Glucometer Testing Alternative Sites

I don't know of any, but wish I did.  We have had that question come up from hospitalized patients who do that with their home-use meter and wonder why the same thing can't be done in the hospital.

Although we policize fingertip capillary sampling only, the unfortunate truth is probably that sites may be doing this and we never know about it...

All of the vendors I have spoken with say that there is no way they could validate all of the alternate sites and achieve FDA approval for such. That is why we do not have a method for alternate site testing. I have had my Diabetes Center people tell me they tested patients ears sort of like the Red Cross used to do for blood donors. They realized it was unapproved in our facility but it was their only alternative.

These patients sound like they would be great candidates for continuous glucose monitoring with a product like Abbott's FreeStyle LibrePro.  There are still indications and exclusions but for the most part would work with the exception of critically ill  patients.  Definitely worth considering.

Hi,

If the Abbot Frestyle Pro is used under a hospital Lab's CLIA/CAP license, does it require monitoring and proficiency testing by POC staff in the Lab.

Thanks in advance,

I know this is an old discussion but I would like to see if anyone has updated information.  We are starting to see inpatients that want to be treated on the values from their continual monitoring systems. How do your hospitals respond to that?  How is the patient result documented?  Is hospital staff giving medication based on the results?  Do you have patients that refuse finger sticks?  Thank you. 

Same here as what Pet stated - it's the same logic that in the past traditionally contraindicated the use of a patient's home meter while an inpatient - we cannot accept responsibility for its accuracy/functionality like we can the equipment we have validated.

I am sure this is going to be coming up a lot in the future as more and more patients get CGM devices.  But thus far, our health system has not adopted any sort of a policy around it other than to not use CGM values for treatment while in the facility.

To all,

Abbott's FreeStyle LibrePro is intended at present only for Doctors office use. According to my rep, it is a wearable sensor with a reader in the doctors office or clinics. The clinic can buy as many of the sensors as they want. The patient wears the sensor and comes into the clinic to read the results sensor. I think they last about 10 days.

I would check with an Abbott rep to see if there is a product that has been approved for hospital use but I do not think there is a product. I think Abbott has a couple of wearable monitoring systems out there.  

For this CGM, all hospitals/POCC eventually will not only have to be aware of this but CLIA will have to make a decision on these devices.  There are patients that are refusing to get stuck. This is the lab CLIA for all testing within the inpatient areas.....but the wearable can't be validated etc.....but the units may not even tell us....and give insulin....

The bilirubin devices do not take a sample and are CLIA exempt....and treatment is done with those results.....Hmmmm...a precedent maybe?

Deanna Bogner

Wanting to address the issue of CGM again as it is starting to come up at our Hospital. How is this being addressed at your hospital?  How is the result being documented in the EMR and is there a disclaimer attached?

Thank you... Jina Hardy