A Milestone Moment: Luna Diabetes Begins Its Pivotal Trial

At Luna Diabetes, we’re excited to announce a major step forward in our mission to revolutionize nighttime glucose control. We’ve officially started our pivotal trial for Luna, our groundbreaking automated insulin delivery system. This trial is more than just a step—it’s a leap toward bringing life-changing diabetes technology to the people who need it most.

But what exactly is a pivotal trial, and why is it so important? Let’s break it down.

What is a Pivotal Trial?

A pivotal trial is a critical, large-scale clinical study that tests the safety and effectiveness of a new medical device. This type of trial typically represents the final stage of clinical testing before a product can be submitted to the FDA for clearance. The goal is simple: to provide clear, robust evidence that the product works as intended and meets stringent safety standards.

In our case, the pivotal trial will determine how well Luna delivers on its promise of improving nighttime glucose control for people who rely on insulin injections. For the past few years, we’ve worked tirelessly on developing this technology, and this trial will show, in a real-world setting, how effective Luna can be at transforming nighttime diabetes management.

We are thrilled to be one of the first companies to use Time in Range Improvement, measured by a connected CGM, to demonstrate the effectiveness of our solution.

Why Is This Trial So Important?

The pivotal trial is the culmination of years of innovation, research, and smaller studies that have led us to this point. This is the moment we put all that hard work to the test on a larger scale. When we are done, the results from this trial will bring us closer to regulatory approval, meaning Luna could soon be available to help millions of people manage their diabetes overnight.

For those of us living with diabetes, especially those managing it with insulin pens, the stakes couldn’t be higher. Nighttime is one of the most challenging times for glucose management, and our goal is to make that a thing of the past. Luna is designed to work while you sleep, providing micro-doses of insulin to keep glucose levels stable, allowing a restful night’s sleep.

Where to Learn More?

If you’re interested in the trial's technical details or want to follow its progress, you can find all the information on ClinicalTrials.gov. This website is the go-to resource for tracking clinical trials like ours. You’ll be able to see updates, learn about the trial design, and even find out if there are opportunities to participate.

Join Us on This Journey

Whether you’re living with diabetes or supporting someone who is, this trial represents hope for a simpler, more manageable future. If you’d like to follow our journey or learn more about Luna, you can sign up for updates directly from us. Stay tuned—we’re just getting started!