Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor

The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by Dexcom (NSDQ:DXCM).

The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin.

Changing the device’s intended use would mean patients could make treatment decision based on the G5’s interstitial glucose readings, rather than merely for tracking them and predicting trends.

The FDA’s August 2015 approval for the Dexcom G5 came months ahead of expectations; the device won CE Mark approval in the European Union less than a month later. Last March Dexcom said it made the G5 compatible with Apple’s (NSDQ:AAPL) Apple Watch, but warned in April of possible alarm and alert malfunctions with the G5 and 1 of its predecessors, the G4 Platinum.

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