RDC Interoperability Guide
1.2.2

Observational data

Observational data administration is structured around 3 key Observation profiles that are generated by a Device and have a Patient subject.

ProfileDescription
Device Instance

Represents a specific instance of a Device, linking it to its corresponding Device Model with details such as serial number and configuration.

Observation BG

A clinical observation capturing a patient’s blood glucose level. This profile serves as a parent observation for related profiles, such as carbohydrate intake or Estimated Weight Mean (EWM), which provide additional context. Blood glucose measurements can be recorded by the patient or directly by a device.

Observation CGM

Defines observations specific to continuous glucose monitoring (CGM), capturing glucose levels over time to support ongoing clinical and patient monitoring.

Patient

Demographic information of a Patient together with the diabetes type as contained Condition resource.

Data model overview

Data Flow for write action

The data flow for administering observational data follows these steps:

  1. Device administration flow (if not already available)
  2. Create RdcPatient instance (if not already available)
  3. Create RdcObservationAdditional instance(s)
  4. Create RdcObservationBG and/or RdcObservationCGM instances, referencing the relevant RdcDeviceInstance, RdcPatient and RdcObservationAdditional (using the .hasMember reference)