{ "FullStudy":{ "Rank":217586, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519466", "OrgStudyIdInfo":{ "OrgStudyId":"ADC-PMR-INX-11012" }, "Organization":{ "OrgFullName":"Abbott Diabetes Care", "OrgClass":"INDUSTRY" }, "BriefTitle":"Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study", "OfficialTitle":"Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study" }, "StatusModule":{ "StatusVerifiedDate":"March 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 6, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 12, 2015", "ResultsFirstSubmitQCDate":"March 3, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 1, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 3, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 1, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Abbott Diabetes Care", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 1 Diabetes" ] }, "KeywordList":{ "Keyword":[ "Diabetes", "SMBG", "Insulin calculator" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"55", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Intervention", "ArmGroupType":"Other", "ArmGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: FreeStyle InsuLinx" ] } },{ "ArmGroupLabel":"Control", "ArmGroupType":"Other", "ArmGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: FreeStyle Freedom Lite" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"FreeStyle InsuLinx", "InterventionDescription":"FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Intervention" ] } },{ "InterventionType":"Device", "InterventionName":"FreeStyle Freedom Lite", "InterventionDescription":"FreeStyle Freedom Lite is a blood glucose meter", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Control" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Time in Target Blood Glucose Range", "PrimaryOutcomeDescription":"Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)", "PrimaryOutcomeTimeFrame":"Day 1-15 compared with Day 60-74" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"HbA1c", "SecondaryOutcomeDescription":"HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).\n\nThe percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).", "SecondaryOutcomeTimeFrame":"Day 1 compared with Day 74" },{ "SecondaryOutcomeMeasure":"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.", "SecondaryOutcomeDescription":"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).\n\nThere is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).\n\nThe 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.", "SecondaryOutcomeTimeFrame":"Day 60 compared to day 1" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting\nHbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive\nAge 18 and over\nIn the investigator's opinion, thought technically capable of using masked CGM\nSubject self reporting a minimum of 21 SMBG tests per week prior to study enrolment\nWilling to perform a minimum of 4 SMBG tests per day during study\n\nExclusion Criteria:\n\nSubject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety\nSubject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management\nSubject is pregnant / planning to become pregnant within the planned study timeline\nSubject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection\nSubject is currently on an insulin pump\nSubject is currently using the FreeStyle InsuLinx\nSubject is currently using the FreeStyle Freedom Lite\nSubject is currently using CGM\nSubject has an allergy to medical grade adhesives", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Prof. Michaela Diamant", "OverallOfficialAffiliation":"VU University Medical Centre (VUMC)", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Diabetes Zentrum Mergentheim", "LocationCity":"Bad Mergentheim", "LocationZip":"97980", "LocationCountry":"Germany" },{ "LocationFacility":"Diabetes-Zentrum für Kinder und Jugendliche", "LocationCity":"Hannover", "LocationZip":"30173", "LocationCountry":"Germany" },{ "LocationFacility":"Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm", "LocationCity":"Ulm", "LocationZip":"D-89081", "LocationCountry":"Germany" },{ "LocationFacility":"VU University Medical Centre (VUMC)", "LocationCity":"Amsterdam", "LocationZip":"1007 MB", "LocationCountry":"Netherlands" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"FreeStyle InsuLinx", "FlowGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study\n\nFreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"FreeStyle Freedom Lite", "FlowGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.\n\nFreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"33" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"33" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"A total of 55 subjects consented and enrolled into the study. Six of these withdrew before randomisation or failed screening. Forty-nine (49) subjects were randomised and completed the study.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"FreeStyle InsuLinx", "BaselineGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study\n\nFreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"FreeStyle Freedom Lite", "BaselineGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.\n\nFreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"33" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"49" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"44.4", "BaselineMeasurementSpread":"15.2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"43.4", "BaselineMeasurementSpread":"16.7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"44.1", "BaselineMeasurementSpread":"15.6" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"23" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"26" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Netherlands", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } } ] } },{ "BaselineClassTitle":"Germany", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"25" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"37" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Body Mass Index (BMI)", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m²", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26.6", "BaselineMeasurementSpread":"3.6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26.4", "BaselineMeasurementSpread":"4.4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"26.5", "BaselineMeasurementSpread":"3.8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Duration of Diabetes", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"18.8", "BaselineMeasurementSpread":"14.1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14.6", "BaselineMeasurementSpread":"8.0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"17.4", "BaselineMeasurementSpread":"12.5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Screening HbA1c", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"mmol/mol", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"61.7", "BaselineMeasurementSpread":"7.7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"64.8", "BaselineMeasurementSpread":"6.8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"62.7", "BaselineMeasurementSpread":"7.5" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Screening HbA1c", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Percentage of Glycosylated Haemoglobin", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7.8", "BaselineMeasurementSpread":"0.7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8.1", "BaselineMeasurementSpread":"0.6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7.9", "BaselineMeasurementSpread":"0.7" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Time in Target Blood Glucose Range", "OutcomeMeasureDescription":"Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)", "OutcomeMeasurePopulationDescription":"One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"hours per day", "OutcomeMeasureTimeFrame":"Day 1-15 compared with Day 60-74", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FreeStyle InsuLinx", "OutcomeGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study\n\nFreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"FreeStyle Freedom Lite", "OutcomeGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.