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[HEALTH] · Japan · 2 sources

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Dexcom Japan receives approval for 15-day CGM system

Dexcom Japan has received regulatory approval for the Dexcom G7 15Day CGM System, a real-time continuous glucose monitoring device. The system features an extended 15-day wear duration, which allows patients to cover an entire month with only two sensor changes. It also includes a 12-hour grace period to facilitate smoother transitions between sensors.

The device utilizes a new algorithm to maintain high accuracy, reporting a Mean Absolute Relative Difference (MARD) of 8.0%, with stability ranging between 7.3% and 8.9% throughout the wear period. This precision is intended to support clinical decision-making and consistent glucose management.

The system is approved for use by diabetic patients aged 18 and older who practice insulin self-injection. In Japan, the device is eligible for coverage under public health insurance, which is expected to reduce the physical and logistical burden on patients while improving adherence to glucose management protocols.

Entities

Dexcom Japan · Dexcom, Inc.