Dexcom Receives FDA Clearance for Smart Basal, a First-of-Its-Kind AI-Powered Basal Insulin Dosing Solution

20 November 2025 | Thursday | News

Built on Dexcom G7 15 Day sensor data, the new tool delivers personalized daily dose recommendations to help adults on glargine U-100 reach optimal insulin dosing more safely, simply, and efficiently.

-DexCom, Inc. (NASDAQ: DXCM), the global leader in glucose biosensing, announced today the FDA has cleared Dexcom Smart Basal, the first and only CGM-integrated basal insulin dosing optimizer designed for adults with Type 2 diabetes on glargine U-100 long-acting insulin therapy.1 Dexcom Smart Basal will use Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily recommendations to guide users towards a more effective long-acting insulin dose, as directed by their healthcare provider.

“We understand that many people with Type 2 diabetes are apprehensive about starting basal insulin due to fears of hypoglycemia and the reality that it often takes months of trial and error to reach the right dose,” said Peter Simpson, senior vice president of innovation and sensor technology at Dexcom. “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.1 We’re excited about the opportunity to improve this experience for users and their healthcare providers by making it simpler and more personalized.”

How Dexcom Smart Basal works:

  • Dexcom Smart Basal begins with an initial basal insulin dose set by a healthcare provider.
  • Users will receive daily dose recommendations and reminders in the Dexcom G7 15 Day app.
  • Dexcom Smart Basal looks at all of a user’s CGM readings to adjust their personalized insulin dose recommendation, instead of using a single fasting blood glucose measurement.
  • 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.1,2
  • When the user’s glucose is consistently within the set target range, they’ll receive their optimal dose and Dexcom Smart Basal will complete.

Dexcom Smart Basal will be added to the Dexcom G7 15 Day experience shortly after the product launches in the United States. Once Dexcom Smart Basal is available, healthcare providers can seamlessly integrate it into their workstreams by prescribing and configuring the system using Dexcom Clarity, saving time and simplifying care for patients.

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

 

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