Dexcom’s System Can Replace Fingerstick Test for Diabetics: FDA

Diabetes Technology Glucose Monitoring
21

Thanks for responding, Tia.

Your example is not the same. The person in question can make a reasonable case for their insulin needs. Most people would agree that demanding someone live a strict LCHF lifestyle isn’t reasonable.

Of course, others will disagree, but that’s not the point. A non-frivolous case is being made.

Directly on-topic, Laddie did exactly this. Her biochemistry reacts with the Dexcom sensor “stuff” in such a way that it requires more frequent calibrations than Dexcom requires. This is good justification for Laddie to have more than 2 strips a day.

However, that is not the common case with Dexcom’s product. In fact, accuracy for most people is good enough with 2 calibrations a day that the FDA just approved the device for insulin dosing.

If a person isn’t calibrating more than twice a day – and I note that Dexcom recommends against it, supported by much discussion in the DOC about this – then why do they need to test separately with a meter?

It’s not an antagonistic question. It’s a sincere one. Laddie answered with something quite understandable, but she’s the exception. Others here have expressed some grief over the prospect of having strips limited if they have a CGM. Why? Are they like Laddie?

People who test their BG because they want to, not because they need to, should pay for that themselves. If a CGM does as good a job as the glucometer in obtaining that data, it makes no more sense to have insurance pay for both than it does to demand two different glucometers with test strips for both so that you can test with each every time.

Either the Dexcom really is a substitute for glucometers (which is what the FDA decision was all about), or it’s not. If it isn’t, why are so many of us relying on it WITHOUT double-checking a glucometer before dosing?

If it is, then what’s the rationale for continuing the spend on test strips? Laddie makes a good case for her outlier situation. There very well may be other good reasons. That’s what I’m asking to hear, as for many of us there simply are NOT good reasons to spend on both.

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Terry, I feel like you are deliberately trying not to understand what I am saying.

There isn’t one iota of selfishness in anything I have posted in this thread. I am insulted at the way you’re treating me here.

If a CGM is a suitable replacement for a glucometer, I don’t see any reason to use a glucometer for anything more than calibration and verification under extraordinary circumstances (like hypo). It makes no sense to me, just like having two glucometers side-by-side testing with both every time – and demanding insurance pay for it.

And if two is good, why not three?

This is not about me, and greed on my part. Indeed, it seems to me that it is those who demand things from others and then behave the way you are when asked to explain the need that are greedy.

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Dave26,
I have a Dexcom, and I still test about 20 times a day. I follow every rule for Dexcom, but it just does not work well for me. Different tissue types and different bodies and all that - it just isn’t the same for me as for other people.

I am thrilled for those it works well for, and those who can dose with it. But for me, it is consistently off by a wide margin for me. I don’t rely on Dex, and as it currently is for me, I would not dose off of it.

I can show you comparisons of simultaneous BG and Dexcom readings that would make you think I have alien interstitial fluid.

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Medtronic CGM need calibrating twice a day with test strips…so I can see strips disappearing from daily use.

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Additionally - CGM is at times wildly incorrect- for a range of reasons. Tests strips are a critical safety measure.

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26

Eddie, you don’t need to prove anything to me. And if insurers do crack down on test strips for CGM users, I really really really hope you don’t have to do anything more than have your doctor justify the strip count to get it approved.

However, for those of us that don’t need to calibrate often to have good accuracy, I’m still curious what the rationale is for more than 2 a day, with a handful of extras each month to handle hypos and other extraordinary circumstances that justify double-checking.

I’m assuming the FDA wouldn’t have approved the G5 for insulin dosing unless it was exactly what they just approved it for: A substitute for a glucometer.

27

I use a CGM and I test 6 -10 times per day. Can I cut down? Yes, will I get to one stick? Nope. So here is the thing, I am concerned that insurance (especially Medicare) will significantly reduce strip availability when it approves CGM’s. I will continue to rely on test strips until I know that CGM’s are 90% or more accurate.

However, we need to recall that test strips are not all that accurate. Remember we have about a 40 point variance (BS could be 20 points higher or lower than the finger stick) with test strips. The Dexcom in particular, is a reasonably accurate (if trailing) indicator of blood sugar.

Now, having said all of that we have to understand that if one exercises the CGM is at best a guide. It is not a good indicator of blood sugar when I ride my bicycle I do know when my CGM says it is dropping but I have no idea what my blood sugar really is. Why? Because it is trailing indicator of blood sugar. Say i am riding and my CGM says blood sugar is 60, I could very likely be 30 or sweat might mean it is really 130. It is a poor indicator of exercising blood sugar and the only thing that gives a good report is blood testing.

So what does it all mean? Nothing really. Medicare has not approved CGM and Medicare has and will limit test strips for years to come. Instead of worrying too much let’s resolve to do this.

Insurance (Medicare and others) are placing these limits because of the gray market for testing supplies. The gray market is all of those strip manufacturers on eBay and in the local newspaper. If we have extra perhaps it is best to share not sell supplies and then adjust what we have covered. If we need test strips let’s try to not buy off the gray market.

