Continuous Glucose Monitoring (CGM) Example 2

The following should be considered when viewing this resource:

• The definition of the Laboratory Test Results (LB) domain is currently, "A findings domain that contains laboratory test data such as hematology, clinical chemistry and urinalysis. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains." This example assumes that "laboratory test data" includes tests performed outside of a laboratory, and ones in which the specimen tested is not removed from the body.
• The Device Identification Parameter "Device Type" is defined as "Generic category of medical device within the device classification established by a regulatory authority." This suggests that terms should be taken from a vocabulary established by a regulatory authority. It is not clear what vocabulary should be used.
• The variable LBLOC was used for the location at which the sensor was attached. The definition of the root variable --LOC is, "The anatomical location of the intervention, event, or assessment." It seems reasonable to model the location of the assessment as the location at which the sensor is attached.
• The variable LBANMETH was not included in this example. It is not clear when it would be included in an LB dataset and, if it is included, what its value should be.
• The device output file includes "Serial Number." Since sensors are replaced every 14 days, we assumed that this is a serial number for the sensor and that it is appropriate to use in forming LBREFID. The definition of the root variable --REFID is, "A sequence of characters used to uniquely identify a source of information."
• The example LB dataset above does not include variables for normal ranges, but normal range variables would likely be included in a regulatory submission. For a validated device, the normal ranges would be supplied by the device manufacturer. and specified in the protocol. For non-validated devices, there may not be a known normal range.