This capability statement describes the requirements for systems receiving CGM data via the $submit-cgm-bundle operation.

Any CGM Data Receiver SHALL populate its /metadata response to ensure that CapabilityStatement.instantiates includes "http://hl7.org/fhir/uv/cgm/CapabilityStatement/cgm-data-receiver".

This operation is used to submit CGM data. The input is a 'transaction' Bundle that conforms to the CGM Data Submission Bundle Profile, containing CGM data (such as summary reports and sensor readings). The output is a 'transaction-response' Bundle containing processing results for each submitted resource, or an OperationOutcome resource for overall failures.

The response Bundle will:

• Maintain the same order as the submission Bundle
• Include status and location information for each successfully processed entry
• Include error details for any entries that could not be processed

Servers SHOULD support conditional create requests and persist client-supplied identifiers. Servers SHALL document in their developer documentation:

• Which search parameters can be used in conditional create requests
• How client-supplied identifiers are handled
• Any deduplication strategies employed

Once a Data Submitter is connected to the EHR, it can POST CGM data as a transaction Bundle to [base]/$submit-cgm-bundle.

The Bundle entry array includes any combination of

• CGM Summary PDF Reports (Profile, Example)
• CGM Summary Observation (Profile, Example)
  • Mean Glucose (Mass per Volume) (Profile, Example)
  • Mean Glucose (Moles per Volume) (Profile, Example)
  • Times in Ranges (Profile, Example)
  • Glucose Management Indicator (Profile, Example)
  • Coefficient of Variation (Profile, Example)
  • Sensor Days of Wear (Profile, Example)
  • Sensor Active Percentage (Profile, Example)
• CGM Devices (Profile, Example)
• CGM Sensor Readings (Mass per Volume) (Profile, Example)
• CGM Sensor Readings (Moles per Volume) (Profile, Example)

The Data Receiver can expose a one-time order indicating:

• What data a Data Submitter should include in the CGM Data Submission Bundle
• The absolute time period for data collection

Guiding Data Submission

Like the CGM Data Submission Standing Order, this one-time order is modeled as a FHIR ServiceRequest resource. This profile is used to request CGM data for on-demand data requests rather than ongoing scheduled submissions. For example, a provider can fetch the most up-to-date results for an upcoming appointment.

DataSubmissionOneTimeSpec

The DataSubmissionOneTimeSpec extension contains:

• timePeriod: A FHIR Period data type specifying the absolute start and end dates/times for data submission (e.g., January 1, 2024, to December 31, 2024).
• submissionDataProfile (1..*): canonical reference to FHIR profiles that represent the types of data to be submitted.

While the value set supports granular units like seconds, minutes, and hours, CGM data submission schedules typically involve longer durations such as days, weeks, or months.

Data Chunking for Large Time Periods

While one-time orders can specify any time period (including a patient's entire history), it's usually better to break large requests into meaningful chunks. Chunking makes data size manageable and summary statistics more relevant. Receivers can control chunking by sending individual requests for yearly or monthly periods where the analysis period is more meaningful.

The Data Receiver can expose a standing order indicating:

• What data a Data Submitter should include in each CGM Data Submission Bundle
• How often should a Data Submitter submit CGM data
• What lookback period should each submission cover

Guiding Data Submission

This standing order is modeled as a FHIR ServiceRequest resource, which Data Submitters can query to guide their future submissions. The standing order specifies the patient, the type of data to be submitted, and the frequency of submission.

DataSubmissionSchedule

The DataSubmissionSchedule extension contains:

• submissionPeriod: Quantity, with units bound to the UnitsOfTime value set (allowing s, min, h, d, wk, mo, a) indicating how often the data should be submitted (e.g., every 2 weeks, every month).
• submissionDataProfile (1..*): canonical reference to FHIR profiles that represent the types of data to be submitted according to the specified schedule.
• lookbackPeriod (optional): Quantity, with units bound to the UnitsOfTime value set (allowing s, min, h, d, wk, mo, a) indicating the period of time the data submission should cover (e.g., past 30 days, past 3 months).

While the value set supports granular units like seconds, minutes, and hours, CGM data submission schedules typically involve longer durations such as days, weeks, or months. Multiple DataSubmissionSchedule extensions can be included in a single DataSubmissionRequest resource if the Data Recipient prefers a different schedule for different data types.

Out-of-band communication between the app developer and the clinical provider system can also be used to establish preferred submission schedules. Note that a patient or provider can also manually trigger a one-time submission within an app, and the CGM Data Submission One-Time Order profile can be used for these on-demand data requests.

A continuous glucose monitoring (CGM) sensor device. This corresponds to the CGM sensor, not a reader or app used to capture or transmit the data.

A continuous glucose monitoring (CGM) sensor reading represented in mass units.

A continuous glucose monitoring (CGM) sensor reading represented in molar units.

An observation representing a summary of continuous glucose monitoring (CGM) data.

A PDF report containing a summary of continuous glucose monitoring (CGM) data.

An observation representing the times in various ranges from a continuous glucose monitoring (CGM) summary. Value: Percent of time, with at least two decimal places of precision.

The Coefficient of Variation (CV) value from a continuous glucose monitoring (CGM) summary.

A base profile for one-time orders that specifies an absolute time period for data collection. This profile can be used as-is for general one-time data submissions or inherited by more specific data submission profiles.

