{
  "FullStudy":{
    "Rank":217981,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514305",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PTL900830"
          },
          "Organization":{
            "OrgFullName":"DexCom, Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System",
          "OfficialTitle":"Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 28, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 20, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 23, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"DexCom, Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing.\n\nDevice performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values.\n\nSafety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"21",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Type 1 Diabetes Mellitus (TIDM)Type 2 Diabetes Mellitus (T2DM)",
                "ArmGroupDescription":"Adults that have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;"
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Absolute Relative Difference (%) to Reference Standard",
                "PrimaryOutcomeDescription":"The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL.",
                "PrimaryOutcomeTimeFrame":"one time measure (day 1)"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAge 18 years or older;\nHave been diagnosed with insulin-requiring diabetes\nAbstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;\nInsert sensors on their own and wear 2 systems simultaneously;\nUse only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study;\nParticipate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;\nHave an intravenous catheter inserted for 4 blood draws per hour\nWilling to perform SMBG during home use with the meter provided;\nRefrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;\nSpeak, read, and write English;\nWilling and able to be compliant with provisions laid out in this protocol.\n\nExclusion Criteria:\n\nHave extensive skin changes/diseases that preclude wearing devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;\nAllergy to medical-grade adhesives;\nPregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,\nDialysis treatment;\nHematocrit that is outside the range of 30-55% at screening visit;",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Subjects that fit the inclusion criteria will be chosen from the general population",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"David Price, MD",
                "OverallOfficialAffiliation":"DexCom, Inc.",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Rocky Mountain Diabetes and Osteoporosis Center",
                "LocationCity":"Idaho Falls",
                "LocationState":"Idaho",
                "LocationZip":"83404",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}