{
  "FullStudy":{
    "Rank":217614,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519102",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CLASS-02"
          },
          "Organization":{
            "OrgFullName":"Institut de Recherches Cliniques de Montreal",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Comparison of Closed-loop Operation After Morning Meal With and Without Carbohydrate Counting",
          "OfficialTitle":"An Open-label, Randomized Two-way, Cross-over Study to Compare Meal-and-carbohydrate-announcement Strategy Versus Meal-announcement Strategy During Closed-loop Regulation of Glucose Levels in a Morning Meal in Adults With Type-1 Diabetes.",
          "Acronym":"CLASS02"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 24, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 7, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 10, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Rémi Rabasa-Lhoret",
            "ResponsiblePartyInvestigatorTitle":"Associate Professor of Medicine",
            "ResponsiblePartyInvestigatorAffiliation":"Institut de Recherches Cliniques de Montreal"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Institut de Recherches Cliniques de Montreal",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"McGill University",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Montreal Children's Hospital of the MUHC",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.\n\nThe main goal of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.\n\nEach patient will be admitted twice to a clinical research facility. In one visit, patients will eat a morning meal accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the other visit, patients will eat the same meal but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. If post-meal glucose levels were indifferent between the two visits, then this would suggest that carbohydrate counting may not be necessary during closed-loop operation as the closed-loop system will give any remaining insulin needed to cover the glucose absorbed from the meal. Twelve subjects will be enrolled in this study."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Type-1 Diabetes"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"CHO-independent partial insulin bolus with closed-loop",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Dual Hormone closed-loop system"
                  ]
                }
              },{
                "ArmGroupLabel":"CHO-dependent full insulin bolus combined with closed-loop",
                "ArmGroupType":"Active Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: Dual Hormone closed-loop system"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"Dual Hormone closed-loop system",
                "InterventionDescription":"The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "CHO-dependent full insulin bolus combined with closed-loop",
                    "CHO-independent partial insulin bolus with closed-loop"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Incremental area under the curve of plasma glucose concentration as compared to pre-meal glucose value of the postprandial glucose excursions",
                "PrimaryOutcomeTimeFrame":"0-300min"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Percentage of postprandial time of plasma glucose concentrations spent in the high range (above 10.0 mmol/l).",
                "SecondaryOutcomeTimeFrame":"0-300 min"
              },{
                "SecondaryOutcomeMeasure":"Mean plasma glucose concentration."
              },{
                "SecondaryOutcomeMeasure":"Total insulin delivery"
              },{
                "SecondaryOutcomeMeasure":"Total glucagon delivery"
              },{
                "SecondaryOutcomeMeasure":"Plasma glucose concentration and incremental plasma glucose concentration at 2 hours postmeal"
              },{
                "SecondaryOutcomeMeasure":"Postprandial peak and incremental postprandial peak of plasma glucose concentration"
              },{
                "SecondaryOutcomeMeasure":"Percentage of time of plasma glucose concentrations spent in target range. Target range is defined to be between 4.0 and 10.0 mmol/l for 150 minutes postmeal and between 4.0 and 8.0 mmol/l afterwards"
              },{
                "SecondaryOutcomeMeasure":"Percentage of postprandial time of plasma glucose concentrations spent in the low range (below 4.0mmol/l)",
                "SecondaryOutcomeTimeFrame":"0-300min"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMales and females ≥ 18 and ≤ 65 years of old.\nClinical diagnosis of type 1 diabetes for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment and medical history (e.g. history of acido-ketosis, etc.); C peptide level and antibody determinations are not needed.\nThe subject will have been on insulin pump therapy for at least 3 months.\nLast (less than 3 months) HbA1c ≤ 12%.\n\nExclusion Criteria:\n\nClinically significant nephropathy, neuropathy (especially clinically significant gastroparesis) or retinopathy as judged by the investigator.\nRecent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.\nPregnancy.\n\nSevere hypoglycemic episode within two weeks of screening.\n\n• Medication likely to affect with the interpretation of the results: Prandase, Victoza, Byetta and Symlin\n\nKnown or suspected allergy to the trial products or meal contents.\nOther serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\nFailure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).\nUnreliable carbohydrate counting\nProblems with venous access",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Institut de Recherches Cliniques de Montréal (IRCM)",
                "LocationCity":"Montreal",
                "LocationState":"Quebec",
                "LocationZip":"H2W 1R7",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24656963",
                "ReferenceType":"derived",
                "ReferenceCitation":"Haidar A, Farid D, St-Yves A, Messier V, Chen V, Xing D, Brazeau AS, Duval C, Boulet B, Legault L, Rabasa-Lhoret R. Post-breakfast closed-loop glucose control is improved when accompanied with carbohydrate-matching bolus compared to weight-dependent bolus. Diabetes Metab. 2014 Jun;40(3):211-4. doi: 10.1016/j.diabet.2013.12.001. Epub 2014 Mar 19."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000006728",
                "InterventionMeshTerm":"Hormones"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafAsFound":"Hormone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003922",
                "ConditionMeshTerm":"Diabetes Mellitus, Type 1"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003920",
                "ConditionAncestorTerm":"Diabetes Mellitus"
              },{
                "ConditionAncestorId":"D000044882",
                "ConditionAncestorTerm":"Glucose Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
              },{
                "ConditionAncestorId":"D000001327",
                "ConditionAncestorTerm":"Autoimmune Diseases"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5698",
                "ConditionBrowseLeafName":"Diabetes Mellitus",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5700",
                "ConditionBrowseLeafName":"Diabetes Mellitus, Type 1",
                "ConditionBrowseLeafAsFound":"Type 1 Diabetes",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23990",
                "ConditionBrowseLeafName":"Glucose Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3210",
                "ConditionBrowseLeafName":"Autoimmune Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}