Key aspects of this profile:

• Specifies what data should be included in the submission
• Defines an absolute time period (using FHIR Period data type) for data collection
• Intended for one-time, on-demand data requests

This profile uses the DataSubmissionOneTimeSpec extension to capture detailed submission requirements.

A base profile for standing orders that indicates data submission requirements. This profile can be used as-is for general data submissions or inherited by more specific data submission profiles.

Key aspects of this profile:

• Specifies what data should be included in each submission
• Defines how often data should be submitted
• Indicates the lookback period each submission should cover

This profile uses the DataSubmissionSchedule extension to capture detailed submission requirements.

The number of days the continuous glucose monitoring (CGM) device was worn during the reporting period.

The Glucose Management Indicator (GMI) value from a continuous glucose monitoring (CGM) summary.

The mean glucose value from a continuous glucose monitoring (CGM) summary, represented in mass units.

The mean glucose value from a continuous glucose monitoring (CGM) summary, represented in molar units.

The percentage of time the continuous glucose monitoring (CGM) sensor was active during the reporting period.

Defines a one-time specification for data submission with an absolute time period

Schedule and type of data to be submitted

Codes to identify content associated with this IG

This example is an instance of the CGM Data Submission Bundle profile. It represents a transaction bundle submitted on May 2, 2024, at 2:30 PM UTC, containing multiple resources related to Continuous Glucose Monitoring (CGM) data. The bundle includes a CGM summary PDF report, summary observations (e.g., mean glucose, times in ranges, GMI, coefficient of variation, days of wear, sensor active percentage), and individual sensor readings.

This example is an instance of the CGM Device profile. It represents a Continuous Glucose Monitoring (CGM) device named Acme CGM System.

This example is an instance of the CGM Sensor Reading (Mass) profile. It represents a Continuous Glucose Monitoring (CGM) sensor reading for a patient, recording a final observation of a glucose level of 120 mg/dL (mass per volume).

This example is an instance of the CGM Sensor Reading (Molar) profile. It represents a Continuous Glucose Monitoring (CGM) sensor reading for a patient, recording a final observation of a glucose level of 6.7 mmol/L (moles per volume) for the patient.

This example is an instance of the CGM Summary profile. It provides a consolidated summary of a patient's CGM data over one month, linking to more detailed observations for specific metrics.

This example is an instance of the CGM Summary PDF Report profile. It represents a PDF report summarizing Continuous Glucose Monitoring (CGM) data for the patient referenced as patientExample, covering the period from May 1, 2024, to May 14, 2024. The report was issued on May 15, 2024, at 2:30 PM UTC, and includes a (base64-encoded) PDF attachment.

This example is an instance of the CGM Summary Times in Ranges profile. It represents a summary observation of the time a patient spent in different glucose ranges over the period from May 1, 2024, to May 31, 2024. The recorded values are 3% in the very low range, 8% in the low range, 65% in the target range, 20% in the high range, and 4% in the very high range.

This example is an instance of the Coefficient of Variation (CV) profile. It represents a summary observation of the glucose variability for a patient over the period from May 1, 2024, to May 31, 2024, with a final recorded coefficient of variation value of 34%.

This example is an instance of the Days of Wear profile. It represents a summary observation of the number of days a Continuous Glucose Monitoring (CGM) device was worn by the patient over the period from May 1, 2024, to May 31, 2024, with a final recorded value of 28 days.

This example represents a one-time order for continuous glucose monitoring (CGM) data submission. It specifies an order to submit data about Patient 123 for the entire year 2024, requesting all raw sensor readings in mg/dL. This type of order is typically used for comprehensive data requests, such as when a patient is transferring care or for research purposes, where all available sensor data is needed.

This example represents a one-time order for continuous glucose monitoring (CGM) data submission. It specifies an order to submit summary data about Patient 123 for the last 30 days (December 17, 2024 to January 16, 2025). This type of order is typically used for upcoming appointments where recent CGM summary data is needed for clinical review and decision-making.

This example represents a standing order for continuous glucose monitoring (CGM) data submission. To ensure the patient's CGM data is routinely available for clinical review, it specifies an order to submit data about Patient 123 every two weeks. Each submission includes a summary of the CGM data and a corresponding PDF report.

This example represents a female patient named Amy Peters, born on June 20, 1964.

This example is an instance of the Glucose Management Indicator (GMI) profile. It represents a summary observation of the estimated A1C-like value (GMI) for a patient over the period from May 1, 2024, to May 31, 2024, with a final recorded value of 6.8%.

This example is an instance of the Mean Glucose (Mass) profile. It represents a summary observation of the mean glucose level for a patient over the period from May 1, 2024, to May 31, 2024, with a final recorded value of 145 mg/dL (mass per volume).

This example is an instance of the Mean Glucose (Molar) profile. It represents a summary observation of the mean glucose level for a patient over the period from May 1, 2024, to May 31, 2024, with a final recorded value of 8.1 mmol/L (moles per volume).

This example is an instance of the Sensor Active Percentage profile. It represents a summary observation of the percentage of time a Continuous Glucose Monitoring (CGM) sensor was active for the patient over the period from May 1, 2024, to May 31, 2024, with a final recorded value of 95%.