Dexcom Smart Basal Receives FDA Clearance for Personalized Basal Insulin Dosing

Dexcom Smart Basal, the first and only continuous glucose monitor (CGM)-integrated basal insulin dosing optimizer, has received FDA clearance. It is designed for adults with type 2 diabetes (T2D) on glargine U-100 long-acting insulin therapy.¹

What is Basal Insulin?

Basal insulin works like the body’s natural background insulin and keeps glucose levels steady between meals and during sleep. This insulin is typically taken once or twice daily as a long-acting dose through subcutaneous injection using a syringe or a pre-filled pen.²

“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 a news release.¹ "Dexcom Smart Basal is designed to remove barriers to insulin initiation—giving health care providers the confidence to start their patients on basal therapy sooner and with greater ease."

What is Dexcom Smart Basal?

Dexcom Smart Basal uses data from the Dexcom G7 15-day sensor and logged insulin doses to generate personalized daily recommendations that help users optimize their long-acting insulin dose under their health care provider’s guidance.¹

With an overall Mean Absolute Relative Difference (MARD) of 8%, the Dexcom G7 15-day enhances the performance of Dexcom CGM systems, which are clinically proven to lower A1c, reduce both high and low glucose episodes, and improve time in range.³

The Dexcom G7 15-day is a new CGM designed to last for 15.5 days, which leads to fewer sensor changes per month for users. The CGM system will launch in the US on December 1, 2025, for adults aged 18 years and older and will initially be available through a durable medical equipment provider, with coverage extended to Medicare beneficiaries under the US Centers for Medicare & Medicaid Services CGM requirements. The study authors noted for users ages 2 to 18, the standard Dexcom G7 continues to be the most accurate CGM option.³

"We’ve heard loud and clear from our users—they want more time with the Dexcom G7 because it gives them confidence, clarity, and control over their health,” Grant Ovzinsky, vice president of product management at Dexcom, said in a news release. “With 15.5 days of wear, we’re delivering on that ask. Fewer sensor changes mean less disruption and more time benefiting from the most accurate CGM. It’s a meaningful step forward in empowering people with diabetes to live life on their terms.”³

Using this new Dexcom G7 15-day sensor, Dexcom Smart Basal is designed to make basal insulin initiation and management simpler and more personalized for users.¹

The treatment plan starts with a basal insulin dose prescribed by a health care provider and then delivers daily dose recommendations and reminders through the Dexcom G7 15-Day app. It then analyzes all CGM readings, not just a single fasting value, and aims to adjust personalized insulin recommendations. It also lowers doses after low-glucose events based on provider-set rules and completes once the user’s glucose remains consistently within the target range.¹

Dexcom Smart Basal will be added to the G7 15-day system soon after the product is launched in December. This will allow health care providers to easily prescribe and set it up through Dexcom Clarity, a diabetes management software, to streamline their workflow and simplify patient care.¹

REFERENCES

1. Dexcom Smart Basal Receives FDA Clearance Becoming the First and Only CGM-integrated Basal Insulin Dosing Optimizer for Type 2 Diabetes. News release. Dexcom. November 19, 2025. Accessed November 20, 2025. https://investors.dexcom.com/news/news-details/2025/Dexcom-Smart-Basal-Receives-FDA-Clearance-Becoming-the-First-and-Only-CGM-integrated-Basal-Insulin-Dosing-Optimizer-for-Type-2-Diabetes/default.aspx

2. Basal vs. Bolus Insulin: What you need to know. News release. Dexcom. May 19, 2025. Accessed November 20, 2025. https://www.dexcom.com/all-access/clinical-corner/basal-bolus-insulin-diabetes

3. Dexcom G7 15 Day Continuous Glucose Monitoring System to Launch on Dec. 1 in the United States. News release. Business Wire. November 20, 2025. Accessed November 20, 2025. https://www.businesswire.com/news/home/20251120288721/en/Dexcom-G7-15-Day-Continuous-Glucose-Monitoring-System-to-Launch-on-Dec.-1-in-the-United-States