American regulator FDA has approved the world’s first glucometer for continuous glucose monitoring, which can now be purchased without a prescription. The Dexcom Stelo Glucose Biosensor System is an innovative system designed for individuals over 18 years old who do not use insulin. It is targeted towards people with diabetes who manage their condition with oral medications, as well as those who are looking to better understand the impact of diet and exercise on blood sugar levels. However, the system is not recommended for individuals with severe hypoglycemia as it does not alert to dangerously low blood sugar levels.
The FDA emphasized the significance of this approval, highlighting that glucometers can serve as a valuable tool for monitoring blood glucose levels. The agency also pointed out that with this new decision, individuals will be able to purchase the device without the need for a doctor’s prescription, a major step towards ensuring equal access to health information regardless of insurance coverage or access to a specialist.
The Stelo Glucose Biosensor System utilizes a wearable sensor that connects to a smartphone or other compatible smart device, such as smartwatches, to continuously measure, record, analyze, and display glucose levels in individuals over 18 years of age. The sensor can be worn for up to 15 days before needing replacement and provides glucose data updates every 15 minutes. However, the FDA advises against making medical decisions solely based on the device data without consulting a healthcare professional.
Clinical studies conducted by the FDA have demonstrated that the device performs comparably to other continuous glucose monitoring systems. During the trials, some side effects were reported, including local infections, skin irritation, and discomfort.