Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-12 @ 4:06 AM
Study NCT ID:
NCT05403502
Status:
COMPLETED
Last Update Posted:
2024-07-26
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}}}, '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': 'clinicalaffairs@tandemdiabetes.com', 'phone': '+18583666900', 'title': 'Sr. Supervisor of Clinical Operations', 'organization': 'Tandem Diabetes Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 weeks', 'description': 'All participants were in the same arm, first completing 2 weeks of Humalog use, and then 13 weeks of Lyumjev use with Control-IQ technology v1.5. Adverse events are noted in which treatment period the event occurred.', 'eventGroups': [{'id': 'EG000', 'title': 't:Slim X2 Insulin Pump With Control-IQ Technology Utilizing Insulin Lyumjev®', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for \\~16 day Humalog Lead-In period and Lyumjev insulin for 3-months of outpatient use.', 'otherNumAtRisk': 183, 'deathsNumAtRisk': 183, 'otherNumAffected': 127, 'seriousNumAtRisk': 183, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Hyperglycemia with or without ketosis not related to the study device', 'notes': 'Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia with or without ketosis not related to the study device', 'notes': 'Humalog Lead-In Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia with or without ketosis related to study device', 'notes': 'Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 40, 'numAffected': 32}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia with or without ketosis related to study device', 'notes': 'Humalog Lead-In Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonglycemic adverse events', 'notes': 'Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 134, 'numAffected': 81}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonglycemic adverse events', 'notes': 'Humalog Lead-In Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonsevere Hypoglycemia', 'notes': 'Humalog Lead-In Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nonsevere Hypoglycemia', 'notes': 'Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Other Serious Adverse Event', 'notes': 'Diagnosis of Breast Cancer in Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Serious Adverse Event', 'notes': 'Diagnosis of hypovolemic shock, positive strep culture in Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe Hypoglycemia', 'notes': 'Requiring third party assistance associated with seizure or loss of consciousness, in Lyumjev Treatment Period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic Ketoacidosis (DKA)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 183, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severe Hypoglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 weeks', 'description': 'Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Diabetic Ketoacidosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 weeks', 'description': 'Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Unanticipated Adverse Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 weeks', 'description': 'Number of unanticipated adverse device effects (UADE) events', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Percent Time Less Than 54 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 Weeks', 'description': 'CGM overall percent time less than 54 mg/dL', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.44', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM postprandial percent time less than 54 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Percent Time Less Than 70 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM overall percent time less than 70 mg/dL', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM postprandial percent time less than 70 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Percent Time in Range Between 70-180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '65', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '67', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range between 70-180 mg/dL', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '62', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '64', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '72', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '75', 'spread': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Percent Time in Range Between 70-140 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '40', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '42', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range between 70-140 mg/dL', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '38', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '40', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '47', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '49', 'spread': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-140 mg/dL, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Percent Time in Range Greater Than 180 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '34', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '32', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range greater than 180 mg/dL', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '16', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '34', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 180 mg/dL, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '26', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '24', 'spread': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 180 mg/dL, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Percent Time in Range Greater Than 250 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '12', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '11', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range greater than 250 mg/dL', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '13', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '12', 'spread': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 250 mg/dL, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '9', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '8', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 250 mg/dL, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall CGM Hyperglycemic Events Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within a 120 minute window', 'unitOfMeasure': 'events per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'events per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'events per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall CGM Hypoglycemia Events Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL', 'unitOfMeasure': 'events per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'events per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'events per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Mean Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '167', 'spread': '26', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '165', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Overall CGM mean glucose mg/dL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Glucose, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '171', 'spread': '27', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '168', 'spread': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM mean glucose mg/dL, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '157', 'spread': '28', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '156', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM mean glucose mg/dL, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Coefficient of Variation, Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM measured Coefficient of Variation, Overall', 'unitOfMeasure': 'percentage of coefficient of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '5', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM measured Coefficient of Variation, daytime only (6:00 AM - 11:59 PM)', 'unitOfMeasure': 'percentage of coefficient of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '32', 'spread': '8', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '33', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM measured Coefficient of Variation, nighttime only (12:00 AM - 5:59 AM)', 'unitOfMeasure': 'percentage of coefficient of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Standard Deviation of All Glucose Values, Overall (24 Hour Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '61', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '60', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM measured Standard Deviation of all glucose values (mg/dL), Overall ( 24 Hour Day). Standard Deviation of Mean Glucose is shown separately in Outcome 26.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '62', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '61', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM measured Standard Deviation of all Glucose Values (mg/dL), daytime only (6:00 AM - 11:59 PM). Standard Deviation of Mean Glucose, Daytime only, is shown separately in Outcome 27.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '52', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '52', 'spread': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'CGM measured Standard Deviation of all Glucose Values (mg/dL), nighttime only (12:00 AM - 5:59 AM). Standard Deviation of Mean Glucose, Nighttime only, is shown separately in Outcome 28.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '55', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '57', 'spread': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time in range between 70-180 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '32', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '33', 'spread': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time in range between 70-140 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '43', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '42', 'spread': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time greater than 180 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '16', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '15', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time greater than 250 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of time', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Postprandial Glucose, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '244', 'spread': '40', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '241', 'spread': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Peak postprandial glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postprandial Mean Glucose, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '180', 'spread': '32', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '177', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM mean glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '31', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '30', 'spread': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM postprandial incremental area under the glucose curve, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '6', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '36', 'spread': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM measured Coefficient of Variation, Postprandial, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.', 'unitOfMeasure': 'percentage of coefficient of variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Humalog Lead-In Period Weeks 1-2 (2 Weeks)', 'categories': [{'measurements': [{'value': '64', 'spread': '15', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period Weeks 3-15 (13 Weeks)', 'categories': [{'measurements': [{'value': '64', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM measured Standard Deviation of all glucose values (mg/dL), Postprandial through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study. Standard Deviation of Mean Glucose, Postprandial through 4 hours after each meal, is shown separately in Outcome 40.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'HbA1c Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 weeks', 'description': 'Change in HbA1c from End of Humalog Lead-in Period (End of Week 2) to End of Lyumjev Treatment Period (End of Week 15)', 'unitOfMeasure': 'percentage of glycated hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Reported Outcomes: TRIM-D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Start of Humalog Lead-In Period (Start of Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74', 'spread': '12', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period (End of Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Patient Reported Outcomes on the Treatment Related Impact Measure-Diabetes (TRIM-D) scale. Total score measured on a scale of 0 to 100 with higher scores indicating better diabetes treatment impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants did not have data at the end of the Lyumjev treatment period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Reported Outcomes: TRIM-DD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Start of Humalog Lead-In Period (Start of Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '82', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period (End of Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Patient Reported Outcomes on the Treatment Related Impact Measure - diabetes device (TRIM-DD) scale. Measured on a scale of 0 to 100 with higher scores indicating more positive diabetes device impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 participants did not have data at the end of the Lyumjev treatment period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Reported Outcomes: ITSQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closed-Loop Use With Control-IQ 1.5 and Lyumjev Insulin', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who performed a Humalog Lead-In Period, and then progressed to the Lyumjev Treatment Period.'}], 'classes': [{'title': 'Start of Humalog Lead-In Period (Start of Week 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75', 'spread': '13', 'groupId': 'OG000'}]}]}, {'title': 'Lyumjev Treatment Period (End of Week 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'spread': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 weeks', 'description': 'Patient Reported Outcomes on the Insulin Treatment Satisfaction Questionnaire (ITSQ) scale. Measured on a scale of 0 to 100 with higher scores indicating better treatment satisfaction. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '5 participants did not have data at the end of the Lyumjev treatment period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Users of Tandem t:Slim X2 Insulin Pump With Control-IQ 1.5 Technology', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor who progressed to the Lyumjev Treatment Period after participating in the Humalog Lead-In Period.'}], 'periods': [{'title': 'Humalog Lead-In Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Lyumjev Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '179 participants completed the Humalog run-in and initiated Lyumjev use.