It is after all the gray market which is the most visual representation of why insurance hates paying for test strips. Yes I know, if you need them and cannot afford them and do not have a source, by all means buy them. The issue is those who sell them. If insurance bought test strips stop selling them, many people need them and all those who need them are part of our wider community. Perhaps if we stop selling them we can find a way to share some much-needed love and work to forestall increased insurance scrutiny over purchase.

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28

I wasn’t snapping at you, I am just off in my own world when it comes to CGM! It’s just incredibly bad for me. :disappointed:
I do believe that if strips are covered less by insurance, as long as there is still a need for them, the free market will cause their price to drop. I am encouraged by the prospect of the all-you-can-test type of deals like OneDrop is doing. That’s good news for me.

I am in 100% agreement with you there, Rphil2. For me, it is off the most when exercising. It is almost at the point where I don’t even look at it anymore when exercising.

29

OneDrop looks very interesting, an amortized model. It could work out a win/win for Jeff Dachis and his customers to provide a steady reliable revenue stream, and a budgetable fixed cost for the customer.

If you don’t need the extra value with live consult, cloud services, etc. but just meter and strips, the True Metrix system (300 strips for about $50 on Amazon) or the Freestyle Precision Pro (meter $20, strips 50/$20) are attractive low cost solutions as well.

30

FWIW @Rphil2 I would never dream of selling any of my stash to on the grey market. I don’t think it right, and it kind of defeats the purpose.

I follow the classic rotation scheme, with the newest stuff “at the back”.

31

Thanks, I will check those out, even though I am worried about the accuracy of TrueMetrix that Sam19 mentioned.

Why would I need all that other stuff, when I have the peeps on this forum?! :wink:

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Yep… I don’t see this as a good thing… first my dex is frequently very off and I never rely on it- I always do fingersticks as a backup so I need both. They’re always looking for ways to screw us over and over an over… seems to be the motto… take advantage of those who have huge medical and other expenses. This is the only developed supposedly leading country that does this to its citizens.

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34

so why do you use the dex then? what benefits are you getting from it if you are still testing so much? is it just peace of mind? because you can? something youre used to?
i dont have one and never have, as i have socialised medicine where i live that pays for basics only. i would love to try one.

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35

They stix to calibrate twice a day.

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I have a question. How did the upcoming Medtronic closed loop pump get FDA approval even if dosing off of their sensors is not FDA approved? I guess the FDA does not consider basal adjustments as dosing?

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I use the Dex because when I am sleeping it will wake me up when I am too low or too high. That is a big benefit. When sleeping, the Dex numbers are much closer to my actual BG number, because it is a slow change.

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38

There are many reasons one might need to test more than twice a day even with an accurate sensor. The three tests 15 minutes apart is recommended by Dexcom to try to get inaccurate sensors back on track, so that’s not some extra calibration method someone just made up. Add to that testing when treating lows or site failures, testing when exercising (especially swimming, when the sensor is inaccurate), testing during warm-up and extended ??? periods, testing when the Dexcom reading does not match symptoms, and testing when wanting to take insulin while there are single or double up or down arrows (when actual BG may differ quite a bit from what the sensor says) and it’s very easy to routinely need to test more than twice a day even when using the sensor to dose insulin off of. According to my meter, I test an average of 6.3 times a day, and that’s as someoen who has good sensor accuracy and does dose off the sensor daily.

To me, it sounds like you not only have good sensor accuracy but also have very tight control with very few highs and lows (given that you say “a handful of extras each month to handle hypos and other extraordinary circumstances”). For me, and I think for many of us with Type 1, blood sugar can be extremely unstable at times and is prone to extreme highs and/or lows with little to no warning (for which the Dexcom is a lifesaver!), and these situations where there may be a need to monitor a rapidly-changing blood sugar may be daily occurances rather than once or twice a month. If my blood sugar were stable most of the time and I rarely had rapid changes and rarely had extreme highs or lows, I can see how I might feel comfortable only testing twice a day.

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39

@Jen, thank you for not attacking me.

Your post was exactly the sort of discussion I was looking for.

I’m just a person, with my experiences that drive my point of view. I was open about it, and very explicit in wanting to understand that I did not.

I got personally attacked by people I had thought had more respect for me than that. It was eye-opening, and has tainted my attitude about and respect for TuD. Sadly, this place is becoming political.

Anyway, I appreciate very much your informative post. It certainly helps me understand the situation better.

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I’ve not read all the responses to this thread, but you can count me as one who routinely tests more than twice a day. Dex can be incredibly accurate for me at times and other times he’s insane. Yes, my Dex is a he and when he’s making me crazy he is Dexter.

I won’t go into all the situations that cause me to test, but they often involve exercise or driving. That being said, do note that I’m using the G4. They tried to upgrade me, but I don’t want the G5. I like that I can use my transmitter for an indefinite period of time. I’ve been able to use one for up to a year. I also like having a separate receiver. I hate being tied to my phone, it often cuts out of reception, the memory gets too full making app upgrading a PITA, and I don’t use an iPhone. I like my G4 with its receiver and I’ll be sad when they stop making them, which will no doubt be very soon.

If my insurance stops paying for an adequate amount of strips, I’ll get the cheapest option I can pay for on my own. As long as I’m financially able to do so, I refuse to allow my insurer to dictate the manner in which I manage my BG

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