Luna Diabetes has announced the launch of its pivotal trial for Luna, a miniature automated insulin delivery system intended to improve nighttime glucose control. The trial represents a crucial step toward providing safer and more effective solutions for individuals requiring insulin therapy.
System Design and Functionality
Luna is designed to be the world's smallest patch pump, delivering micro-doses of insulin while the user sleeps. The system integrates with continuous glucose monitors (CGMs) to calculate and administer rapid-acting insulin doses. According to Luna Diabetes, the system offers the simplest onboarding experience of any automated insulin delivery system and features an algorithm designed for use with insulin pens.
Trial Objectives and Design
The pivotal trial, as detailed on ClinicalTrials.Gov, aims to evaluate the impact of the wearable insulin pump on blood sugar levels during sleep. Participants will use the device nightly for 13 weeks, with the total study duration extending to 17 weeks. The primary objectives are to assess the safety and efficacy of Luna in reducing blood sugar levels among individuals with consistently elevated nighttime glucose levels and upon waking.
Luna is not intended to replace long-acting, correction, or mealtime insulin. The trial will assess whether the device can effectively lower blood sugar levels in the target population.
Leadership and Company Background
Luna Diabetes was co-founded by John Sjölund, Jon Brilliant, and Sean Saint. Sjölund, who serves as CEO, previously co-founded and led Timesulin until its acquisition by Bigfoot Biomedical. He also held positions at Bigfoot Biomedical, including VP of connected injection systems and chief of staff. His personal experience with type 1 diabetes, diagnosed at age four, motivated the development of Luna to address the challenges of nighttime glucose management.
Enrollment and Projected Outcomes
The company anticipates enrolling approximately 130 patients in the trial, with a projected completion date of August 2025. The trial's outcomes are expected to provide critical data for regulatory approval and demonstrate Luna's potential to revolutionize diabetes management during sleep.
"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," said Sjöslund. "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."
