Dexcom G5 Mobile Gets FDA Approval

Fans of the Dexcom G5 Mobile have something to smile about.

At yesterday's hearing with the U.S. Food and Drug Administration (FDA), the Dexcom G5 received approval for use as a replacement for fingerstick glucose monitoring. In a vote held by the FDA's clinical chemistry and clinical toxicology advisory panel, the device passed 8 to 2 in favor of safety, 9 to 1 for efficacy, and 8 to 2 that the benefits would outweigh the risks.

What Does It Mean?

Currently, the Dexcom G5 Mobile is used in addition to a fingerstick test, which would provide patients with trend information and keep them aware of highs and lows. However, this new vote indicates that, according to the FDA, patients could safely skip their premeal fingersticks and rely on the data from their Dexcom G5 to determine their insulin doses.

Dexcom G5 devices will now bear a new label, explaining to patients how to read the data on their device and adjust their insulin accordingly. The instructions will also explain situations when fingerstick glucose monitoring is necessary, such as after a failed reading or when a patient's symptoms do not match the reading.

Why Only 8 Out Of 2?

Though the vote was overwhelmingly in favor of the Dexcom technology, some panelists remained insistent that the company gather more information. Their clinical data reflected a study of only 71 patients, all of whom had type 1 diabetes, and panelists expressed concern that a simple pamphlet would not be enough to properly educate users to safely use the Dexcom G5.

However, as Dexcom pointed out in the hearing, many patients are already using the device to determine insulin doses – as many as 69% according to market survey data presented by DiaTribe founder Kelly Close. And, as panelist George Grunberger, MD said, "It's a catch 22. You have to teach people to use it to see what role it plays in diabetes management. But first you need permission to teach people to use it."