{
  "FullStudy":{
    "Rank":218167,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511861",
          "OrgStudyIdInfo":{
            "OrgStudyId":"gluco02"
          },
          "Organization":{
            "OrgFullName":"GlucoVista",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device",
          "OfficialTitle":"Assessing the Reliability of Non-invasive Blood Glucose Monitoring Device"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2020",
          "OverallStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2021",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 18, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 19, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"GlucoVista",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Adequate glycemic control in patients with Diabetes Mellitus (DM) is a desired therapeutic goal that is difficult to achieve with current blood glucose monitoring technology. Home blood glucose monitoring (HBGM) technology, which requires finger pricking, is a source of severe inconvenience and hence, a lack of compliance.Thus, the need for non-invasive and easy to operate glucose monitoring in DM patients for strict glycemic control cannot be overemphasized.\n\nThe Glucometer GM-205 blood glucose readings are accurate and measure blood glucose with an acceptable mean relative error when compared to acceptable invasive blood glucose measurements.\n\nThe primary objectives of the trial are to determine:\n\nAssessing the reliability of the Glucometer GM-205 in evaluating blood glucose levels compare to the standard glucose blood test\nCreating database of glucose levels readings utilizing the Glucometer GM-205."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Diabetes Mellitus"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"137",
            "EnrollmentType":"Anticipated"
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiabetes Mellitus type one or type two.\nPatients that are using Insulin.\n\nExclusion Criteria:\n\nVascular diseases\nPregnant and lactating women.\nExclusive use of long term Insulin.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"85 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"patients with diabetes mellitus type 1 or type 2.",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Edith Wolfson Medical Center",
                "LocationCity":"Holon",
                "LocationCountry":"Israel"
              }
            ]
          }
        }
      },
      "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"
              }
            ]
          }
        }
      }
    }
  }
}