Glucometers for GTT Testing
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Wanted to get some additional opinions, especially with Nova announcing they were able to get their waived for critically ill designation this month for all specimens, including capillary samples.
Do you consider using the meters for GTT testing to still be considered "off-label" considering the intended use statement still says " Not Intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia".
Isn't the point of Glucose Tolerance Testing to "screen for diabetes"?
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I see your point Silka, but I am guessing that is going to be a tough sell to most regulatory organizations. Combined with the fact that a GTT determination and the resulting diagnosis is generally not an 'urgent' situation, I am wondering if there would be much interest to fuel that.
I'm curious, what would the clinical situation be where you would consider a meter result to be of particular advantage over a venipuncture sample sent to a lab (other than for patients that are difficult to venipuncture)?
I actually lean towards considering GTT to be off-label - but was curious if others also think that?
Main reason why I've seen it done is outpatient lab settings where they can run the test in 6 seconds, rather than make the patient wait 30-60 minutes.
Silka,
I believe you would be violating the "it is not for diagnosis of or screening for diabetes." A GGT is just that a screening test for diabetes. The Nova meter is great we use them here at out facility but all POCT have limitations especially preanalytical! A lab draw would be the gold standard for diagnosing any other type of diabetes.
Thanks Amanda! I have a little more information now - so they run a fasting glucose on the meter in order to determine if the patient can receive glucola that day. If their fasting glucose on the meter is below a certain threshold, then they will proceed with the GTT and those samples are all sent to the lab.
In that context, I do think it is waived and they can use it that way. With that said, I did ask the Nova sales rep if the meter can be used for GTT and his fast response was basically "Yes, the meter has NO LIMITATIONS of any kind..." hmmmmm, now that I am not sure I agree with.
Yes, I'd say the practice they have now for screening just for eligibility for glucola with a meter would not violate anything.
Silka, this is how it is done here as well. They do it initially to get an initial reading but then the GTT samples are sent to the lab.