Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 10:55 PM
Study NCT ID:
NCT05204134
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Sponsor:
Organization:
Raw JSON
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'adverseEventsModule': {'timeFrame': '15 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MDI Run-In With CGM', 'description': 'Run-In with MDI therapy and CGM for 2 weeks.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals through 13 weeks of use.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 8, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ketonemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Severe Hypoglycemia', 'notes': 'The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Hypoglycemic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Control-IQ with Adaptation (13 Weeks)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Number of Severe Hypoglycemic Events 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weeks', 'description': 'Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)', 'unitOfMeasure': 'number of events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time < 54 mg/dL, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.7'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 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'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.9'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 54 mg/dL, Overnight Outcomes between 00:00-06:00', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time < 70 mg/dL, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '3.8'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.7'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 70 mg/dL, Overall Study Participation', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time < 70 mg/dL, Daytime Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '3.0'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.9'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 70 mg/dL, Daytime Outcomes between 06:00-00:00', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time < 70 mg/dL, Overnight Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing 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'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '40.5', 'upperLimit': '56.7'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '61.8', 'upperLimit': '73.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-180 mg/dL, Overall Study Participation', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Time 70-180 mg/dL, Daytime Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '36.8', 'upperLimit': '54.3'}]}]}, {'title': 'Control-IQ with 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'24.2', 'upperLimit': '38.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 180 mg/dL, Daytime Outcomes between 06:00-00:00', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time > 180 mg/dL, Overnight Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000', 'lowerLimit': '35.4', 'upperLimit': '61.1'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '13.2', 'upperLimit': '34.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 180 mg/dL, Overnight Outcomes between 00:00-06:00', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time > 250 mg/dL, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and 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'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time > 250 mg/dL, Daytime Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '29.4'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '11.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 250 mg/dL, Daytime Outcomes between 06:00-00:00', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Time > 250 mg/dL, Overnight Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '27.1'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '10.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 250 mg/dL, Overnight Outcomes between 00:00-06:00', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Sensor Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 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'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '40.8', 'upperLimit': '71.3'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '79.9'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'Total Daily Insulin Use (Units/Day)', 'unitOfMeasure': 'units/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Daily Bolus Insulin Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '25.0'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '38.1'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'Total Daily Bolus Insulin Use (units/day)', 'unitOfMeasure': 'units/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Daily Basal Insulin Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'title': 'MDI Run-In with CGM (2 Weeks)', 'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '20.8', 'upperLimit': '44.5'}]}]}, {'title': 'Control-IQ with Adaptation (at 13 Weeks)', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '44.9'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '15 weeks', 'description': 'Total Daily Basal Insulin Use (units/day)', 'unitOfMeasure': 'units/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physician Overrides/Physician Initiated Changes in Pump Settings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals over 13 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Number of physician overrides/physician initiated changes in pump settings during the entire study.', 'unitOfMeasure': 'number of events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 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The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. 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'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study performed at a single clinical site, Barbara Davis Center, from March to September 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c at Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Male and female participants ≥ 18 years of age with type 1 diabetes, who were multiple daily injection (MDI) users, who have a baseline hemoglobin A1c at screening between 7.5 to 11%.