Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 9:02 PM
Study NCT ID:
NCT02609633
Status:
COMPLETED
Last Update Posted:
2018-05-18
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accu-Chek® CONNECT at School (CATS) Pediatric Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Month 6', 'description': 'The Safety Population included all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 28, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 6, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) Parent Questionnaire Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '17.82', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '21.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.3', 'spread': '21.42', 'groupId': 'OG000'}, {'value': '70.4', 'spread': '24.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '18.06', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '19.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'spread': '26.85', 'groupId': 'OG000'}, {'value': '62.2', 'spread': '24.44', 'groupId': 'OG001'}]}]}, {'title': 'Change at Months 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '16.89', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '17.44', 'groupId': 'OG001'}]}]}, {'title': 'Change at Months 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '18.00', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '17.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Children/adolescents DFCS Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '10.54', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '9.57', 'groupId': 'OG001'}]}]}, {'title': 'Children/adolescents DFCS Change Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '11.23', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '9.37', 'groupId': 'OG001'}]}]}, {'title': 'Children/adolescents DFCS Change Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '12.09', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.93', 'groupId': 'OG001'}]}]}, {'title': 'Parent/Caregiver DFCS Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'Parent/Caregiver DFCS Change Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '8.02', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Parent/Caregiver DFCS Change Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '9.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The DFCS Questionnaire has 19 questions, each question ranges in response values between 1 ("Almost Never") and 3 ("Almost Always"). The derived total score (19 questions) ranges between 19 and 57, where higher score indicates worsened condition. This questionnaire was answered by Children/adolescents and Parents.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Children/Adolescents BGMC Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': 'Children/Adolescents BGMC Change Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Children/Adolescents BGMC Change Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.90', 'groupId': 'OG001'}]}]}, {'title': 'Parents/Caregivers BGMC Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Parents/Caregivers BGMC Change Score at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Parents/Caregivers BGMC Score Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.80', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '4.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The BGMC Questionnaire has 8 questions, each question ranges in response values from 1 ("Almost Never") to 3 ("Almost Always"). The derived total score ranges between 8 and 24, where higher score indicates worsened condition.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'Assessment of HbA1c is an indicator of long-term control of diabetes.', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Target Range 70-160 mg/dl: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'spread': '18.91', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '19.42', 'groupId': 'OG001'}]}]}, {'title': 'Target Range 70-160 mg/dl: Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '25.56', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '12.46', 'groupId': 'OG001'}]}]}, {'title': 'Target Range 70-160 mg/dl: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '22.13', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '15.60', 'groupId': 'OG001'}]}]}, {'title': 'Target Range 80-180 mg/dl: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.4', 'spread': '19.03', 'groupId': 'OG000'}, {'value': '31.9', 'spread': '20.26', 'groupId': 'OG001'}]}]}, {'title': 'Target Range 80-180 mg/dl: Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'spread': '25.60', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '12.99', 'groupId': 'OG001'}]}]}, {'title': 'Target Range 80-180 mg/dl: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.2', 'spread': '22.68', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '14.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The percentage of target range measurements was defined as the number of within target range readings in the interval divided by the total number of BG checks in the interval.', 'unitOfMeasure': 'percentage of blood glucose measurements', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.0', 'spread': '30.84', 'groupId': 'OG000'}, {'value': '99.2', 'spread': '32.38', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '30.47', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '21.78', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '20.39', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '23.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'Glycemic variability, expressed as mean of all blood glucose(BG) readings per subject within the interval. BG variability was defined as standard deviation (SD) of all glucose readings over the interval.', 'unitOfMeasure': 'milligrams per deciliter (mg/dl)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'OG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Hypoglycemia (< 70 mg/dl): Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '6.20', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 70 mg/dl) Change at Months 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '7.55', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 70 mg/dl): Change at Months 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '6.22', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '9.04', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 60 mg/dl): Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '4.64', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 60 mg/dl): Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '5.53', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 60 mg/dl): Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '6.37', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 50 mg/dl): Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '3.45', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 50 mg/dl): Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.74', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia (< 50 mg/dl): Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '3.21', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '3.