4 min reading time

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?

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10x AGENDA COMING TOGETHER!
Take a look at http://medicaldeviceevents.com/#schedule and apply to speak at http://medgroup.biz/callforspeakers

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. New medical device marketing posts at https://MedicalMarcom.com/blog

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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Robin Baum, by all means, yes!

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Gary Cohen, can you or a team member comment on Eddie’s post?

Julie Omohundro
Principal Consultant at Class Three, LLC
My concern would be that, just because patients are doing it, doesn’t mean it’s a good idea. Patients misuse drugs and devices in all sorts of dangerous ways. In this case, the patients who would get Medicare coverage if the label was changed also had a financial conflict of interest.

Bart Brevik
Sr. Manufacturing Engineering Manager, New Product Development at Endologix Inc
This a really big deal, and it puts a lot of pressure on Dexcoms competitors.

Cornelio Florian
Engineering, Operations, Production, Quality, and Supplier Quality Management.
It’s a very interesting experience this off label use was on the benefit of the company. Some times the off label use can become a big issue for a medical device company if advice is not given to the customers about the not intended use.

Thomas Blank
Director, Chemometrics Research and Development at Steep Hill
I think its ok to get it funded for patients but I expect all of these CGM’s still have an issue with BG time lag vs brain or fingerstick glucose. This will be especially significant when glucose is moving faster. Some diabetics move faster than others, generally children move particularly fast. The lag means that CGM’s will predict a fall in BG with a delay vs the brain or fingerstick. Of concern is that on a downward trend, they will read higher than actual BG. So if you are going down and the unit says you are 150, you are likely lower than that in the brain, so you’d better take a finger stick immediately. The risk is that after insulin administration that you may go dangerously low without the meter indicating this in time. If you are a slow mover, the risk will be less. If patients/parents are aware that these CGM’s shouldnt be used when glucose is moving down quickly and are reading under 200, I see no issue with it.

Robin Baum
Writing/editing pro providing print and digital content and services for entrepreneurs, start-up businesses and authors
Joe, your comments would be very helpful to the four adult diabetics in my family and countless others among my Facebook network. Can I share your comments with them on FB?

Helen Liou
Compliance Manager
That’s certainly makes life just a little easier for those who are diabetic.

Eddie Anderson, RAC
Regulatory Affairs Manager at E4D Technologies
My wife and daughter are both Type 1 diabetics. My wife uses Dexcom and has for several years. While I agree 100% with the FDA labeling decision for the reasons noted and would not argue the benefits of using the Dexcom, I would also state emphatically that Dexcom cannot replace the finger sticks 100%. It is simply not as reliable or accurate or trustworthy as the finger stick, expecially when BG numbers are moving up or down fast as stated so well in a previous comment. Patients must know their own body’s signals and double check with a finger stick if they suspect the Dexcom reading may not be correct. There are many more variables involved with the Dexcom and there are times when my wife’s Dexcom readings have been off significantly by over 100 points. Point being there is a lot of benefit that can be experienced with Dexcom IF the patient understands what they have and how to use it properly and does not try to use it as 100% replacement for finger stick.

Scott Crandall
President at AXELERIST FINANCIAL / MRC LEASING
From personal experience, I wouldn’t rely on the CGM technology without having some reservation about its 100% reliability and whether to treat a low or high BG. Having said that I use the Dexcom CGM and love it. I rely on its accuracy 90% of the time and am happy for all those that will now be able to use it.

Neelima Firth
Biotech Executive ǀ VP ǀ Director ǀ Commercialization ǀ Reimbursement
Real world experience together with patient advocacy helped to make this labeling change and hence reimbursement. Dexcom’s need for this change, I am sure, was driven by the need to have medicare reimbursement. Already seeing the advertisements!

Jim Mertz, PMP, CSM
Engineering Project Manager
It is good to see that this device will now be available to thousands of people who previously did not have access to it.