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-01', 'size': 1946359, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-17T10:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-09', 'studyFirstSubmitDate': '2022-01-10', 'resultsFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-09', 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Hypoglycemic Events', 'timeFrame': '15 weeks', 'description': 'Number of Severe Hypoglycemic Events (with altered mental status)'}, {'measure': 'Diabetic Ketoacidosis Events', 'timeFrame': '15 weeks', 'description': 'Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)'}], 'secondaryOutcomes': [{'measure': 'Percent Time < 54 mg/dL, Overall', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 54 mg/dL, Overall Study Participation'}, {'measure': 'Percent Time < 54 mg/dL, Daytime Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 54 mg/dL, Daytime Outcomes between 06:00-00:00'}, {'measure': 'Percent Time < 54 mg/dL, Overnight Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 54 mg/dL, Overnight Outcomes between 00:00-06:00'}, {'measure': 'Percent Time < 70 mg/dL, Overall', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 70 mg/dL, Overall Study Participation'}, {'measure': 'Percent Time < 70 mg/dL, Daytime Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 70 mg/dL, Daytime Outcomes between 06:00-00:00'}, {'measure': 'Percent Time < 70 mg/dL, Overnight Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\< 70 mg/dL, Overnight Outcomes between 00:00-06:00'}, {'measure': 'Percent of Time 70-140 mg/dL, Overall', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-140 mg/dL, Overall Study Participation'}, {'measure': 'Percent of Time 70-140 mg/dL, Daytime Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00'}, {'measure': 'Percent of Time 70-140 mg/dL, Overnight Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00'}, {'measure': 'Percent of Time 70-180 mg/dL, Overall', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-180 mg/dL, Overall Study Participation'}, {'measure': 'Percent of Time 70-180 mg/dL, Daytime Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00'}, {'measure': 'Percent of Time 70-180 mg/dL, Overnight Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00'}, {'measure': 'Percent Time > 180 mg/dL, Overall', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 180 mg/dL, Overall Study Participation'}, {'measure': 'Percent Time > 180 mg/dL, Daytime Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 180 mg/dL, Daytime Outcomes between 06:00-00:00'}, {'measure': 'Percent Time > 180 mg/dL, Overnight Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 180 mg/dL, Overnight Outcomes between 00:00-06:00'}, {'measure': 'Percent Time > 250 mg/dL, Overall', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 250 mg/dL, Overall Study Participation'}, {'measure': 'Percent Time > 250 mg/dL, Daytime Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 250 mg/dL, Daytime Outcomes between 06:00-00:00'}, {'measure': 'Percent Time > 250 mg/dL, Overnight Outcomes', 'timeFrame': '15 weeks', 'description': 'CGM percent time \\> 250 mg/dL, Overnight Outcomes between 00:00-06:00'}, {'measure': 'Median Sensor Glucose', 'timeFrame': '15 weeks', 'description': 'CGM-measured median glucose (mg/dL)'}, {'measure': 'Total Daily Insulin Use', 'timeFrame': '15 weeks', 'description': 'Total Daily Insulin Use (Units/Day)'}, {'measure': 'Total Daily Bolus Insulin Use', 'timeFrame': '15 weeks', 'description': 'Total Daily Bolus Insulin Use (units/day)'}, {'measure': 'Total Daily Basal Insulin Use', 'timeFrame': '15 weeks', 'description': 'Total Daily Basal Insulin Use (units/day)'}, {'measure': 'Physician Overrides/Physician Initiated Changes in Pump Settings', 'timeFrame': '13 weeks', 'description': 'Number of physician overrides/physician initiated changes in pump settings during the entire study.'}, {'measure': 'Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion', 'timeFrame': '13 weeks', 'description': 'The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings'}, {'measure': 'Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion', 'timeFrame': '13 weeks', 'description': 'The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'Control-IQ Technology', 'automated insulin dosing', 'automated insulin delivery'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38323362', 'type': 'RESULT', 'citation': 'Shah VN, Akturk HK, Trahan A, Piquette N, Wheatcroft A, Schertz E, Carmello K, Mueller L, White K, Fu L, Sassan-Katchalski R, Messer LH, Habif S, Constantin A, Pinsker JE. Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology. J Diabetes Sci Technol. 2024 Nov;18(6):1281-1287. doi: 10.1177/19322968241229074. Epub 2024 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.', 'detailedDescription': 'This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects ≥ age 18 years\n* Clinical diagnosis of type 1 diabetes for at least one year\n* Using a basal/bolus regimen by injection (MDI therapy)\n* Total daily dose ≥10 units/day\n* Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.\n* A1c ≥ 7.5% and ≤ 11% at screening\n* Not pregnant or planning a pregnancy during the time period of the study.\n* Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)\n* Willingness to follow study procedures and a signed informed consent form\n\nExclusion Criteria:\n\n* Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months\n* Two or more episodes of diabetic ketoacidosis in the past 6 months\n* Inpatient psychiatric treatment in the past 6 months\n* History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study\n* Significant chronic kidney disease or hemodialysis\n* Significant liver disease\n* History of adrenal insufficiency\n* Hypothyroidism or hyperthyroidism that is not appropriately treated\n* Other chronic disease/condition determined by investigator to interfere with participation in the study\n* Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study\n* Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump\n* Subject is pregnant or lactating or intending to become pregnant before or during participation in this study\n* Investigator judgement that subject would not be able to complete the trial'}, 'identificationModule': {'nctId': 'NCT05204134', 'briefTitle': 'Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use', 'orgStudyIdInfo': {'id': 'TP-0009348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates', 'description': 'After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.', 'interventionNames': ['Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm']}], 'interventions': [{'name': 'Automated Insulin Delivery Settings Initialization and Adaptation Algorithm', 'type': 'DEVICE', 'description': 'All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.', 'armGroupLabels': ['Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Jordan E Pinsker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tandem Diabetes Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}