The system is designed specifically for Type 2 diabetes and is intended to remove the burden of mealtime insulin interaction and the need for doctors to start and titrate insulin therapy, which can be a barrier to adopting insulin therapy. Everyone using the system has the same starting dose, Ly said, and then the algorithm adjusts over time based on a person’s insulin needs.
People in the study had a broad range of insulin needs; some needed 10 units per day while other people needed 150 units per day, Ly added. Because the system is intended for people with Type 2 diabetes, there are fewer concerns about hypoglycemia and exercise.
Insulet is using the results to support a pivotal trial of the system, called Evolve, which will compare the current standard therapy to the fully closed loop system. Insulet expects a readout of the roughly 300-person, randomized, controlled trial next year and a 2028 commercial launch.
Omnipod 6 findings
Insulet also shared the results of a pivotal trial of its Omnipod 6 algorithm, for people with Type 1 or Type 2 diabetes. Insulet is planning a Food and Drug Administration submission this year and a launch of Omnipod 6 next year.
The main difference between the Omnipod 6 and Insulet’s current Omnipod 5 patch pumps is that the new system has a lower glucose target of 100 mg/dL. Patients can stay in automated mode for longer, allowing the device to continue to make automated insulin adjustments. The algorithm has also been changed to allow it to deliver up to 50% more insulin in certain scenarios, Ly said.
The new device should have better Bluetooth connectivity, giving people more flexibility to wear the patch pump where they want. The devices will also have the capability to support over-the-air updates, reducing the lag time before people get access to updates.
For the study, 132 people were randomized to use either Omnipod 5 or Omnipod 6 for four weeks, then switch to the other device for another four weeks. After that, they went to an additional “bolus optional” phase to see if glycemic outcomes could be maintained with three or fewer boluses per day.
People with Type 1 diabetes saw their time in range improve from 73% on the Omnipod 5 to 77% on the Omnipod 6, while people with Type 2 diabetes had an improvement from 73% to 76%. During the bolus optional phase, people with Type 1 diabetes maintained a 76% time in range, while people with Type 2 diabetes had a 74% time in range.
Ly said Insulet will still recommend that people bolus while using the Omnipod 6 system, but the new algorithm should be able to better offset small meals.
“It’s all about doing more for the user, so that they can worry less about diabetes,” Ly said.
