Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-26 @ 4:01 AM
Study NCT ID:
NCT01519466
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2012-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'joe.bugler@abbott.com', 'phone': '01993 863164', 'title': 'Snr Director, Clinical Development & Regulatory Affairs', 'organization': 'Abbott Diabetes Care'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected from enrolment to completion by last subject (up to 3 months).', 'eventGroups': [{'id': 'EG000', 'title': 'FreeStyle InsuLinx', 'description': '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.', 'otherNumAtRisk': 33, 'otherNumAffected': 8, 'seriousNumAtRisk': 33, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'FreeStyle Freedom Lite', 'description': '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', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingiva abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured Metacarpus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensor tip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time in Target Blood Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FreeStyle InsuLinx', 'description': '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.'}, {'id': 'OG001', 'title': 'FreeStyle Freedom Lite', 'description': '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'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '15.28', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '15.31', 'spread': '3.15', 'groupId': 'OG001'}]}]}, {'title': 'Final', 'categories': [{'measurements': [{'value': '14.56', 'spread': '2.99', 'groupId': 'OG000'}, {'value': '14.14', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0926', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.32', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.17', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.97', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1-15 compared with Day 60-74', 'description': '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)', 'unitOfMeasure': 'hours per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'HbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FreeStyle InsuLinx', 'description': '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.'}, {'id': 'OG001', 'title': 'FreeStyle Freedom Lite', 'description': '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'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.87', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Final', 'categories': [{'measurements': [{'value': '7.78', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3251', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.49', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.09', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.51', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 compared with Day 74', 'description': '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).', 'unitOfMeasure': 'Percentage of Glycosylated Haemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FreeStyle InsuLinx', 'description': '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.'}, {'id': 'OG001', 'title': 'FreeStyle Freedom Lite', 'description': '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'}], 'classes': [{'title': 'Hyperglycaemia', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '1.53', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycaemia', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '1.02', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Satisfaction', 'categories': [{'measurements': [{'value': '4.36', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '7.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5798', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.26', 'groupDescription': 'Hyperglycaemia, glucose above 10mmol/l (180mg/dL)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0960', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.03', 'groupDescription': 'Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0007', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.36', 'ciLowerLimit': '2.01', 'ciUpperLimit': '6.71', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.53', 'groupDescription': 'Treatment Satisfaction', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 60 compared to day 1', 'description': '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.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FreeStyle InsuLinx', 'description': '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.'}, {'id': 'FG001', 'title': 'FreeStyle Freedom Lite', 'description': '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FreeStyle InsuLinx', 'description': '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.'}, {'id': 'BG001', 'title': 'FreeStyle Freedom Lite', 'description': '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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '43.4', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '44.1', 'spread': '15.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '17.4', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Screening HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '61.7', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/mol', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Screening HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage of Glycosylated Haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '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.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2012-01-06', 'resultsFirstSubmitDate': '2015-11-12', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-03', 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in Target Blood Glucose Range', 'timeFrame': 'Day 1-15 compared with Day 60-74', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Day 1 compared with Day 74', 'description': '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).'}, {'measure': 'Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.', 'timeFrame': 'Day 60 compared to day 1', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes', 'SMBG', 'Insulin calculator'], 'conditions': ['Type 1 Diabetes']}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting\n* HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive\n* Age 18 and over\n* In the investigator's opinion, thought technically capable of using masked CGM\n* Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment\n* Willing to perform a minimum of 4 SMBG tests per day during study\n\nExclusion Criteria:\n\n* Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety\n* Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management\n* Subject is pregnant / planning to become pregnant within the planned study timeline\n* Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection\n* Subject is currently on an insulin pump\n* Subject is currently using the FreeStyle InsuLinx\n* Subject is currently using the FreeStyle Freedom Lite\n* Subject is currently using CGM\n* Subject has an allergy to medical grade adhesives"}, 'identificationModule': {'nctId': 'NCT01519466', 'briefTitle': 'Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diabetes Care'}, 'officialTitle': 'Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study', 'orgStudyIdInfo': {'id': 'ADC-PMR-INX-11012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'Subjects will use a FreeStyle InsuLinx blood glucose meter during the study', 'interventionNames': ['Device: FreeStyle InsuLinx']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.', 'interventionNames': ['Device: FreeStyle Freedom Lite']}], 'interventions': [{'name': 'FreeStyle InsuLinx', 'type': 'DEVICE', 'description': 'FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.', 'armGroupLabels': ['Intervention']}, {'name': 'FreeStyle Freedom Lite', 'type': 'DEVICE', 'description': 'FreeStyle Freedom Lite is a blood glucose meter', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Diabetes Zentrum Mergentheim', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '30173', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Diabetes-Zentrum für Kinder und Jugendliche', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Institut für Diabetes - Technology Forschungs - und Entwicklungsgesellschaft mbH an der Universität Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '1007 MB', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Centre (VUMC)', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Prof. Michaela Diamant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VU University Medical Centre (VUMC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}