The US Meals and Drug Administration has approved the primary steady glucose monitor (CGM) individuals should purchase with out a prescription. Dexcom’s Stelo Glucose Biosensor System has a sensor customers are supposed to insert into their higher arm, just like the corporate’s different CGMs that want a health care provider’s prescription for buy. It pairs with a smartphone software that may present the person’s blood glucose measurements and traits each quarter-hour.
The corporate designed the gadget particularly for adults 18 and up who are usually not utilizing insulin, corresponding to these managing their diabetes with oral drugs and non-diabetics making a aware effort to regulate their sugar consumption. It could possibly be an awesome device for individuals with insulin resistance, together with people with PCOS and different metabolic points that heighten their likelihood of creating diabetes sooner or later. Usually, it may give customers the perception to have the ability to higher perceive how the meals they eat and the actions they make impression their general well being.
Whereas CGMs aren’t something new, they’ve change into a wellness trend on social media final 12 months, and even non-diabetics began utilizing them. By clearing Stelo, the FDA is making the displays extra accessible than earlier than. “CGMs is usually a highly effective device to assist monitor blood glucose,” mentioned Jeff Shuren, MD, director of the FDA’s Heart for Gadgets and Radiological Well being. “Immediately’s clearance expands entry to those units by permitting people to buy a CGM with out the involvement of a well being care present. Giving extra people worthwhile details about their well being, no matter their entry to a health care provider or medical health insurance, is a crucial step ahead in advancing well being fairness for U.S. sufferers.”
Stelo will likely be accessible beginning this summer season. Every patch is supposed to final for 15 days earlier than customers might want to exchange it. Dexcom has but to disclose how a lot it might value, nevertheless it mentioned Stelo will “present an possibility for individuals who shouldn’t have insurance coverage protection for CGM.”
