FDA Okays New Device to Monitor Glucose in Adults with Diabetes

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The first continuous glucose monitoring system that doesn’t require blood sample calibration – “finger sticks” – was recently approved by the U.S. Food and Drug Administration for use in people over 18 who have diabetes.

The system uses a small sensor wire inserted below the skin to continuously measure and monitor glucose levels, reducing the need for finger-stick testing. Users determine glucose levels by waving a mobile reader above the sensor wire. The device, which can be worn for up to 10 days after a 12-hour start-up period, is able to detect too-high (hyperglycemia) too-low (hypoglycemia) blood sugar levels and can also measure changes in glucose levels.

Possible risks include inaccurate measurements leading to mistakes in treatment decisions and minor irritation at the site of insertion. The system doesn’t provide real-time alerts without user-initiated action; for example, it cannot alert users to low blood glucose levels while they’re sleeping.

Sourced from: FDA