Glucose meters used on diabetic patients only?

The manufacturer’s package insert of the glucometer states the “Intended Use” of the meter.  The end user must exactly follow the instructions as stated in the package insert, otherwise the glucose test becomes a high complexity and used “off label.“  Thus CLIA high complexity requirements applies when a test is used “off label.”  

I asked this question of Roche several years ago.  Not in regards to billing, but if the meter could be used on patients that were not known diabetics, in a code stroke situation.  Here is their response:

All,  

Elevated blood glucose at the time of acute stroke increases the risk of hemorrhagic transformation with tPA treatment and it is associated with poor clinical outcomes, longer in-hospital stay, increased cost, and mortality. The optimal approach to manage these patients, especially with respect to glucose control and tPA treatment, is not clear and the various professional guidelines differ in their recommendations.   

It is common for stroke protocols to include a glucose measurement in their initial assessment of the patient.  There are other reasons to determine a glucose level or determine someone's level of control other than screening or diagnosing diabetes.  This is one of those situations.  The clinicians are not screening for or attempting to make a diagnosis of diabetes, they are looking to define the level of glucose control.  It sounds like they are then determining the risk of proceeding with TPA in a patient presenting with stroke.   

Our label is silent on this issue as it should be.  This is a clinical decision and the provider is ultimately responsible for making those decisions.  The meter is providing the level of glucose control for a particular patient.  We provide no information regarding a cutoff or treatment decision. We do not provide guidance on how patients should or should not be treated based on a POC glucose result even in diabetic patients. 

If the end user believes this to be an off-label indication, then they would have to ensure the test is validated for high complexity use.   I will reiterate that our label with respect to this use is it is neither on or off label. 

Per the user manual it says:

Do not use for diagnosis of diabetes or for testing blood glucose in newborns.

It says nothing about who the intended use is for but just that it cannot be used for diagnosis.

Anastasia Augustine

For the Roche Inform II....Intended Use:

"The ACCU-CHEK® Inform II test strips are for use with the

ACCU-CHEK Inform II meter to quantitatively measure

glucose (sugar) in venous whole blood, arterial whole

blood, heel stick neonatal, or fresh capillary whole blood

samples drawn from the fingertips as an aid in monitoring

the effectiveness of glucose control. The system is not for

use in diagnosis or screening of diabetes mellitus, nor for

testing neonate cord blood samples."

The underlined portion to me indicates that it can be used in non-diabetic patients. IMO...

Lois Snider

lois.snider@stclair.org