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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