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'A measurement was defined as hypoglycemic if the glucose value was below 70 mg/dl or below 60 mg/dl or below 50 mg/dl.', 'unitOfMeasure': 'percentage of hypoglycemic measurements', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Children/Adolescents: BSM - Frequently Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: BSM - Frequently Not Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: PA - Frequently Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: PA - Frequently Not Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: WP - Frequently Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: WP - Frequently Not Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.4', 'groupId': 'OG000'}]}]}, {'title': 'Parents: BSM - Frequently Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}]}]}, {'title': 'Parents: BSM - Frequently Not Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}]}]}, {'title': 'Parents: PA - Frequently Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}]}]}, {'title': 'Parents: PA - Frequently Not Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Parents: WP - Frequently Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000'}]}]}, {'title': 'Parents: WP - Frequently Not Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Percentage of participants who frequently used Accu-Chek® CONNECT Diabetes Management System (blood sugar meter \\[BSM\\], phone application \\[PA\\] and web portal \\[WP\\]) according to the questionnaire about usability answered by children/adolescents and Parent were reported. Here, in parent post questionnaire for usability the sum of percentages are not equal to 100%, because percentage is based on n=44.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Children/Adolescents: Q 1- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 1- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 2- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 2- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 3- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 3- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 4- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 4- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 5- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000'}]}]}, {'title': 'Children/Adolescents: Q 5- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 1- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 1- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 2- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 2- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 3- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 3- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 4- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 4- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 5- Mostly Agree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Q 5- Mostly Disagree', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Participants preference the Accu-Chek® CONNECT process compared with previous technology/process assessed by questionnaire including following questions; Q 1: Felt more sure of myself using the system, Q 2: Less worried about low BG than used to be, Q 3: Would rather use the system than what used before, Q 4: Felt safer managing diabetes using system than what used before, Q 5: Friends with diabetes should also use the system. Questionnaire was answered by children/adolescents and parents. Here, in children/adolescents post questionnaire for preference the percentage sum is not equal to 100%, because percentage is based on n=41.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analyzed' is the participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'classes': [{'title': 'Children/adolescents: Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000'}]}]}, {'title': 'Children/adolescents: Not Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}]}]}, {'title': 'Parent: Not Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Percentage of participants with overall treatment satisfaction with the use of Accu-Chek® CONNECT Diabetes Management system according to the questionnaire answered by children/adolescents and parents were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'FG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliant with Study Procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Families of participants were identified and recruited from the investigators' established participant populations or from the participant populations of other physicians within the group practice, using protocol-specified inclusion and exclusion criteria.", 'preAssignmentDetails': 'Although a total of 196 parents and children/adolescents were enrolled, only the 98 children/adolescents were considered participants in the study. Baseline and adverse events data were only collected for children/adolescents.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants of enrolled families continued to use their self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device.'}, {'id': 'BG001', 'title': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants of enrolled families who used Accu-Chek® CONNECT DMS for 6 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '3.06', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '3.03', 'groupId': 'BG001'}, {'value': '12.9', 'spread': '3.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Hispanic/latino:Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Hispanic/latino:No', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes-Related Distress According to the PAID Child and Teen (C&T) Parent Questionnaire Score', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '21.72', 'groupId': 'BG000'}, {'value': '71.1', 'spread': '24.53', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '23.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the Problem Areas in Diabetes (PAID) Parent \\[Parents of Youth (YP) or Parents of Teens (TP)\\] Questionnaire at both baseline and Visit 4 (Month 6).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-27', 'size': 9431377, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-04T15:14', 'hasProtocol': True}, {'date': '2016-06-27', 'size': 330505, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-04T15:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2015-11-18', 'resultsFirstSubmitDate': '2018-01-04', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-19', 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) Parent Questionnaire Score at Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3', 'timeFrame': 'Baseline, Month 3', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.'}, {'measure': 'Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.'}, {'measure': 'Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The DFCS Questionnaire has 19 questions, each question ranges in response values between 1 ("Almost Never") and 3 ("Almost Always"). The derived total score (19 questions) ranges between 19 and 57, where higher score indicates worsened condition. This questionnaire was answered by Children/adolescents and Parents.'}, {'measure': 'Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The BGMC Questionnaire has 8 questions, each question ranges in response values from 1 ("Almost Never") to 3 ("Almost Always"). The derived total score ranges between 8 and 24, where higher score indicates worsened condition.'}, {'measure': 'Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'Assessment of HbA1c is an indicator of long-term control of diabetes.'