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DexCom, Inc. (DXCM) Message Board

  • itsallstatistics itsallstatistics Feb 28, 2006 4:46 PM Flag

    Did I miss something?

    Did I miss something in their conference call? I see Cygnus all over again. Tell me if my points are wrong.

    1. This first device will only be for adjunctive use only, which means that individuals will need to test their blood sugars if they want to adjust their insulin (either the 3-day or the 7-day)

    2a. They did a small study to get a better understanding of what would be required to achieve replacement. They have written a protocol, but cannot get consensus from the FDA that it provides the information necessary to make the decision.

    2b. This new study requires another IDE, which has not been applied for. Once the IDE is achieved then the protocol will need IRB approvals.

    2c. The study to achieve replacement labeling will require 400 subjects at 20 sites. Considering their PMA application was ~90 subjects, this sound like this will be an entirely new PMA application, rather than a supplement.

    2d. If all of the above are reasonable assumptions, then they likelihood of having a product that will meet the INITIAL needs of the consumer is at least two years away from approval (2 months for IDE, 6 months for IRB, 3 months for study, 3 months for application, 1 year for approval).

    3a. I read the article in Diabetes Care. Two thoughts related to the data stuck out. First, the data was biased high. I would think this is a detriment when monitoring blood glucose since the reaction of an individual with diabetes would be to give themselves a bolus of insulin. Secondly, it appears that something strange happened to the data since they needed to use the 90% confidence interval (rather than the typical 95%) to make all the ranges meet their Null Hypothesis.

    3b. Their sensor requires a calibration finger stick every 12-hours, which corresponds to twice a day. Considering the average individual only measures themselve 3x per day, are they willing to have another insertion that is not very accurate?

    3c. I was not very impressed by the absolute relative of 21.2%, nor the fact that the median and mean were so far apart, which is not the case with a normal distribution.

    3d. OH MY GOD!!! I was just re-reading the paper because I had a question related to insertions. These subjects went into the clinic every 3 days and had the device inserted. This means that for the approved device, they will need to go to their physician's office every three days to have the sensor inserted. NO WAY IS THIS ACCEPTABLE TO THE CONSUMER OR PAYORS!

    I only bring this up, because I remember data from the Abbott Navigator device where on average it took 1.75 insertions to get a good application of the sensor to the body.

    I hope my interpretation is wrong about this, because this would be really bad.

    I have to go back and think about this again.

    -itsallstatistics

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    • >>Did I miss something?<<

      Yes. You've missed a lot.

      >>1. This first device will only be for adjunctive use only, which means that individuals will need to test their blood sugars if they want to adjust their insulin (either the 3-day or the 7-day)<<

      No. You need to spend time re-reading the prospectus and listening to investor conferences on Dexcom's website.


      >>2a. They did a small study to get a better understanding of what would be required to achieve replacement. <<

      Yes. In the past, the FDA has delayed (ongoing) the approval of replacement devices. Filing an IDE for a replacement device is not the best strategic first step. A PMA filing is a much better strategy.


      >>2d. If all of the above are reasonable assumptions, then they likelihood of having a product that will meet the INITIAL needs of the consumer is at least two years away from approval<<

      Not true. The needs of the patient are to know how their glucose levels are varying throughout the day in a continuous non-invasive manner.


      >>3b. Their sensor requires a calibration finger stick every 12-hours, which corresponds to twice a day.<<

      Not true. Their device needs a finger stick test result for initial calibration and if further calibrations are needed during the life of the sensor (3-day or 7-day) then I believe the device will prompt for another stick test. Read the prospectus closely about
      calibration.


      >>3d. OH MY GOD!!! I was just re-reading the paper because I had a question related to insertions. These subjects went into the clinic every 3 days and had the device inserted. This means that for the approved device, they will need to go to their physician's office every three days to have the sensor inserted<<

      Absolutely not true. The clinical trials were set up to obtain approval for self-insertion. You need to spend more time reading all of the available information.

    • aren't they just a start-up, is there something better then.

 
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