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Users of Control-IQ 1.5 Technology Who Initiated the Lyumjev Treatment Period', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, using the t:slim X2 insulin pump with Control-IQ technology 1.5, wearing the Dexcom G6 sensor and using Lyumjev insulin'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '166', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '179', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes Duration at Enrollment', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-13', 'size': 1268168, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-19T14:34', 'hasProtocol': True}, {'date': '2023-08-25', 'size': 702018, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-19T16:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2022-05-19', 'resultsFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2022-05-31', 'lastUpdatePostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-24', 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall Percent Time in Range Between 70-180 mg/dL', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range between 70-180 mg/dL'}, {'measure': 'Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-180 mg/dL, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-180 mg/dL, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Overall Percent Time in Range Between 70-140 mg/dL', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range between 70-140 mg/dL'}, {'measure': 'Percent Time in Range Between 70-140 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-140 mg/dL, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'Percent Time in Range Between 70-140 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range between 70-140 mg/dL, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Overall Percent Time in Range Greater Than 180 mg/dL', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range greater than 180 mg/dL'}, {'measure': 'Percent Time in Range Greater Than 180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 180 mg/dL, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'Percent Time in Range Greater Than 180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 180 mg/dL, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Overall Percent Time in Range Greater Than 250 mg/dL', 'timeFrame': '15 weeks', 'description': 'Overall CGM percent time in range greater than 250 mg/dL'}, {'measure': 'Percent Time in Range Greater Than 250 mg/dL, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 250 mg/dL, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'Percent Time in Range Greater Than 250 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM percent time in range greater than 250 mg/dL, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Overall CGM Hyperglycemic Events Per Week', 'timeFrame': '15 weeks', 'description': 'Overall CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within a 120 minute window'}, {'measure': 'CGM Hyperglycemic Events Per Week, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'CGM Hyperglycemic Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM hyperglycemic events per week, defined as 90 or more minutes greater than 300 mg/dL within 120 minute window, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Overall CGM Hypoglycemia Events Per Week', 'timeFrame': '15 weeks', 'description': 'Overall CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL'}, {'measure': 'CGM Hypoglycemia Events Per Week, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'CGM Hypoglycemia Events Per Week, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM hypoglycemia events per week defined as 15 or more consecutive minutes less than 54 mg/dL, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Overall Mean Glucose', 'timeFrame': '15 weeks', 'description': 'Overall CGM mean glucose mg/dL'}, {'measure': 'Mean Glucose, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM mean glucose mg/dL, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'Mean Glucose, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM mean glucose mg/dL, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Coefficient of Variation, Overall', 'timeFrame': '15 weeks', 'description': 'CGM measured Coefficient of Variation, Overall'}, {'measure': 'Coefficient of Variation, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM measured Coefficient of Variation, daytime only (6:00 AM - 11:59 PM)'}, {'measure': 'Coefficient of Variation, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM measured Coefficient of Variation, nighttime only (12:00 AM - 5:59 AM)'}, {'measure': 'Standard Deviation of All Glucose Values, Overall (24 Hour Day)', 'timeFrame': '15 weeks', 'description': 'CGM measured Standard Deviation of all glucose values (mg/dL), Overall ( 24 Hour Day). Standard Deviation of Mean Glucose is shown separately in Outcome 26.'}, {'measure': 'Standard Deviation of All Glucose Values, Daytime Only (6:00 AM - 11:59 PM)', 'timeFrame': '15 weeks', 'description': 'CGM measured Standard Deviation of all Glucose Values (mg/dL), daytime only (6:00 AM - 11:59 PM). Standard Deviation of Mean Glucose, Daytime only, is shown separately in Outcome 27.'}, {'measure': 'Standard Deviation of All Glucose Values, Nighttime Only (12:00 AM - 5:59 AM)', 'timeFrame': '15 weeks', 'description': 'CGM measured Standard Deviation of all Glucose Values (mg/dL), nighttime only (12:00 AM - 5:59 AM). Standard Deviation of Mean Glucose, Nighttime only, is shown separately in Outcome 28.'}, {'measure': 'Postprandial Percent Time in Range Between 70-180 mg/dL, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time in range between 70-180 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Postprandial Percent Time in Range Between 70-140 mg/dL, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time in range between 70-140 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Postprandial Percent Time Greater Than 180 mg/dL, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time greater than 180 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Postprandial Percent Time Greater Than 250 mg/dL, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM percent time greater than 250 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Peak Postprandial Glucose, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Peak postprandial glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Postprandial Mean Glucose, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'Postprandial CGM mean glucose (mg/dL), through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Postprandial Incremental Area Under the Glucose Curve, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM postprandial incremental area under the glucose curve, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Coefficient of Variation, Postprandial, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM measured Coefficient of Variation, Postprandial, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Standard Deviation of All Glucose Values, Postprandial Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM measured Standard Deviation of all glucose values (mg/dL), Postprandial through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study. Standard Deviation of Mean Glucose, Postprandial through 4 hours after each meal, is shown separately in Outcome 40.'