Dexcom receives FDA clearance for first CGM-integrated basal insulin optimizer

SAN DIEGO - DexCom, Inc. (NASDAQ:DXCM) announced Wednesday that the FDA has cleared Dexcom Smart Basal, the first CGM-integrated basal insulin dosing optimizer for adults with Type 2 diabetes using glargine U-100 long-acting insulin therapy. The medical device maker, currently valued at $23.5 billion and considered undervalued according to InvestingPro Fair Value metrics, continues to strengthen its product portfolio despite experiencing a 22.6% stock price decline year-to-date.

The new technology will use Dexcom G7 15 Day sensor data and logged doses to calculate personalized daily insulin recommendations, according to a company press release.

Dexcom Smart Basal aims to simplify the process of initiating and managing basal insulin by providing users with daily dose recommendations and reminders through the Dexcom G7 15 Day app. The system analyzes continuous glucose monitoring readings rather than relying on a single fasting blood glucose measurement.

"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.

The system begins with an initial basal insulin dose set by a healthcare provider. If low glucose events occur, it automatically lowers the user's insulin dose recommendation by the amount predetermined by their healthcare provider. The system also offers customizable low alerts to help prevent hypoglycemic events.

Dexcom Smart Basal will be added to the Dexcom G7 15 Day experience shortly after the product launches in the United States. Healthcare providers will be able to prescribe and configure the system using Dexcom Clarity.

The company stated it is working to bring Dexcom Smart Basal to international markets in the future.

In other recent news, DexCom reported its third-quarter earnings for 2025, surpassing analysts' expectations with an earnings per share (EPS) of $0.61 compared to the forecasted $0.57. The company also reported revenue of $1.21 billion, exceeding predictions of $1.18 billion, marking a 2.54% surprise. Despite these positive results, several firms have adjusted their stock price targets for DexCom. Bernstein lowered its price target to $84, citing valuation concerns, while maintaining an Outperform rating. Piper Sandler also reduced its target to $75, noting growth concerns despite the strong quarterly performance. BTIG adjusted its target to $85, maintaining a Buy rating, and highlighted the company's 20% organic year-over-year revenue growth. Canaccord Genuity decreased its target to $99, pointing to quality costs, but acknowledged the strong revenue beat. These developments reflect a mixed sentiment among analysts regarding DexCom's future growth prospects.

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