Dexcom Smart Basal Receives FDA Clearance for the First CGM-Integrated Basal Insulin Optimizer

Dexcom has received clearance from the US Food and Drug Administration (FDA) for Dexcom Smart Basal, the first basal insulin dosing optimiser that directly integrates with continuous glucose monitoring (CGM) for adults with Type 2 diabetes using long-acting glargine U-100 insulin.

Dexcom Smart Basal is designed to improve the early stages of insulin therapy, where achieving the appropriate dose can be slow and challenging. 

The system works alongside the Dexcom G7 15-Day sensor, using real-time glucose data and logged insulin doses to deliver personalised daily recommendations through the Dexcom G7 15-Day app. 
This approach offers a more complete picture of glucose patterns compared with relying on a single fasting reading.

The optimiser starts with a dose set by a healthcare professional and automatically adjusts recommendations based on individual glucose trends. 

If low-glucose events occur, the system reduces the advised dose in line with clinical settings. Once glucose levels remain within the targeted range consistently, dosing guidance concludes.
Healthcare providers can prescribe and configure the solution through Dexcom Clarity, helping streamline diabetes care.

Dexcom Smart Basal will be added to the Dexcom G7 15-Day system following its US launch, with plans for global expansion in the future.