FDA Clears Dexcom (NASDAQ:DXCM)’s Smart Basal Insulin Dosing Optimizer for Type 2 Diabetes

November 19, 2025. Leads & Copy — DexCom, Inc. (NASDAQ: DXCM) announced that the FDA has cleared Dexcom Smart Basal, a CGM-integrated basal insulin dosing optimizer for adults with Type 2 diabetes on glargine U-100 long-acting insulin therapy.

Dexcom Smart Basal utilizes Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily recommendations. These recommendations guide users toward a more effective long-acting insulin dose, as directed by their healthcare provider.

The company said Dexcom Smart Basal is designed to simplify basal insulin initiation and management for users and healthcare providers.

Peter Simpson, senior vice president of innovation and sensor technology at Dexcom, said that many people with Type 2 diabetes are apprehensive about starting basal insulin due to fears of hypoglycemia and the potential months of trial and error involved in finding the right dose.

Simpson said Dexcom Smart Basal is designed to remove barriers to insulin initiation, giving healthcare providers the confidence to start their patients on basal therapy sooner and with greater ease.

How Dexcom Smart Basal works:

  1. Dexcom Smart Basal begins with an initial basal insulin dose set by a healthcare provider.
  2. Users receive daily dose recommendations and reminders in the Dexcom G7 15 Day app.
  3. Dexcom Smart Basal analyzes CGM readings to adjust personalized insulin dose recommendations, rather than relying on a single fasting blood glucose measurement.
  4. If low glucose events occur, Dexcom Smart Basal lowers the user’s insulin dose recommendation by the amount set by their healthcare provider. Dexcom G7 15 Day also offers customizable low alerts that deliver proactive protection against hypoglycemic events and allow users to treat low glucose in real-time.
  5. When the user’s glucose is consistently within the set target range, they receive their optimal dose, and Dexcom Smart Basal is complete.

Dexcom Smart Basal will be added to the Dexcom G7 15 Day experience shortly after the product launches in the United States. Healthcare providers can integrate the system into their workflows by prescribing and configuring it using Dexcom Clarity.

Efforts are underway to bring Dexcom Smart Basal to international markets in the future.

Dexcom empowers people to take control of health through innovative biosensing technology. Founded in 1999, Dexcom has pioneered and set the standard in glucose biosensing for more than 25 years. Its technology has transformed how people manage diabetes and track their glucose.

For more information, visit www.dexcom.com.

*When compared to SMBG and a single fasting blood glucose measurement.

1 Dexcom, data on file, 2025.

2 Dexcom G7 15 Day User Guide.

Source: Dexcom, Inc.

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