Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-03-02 @ 8:38 AM
Study NCT ID:
NCT03028220
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2016-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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': 'nick.oliver@imperial.ac.uk', 'phone': '02075942460', 'title': 'Prof Nick Oliver', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '-0.3'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '3.6'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hypoglycaemia (\\<3.3mmol/L, 60mg/dL) change from baseline', 'unitOfMeasure': 'percentage of time <3.3mmol/l', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '-0.5'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '2.4'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hypoglycaemia (\\<2.8mmol/L, 50mg/dL) change from baseline', 'unitOfMeasure': 'percentage of time <2.8mmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-6.1', 'upperLimit': '-0.1'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '5.4'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hypoglycaemia (\\<3.9mmol/L, 70mg/dL) change in baseline to endpint', 'unitOfMeasure': 'percentage of time <3.9mmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '14.4'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '-2.4', 'upperLimit': '9.0'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint', 'unitOfMeasure': 'percentage of time >3.9<7.8 mmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '15.8'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '11.7'}]}]}], 'analyses': [{'pValue': '1', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint', 'unitOfMeasure': 'percentage of time >3.9<10 mmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.6', 'groupId': 'OG000', 'lowerLimit': '-13.0', 'upperLimit': '-1.1'}, {'value': '-7.0', 'groupId': 'OG001', 'lowerLimit': '-16.9', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hyperglycaemia (\\>10mmol/L, 180mg/dL) change in baseline to endpoint', 'unitOfMeasure': 'percentage of time >10mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'groupId': 'OG000', 'lowerLimit': '-8.6', 'upperLimit': '-0.7'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '-0.4'}]}]}], 'analyses': [{'pValue': '0.820', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '10 weeks', 'description': '% time spent in hyperglycaemia (\\>15mmol/L, 270mg/dL) change in baseline to endpoint', 'unitOfMeasure': 'percentage of time >15 mmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.570', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Number of participants with hypoglycemic excursions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severe Hypoglycaemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Number of participants with episodes of severe hypoglycaemia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Glucose Variability Measured', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.910', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1', 'unitOfMeasure': 'percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glucose Variability Measured by MAGE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '-0.5'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-1.6', 'upperLimit': '0.1'}]}]}], 'analyses': [{'pValue': '0.460', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glucose Variability Measured by CONGA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'OG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '0.2'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}], 'analyses': [{'pValue': '0.191', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'FG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Real Time Continuous Glucose Monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring\n\nDexcom G5 Continuous Glucose Monitor: Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values'}, {'id': 'BG001', 'title': 'Flash Glucose Monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring\n\nAbbott Freestyle Libre: Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '64.5'}, {'value': '48.5', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '63'}, {'value': '49.5', 'groupId': 'BG002', 'lowerLimit': '37.5', 'upperLimit': '63.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '1 participant in the CGM group was randomised and completed the trial but the CGM data could not be analysed due to an uploading error. All other data was analysed for this participant.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-30', 'size': 385908, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-22T05:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2016-12-16', 'resultsFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-12', 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hypoglycaemia (\\<3.3mmol/L, 60mg/dL) change from baseline'}], 'secondaryOutcomes': [{'measure': '% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hypoglycaemia (\\<2.8mmol/L, 50mg/dL) change from baseline'}, {'measure': '% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hypoglycaemia (\\<3.9mmol/L, 70mg/dL) change in baseline to endpint'}, {'measure': '% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint'}, {'measure': '% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint'}, {'measure': '% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)', 'timeFrame': '10 weeks', 'description': 'Percentage time spent in hyperglycaemia (\\>10mmol/L, 180mg/dL) change in baseline to endpoint'}, {'measure': '% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)', 'timeFrame': '10 weeks', 'description': '% time spent in hyperglycaemia (\\>15mmol/L, 270mg/dL) change in baseline to endpoint'}, {'measure': 'Hypoglycemia', 'timeFrame': '8 weeks', 'description': 'Number of participants with hypoglycemic excursions'}, {'measure': 'Severe Hypoglycaemia', 'timeFrame': '8 weeks', 'description': 'Number of participants with episodes of severe hypoglycaemia'}, {'measure': 'Changes in Glucose Variability Measured', 'timeFrame': '8 weeks', 'description': 'Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1'}, {'measure': 'Glucose Variability Measured by MAGE', 'timeFrame': '8 weeks', 'description': 'Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)'}, {'measure': 'Glucose Variability Measured by CONGA', 'timeFrame': '8 weeks', 'description': 'Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Hypoglycemia'], 'conditions': ['Type 1 Diabetes Mellitus With Hypoglycemia', 'Impaired Awareness of Hypoglycemia', 'Type1diabetes']}, 'referencesModule': {'references': [{'pmid': '31375042', 'type': 'DERIVED', 'citation': 'Avari P, Moscardo V, Jugnee N, Oliver N, Reddy M. Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes. J Diabetes Sci Technol. 2020 May;14(3):567-574. doi: 10.1177/1932296819867688. Epub 2019 Aug 2.'}, {'pmid': '29230878', 'type': 'DERIVED', 'citation': 'Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N. A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med. 2018 Apr;35(4):483-490. doi: 10.1111/dme.13561. Epub 2017 Dec 29.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.', 'detailedDescription': "Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.\n\nThe Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 18 years of age\n* Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide \\<200 pmol/L\n* Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4\n* Type 1 diabetes for greater than 3 years\n* On an intensified multiple dose insulin injection regimen for \\> 6 months (MDI)\n* Previous type 1 diabetes structured education (either group or 1:1)\n\nExclusion Criteria:\n\n* Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)\n* Use of regular paracetamol\n* Pregnant or planning pregnancy\n* Breastfeeding\n* Enrolled in other clinical trials, except at the discretion of the chief investigator\n* Have active malignancy or under investigation for malignancy\n* Severe visual impairment\n* Reduced manual dexterity\n* Unable to participate due to other factors, as assessed by the Chief Investigators'}, 'identificationModule': {'nctId': 'NCT03028220', 'acronym': 'IHART-CGM', 'briefTitle': 'Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous', 'orgStudyIdInfo': {'id': '15HH2875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Real time continuous glucose monitoring', 'description': 'Use of Dexcom G5 continuous glucose monitoring', 'interventionNames': ['Device: Dexcom G5 Continuous Glucose Monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flash glucose monitoring', 'description': 'Use of Abbott FreeStyle Libre flash glucose monitoring', 'interventionNames': ['Device: Abbott Freestyle Libre']}], 'interventions': [{'name': 'Dexcom G5 Continuous Glucose Monitor', 'type': 'DEVICE', 'description': 'Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values', 'armGroupLabels': ['Real time continuous glucose monitoring']}, {'name': 'Abbott Freestyle Libre', 'type': 'DEVICE', 'description': 'Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data', 'armGroupLabels': ['Flash glucose monitoring']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nick Oliver, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}