Requirements
Scope
Provide FHIR modelling for the data points related to the following categories for integration with Big Data:
- Patient Profile
- CGM Pairing
- CGM
- bG
- Insulin
- Meals
The data will not be stored on FHIR database.
Data Points
Patient Profile
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| birthyear | Birth year of the patient | Patient.birthDate | Sample |
| medications | Type of medication given to the patient | Careplan.extension - careplan-therapy-medication | Sample |
| diagnosisYear | diagnosis year of the patient | Condition.assertedDate | Sample |
| height | height of the patient | Observation.valueQuantity (category=vital-signs) | Sample |
| weight | weight of the patient | Observation.valueQuantity (category=vital-signs) | Sample |
| bloodGlucoseLowerTarget | Blood glucose lower target range | Goal.detailRange (category=patientTargetRange) | Sample |
| bloodGlucoseUpperTarget | Blood glucose Upper target range | Goal.detailRange (category=patientTargetRange) | Sample |
| latestHBA1C | HBA1c value | Observation.valueQuantity (category=Laboratory) | Sample |
| bolusInsulinType | name of bolus insulin type | Careplan.extension - careplan-therapy-insulin-type | Sample |
| basalInsulinType | name of basal insulin type | Careplan.extension - careplan-therapy-insulin-type | Sample |
| insulinSensitivity | sensitivity range of the insulin | Careplan.extension - careplan-bolus-advice | Sample |
| insulinCarbsRatio | hourly carb ratio for insulin unit | Careplan.extension - careplan-bolus-advice | Sample |
| bloodGlucoseUnit | blood glucose unit 1 - mg/dL 2 - mmol/L The multiple units are only for profile settings, BG will be stored in the backend and sent to Data Lake only in mg/dL |
DeviceMetric.unit | Sample |
| carbohydratesUnit | Carbohydrate units 1 - g 2 - BE 3 - KE 4 - CC (The multiple units are only for profile settings, carbohydrates will be stored in the backend and sent to Data Lake only in g. ) |
Observation.valueQuantity | Sample |
| hba1cUnit | hba1c Unit 1- "mmol/mol" 2-% The multiple units are only for profile settings, hba1c will be stored in the backend and sent to Data Lake only in mmol/mol. |
DeviceMetric.unit | Sample |
CGM pairing
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| Type of device | Type of device | DeviceComponent | CGM Pairing |
| Device Model | Device Model (datasource): 1 - CGM Simulator 2 - Eversense CGM Cloud |
DeviceComponent.productionSpecification | same as above |
| Device ID | Device serial no # | DeviceComponent.productionSpecification | same as above |
| Connection Status | Connection Status: 0 - Disconnected 1 - Connected |
DeviceComponent.extension - device-component-paired-status | same as above |
CGM Data
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| Timestamp | Timestamp of the CGM measurement | To be derived from Observation.effectivePeriod and Observation.valueSampledData.period for each CGM entry in the array | CGM data |
| Device Model (datasource) | Device Model (datasource): 1 - CGM Simulator 2 - Eversense CGM Cloud |
DeviceComponent resource for the relevant source + DeviceMetric resource | same as above |
| glucose Value | Measured glucose level in mg/dL | Observation.valueSampledData | same as above |
BGM Data : Blood Glucose measurements form Glucometer
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| Timestamp | Timestamp of the BG measurement | Observation.effectiveDateTime | BGM data |
| bg Value | value of BG in mg/dL | Observation.valueQuantity | same as above |
| Entry mechanism (datasource) | Entry mechanism (datasource) 1 - Manual Entry 2 - Automatic - Unspecified Glucose Meter 3 - Automatic - Accu-Chek Guide 4 - Automatic - Accu-Chek Mobile 5 - Automatic - Accu-Chek Instant |
DeviceComponent resource linked to the Observation | same as above |
| Out of measurement range indicator | Out of measurement range Indicator (range) 1 - LO value 2 - HI value |
Observation.dataAbsentReason | same as above |
Insulin Data : Insulin Administration from InsulinPen
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| Timestamp | Timestamp of the Insulin administration | MedicationAdministration.effectiveDateTime or EffectivePeriod | Insulin data |
| Insulin amount | value in IU | MedicationAdministration.dosage | same as above |
| Entry mechanism (datasource) | Entry mechanism (datasource) 1 - Manual Entry 2 - Automatic |
DeviceMetric resource linked to the MedicationAdministration | same as above |
| Insulin Type | Integer - Numeric codes (1 - 2) 1 - Bolus Injected 2 - Basal Injected - URL path parameter |
MedicationAdministration.medicationCodeableConcept | same as above |
Meal Data : Carbohydrate intake data from SmartLifeApp
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| Timestamp | Timestamp of the meal data entry | Observation.effectiveDateTime or EffectivePeriod | Sample |
| estimatedCarbs | value in g | Observation.valueQuantity | Sample |
| mealType | mealType 1 - Breakfast 2 - Lunch 3 - Dinner 4 - Snack 5 - Beverage |
Observation.valueCodeableConcept | Sample |
| mealComposition | mealComposition 1 - Low carb meal 2 - Balanced carb meal 3 - High carb meal |
Observation.component.value[x]:valueCodeableConcept | Sample |
| carbsComplexity | 1 - Simple Carbs 2 - Complex Carbs |
Observation.component.value[x]:valueCodeableConcept | Sample |
Therapy Type
| Data Point | Description | FHIR resource and element | FHIR Sample |
|---|---|---|---|
| Therapy Type | Therapy Type of the patient | CarePlan.ext.careplan-therapy-type | Sample |
Solution Architecture
| Description | Link | Comments |
|---|---|---|
| SmartLife | link | |
| Data Lake Integration | link |
High-Level Requirements
| Description | Link | Comments |
|---|---|---|
| Input data specification | link |