{ "FullStudy":{ "Rank":218104, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512680", "OrgStudyIdInfo":{ "OrgStudyId":"8749" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"ID-RCB : 2011-A00645-36", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Afssaps" } ] }, "Organization":{ "OrgFullName":"University Hospital, Montpellier", "OrgClass":"OTHER" }, "BriefTitle":"Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients", "OfficialTitle":"Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps", "Acronym":"IFOPI" }, "StatusModule":{ "StatusVerifiedDate":"November 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"November 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 16, 2011", "StudyFirstSubmitQCDate":"January 14, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 28, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 29, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"University Hospital, Montpellier", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.", "DetailedDescription":"Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 1 Diabetes" ] }, "KeywordList":{ "Keyword":[ "Functional Insulin Thearpy", "Carbs counting", "Type 1 diabetes mellitus", "Insulin pump", "Treatment by external insulin pump" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"52", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Type 1 diabetes patient", "ArmGroupType":"Experimental", "ArmGroupDescription":"Type 1 diabetes patient are included in this study to have an education to Functional Insulin Therapy (intervention)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Education to Functional Insulin Therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Education to Functional Insulin Therapy", "InterventionDescription":"Intake of Continuous Glucose Monitor for 5 to 7 days\n\"Functional Insulinotherapy\" training during 3 days, blood sampling, autoevaluation and QOL questionnary.\n1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes\n3 months after the training: Blood sampling, vital signs and data on diabetes\n6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days\n9 months after the training: Blood sampling, vital signs and data on diabetes\n1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days\n12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Type 1 diabetes patient" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Difference between HbA1c at Month 12 and Month 0 > 0.5%", "PrimaryOutcomeTimeFrame":"at baseline et at Month 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Difference between HbA1c at Month 3 and Month 0 > 0.3%", "SecondaryOutcomeTimeFrame":"at baseline et at Month 3" },{ "SecondaryOutcomeMeasure":"Difference between HbA1c at Month 6 and Month 0 > 0.5%", "SecondaryOutcomeTimeFrame":"at baseline and at Month 6" },{ "SecondaryOutcomeMeasure":"Difference between HbA1c at Month 9 and Month 0 > 0.5%", "SecondaryOutcomeTimeFrame":"at baseline and at Month 9" },{ "SecondaryOutcomeMeasure":"Reduction of 50% of hypoglycemia < 60mg/dl", "SecondaryOutcomeTimeFrame":"at Month 12" },{ "SecondaryOutcomeMeasure":"Reduction of 30% of hypoglycemia between 60 and 80mg/dl", "SecondaryOutcomeTimeFrame":"at Month 12" },{ "SecondaryOutcomeMeasure":"Reduction of number of patients who have severe hypoglycemia", "SecondaryOutcomeTimeFrame":"at MONTH 12" },{ "SecondaryOutcomeMeasure":"Better score at surveys of quality of life (SF-6D, DQOL) and auto-management", "SecondaryOutcomeTimeFrame":"at baseline, at Month 6 and at Month 12" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAge between 18 and 70\nType 1 diabetes for more than 1 year\nTreatment by basal/bolus insulin therapy and insulin pump for more than 6 months\nHbA1c between 7.5 and 12%\nVolunteer to be educated to Functional Insulin Therapy\nPatient must be willing to undergo all study procedures\nPatient must be affiliated or beneficiary of a social medical insurance\nPatient has signed informed consent form prior to study entry\n\nExclusion Criteria:\n\nType 2 diabetes\nDifficulties with mathematics calculation (simple algebra)\nPatient is pregnant, or breast feeding during the period of the study\nManifest psychological disorders\nPatient with eating behaviour desorder\nAlcohol or drug addiction, as identified by investigator during screening visit\nPersons deprived of freedom, adults protected by law or vulnerable persons", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Eric ER RENARD, MD", "OverallOfficialAffiliation":"University Hospital, Montpellier", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Montpellier University Hospital", "LocationCity":"Montpellier", "LocationZip":"34000", "LocationCountry":"France" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000007328", "InterventionMeshTerm":"Insulin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007004", "InterventionAncestorTerm":"Hypoglycemic Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M8948", "InterventionBrowseLeafName":"Insulin", "InterventionBrowseLeafAsFound":"Insulin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M178017", "InterventionBrowseLeafName":"Insulin, Globin Zinc", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8637", "InterventionBrowseLeafName":"Hypoglycemic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Hypo", "InterventionBrowseBranchName":"Hypoglycemic Agents" },{ "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" } ] } } } } } }