Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: NCT03421379 Eligibility Criteria - XML Representation

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<Group xmlns="http://hl7.org/fhir">
  <id value="267225"/>
  <meta>
    <versionId value="6"/>
    <lastUpdated value="2025-09-14T18:30:51.295Z"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Group 267225</b></p><a name="267225"> </a><a name="hc267225"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 6; Last updated: 2025-09-14 18:30:51+0000</p></div><p><b>Artifact Author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>CiteAs</b>: </p><div><p>NCT03421379 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267225. Revised 2025-09-14. Available at: https://fevir.net/resources/Group/267225. Computable resource at: https://fevir.net/resources/Group/267225#json.</p>
</div><p><b>url</b>: <a href="https://fevir.net/resources/Group/267225">https://fevir.net/resources/Group/267225</a></p><p><b>identifier</b>: FEvIR Object Identifier/267225, FEvIR Linking Identifier/NCT03421379 Eligibility Criteria</p><p><b>name</b>: NCT03421379_Eligibility_Criteria</p><p><b>title</b>: NCT03421379 Eligibility Criteria</p><p><b>status</b>: Active</p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href="mailto:support@computablepublishing.com">support@computablepublishing.com</a></p><p><b>description</b>: </p><div><p>Inclusion Criteria:</p>
<ul>
<li>Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)</li>
<li>Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D</li>
<li>Hemoglobin A1c (HbA1c) ≤10%</li>
</ul>
<p>Exclusion Criteria:</p>
<ul>
<li>Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month</li>
<li>Have received a total daily dose of insulin &gt;1.2 units per kilogram (U/kg)</li>
</ul>
</div><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>membership</b>: Conceptual</p><p><b>combinationMethod</b>: All of</p><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Eligibility Criteria</span></p><p><b>value</b>: Inclusion Criteria:

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \&gt;1.2 units per kilogram (U/kg)</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Accepts Healthy Volunteers</span></p><p><b>value</b>: false</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Age</span></p><p><b>value</b>: 18-70 year</p><p><b>exclude</b>: false</p></blockquote><blockquote><p><b>characteristic</b></p><p><b>code</b>: <span title="Codes:">Age Group</span></p><p><b>value</b>: <span title="Codes:">Adult or Older Adult</span></p><p><b>exclude</b>: false</p></blockquote></div>
  </text>
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    <valueContactDetail>
      <name
            value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
    </valueContactDetail>
  </extension>
  <extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as">
    <valueMarkdown
                   value="NCT03421379 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267225. Revised 2025-09-14. Available at: https://fevir.net/resources/Group/267225. Computable resource at: https://fevir.net/resources/Group/267225#json."/>
  </extension>
  <url value="https://fevir.net/resources/Group/267225"/>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="ACSN"/>
        <display value="Accession ID"/>
      </coding>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="https://fevir.net/FOI"/>
    <value value="267225"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <type>
      <text value="FEvIR Linking Identifier"/>
    </type>
    <system value="https://fevir.net/FLI"/>
    <value value="NCT03421379 Eligibility Criteria"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <name value="NCT03421379_Eligibility_Criteria"/>
  <title value="NCT03421379 Eligibility Criteria"/>
  <status value="active"/>
  <publisher value="Computable Publishing LLC"/>
  <contact>
    <telecom>
      <system value="email"/>
      <value value="support@computablepublishing.com"/>
    </telecom>
  </contact>
  <description
               value="Inclusion Criteria:

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \&gt;1.2 units per kilogram (U/kg)"/>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <membership value="conceptual"/>
  <combinationMethod value="all-of"/>
  <characteristic>
    <code>
      <text value="Eligibility Criteria"/>
    </code>
    <valueReference>
      <display
               value="Inclusion Criteria:

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \&gt;1.2 units per kilogram (U/kg)"/>
    </valueReference>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Accepts Healthy Volunteers"/>
    </code>
    <valueBoolean value="false"/>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Age"/>
    </code>
    <valueRange>
      <low>
        <value value="18"/>
        <unit value="year"/>
        <system value="http://unitsofmeasure.org"/>
        <code value="a"/>
      </low>
      <high>
        <value value="70"/>
        <unit value="year"/>
        <system value="http://unitsofmeasure.org"/>
        <code value="a"/>
      </high>
    </valueRange>
    <exclude value="false"/>
  </characteristic>
  <characteristic>
    <code>
      <text value="Age Group"/>
    </code>
    <valueCodeableConcept>
      <text value="Adult or Older Adult"/>
    </valueCodeableConcept>
    <exclude value="false"/>
  </characteristic>
</Group>