The approval expands the use of the therapy to delay the onset of Stage 3 Type 1 diabetes in children as young as one year old.
The study will use the Dexcom G7 Continuous Glucose Monitoring system, developed by a global leader in CGM technology, to assess whether continuous monitoring can improve blood sugar control when integrated into a structured, multidisciplinary care programme.
The collaboration follows the signing of a Memorandum of Understanding and forms part of Saudi Arabia’s broader efforts to enhance preventive healthcare and improve outcomes for people living with chronic diseases.
Insulet received Investigational Device Exemption approval from the U.S. Food and Drug Administration in March 2026, clearing the way for the trial to begin.
The Omnipod 5 System streamlines diabetes care through automated insulin adjustments every five minutes, eliminating the burden of multiple daily injections.