Top in endocrinology: FDA OKs OTC continuous glucose monitor; limited claims for yogurt
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The FDA is allowing Dexcom Stelo to market and sell a continuous glucose monitor to patients without a prescription. The Dexcom Stelo Glucose Biosensor System will be the first over-the-counter CGM on the market.
The wearable sensor will be available to adults who use oral medication to treat diabetes, as well as people without diabetes who want to track their glucose levels throughout the day.
“CGMs can be a powerful tool to help monitor blood glucose. [This] clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a press release.
It was the top story in endocrinology last week.
In another top story, the FDA is allowing Danone North America, which owns Dannon and Activia, to use two limited health claims that eating two cups of yogurt each week was associated with lower risk for developing type 2 diabetes. Although some observational studies have noted a lower incidence of type 2 diabetes among people who eat yogurt regularly, many others have not found a statistically significant association.
Read these and more top stories in endocrinology below:
FDA clears first OTC CGM for adults with and without diabetes who do not use insulin
The FDA cleared for marketing an over-the-counter continuous glucose monitor for adults with or without diabetes, according to an agency press release. Read more.
FDA to allow limited claims that eating yogurt may reduce risk for type 2 diabetes
The FDA said it will permit the use of two limited health claims that eating yogurt may reduce the risk for type 2 diabetes, according to a press release. Read more.
FLOW: Semaglutide slows CKD progression, cuts risks for kidney, CV death in diabetes
Adults with type 2 diabetes and chronic kidney disease have a 24% lower risk for kidney disease progression and cardiovascular and kidney mortality with once-weekly semaglutide 1 mg, according to topline results from the FLOW trial. Read more.
More studies needed to assess effects of inositol on PCOS outcomes
Findings on the use of inositol for managing polycystic ovary syndrome are inconclusive, with results varying based on therapy, trial design and outcomes reported, according to a systematic review and meta-analysis. Read more.
Higher BMI linked to worse depressive symptoms among middle-aged and older adults
Adults with a higher BMI and waist-to-hip ratio may be more likely to report worse depression, according to study findings published in PLoS One. Read more.