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
| Page standards status: Informative |
{
"resourceType" : "Group",
"id" : "267225",
"meta" : {
"versionId" : "20",
"lastUpdated" : "2026-09-02T17:15:21.850Z"
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<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 >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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
"code" : "active",
"display" : "Active"
}
]
}
},
{
"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 2026-09-02. 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* 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)",
"copyright" : "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).",
"membership" : "conceptual",
"combinationMethod" : "all-of",
"characteristic" : [
{
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)"
},
"exclude" : false,
"description" : "Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)"
},
{
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "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"
},
"exclude" : false,
"description" : "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"
},
{
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Hemoglobin A1c (HbA1c) ≤10%"
},
"exclude" : false,
"description" : "Hemoglobin A1c (HbA1c) ≤10%"
},
{
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month"
},
"exclude" : true,
"description" : "Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month"
},
{
"code" : {
"text" : "Defined by CodeableConcept"
},
"valueCodeableConcept" : {
"text" : "Have received a total daily dose of insulin \\>1.2 units per kilogram (U/kg)"
},
"exclude" : true,
"description" : "Have received a total daily dose of insulin \\>1.2 units per kilogram (U/kg)"
}
]
}