Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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-ballot3 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

Page standards status: Informative

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

<http://hl7.org/fhir/Group/267225> a fhir:Group ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "267225"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "20" ] ;
     fhir:lastUpdated [ fhir:v "2026-09-02T17:15:21.850Z"^^xsd:dateTime ]
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
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     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n  <table class=\"narrative-table\">\n    <tbody>\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\"><a name=\"metadata\"> </a>Metadata</th>\n\n\n</tr>\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">NCT03421379 Eligibility Criteria</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n  \n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Identifier</th>\n\n\n\n<td class=\"content-container\">267225</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward (Publisher)</th>\n\n\n\n<td class=\"content-container\">Computable Publishing LLC</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>Inclusion Criteria:</p>\n<ul>\n<li>Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)</li>\n<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>\n<li>Hemoglobin A1c (HbA1c) ≤10%\nExclusion Criteria:</li>\n<li>Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month</li>\n<li>Have received a total daily dose of insulin &gt;1.2 units per kilogram (U/kg)</li>\n</ul>\n</div></td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Copyright</th>\n\n\n\n<td class=\"content-container\"><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n  <th colspan=\"2\" scope=\"row\" class=\"row-header\">Generated using version 0.5.6 of the sample-content-ig Liquid templates</th>\n</tr>\n\n    </tbody>\n  </table>\n</div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
     fhir:url [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status>
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:coding ( [
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           fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/cited-artifact-status-type>
         ] ;
         fhir:code [ fhir:v "active" ] ;
         fhir:display [ fhir:v "Active" ]
       ] )
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       fhir:l <http://hl7.org/fhir/StructureDefinition/artifact-author>
     ] ;
     fhir:value [
       a fhir:ContactDetail ;
       fhir:name [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ]
     ]
  ] [
     fhir:url [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as>
     ] ;
     fhir:value [
       a fhir:Markdown ;
       fhir:v "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 2026-09-02. Available at: https://fevir.net/resources/Group/267225. Computable resource at: https://fevir.net/resources/Group/267225#json."
     ]
  ] ) ; # 
  fhir:url [
     fhir:v "https://fevir.net/resources/Group/267225"^^xsd:anyURI ;
     fhir:l <https://fevir.net/resources/Group/267225>
  ] ; # 
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         fhir:system [
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           fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>
         ] ;
         fhir:code [ fhir:v "ACSN" ] ;
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       ] ) ;
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     ]
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     fhir:value [ fhir:v "NCT03421379 Eligibility Criteria" ] ;
     fhir:assigner [
       fhir:display [ fhir:v "Computable Publishing LLC" ]
     ]
  ] ) ; # 
  fhir:name [ fhir:v "NCT03421379_Eligibility_Criteria"] ; # 
  fhir:title [ fhir:v "NCT03421379 Eligibility Criteria"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # 
  fhir:contact ( [
     fhir:telecom ( [
       fhir:system [ fhir:v "email" ] ;
       fhir:value [ fhir:v "support@computablepublishing.com" ]
     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Inclusion Criteria:\n* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)\n* 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\n* Hemoglobin A1c (HbA1c) ≤10%\nExclusion Criteria:\n* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month\n* Have received a total daily dose of insulin \\>1.2 units per kilogram (U/kg)"] ; # 
  fhir:copyright [ fhir:v "Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse)."] ; # 
  fhir:membership [ fhir:v "conceptual"] ; # 
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     ] ;
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       fhir:text [ fhir:v "Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)" ]
     ] ;
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     fhir:description [ fhir:v "Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)" ]
  ] [
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     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "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" ]
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "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" ]
  ] [
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     fhir:value [
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       fhir:text [ fhir:v "Hemoglobin A1c (HbA1c) ≤10%" ]
     ] ;
     fhir:exclude [ fhir:v false ] ;
     fhir:description [ fhir:v "Hemoglobin A1c (HbA1c) ≤10%" ]
  ] [
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     ] ;
     fhir:value [
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       fhir:text [ fhir:v "Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month" ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month" ]
  ] [
     fhir:code [
       fhir:text [ fhir:v "Defined by CodeableConcept" ]
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     fhir:value [
       a fhir:CodeableConcept ;
       fhir:text [ fhir:v "Have received a total daily dose of insulin \\>1.2 units per kilogram (U/kg)" ]
     ] ;
     fhir:exclude [ fhir:v true ] ;
     fhir:description [ fhir:v "Have received a total daily dose of insulin \\>1.2 units per kilogram (U/kg)" ]
  ] ) . #