Dexcom Smart Basal Receives FDA Clearance Becoming the First and Only CGM-integrated Basal Insulin Dosing Optimizer for Type 2 Diabetes

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8:30 AM on Wednesday, November 19

The Associated Press

SAN DIEGO--(BUSINESS WIRE)--Nov 19, 2025--

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.

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Dexcom Smart Basal is designed to make basal insulin initiation and management simpler and more personalized for users and their healthcare providers.

“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.

About Dexcom

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, helping them feel more in control and live more confidently.

Dexcom. Discover what you’re made of. For more information, visit www.dexcom.com.

Category: IR

*When compared to SMBG and a single fasting blood glucose measurement. 1 Dexcom, data on file, 2025. 2 Dexcom G7 15 Day User Guide.

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KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: GENERAL HEALTH DIABETES MEDICAL DEVICES HEALTH HEALTH TECHNOLOGY

SOURCE: DexCom, Inc.