Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

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 - JSON Representation

Raw json | Download

{
  "resourceType" : "Group",
  "id" : "267225",
  "meta" : {
    "versionId" : "6",
    "lastUpdated" : "2025-09-14T18:30:51.295Z"
  },
  "text" : {
    "status" : "extensions",
    "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 &gt;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 \\&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>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/artifact-author",
      "valueContactDetail" : {
        "name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
      }
    },
    {
      "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
      "valueMarkdown" : "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."
    }
  ],
  "url" : "https://fevir.net/resources/Group/267225",
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ACSN",
            "display" : "Accession ID"
          }
        ],
        "text" : "FEvIR Object Identifier"
      },
      "system" : "https://fevir.net/FOI",
      "value" : "267225",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    },
    {
      "type" : {
        "text" : "FEvIR Linking Identifier"
      },
      "system" : "https://fevir.net/FLI",
      "value" : "NCT03421379 Eligibility Criteria",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    }
  ],
  "name" : "NCT03421379_Eligibility_Criteria",
  "title" : "NCT03421379 Eligibility Criteria",
  "status" : "active",
  "publisher" : "Computable Publishing LLC",
  "contact" : [
    {
      "telecom" : [
        {
          "system" : "email",
          "value" : "support@computablepublishing.com"
        }
      ]
    }
  ],
  "description" : "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)",
  "copyright" : "https://creativecommons.org/licenses/by-nc-sa/4.0/",
  "membership" : "conceptual",
  "combinationMethod" : "all-of",
  "characteristic" : [
    {
      "code" : {
        "text" : "Eligibility Criteria"
      },
      "valueReference" : {
        "display" : "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)"
      },
      "exclude" : false
    },
    {
      "code" : {
        "text" : "Accepts Healthy Volunteers"
      },
      "valueBoolean" : false,
      "exclude" : false
    },
    {
      "code" : {
        "text" : "Age"
      },
      "valueRange" : {
        "low" : {
          "value" : 18,
          "unit" : "year",
          "system" : "http://unitsofmeasure.org",
          "code" : "a"
        },
        "high" : {
          "value" : 70,
          "unit" : "year",
          "system" : "http://unitsofmeasure.org",
          "code" : "a"
        }
      },
      "exclude" : false
    },
    {
      "code" : {
        "text" : "Age Group"
      },
      "valueCodeableConcept" : {
        "text" : "Adult or Older Adult"
      },
      "exclude" : false
    }
  ]
}