WAYNE Z wrote:
I finally heard back from my doctor that he won't give me a prescription for the new sensors unless I have the new pump.
The Enlite sensors are not approved for use with the older model pump and therefore Dr.***** will not approve their use in that situation. You will have to get the new pump to use the Enlite sensors.
I really don't care about the suspend feature which seems like the only upgrade...just want the new sensors.
It sounds as though you may be suffering from IDS: Idiot Doctor Syndrome. :-(
Here's my understanding of the Enlite with a 723 scenario.
The Enlites are not approved for use with the 723 primarily for strict bureaucratic rule reasons rather than due to a functional or medical safety problem. I believe the testing trials in the US were conducted using only the 530G with the Enlite so, officially, that is all that the FDA can claim is supported. That's all that was verified. On paper.
For what it's worth, Medtronic also can not recommend any insertion site for their CGM other than the abdomen. Other sites have not been tested/approved. Of course, they still work. But I'm not sure Medtronic would replace a "bad sensor" if it was inserted on your thigh or arm instead of your abdomen.
Enlite with a 723 works fine ... and is completely allowed by Medtronic if approved by your doctor. This use is considered "off label" and this is why Medtronic wants/needs a doctor to sign off on it. Medtronic is probably required by regulations to remain at "arms length" in the decision.
It's not a "medical necessity" type of approval which is needed. As far as I know, Medtronic only needs to get and keep on file a prescription for the Enlites for you from your doctor. No letters or other falderal.
So I guess I would start by discussing this further with your doctor and seeing if you can get him to realize he is being, well, a knee-jerk, unthinking idiot. Perhaps one way to approach it might be to turn it around. Ask your doctor to provide detail on his reasons for refusing. What does your doctor know about the combination of the 723 and the Enlite which prevents him from recommending this "off label" usage. If he doesn't know, ask him to research it and come up with the specific documented failings behind his refusal.
If that fails, then maybe switch doctors? I suppose you could also try enlisting the aid of a Medtronic rep. But that might be tricky. I think technically Medtronic is not allowed to advocate/push for the use of "off label" solutions. But that's just a guess on my part. You could always just ask Medtronic and see what answer you get back. (Maybe ask two or three times because you might get a different answer each time. :-)
T1 LADA ~1980; 1st pump: Minimed 507; May 2013: Paradigm 723 + CGM