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- The FDA has granted marketing approval for the first OTC continuous glucose monitor.
- The wearable device, manufactured by Dexcom, is expected to hit the market this summer.
- This product is intended for adults with type 2 diabetes who are not using insulin.
The Food and Drug Administration (FDA) received marketing approval The first over-the-counter continuous glucose monitor (CGM).
This product, Dexcom’s Stelo Glucose Biosensor System, is approved to support adults with type 2 diabetes who are not using insulin and adults without diabetes who want to monitor their blood sugar levels. It is scheduled for release in summer 2024.
Stelo is a wearable sensor that can last up to 15 days before needing to be replaced. It connects to an app on your phone and measures your blood sugar levels every 15 minutes. The approval came after data was presented to the FDA showing it was as effective as similar products. However, the data is currently not publicly available.
Chief Operating Officer of Dexcom Jake Leach He said he was enthusiastic about Stelo’s potential to reach a wider audience. Being available over-the-counter allows people to avoid some of the financial hurdles associated with insurance companies.
“As we look back at the milestones to date, this is one that will rank high on the chart of major changes in the CGM industry, and we couldn’t be more excited that Dexcom is leading the charge.” I can’t,” Leach told Berrywell.
Pouya Shafipur, MarylandThe family and bariatric medicine physician at Providence St. John’s Health Center said the product is a promising development, but expressed concerns about its accuracy and patient response to near real-time data.
“There are a lot of things that can affect your results: your diet, your exercise, your supplements, the vitamins you take. ‘I’m worried that it might affect me.’ It’s worrying when I see my blood sugar levels suddenly go up,’ Shafipour told Berrywell.
Shafipour said patients who are successful with CGM focus on broader trends rather than individual spikes or dips. The ideal patient for the product is someone with prediabetes or early-onset type 2 diabetes, he added.
“They can use this to guide their future diet, behavior or exercise management,” Shafipour said.
With increasing interest in longevity and athletic performance, the popularity of CGM has also skyrocketed.
Dexcom Chief Operating Officer Leach said the company is interested in the sports market, but is prioritizing diabetics.
“I can’t tell you how many people I know who don’t have diabetes who have tried CGM say, ‘I learned something interesting.’ That’s great, but what do we do with this information? How can I improve my performance? How can I actually lose weight?” Leach said. “Products have to be designed for that. In the future, we plan to offer products that address these use cases. But Stelo is designed specifically for type 2 diabetes. ”
According to the FDA, side effects from using Stelo may include local infections, skin irritation, and pain.
The agency said Stero does not have a warning system for hypoglycemia and is not intended as an option for insulin users. Users are also asked not to use the data provided to make important health decisions without consulting a medical professional.
Despite the potential risks of improper use and patients over-analyzing short-term data, Shafipour said he believes there is a viable market for the device.
“I think these are great devices,” Shafipour said. “It will give you a lot of information about activities and different types of foods that can affect your health. [blood sugar levels]And there are also a lot of doctors who have great podcasts recommending these devices for people to manage their health and diet. ”
Dexcom’s Stelo (wearable continuous blood sugar monitor) is expected to be available in stores soon this year.