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For 10 years, Dexcom made this claim: Continuous glucose monitoring (CGM) is intended to supplement, not replace, a blood glucose meter. A confirmatory finger stick is required prior to treatment.
This is known as an adjunctive claim, because the monitoring only assisted in glucose monitoring. A non-adjunctive claim would allow for treatment decisions (insulin dosing) to be made off of CGM data without the need to confirm with a blood glucose meter finger stick.
As you’ll see in this 10x Conference video at http://medgroup.biz/Dexcom (with slides), Dexcom’s Gary Cohen explained how it won the non-adjunctive claim in 2016.
Health care providers, advocate organizations, and – importantly 30+ patients – participated in an FDA Advisory panel in July 2016 to present reasons why Dexcom’s CGM device should be given a non-adjunctive claim.
And while Dexcom couldn’t talk about any off-label use, patients could (and did) tell FDA how they already dosed off CGM readings.
FDA approved the labeling change and now the company can claim, “The Dexcom G5 is FDA-cleared and lets you monitor without pricking your finger.”
If patients were already dosing off label, why was the labeling change such a big deal? Because Medicare does not cover adjunctive devices. Due to the change, tens of thousands of patients are now covered for Dexcom G5.
Fewer finger pricks make happier diabetics, Dexcom can talk openly educate patients and doctors, and awareness in the diabetic community continues to grow.
My takeaway: As technologies advance, educate the industry and involve the user. The user may be your best advocate to advancing your products.
Do you agree? What would you add to the discussion?
Make it a great week.
P.S. New medical device marketing posts at https://MedicalMarcom.com/blog
Eddie Anderson, RAC
Jim Mertz, PMP, CSM
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