The U.S. Food and Drug Administration has approved the marketing of the world's first wearable device capable of continuously monitoring both glucose and ketone levels together, which could help diabetes patients detect signs of diabetic ketoacidosis before it develops into a life-threatening medical emergency.
اضافة اعلان
The device, called "Libre Duo 10 Day," was developed by Abbott Diabetes Care, and the FDA has authorized its use for people with diabetes aged two and older.
The device measures glucose and ketone levels in the interstitial fluid beneath the skin every minute, day and night, for up to 10 days of continuous use.
Readings are sent wirelessly to a compatible smartphone, allowing users to check their current glucose and ketone levels and track whether they are rising or falling.
The device can also issue an automatic alert if ketone levels reach a concerning threshold, giving the patient or their family a chance for early intervention and to seek medical help.
Ketones form when the body starts using fat instead of glucose as an energy source. Their buildup can lead to diabetic ketoacidosis, one of the most serious complications of diabetes, which can develop quickly and become life-threatening if left untreated.
Previously, patients who needed to monitor ketones relied on separate tests that provided a single reading at a specific moment, without showing whether levels were rising or falling. The new device, however, allows for continuous trend monitoring.
The FDA based its decision on data from six clinical studies involving more than 600 participants aged two and older.
The results showed the device's ability to track clinically significant changes in ketone levels throughout the period of use, including detecting rising levels before the onset of diabetic ketoacidosis.
The FDA stressed the importance of interpreting ketone readings in conjunction with glucose levels and the symptoms the patient is experiencing.
The device is not a treatment for diabetes or a substitute for medical follow-up, but it shifts ketone testing from a separate, one-time test into continuous monitoring that may give patients and caregivers an early warning before dangerous complications develop.
