Dive Brief:
- Insulet reported data Wednesday on a fully closed-loop automated insulin delivery system in people with Type 2 diabetes.
- The 24 people in the trial spent 24% more time in the target blood glucose range using the system than when receiving standard injection therapy.
- Insulet plans to start a pivotal study this year and apply for 510(k) clearance in 2027, putting the company in a close race to market with its rivals MiniMed and Tandem Diabetes Care.
Dive Insight:
CEO Ashley McEvoy said on an earnings call last month that Insulet defines “fully closed-loop” as a system that adapts without any user intervention, eliminating the need for clinicians to define initial settings or make ongoing adjustments and freeing patients from dosing and mealtime actions. Hybrid closed-loop systems require users to count carbohydrates and check that the system is working.
Insulet published clinical data on an early version of its fully closed-loop algorithm last year. The readout informed algorithm changes intended to simplify the user experience. Insulet tested multiple versions of the algorithm in the clinical trial that reported data this week.
Using the final algorithm and no bolus insulin, patients’ time in the target blood glucose range averaged 68%, a 24% improvement over standard injection therapy. Median time below the range was 0.14%. The American Diabetes Association recommends patients are below the range less than 4% of the time. No patients had severe hypoglycemia or diabetic ketoacidosis, adverse events linked to low or high insulin levels.
More than 90% of patients joined an ongoing extension phase of the study, which Insulet said reflected strong interest and positive experiences. In theory, fully closed-loop systems can reduce the burdens that diabetes puts on patients while improving outcomes. McEvoy said on the earnings call that 25% of the 5.5 million people with Type 2 diabetes who take insulin currently achieve recommended glucose targets.
Insulet aims to launch its fully closed-loop system in 2028. Rival insulin pump manufacturer Tandem is on a similar course. Tandem CEO John Sheridan told investors on an earnings call last month that his team plans to start a pivotal trial this year to support a filing with the Food and Drug Administration in 2027.
Medtronic disclosed the start of a pivotal trial of its Vivera fully closed-loop algorithm last month, shortly before spinning off the program as part of the MiniMed initial public offering. The algorithm, which is designed to eliminate carb counting and manual food bolusing, achieved a mean time in range of 73.8% without manual user input in a feasibility study.
