The first-of-its-kind study will be the first to evaluate closed-loop technology in people using Insulin Pens with Time-in-Range as a primary efficacy endpoint.
SAN DIEGO, CA / ACCESSWIRE / October 23, 2024 / Luna Diabetes announces the start of its pivotal trial for the Luna System today. Luna is the first automated insulin delivery solution intended for the >90% of all people with insulin-requiring diabetes who take their insulin with an insulin pen, commonly called multiple daily injections (MDI). The first-of-its-kind study will be the first to evaluate closed-loop technology in people on MDI in a pivotal study.
The AID4MDI study will use Time In Range (TIR) as the primary endpoint to assess the system's effectiveness in maintaining optimal glucose levels. Luna's pioneering solution integrates the world's smallest patch pump and a fully closed-loop algorithm, offering a unique approach to improving safety and convenience for individuals with diabetes who cannot or will not use a traditional insulin pump.
Dr. Jeremy Pettus, Endocrinologist and Associate Professor of Medicine at the University of California, San Diego, and Principal Investigator of the study, said: "In my career and in living with type 1 diabetes myself, I have had the opportunity to use and work on some of the most innovative diabetes technologies and therapies that exist. The clinical data from Luna shows remarkable performance in bringing insulin automation to the masses for the first time. This product could be used by anybody using insulin pens who is unwilling or unable to use an insulin pump."
John Sjölund, Luna Diabetes CEO, says: "Throughout my career, it has been my objective to find and work alongside the brightest minds and engineers to bring the most advanced technologies to the masses through better user experiences, lower costs, and more discretion. Our solutions aim to deliver the outcomes that matter most to patients. Our focus is squarely on better nights for better days."
The study is expected to be completed in early 2025, with a planned commercial launch soon after.
Media Contacts: [email protected]
Link to Study: https://clinicaltrials.gov/study/NCT06627517
Luna Website: https://www.lunadiabetes.com
About Luna Diabetes
Luna Diabetes is committed to advancing diabetes care through patient-focused technologies that improve the quality of life for people with diabetes. Luna's innovations, including the world's smallest patch pump and a fully closed-loop insulin dosing algorithm, aim to make automated insulin delivery accessible, safe, and effective for insulin pen users for the first time.
SOURCE: Luna Health, Inc.