\n\nFreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"32" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.28", "OutcomeMeasurementSpread":"2.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.31", "OutcomeMeasurementSpread":"3.15" } ] } } ] } },{ "OutcomeClassTitle":"Final", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.56", "OutcomeMeasurementSpread":"2.99" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.14", "OutcomeMeasurementSpread":"2.36" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0926", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.71", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-1.55", "OutcomeAnalysisCIUpperLimit":"0.12", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"2.32" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-1.17", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"2.97" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"HbA1c", "OutcomeMeasureDescription":"HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).\n\nThe percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol).", "OutcomeMeasurePopulationDescription":"One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Percentage of Glycosylated Haemoglobin", "OutcomeMeasureTimeFrame":"Day 1 compared with Day 74", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FreeStyle InsuLinx", "OutcomeGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study\n\nFreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"FreeStyle Freedom Lite", "OutcomeGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.\n\nFreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"32" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.87", "OutcomeMeasurementSpread":"0.76" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.07", "OutcomeMeasurementSpread":"0.76" } ] } } ] } },{ "OutcomeClassTitle":"Final", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7.78", "OutcomeMeasurementSpread":"0.58" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7.98", "OutcomeMeasurementSpread":"0.69" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.3251", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.09", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.27", "OutcomeAnalysisCIUpperLimit":"0.09", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"0.49" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.09", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"0.51" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.", "OutcomeMeasureDescription":"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).\n\nThere is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).\n\nThe 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test.", "OutcomeMeasurePopulationDescription":"One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"Day 60 compared to day 1", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FreeStyle InsuLinx", "OutcomeGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study\n\nFreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"FreeStyle Freedom Lite", "OutcomeGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.\n\nFreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"32" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"16" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hyperglycaemia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.13", "OutcomeMeasurementSpread":"1.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.25", "OutcomeMeasurementSpread":"1.53" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycaemia", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.31", "OutcomeMeasurementSpread":"1.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.13", "OutcomeMeasurementSpread":"1.02" } ] } } ] } },{ "OutcomeClassTitle":"Treatment Satisfaction", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.36", "OutcomeMeasurementSpread":"6.53" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.94", "OutcomeMeasurementSpread":"7.92" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Hyperglycaemia, glucose above 10mmol/l (180mg/dL)", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.5798", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"0.13", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.33", "OutcomeAnalysisCIUpperLimit":"0.58", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"1.26" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0960", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"-0.31", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.68", "OutcomeAnalysisCIUpperLimit":"0.06", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"1.03" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisGroupDescription":"Treatment Satisfaction", "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.0007", "OutcomeAnalysisStatisticalMethod":"t-test, 2 sided", "OutcomeAnalysisParamType":"Mean Difference (Final Values)", "OutcomeAnalysisParamValue":"4.36", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"2.01", "OutcomeAnalysisCIUpperLimit":"6.71", "OutcomeAnalysisDispersionType":"Standard Deviation", "OutcomeAnalysisDispersionValue":"6.53" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events collected from enrolment to completion by last subject (up to 3 months).", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"FreeStyle InsuLinx", "EventGroupDescription":"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study\n\nFreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.", "EventGroupSeriousNumAffected":"3", "EventGroupSeriousNumAtRisk":"33", "EventGroupOtherNumAffected":"8", "EventGroupOtherNumAtRisk":"33" },{ "EventGroupId":"EG001", "EventGroupTitle":"FreeStyle Freedom Lite", "EventGroupDescription":"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.\n\nFreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter", "EventGroupSeriousNumAffected":"2", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"16" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Middle ear effusion", "SeriousEventOrganSystem":"Ear and labyrinth disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" } ] } },{ "SeriousEventTerm":"Gingiva abcess", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"33" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"16" } ] } },{ "SeriousEventTerm":"Fractured Metacarpus", "SeriousEventOrganSystem":"Musculoskeletal and connective tissue disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"33" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" } ] } },{ "SeriousEventTerm":"Sensor tip", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"33" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" } ] } },{ "SeriousEventTerm":"Haematoma", "SeriousEventOrganSystem":"Skin and subcutaneous tissue disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"33" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"16" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Cold", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"33" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"3", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"16" } ] } },{ "OtherEventTerm":"Erythema", "OtherEventOrganSystem":"Skin and 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Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"33" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"16" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"GT60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Snr Director, Clinical Development & Regulatory Affairs", "PointOfContactOrganization":"Abbott Diabetes Care", "PointOfContactEMail":"joe.bugler@abbott.com", "PointOfContactPhone":"01993 863164" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" } ] }, "ConditionAncestorList":{ 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