}, {'measure': 'Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'The percentage of target range measurements was defined as the number of within target range readings in the interval divided by the total number of BG checks in the interval.'}, {'measure': 'Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'Glycemic variability, expressed as mean of all blood glucose(BG) readings per subject within the interval. BG variability was defined as standard deviation (SD) of all glucose readings over the interval.'}, {'measure': 'Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6', 'timeFrame': 'Baseline, Months 3 and 6', 'description': 'A measurement was defined as hypoglycemic if the glucose value was below 70 mg/dl or below 60 mg/dl or below 50 mg/dl.'}, {'measure': 'Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability', 'timeFrame': 'Month 6', 'description': 'Percentage of participants who frequently used Accu-Chek® CONNECT Diabetes Management System (blood sugar meter \\[BSM\\], phone application \\[PA\\] and web portal \\[WP\\]) according to the questionnaire about usability answered by children/adolescents and Parent were reported. Here, in parent post questionnaire for usability the sum of percentages are not equal to 100%, because percentage is based on n=44.'}, {'measure': 'Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process', 'timeFrame': 'Month 6', 'description': 'Participants preference the Accu-Chek® CONNECT process compared with previous technology/process assessed by questionnaire including following questions; Q 1: Felt more sure of myself using the system, Q 2: Less worried about low BG than used to be, Q 3: Would rather use the system than what used before, Q 4: Felt safer managing diabetes using system than what used before, Q 5: Friends with diabetes should also use the system. Questionnaire was answered by children/adolescents and parents. Here, in children/adolescents post questionnaire for preference the percentage sum is not equal to 100%, because percentage is based on n=41.'}, {'measure': 'Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire', 'timeFrame': 'Month 6', 'description': 'Percentage of participants with overall treatment satisfaction with the use of Accu-Chek® CONNECT Diabetes Management system according to the questionnaire answered by children/adolescents and parents were reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This interventional, 6-month post-marketing study is designed to evaluate the change in diabetes-related distress among parents/caregivers of school-age children and adolescents with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy. Investigational sites will be assigned using cluster randomization, with approximately 10 to 20 children at each site. In order to maintain a true control group for comparison, the investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management System (DMS) or usual care/continued use of current DMS devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children or adolescents, aged 6 to 18 years\n* Diagnosis of T1D for at least 3 months\n* Currently managed with insulin Multiple Daily Injection (MDI) therapy\n* Attending full-day school schedule in Grade K through 12\n* Able to provide SMBG data minimum of one month prior to study start\n* Currently using a compatible Smartphone with ability to download the Accu-Chek® CONNECT System App accordingly OR ability to utilize Smartphone and Accu-Chek® CONNECT System App as provided for use in study\n* Adolescents (18 years) with diabetes provide written informed consent\n* Children 7 to 17 years to provide age-appropriate child assent\n* Parent/caregiver currently using a compatible Smartphone with ability to receive Short Message Service/Multimedia Messaging Service (SMS/MMS) messages\n* Able to read/write in English and comply with study procedures, including provision of self-monitoring blood glucose (SMBG) data at least 1 month prior to the study\n\nExclusion Criteria:\n\n* Current or planned use of continuous subcutaneous insulin infusions during the study period\n* Use of continuous glucose monitoring or a remote data-sharing system/device (i.e. NightScout, DexCom Share, Medtronic Connect) during the study\n* Pregnancy\n* Clinically significant medical condition(s) such as anemia, major organ system disease, infection, psychosis, or cognitive impairment\n* Requirement for chronic steroids, immunomodulatory medication, or chemotherapy in adrenal suppressive doses\n* Visual impairment preventing use of the Accu-Chek® CONNECT system\n* Parent/caregiver is an investigator, general practitioner, practice staff, pharmacist, research assistant, or other staff or relative of those directly involved in the study'}, 'identificationModule': {'nctId': 'NCT02609633', 'acronym': 'CATS', 'briefTitle': 'Accu-Chek® CONNECT at School (CATS) Pediatric Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Accu-Chek® CONNECT at School (CATS) Pediatric Study', 'orgStudyIdInfo': {'id': 'RD002489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Usual Care - Current Diabetes Management System (DMS)', 'description': 'Participants will perform self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the type 1 diabetes (T1D) regimen as needed.', 'interventionNames': ['Device: DMS']}, {'type': 'EXPERIMENTAL', 'label': 'Interventional: Accu-Chek® CONNECT DMS', 'description': 'Participants will receive training on Day 1 with the Accu-Chek® CONNECT DMS and will thereafter perform SMBG for 6 months. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the T1D regimen as needed.', 'interventionNames': ['Device: Accu-Chek® CONNECT DMS']}], 'interventions': [{'name': 'Accu-Chek® CONNECT DMS', 'type': 'DEVICE', 'description': 'SMBG will be performed during the 6-month study using the Accu-Chek® Aviva CONNECT monitoring device, and corresponding Smartphone app and online tracking tool.', 'armGroupLabels': ['Interventional: Accu-Chek® CONNECT DMS']}, {'name': 'DMS', 'type': 'DEVICE', 'description': "SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek® CONNECT DMS).", 'armGroupLabels': ['Control: Usual Care - Current Diabetes Management System (DMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pediatric Endocrinology of Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Center of Excellence in Diabetes and Endocrinology', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center for Childhood Diabetes', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Childrens Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Tallahassee Memorial Hospital', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida College of Medicine', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pediatric Endocrine Associates', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Diabetes & Osteoporosis Center', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Center for Pediatric Research', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Riley', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Childrens Hospital and Clinics of Minnesota', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "Women and Children's Hospital of Buffalo", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Caroline University - Pediatric specialty Care', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Lena Borsa', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Roche Diabetes Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}