DexCom announced that the U.S. Food and Drug Administration has cleared its Smart Basal product, the first continuous glucose monitoring‑integrated basal insulin dosing optimizer for adults with type 2 diabetes on glargine U‑100 long‑acting insulin therapy. The clearance, issued on November 19, 2025, allows Smart Basal to use data from the DexCom G7 15‑day sensor and logged insulin doses to calculate personalized daily basal insulin recommendations, potentially improving glycemic control and simplifying insulin titration for patients and clinicians.
The approval marks a significant operational milestone for DexCom, which has historically focused on continuous glucose monitoring. By adding a dosing‑optimization tool, the company is creating a new revenue stream and strengthening its position in the larger type 2 diabetes market. The product’s ability to analyze continuous glucose readings rather than a single fasting blood glucose measurement gives clinicians a more dynamic and data‑driven approach to basal insulin management, addressing a key unmet need for patients who are hesitant to start or adjust basal therapy.
Market reaction to the announcement was muted. DexCom shares fell 0.28 % in pre‑market trading on November 19, and a November 20 report noted that the stock declined despite the clearance, suggesting that other factors were weighing on investor sentiment at the time of the announcement.
Peter Simpson, senior vice president of innovation and sensor technology, said the new tool “removes barriers to insulin initiation—giving healthcare providers the confidence to start their patients on basal therapy sooner and with greater ease.” The quote underscores the company’s focus on improving both patient outcomes and clinician workflow.
The G7 15‑day sensor, which received FDA clearance in April 2025, will soon be integrated with Smart Basal, allowing the new feature to be rolled out across DexCom’s existing sensor ecosystem. The company’s broader strategy includes expanding Smart Basal to international markets and continuing to target the growing type 2 diabetes population with integrated CGM and insulin‑dosing solutions.
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