Only July 21, FDA approved DEXCOM CGM for insulin Dosing
FDA Panel Supports Dexcom CGM For Insulin Dosing in Diabetes
A US Food and Drug Administration (FDA) advisory panel has voted in favor of allowing the Dexcom G5 Mobile continuous glucose monitoring (CGM) system to be used as a replacement for fingerstick glucose monitoring in patients with diabetes.
At a hearing held July 21, 2016, the FDA's clinical chemistry and clinical toxicology advisory panel voted 8 to 2 in favor of safety, 9 to 1 for efficacy, and 8 to 2 that the benefits of the proposed new indication would outweigh the risks.
Over 30 people, including endocrinologists and patients, spoke during the public comment session, nearly all in favor of approval for the dosing indication. Representatives from the American Diabetes Association, Endocrine Society, and American Association of Clinical Endocrinologists also spoke in support of the indication.
The medical world is finally catching up to the rest of the CGM users. It was long overdue
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