}, {'measure': 'HbA1c Change From Baseline', 'timeFrame': '13 weeks', 'description': 'Change in HbA1c from End of Humalog Lead-in Period (End of Week 2) to End of Lyumjev Treatment Period (End of Week 15)'}, {'measure': 'Patient Reported Outcomes: TRIM-D', 'timeFrame': '15 weeks', 'description': 'Patient Reported Outcomes on the Treatment Related Impact Measure-Diabetes (TRIM-D) scale. Total score measured on a scale of 0 to 100 with higher scores indicating better diabetes treatment impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).'}, {'measure': 'Patient Reported Outcomes: TRIM-DD', 'timeFrame': '15 weeks', 'description': 'Patient Reported Outcomes on the Treatment Related Impact Measure - diabetes device (TRIM-DD) scale. Measured on a scale of 0 to 100 with higher scores indicating more positive diabetes device impact. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).'}, {'measure': 'Patient Reported Outcomes: ITSQ', 'timeFrame': '15 weeks', 'description': 'Patient Reported Outcomes on the Insulin Treatment Satisfaction Questionnaire (ITSQ) scale. Measured on a scale of 0 to 100 with higher scores indicating better treatment satisfaction. Assessed at the start of Humalog Run-In (Start of Week 1) and again at End of Lyumjev use (End of Week 15).'}], 'primaryOutcomes': [{'measure': 'Severe Hypoglycemia', 'timeFrame': '15 weeks', 'description': 'Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study'}, {'measure': 'Diabetic Ketoacidosis', 'timeFrame': '15 weeks', 'description': 'Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.'}, {'measure': 'Unanticipated Adverse Device Effects', 'timeFrame': '15 weeks', 'description': 'Number of unanticipated adverse device effects (UADE) events'}], 'secondaryOutcomes': [{'measure': 'Overall Percent Time Less Than 54 mg/dL', 'timeFrame': '15 Weeks', 'description': 'CGM overall percent time less than 54 mg/dL'}, {'measure': 'Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM postprandial percent time less than 54 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}, {'measure': 'Overall Percent Time Less Than 70 mg/dL', 'timeFrame': '15 weeks', 'description': 'CGM overall percent time less than 70 mg/dL'}, {'measure': 'Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal', 'timeFrame': 'during 4 hour postprandial period after each meal, up to 15 weeks', 'description': 'CGM postprandial percent time less than 70 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'Control-IQ Technology', 'lyumjev'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38696672', 'type': 'RESULT', 'citation': 'Levy CJ, Bailey R, Laffel LM, Forlenza G, DiMeglio LA, Hughes MS, Brown SA, Aleppo G, Bhargava A, Shah VN, Clements MA, Kipnes M, Bruggeman B, Daniels M, Rodriguez H, Calhoun P, Lum JW, Sasson-Katchalski R, Pinsker JE, Pollom R, Beck RW; TL1 Study Group. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):652-660. doi: 10.1089/dia.2024.0048. Epub 2024 May 22.'}]}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.', 'detailedDescription': 'This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80 years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump. After a run-in period, participants will use the study pump with Control-IQ technology 1.5 and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be enrolled so at least 160 complete the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 6 to \\<81 years\n2. Diagnosis of type 1 diabetes for at least 1 year\n3. Currently using Control-IQ technology for at least 3 months, with CGM data recorded indicative of system use (active closed loop) for at least 85% of the possible time in 14 days prior to enrollment\n4. Total daily insulin dose (TDD) at least 2 U/day\n5. HbA1c \\< 10.5%\n6. Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.\n7. For participants \\<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.\n8. If \\>18 years old, participant has someone who lives within 30 minutes of them who is willing to be contacted if the study team can't reach the participant in case of a suspected medical emergency.\n9. Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF) and assent, if applicable; and has agreed to follow all study procedures, including:\n\n 1. suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use\n 2. switching to or continuing to use Humalog during the lead-in period\n 3. switching to Lyumjev for the main study period.\n 4. willing and able to perform the study exercise and meal challenges.\n10. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.\n11. Participant and/or parent/legal guardian have the ability to read and understand English\n\nExclusion Criteria:\n\n1. More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months\n2. More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months\n3. Inpatient psychiatric treatment in the past 6 months\n4. 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.\n5. For Female: Currently pregnant or planning to become pregnant during the time period of study participation\n\n 1. A negative pregnancy test will be required for all females of child-bearing potential (menarchal)\n 2. Counseling on appropriate birth control options will be provided to females with child-bearing potential in the event the participant does not have an acceptable plan.\n6. Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator\n7. Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).\n8. Hemophilia or any other bleeding disorder\n9. Hemoglobinopathy\n10. History of heart, liver, lung or kidney disease determined by investigator to interfere with the study\n11. History of allergic reaction to Humalog or Lyumjev\n12. Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study\n13. Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (\\>450 ms) (Screening ECG only required for participants age \\> 50 years, duration of diabetes \\> 20 years, or history of coronary artery disease)\n14. Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis\n15. History of adrenal insufficiency\n16. History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated\n17. History of gastroparesis\n18. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk\n19. Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation\n20. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Eli Lilly and Co., or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial"}, 'identificationModule': {'nctId': 'NCT05403502', 'briefTitle': 'Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'TP-0009650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 't:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®', 'description': 'Current Control-IQ technology users with type 1 diabetes, age 6-80, will use the t:slim X2 insulin pump with Control-IQ technology 1.5 and Lyumjev insulin for 3-months of outpatient use.', 'interventionNames': ['Device: t:slim X2 insulin pump with Control-IQ technology 1.5']}], 'interventions': [{'name': 't:slim X2 insulin pump with Control-IQ technology 1.5', 'type': 'DEVICE', 'description': 't:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.', 'armGroupLabels': ['t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida Diabetes Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University / Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Diabetes and Endocrinology Research Center (IDERC)', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mt. Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes & Glandular Disease (DGD)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Jordan Pinsker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tandem Diabetes Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}