United States: On Tuesday, the US Food and Drug Administration (FDA) brought the first continuous glucose monitor (CGM) to the market that can be secured without a prescription for people with type 2 diabetes entities.
The FDA aims to authorize the said product by the summer of this year, a new Dexcom Stelo Glucose Biosensor Device System for people who age 18 and above and don’t take insulin even in case of type 2 diabetes, disclosed by the organization.
More about CGM
This system is composed of tiny sensors that pierce through the skin measuring the amount of blood sugar levels 24 hours a day.
Receiving those real-time data on his or her smartphone specially designed to alert users and their families and doctors may help in early detection of dangerous range of blood sugar level.
CGM is a power tool, according to the FDA
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said, “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” as US News reported.
He added further, “Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for US patients.”
Know a few shortcomings of the device
The agency alerts that the new system is not for patients with problematic hypoglycemia (low blood sugar), noting it was “not designed to alert the user to this potentially dangerous condition.”
Twenty-five million people with type 2 diabetes who are not treated with insulin have been highlighted by Dexcom.
However, when patients apply for the company’s G7 CGM system to these groups, it is necessary to get a prescription for it.
CGM will empower people with diabetes – Experts
According to US News reports, Dr. Tamara Oser, a family physician, said in a Dexcom news release that “Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values” and “For people newly diagnosed with Type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”
The sensor can be worn on the upper arm and lasts up to 15 days, according to the manufacturer’s information on the Dexcom site.
Data from a clinical study submitted to the FDA showed that the device compared well with other items in terms of performance, according to the FDA. Adverse events reported in the research were infection in the area, irritation of the skin, and pain or discomfort.