A1C surprise

I just checked Insulet's latest 10-Q. The agreement with Abbot was signed in 2008 and it has a term of 5 years

Helmet and others,
I am having the same problem with my daughter’s OmniPod PDM. Grace is 9, diagnosed at age 6. Pumping for more than 2 years with OP. her A1C normally runs 6.6 - 6.4. That is, until about 6 months ago, when we started using the butterfly strips in her PDM. Yes, I know they are not FDA approved, but I couldn’t find the older strips anywhere and insurance filled them. I used them. Until 6 months ago, when her A1C shot to 7.1, which did not correspond to her numbers in her PDM. Nothing else had changed. Growth hormones, sure, but that much of a jump? Again 3 months ago, still 7.1. Frustrating!

Then I thought about the butterfly strips. That HAD changed in 6 months. I did some cross checking of the strips with the OneTouch and Contour meters over Thanksgiving. For a total of 15 random trials. Every single time, the PDM with butterfly strips was lower. Significantly lower. Like 75 compared to OneTouch 96, Countour 93. The OneTouch and Contour were always within about 10 points of each other. The biggest gaps started to show when her BG was high. The PDM was once 50 points lower than the other two.

I’ve decided to abandon the butterfly strips in her PDM. Right now, we are using the OneTouch meter and then manually inputting the BG into the PDM. Bug change for my independent girl.

I am wondering about this talk of changing the code. Does it matter? Ours are always 16, as you know. If I changed the code, will that change the strip??? Interested to know more about this. I feel I just can’t trust the butterfly strips, especially in regards to her unexpected A1C increase.

Thoughts are welcomed.

Penny,
I agree with your decision to have your daughter use the OneTouch meter.

"If I changed the code, will that change the strip???"
Changing the code does not change the strip. However, it does change what the PDM displays.
Let's assume you knew that the PDM always reads 20% too low. You could compensate for this deficiency by adjusting the displayed value for the 20%. Changing the code does the same. My experiments show that for every code point increase the displayed value increases by about 10%. So instead of doing the math in my head all the time I chose to use code 18 (even that the code on the package is 16).

Helmut,

Did you have a chance to check use of the code 18 for high and low ranges in addition to the area around 100 ?
Did changing the code work for higher and lower BGs as well ?

Jack

Jack,
I compared old and butterfly strips at 60 mg/dl. The butterfly strips with code 18 were reading a little low. I decided to switch to code 19. The butterfly strips now read on par with the old strips at 60 mg/dl and a little higher at 100 mg/dl.

Helmut,
This discussion has proved so useful. When I changed the code on my daughter's PDM to 17, it now matches the OneTouch meter, within 5%. I also compared the PDM at code 17 with the Freedom meter at code 16, and they correspond within 10%, and both use the new butterfly strips.
For now, I am still using the OneTouch and manually entering her BGs into the PDM. About every 3rd BG, we compare the PDM reading and the OneTouch. Code 17 seems to put it on par with the OneTouch.
I am waiting on using the butterfly strips in the PDM however and strictly going with them. I'm hesitant.
Just one question Helmut, when you say you compared the old and butterfly strips at 60 mg/dl are you using the control solution to compare them. How are you comparing them at 60 and 100?
Thanks,
Penny

Penny,
The control solution should always read 104 mg/dl, no matter which meter. I tested at 60 mg/dl when my BG was 60 mg/dl. At 60 mg/dl I don't have an absolute reference anymore. All I can do is to make the butterfly strips read like the old strips. I have no idea whether the old strips read too low or too high or just right at 60 mg/dl. I was happy with the A1C results that I got with the old strips. This is the reason why I decided to make the butterfly strips read the same as the old strips at 60 mg/dl.

Gotcha Helmut, thank you for the explanation.
With the butterfly strips in the PDM and using the control solution, I end up on the far end of low for the solution, about 83-85. My Freedom reads about 95-97 with the control solution and codce 16.
When I change the PDM to read code 17 and use the control solution, I get a 98-100 reading. I have found that code 18 jumps the reading too far - to about 120-122 for some reason.
I agree, the old strips, for us, led us to truer numbers and a truer A1C I believe. Trends in my daughter's PDM matched her A1C using the old strips. They do not match using the butterfly strips and we have seen her A1C go from 6.4 to 7.1, with not many other variables present other than the change in strips during the past 3-4 months.
You are very helpful on this thread Helmut, with all your comparisons. I want to thank you for that. You have helped me a lot.

You are very welcome.

Butterfly strips are now FDA approved for the PDM.
I showed the FDA approval letter to my PDM.
My PDM is unimpressed.
It decided to keep reading too low at code 16.

lol!

I would love to see the data they submitted to show substantial equivalence. I couldn't find the full 501(k) application online.

I had to laugh at this Helmut! I have been using code 17 since you brought this issue up and I decided/discovered that using code 16 resulted in skewed lows for my daughter too. We are using code 17 for about 6 weeks now. Her next A1C is in February. Will be interesting to see, as we had a jump from 6.3 to 7.1 on code 16 with the butterfly strips.
I am also unimpressed that they received approval from the dear old FDA.

What irritates me more is that the smaller OmniPod and the Dexcom Gen4 sensor are delayed because they need the FDA stamp of approval. What am I getting out of this delay?

I am back on track. A1C is 4.9%. Could not be happier.

Hi: I also find that the new butterfly strips run lower than the old style strips. My A1C also went up a bit with the introduction of the butterfly strips. I do not do a correction now unless I get a number in the low 60's. Used to correct at 70. Funny, I emailed Abbott Monday about getting a new meter but haven't received a response yet.

Sue

I just got my PDM/pods yesterday. I'm a new Omnipod user starting this weekend. Wondered why the Freestyle was in there too. Thanks for the info, it makes sense now.

Reading this whole thread was interesting. I switched last year from using Freestyle meters to another brand because I thought my A1C was off from my meter readings too. I swtiched to Accu-Chek and got much better results. I thought it was just me or a bad reader or something, now I see that it's not. Of course I'm starting on the Ominpods this week, which means I'll be switching back to the Freestyles. At first I was amused at this change of events with the BG strips and all, but glad to find this thread so that I know 1. I was not crazy last year. And 2. what to do about the strips in my new Omnipod PDM unit.

I am keeping the lancet device that came with the Accu-Chek though, it's much nicer than the Freestyle lancing device. It uses a barrel cartridge of needles and the needle is much smaller making the pain a bit less. http://www.amazon.com/Accu-Chek-Accu-Chek-Multiclix-Device/dp/B003UC8SE0

Thanks Helmut!

My Freestyle Freedom is not much better than the PDM. My Freestyle Freedom reads low too.

Excellent job Helmut! Thank goodness for this thread. After extensive checking between meters I've found that the PDM consistently reads low. I've changed to code 17 and now it matches almost exactly with the other meters. This should help me restore my A1c to its prior level. I still can't believe that Insulet has not addressed the issue although starting next March the new PDM will be using OneTouch instead (per the Omnipod conference call yesterday) which might make the issue academic. Now all we need is the smaller pods which will hopefully be released before year end!

Thanks. I just read on CWD that the smaller pods are delayed. I hope that this means that Insulet will skip the Abbott PDM and give us the OneTouch PDM right away.