Retrieval of Real World Data for Clinical Research
1.0.0 - trial-use

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## Diabetes Study

The following use case was used to determine the requirements for determining a patient cohort along with what data elements were necessary when retrieving clinical data:

### Type 1 or Type 2 Diabetes Treatment Patterns

The details of this study can be found on ClinicalTrials.gov: NCT05088265.

This study is observational, designed to collect real world use and safety data for those using the Bigfoot Unity Diabetes Management System for 12 months.

#### Cohort Criteria

The patients for this study would have the following criteria:

- female or male aged 12 years or greater
- diagnosed with type 1 or type 2 diabetes diagnosis
- have a baseline HbA1c collected within 90 days

These criteria would be represented by the following queries:

    /Patient?birthdate=le<birthdate of 12 years before today>&gender=male,female
    /Condition?code:in=http://hl7.org/fhir/uv/vulcan-rwd/ValueSet/ExampleDiabetesConditionCodes
    /Observation?status=final&code:in=http://hl7.org/fhir/uv/vulcan-rwd/ValueSet/ExampleHbA1cTestCodes

The patients would also not have the following criteria:

- Females who are pregnant
- Persons on dialysis

This exclusion criteria would be represented by the following query:

    /Condition?code=http://hl7.org/fhir/sid/icd-10-cm|Z33.1
    /Procedure?code:in=http://hl7/org/fhir/uv/vulcan-rwd/ValueSet/ExampleDialysisProcedureCodes

The patients that were common to the first three queries and were not found in the exclusion queries would form the set of patients representing this cohort.

#### Retrieved Data

For patients that meet the criteria above, the following data, as a minimum, would be retrieved:

- patient demographics
- all HbA1c tests
- all concomitant medications