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Dexcom wins FDA nod for smart CGM-integrated basal dosing for type 2 diabetes

November 19, 2025 By Sean Whooley

Dexcom Smart Basal insulin dosing type 2 diabetes with G7 CGM
The Smart Basal offering with the G7 CGM. [Images courtesy of Dexcom]
Dexcom (NSDQ:DXCM) announced today that the FDA cleared its Smart Basal CGM-integrated basal insulin dosing optimizer.

The continuous glucose monitor (CGM)-based offering received clearance for adults with type 2 diabetes on glargine U-100 long-acting insulin therapy. San Diego-based Dexcom says it marks the first and only CGM-integrated basal dosing optimizer cleared for type 2 diabetes.

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

Dexcom — one of the largest diabetes tech companies in the world — designed its new offering to begin with an initial base insulin dose set by a healthcare provider. Users then receive daily dose recommendations and reminders in their G7 15 Day app. The platform looks at all of the user’s CGM readings to adjust personalized dose recommendations. This differs from the conventional use of a single fasting blood glucose measurement, according to a news release.

Read more about Dexcom and the rest of the diabetes tech industry in our free Diabetes Technology Special Report.
Visit here to purchase our Medtech Market Special Report on CGMs.

If low glucose events occur, Smart Basal lowers the user’s insulin dose recommendation by the amount set by their healthcare provider. The 15 Day G7 also offers customizable low alerts that deliver proactive protection against hypoglycemic events and allow users to treat low glucose in real time.

Dexcom said that when glucose remains in the target range, users receive their optimal dose, as Smart Basal completes.

The company plans to add the offering to its 15 Day offering shortly after its U.S. launch. Once available, providers can integrate it into their workstreams by prescribing and configuring the system using Dexcom Clarity.

Dexcom also plans to bring Smart Basal to international markets “in the future.”

“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, SVP 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. We’re excited about the opportunity to improve this experience for users and their healthcare providers by making it simpler and more personalized.”

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Dexcom, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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