The company describes the system — designed to transform nighttime glucose management — as the world’s smallest patch pump. Luna delivers micro-doses of insulin while the user sleeps. According to the company, it offers the “simplest onboarding experience” of any automated insulin delivery system. It also has the first algorithm designed for use with insulin pens, the company’s co-founder John Sjölund said in a blog post.
“We’re thrilled to announce the launch of our pivotal trial for Luna, our innovative automated insulin delivery system designed to transform nighttime glucose management,” the company wrote in a LinkedIn post. “This is a crucial step in our journey to provide safer, more effective solutions for those needing insulin therapy.
Sjölund founded Luna alongside Jon Brilliant, who co-founded Bigfoot Biomedical (acquired by Abbott), and Sean Saint, Beta Bionics CEO. Sjölund, himself Luna’s CEO, co-founded and led Timesulin as CEO until its acquisition by Bigfoot Biomedical. After that, he served as VP of connected injection systems, then chief of staff at Bigfoot. He said managing diabetes became a part of his everyday life when diagnosed with type 1 diabetes at age 4. Sjölund now says Luna was born “out of necessity” for the difficulties of nighttime glucose management.
About the Luna Diabetes pivotal trial
According to ClinicalTrials.Gov, the study aims to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep. The device works with continuous glucose monitors (CGMs) to calculate and deliver rapid-acting insulin doses during sleep.
Luna does not replace long-acting, correction or mealtime insulin. The study involves applying the device before bed for a period of 13 weeks, with the overall length extending to 17 weeks. Investigators aim to evaluate safety and efficacy, seeing if Luna lowers blood sugar levels in those with consistently high blood sugar during sleep and at wake.
The company expects to enroll about 130 patients in the trial, for which it projects a completion date of August 2025.
“Starting this trial is a significant milestone for us, bringing us closer to offering Luna to the millions of people who could benefit from it,” Sjölund wrote. “The trial will evaluate the safety and effectiveness of our system, and it’s a significant step toward regulatory approval. We are confident that the results will demonstrate how Luna can revolutionize how people manage diabetes at night.”
