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FDA OKs Dexcom’s Insulin Dosing Optimizer for Type 2 Diabetes

Smart Basal uses Dexcom G7 15-day CGM sensor data and logged doses to calculate personalized daily recommendations.

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By: Sam Brusco

Associate Editor

Smart Basal is designed to make basal insulin initiation and management simpler and more personalized for users and their healthcare providers. Photo: Dexcom

Dexcom announced the U.S. Food and Drug Administration (FDA) has cleared Dexcom Smart Basal, a continuous glucose monitor (CGM)-integrated basal insulin dosing optimizer designed for adults with Type 2 diabetes on glargine U-100 long-acting insulin therapy.

Smart Basal uses G7 15 Day CGM sensor data and logged doses to calculate personalized daily recommendations that guide users toward a more effective long-acting insulin dose, as directed by their doctor.

It begins with an initial basal insulin dose set by a healthcare provider. Users receive daily dose recommendations in the G7 15 Day app. Smart Basal examines all CGM readings to adjust personalized insulin dose recommendation instead of using a single fasting blood glucose measurement.

If low glucose events happen, Smart Basal lowers the insulin dose recommendation by the amount set by their doctor. Dexcom G7 15 Day also provides customizable low alerts that offer proactive protection against hypoglycemic events and let users treat low glucose in real-time.

When glucose is consistently within the target range, the optimal dose will be received and Smart Basal will complete. Smart Basal will be added to the G7 15 Day experience soon after launch in the U.S., the company said.

“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. “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.”

Earlier this year, the company released a new AI-powered meal logging feature for its Stelo over-the-counter glucose biosensor, following the feature’s launch on G7 last year.

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