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
@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 -------------------------------------------------------------------
a fhir:Group ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "267225"] ; #
fhir:meta [
fhir:versionId [ fhir:v "6" ] ;
fhir:lastUpdated [ fhir:v "2025-09-14T18:30:51.295Z"^^xsd:dateTime ]
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<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>\n</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>\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%</li>\n</ul>\n<p>Exclusion Criteria:</p>\n<ul>\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 >1.2 units per kilogram (U/kg)</li>\n</ul>\n</div><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</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:\n\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%\n\nExclusion Criteria:\n\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)</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>"^^rdf:XMLLiteral
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
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: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 2025-09-14. 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:identifier ( [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ] ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ;
fhir:system [ fhir:v "https://fevir.net/FOI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "267225" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ] ]
] [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ] ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
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\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%\n\nExclusion Criteria:\n\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 "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; #
fhir:membership [ fhir:v "conceptual"] ; #
fhir:combinationMethod [ fhir:v "all-of"] ; #
fhir:characteristic ( [
fhir:code [
fhir:text [ fhir:v "Eligibility Criteria" ] ] ;
fhir:value [
a fhir:Reference ;
fhir:display [ fhir:v "Inclusion Criteria:\n\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%\n\nExclusion Criteria:\n\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:exclude [ fhir:v false ]
] [
fhir:code [
fhir:text [ fhir:v "Accepts Healthy Volunteers" ] ] ;
fhir:value [
a fhir:boolean ;
fhir:v false ] ;
fhir:exclude [ fhir:v false ]
] [
fhir:code [
fhir:text [ fhir:v "Age" ] ] ;
fhir:value [
a fhir:Range ;
fhir:low [
fhir:value [ fhir:v "18"^^xsd:decimal ] ;
fhir:unit [ fhir:v "year" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "a" ] ] ;
fhir:high [
fhir:value [ fhir:v "70"^^xsd:decimal ] ;
fhir:unit [ fhir:v "year" ] ;
fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "a" ] ] ] ;
fhir:exclude [ fhir:v false ]
] [
fhir:code [
fhir:text [ fhir:v "Age Group" ] ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "Adult or Older Adult" ] ] ;
fhir:exclude [ fhir:v false ]
] ) . #
IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot3. Generated 2025-10-12
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