MannKind Corporation has begun enrollment of its INHALE-1ST clinical trial, aiming to expand the use of its inhaled insulin, Afrezza, to children. The first participant was enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado. Approximately 100 newly diagnosed children ages 10 to 18 with type 1 diabetes will participate across about 10 clinical sites nationwide. The 13-week study will evaluate early use of Afrezza in combination with a once-daily basal insulin injection, measuring both clinical outcomes and satisfaction among patients and caregivers.

Afrezza is a rapid-acting insulin delivered through a small inhaler. Users insert a cartridge, close the device, and inhale the insulin powder in about two seconds. We spoke with an Afrezza user on our podcast, where she described the device as offering greater flexibility and convenience. If approved, Afrezza would become the first needle-free insulin option for pediatric patients, a significant milestone in more than a century of insulin therapy. The FDA is currently reviewing a supplemental application to expand its use to children ages 4 to 17, with a decision expected by May 29, 2026.

MannKind’s trial also arrives amid a larger wave of innovation in rapid insulin delivery, including an implantable pump system in early development by Portal Diabetes that aims to release insulin directly into the intraperitoneal cavity for 4-5x faster absorption. Together, these efforts reflect a growing focus on improving flexibility, comfort, and outcomes—especially for young people newly diagnosed with diabetes.

Disclaimer: Diabetech content is not medical advice—it’s for educational purposes only. Always consult with a physician before making changes to your healthcare.