FDA Clears First CGM-Integrated Basal Insulin Dosing Optimizer for Adults With Type 2 Diabetes

The US Food and Drug Administration (FDA) has cleared Dexcom Smart Basal, the first continuous glucose monitoring (CGM)-integrated basal insulin dosing optimizer for adults aged 18 years and older with type 2 diabetes (T2D) who are using long-acting insulin.

DexCom announced the clearance on November 19, 2025, in a press release. The system is designed for adults with T2D on glargine U-100 long-acting insulin therapy and will use Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily recommendations to guide users toward 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," Peter Simpson, senior vice president of innovation and sensor technology at Dexcom, said in the press release. "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."

According to the company, 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.

The system analyzes all of a user's CGM readings to adjust their personalized insulin dose recommendation, instead of relying on a single fasting blood glucose measurement, noted the company. If low glucose events occur, Dexcom Smart Basal lowers the user's insulin dose recommendation by the amount set by their healthcare provider. The 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, according to the release.

When the user's glucose is consistently within the set target range, they will receive their optimal dose and Dexcom Smart Basal will complete, stated the company.

Dexcom Smart Basal will be added to the Dexcom G7 15 Day experience shortly after the product launches in the US, according to the manufacturer. Once available, healthcare providers can seamlessly integrate it into their workstreams by prescribing and configuring the system using Dexcom Clarity, the company noted.

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