CGMS

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Does anyone have a policy for use and/or documenting results from continuous glucose monitoring systems that they would be willing to share? 
Thanks!! 

7 Replies

I have a clarifying question. Are you asking about patients that have a Dexcom or a Libre on when they are in the hospital and using the glucose value on the device to document their glucose results?

Angela Robinson - yes. I know that pre-pandemic, the CGMs were not approved for Hospital use. But now it appears that at least the Dexcom has been approved. We are trying to write a policy regarding the use and documentation of these results. I believe the results have been acted upon for quite some time. I'm working with our Glycemic QM committee to initiate a policy that will work for nursing and lab. 

Sorry Cindy, we do not have an official 'inpatient' or 'outpatient' policy for CGMs. I've asked off and on for many years. 
I'm not sure this document will help you, but if you subscribe/can purchase CLSI documents through your lab, this one is not hot off the press but industry constituents and POC professionals producted this document when CGM arrived on the scene.

CLSI POCT05, Performance Metrics for Continuous Interstitial Glucose Monitoring 

Cindy, can you send me the documentation that the Dexcom has been approved for hospital use?
vmcardle@stlukeshealth.org
Thanks!

I'm looking at the FDA 510k database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm) and all the DexCom summaries still list Home Use in the Clinical setting/sites of use

In the ADA Standards of Care, Section 16: Diabetes Care in the Hospital (https://diabetesjournals.org/care/article/46/Supplement_1/S267/148051/16-Diabetes-Care-in-the-Hospital-Standards-of-Care), the CGM section is on page 3, and it says "Even though CGM has theoretical advantages over POC glucose monitoring in detecting and reducing the incidence of
hypoglycemia,
it has not been approved by the FDA for inpatient use. Some hospitals with established glucose management teams allow the use of CGM in selected people with diabetes on an individual basis, mostly in noncritical care settings, provided both the individual and the glucose management team are well educated in the use of this technology. CGM is not currently approved for intensive care unit use due to accuracy concerns such as hypovolemia, hypoperfusion, and use of therapies such as vasopressor agents."

A portion of our policy below:
With a provider order, patients may continue to use their continuous glucose monitor for their own information, but all blood glucose values used for patient treatment must be done utilizing a hospital approved glucose meter or serum lab. Data from the CGM will not be entered into the electronic medical record (EMR).
CGM has not been approved to guide insulin therapy or treatment decisions (including hypoglycemia) in the hospital setting, and therefore, point of care glucose monitoring or serum lab results are required for treatment decisions and charting in the EMR.


This is a hot button issue, particularly from a lab standpoint. These devices have not been given a CLIA designation, and FDA even called it non-invasive, and many places have taken a stance that this is not a "lab" test and therefore should not be documented in the same manner as lab glucose values. We are considering whether creating a separate set of fields in the 'vitals' section of our EMR to house these results would be a good way forward, though providers would ideally like to see them trend with WB and plasma glucose values.

Thank you for those links, Danielle!
I just became aware of CGM at my facility and was able to provide references to guide policies.

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Cindy Roller
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