Dive Brief:
- Insulet has enrolled the first participant in a pivotal study of a fully closed loop automated insulin delivery system for people with Type 2 diabetes.
- Automated insulin delivery, or AID, systems combine an insulin pump with a continuous glucose monitor, and use an algorithm to anticipate the needed dose of insulin. While systems on the market today require users to input bolus doses and count carbohydrates, Insulet’s fully automated system would remove those requirements.
- Insulet plans to make a 510(k) submission to the Food and Drug Administration in 2027 and launch the device in 2028, according to the Monday announcement.
Dive Insight:
Insulet first disclosed plans to make a fully closed loop system last year. Chief Operating Officer Eric Benjamin, speaking at an investor event, said the company was starting with Type 2 diabetes because people with Type 1 expect tight glycemic control and have a higher risk of hypoglycemia. The diabetes tech firm shared results of a small feasibility study in March showing that users of the system spent more time in range than people who used standard injection therapy to manage their diabetes.
For Insulet’s pivotal trial, called Evolve, the firm plans to enroll up to 350 adults across 40 sites in the U.S. Study participants must have Type 2 diabetes and use insulin to manage their care.
With a streamlined system, Insulet hopes to make AID easier to access, particularly for people who are working to manage their diabetes in a primary care setting.
About 70% of people with Type 2 diabetes are managed in primary care, according to the company. While Insulet’s prescriber base for Type 2 grew last year, adoption of AID systems by the roughly 5.5 million people with Type 2 who take insulin is less than 5%.
The fully closed loop system is intended to be simpler to use by streamlining onboarding and training, and eliminating start-up settings.
