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Maryland Endocrine News

Dr Argento gives testimony to the FDA, representing The Endocrine Society, in a successful effort to get non-adjunctive use approval for Dexcom G5.


An FDA Advisory Board voted 8-2 on July 21st, 2016 to recommend that Dexcom G5 be labeled as safe and effective to use as a substitute for fingersticks in making treatment decisions. That is as long as the Dexcom is calibrated twice daily, and the value is credible and does not conflict with any symptoms the person might have. Up until now, the label recommended that all treatment decisions, either treating hypoglycemia or dosing insulin, be verified with a fingerstick before the patient acted on the information. Many patients currently treat based on their Dexcom CGM at least some of the time. Of note, the approval only applies to the Dexcom G5, but would by extension also would apply to the Dexcom G4P, which has the same accuracy as the G5. And it does not apply to the Medtronic Enlite, which is less accurate.

A link to a copy of his testimony is here:

https://www.endocrine.org/advocacy-and-outreach/letters-and-alerts/society-testimony the one labeled "Endocrine Society Testimony to FDA on CGM Indication Change"