Replies to This Discussion

Permalink Reply by HPNpilot on December 7, 2011 at 10:41am

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

Permalink Reply by Helmut on December 7, 2011 at 2:50pm

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.

Permalink Reply by Penny on December 7, 2011 at 3:46pm

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

Permalink Reply by Helmut on December 7, 2011 at 3:58pm

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.

Permalink Reply by Penny on December 7, 2011 at 4:11pm

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.

Permalink Reply by Helmut on December 7, 2011 at 4:15pm

You are very welcome.

Permalink Reply by Helmut on January 13, 2012 at 5:39pm

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.

Permalink Reply by Penny on January 13, 2012 at 5:59pm

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.

Permalink Reply by HPNpilot on January 13, 2012 at 5:42pm

lol!

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

Permalink Reply by Helmut on January 13, 2012 at 6:15pm

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?

Permalink Reply by Helmut on May 8, 2012 at 3:42pm

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

Permalink Reply by Mike W on May 10, 2012 at 6:50pm

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!

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