Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 6:07 AM
Study NCT ID:
NCT05683392
Status:
COMPLETED
Last Update Posted:
2024-12-20
First Post:
2023-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycemia without ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycemia with ketosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Foot Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Yeast Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin Infection', 'notes': 'at site of CGM insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 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'OG001', 'title': 'Standard Range', 'description': 'Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a standard range for two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '160.2', 'groupId': 'OG000', 'lowerLimit': '149.7', 'upperLimit': '172.6'}, {'value': '166.0', 'groupId': 'OG001', 'lowerLimit': '152.6', 'upperLimit': '183.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': 'Mean CGM glucose mg/dL during each study period.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glucose SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Range', 'description': 'Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.'}, {'id': 'OG001', 'title': 'Standard Range', 'description': 'Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a standard range for two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '71.0'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '72.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': 'Glucose SD mg/dL during each study period.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Glucose Coefficient of Variation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lower Range', 'description': 'Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.'}, {'id': 'OG001', 'title': 'Standard Range', 'description': 'Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a standard range for two weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '42.5'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '34.0', 'upperLimit': '41.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': 'Glucose Coefficient of Variation (%) during each study period.', 'unitOfMeasure': 'percentage of coefficient of variation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control-IQ 2.0 Lower Range First, Then Standard Range', 'description': 'After a 2 week Run-In Period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 at a lower treatment range for two weeks, then at a standard treatment range for 2 weeks.'}, {'id': 'FG001', 'title': 'Control-IQ 2.0 Standard Range First, Then 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'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-20', 'size': 1504060, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-08T16:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 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180 mg/dL', 'timeFrame': '2 weeks', 'description': 'CGM percent time \\>180 mg/dL during each study period.'}, {'measure': 'Percent Time > 250 mg/dL', 'timeFrame': '2 weeks', 'description': 'CGM percent time \\>250 mg/dL during each study period.'}, {'measure': 'Mean Glucose', 'timeFrame': '2 weeks', 'description': 'Mean CGM glucose mg/dL during each study period.'}, {'measure': 'Glucose SD', 'timeFrame': '2 weeks', 'description': 'Glucose SD mg/dL during each study period.'}, {'measure': 'Glucose Coefficient of Variation', 'timeFrame': '2 weeks', 'description': 'Glucose Coefficient of Variation (%) during each study period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Control-IQ technology', 'type 1 diabetes'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '39601043', 'type': 'RESULT', 'citation': 'Brown SA, Laffel LM, Akturk HK, Forlenza GP, Shah VN, Wadwa RP, Cobry EC, Isganaitis E, Schoelwer M, Lu VS, Rueda R, Sherer N, Corbett JP, Sasson-Katchalski R, Pinsker JE. Randomized, Crossover Trial of Control-IQ Technology with a Lower Treatment Range and a Modified Meal Bolus Module in Adults, Adolescents, Children, and Preschoolers with Varying Levels of Baseline Glycemic Control. Diabetes Technol Ther. 2025 Mar;27(3):187-193. doi: 10.1089/dia.2024.0501. Epub 2024 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.', 'detailedDescription': 'This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 2 to ≤ 81 years\n* Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment\n* Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility\n* Total Daily Insulin Dose (TDD) at least 2 units/day\n* Weight ≥ 20 lbs\n* HbA1c ≤ 10.5%\n* For participants \\<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.\n* For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight.\n* Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol.\n* Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices.\n* Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)\n* Willing and able to perform study meal challenges.\n\nExclusion Criteria:\n\n* More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months\n* More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months\n* Inpatient psychiatric treatment in the past 6 months\n* 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\n 2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential\n* 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).\n* Hemophilia or any other bleeding disorder\n* Hemoglobinopathy\n* History of heart, liver, lung or kidney disease determined by investigator to interfere with the study\n* History of allergic reaction to Humalog or Novolog\n* Use of any medications determined by investigator to interfere with study\n* Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis\n* Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea\n* History of adrenal insufficiency\n* History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated\n* History of gastroparesis\n* A condition, which in the opinion of the investigator or designee, would put the participant or study at risk\n* Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation\n* Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., 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': 'NCT05683392', 'briefTitle': 'Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'TP-0011713'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control-IQ 2.0 Lower Range First, then Standard Range', 'description': 'After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks.', 'interventionNames': ['Device: t:slim X2 insulin pump with Control-IQ technology 2.0']}, {'type': 'EXPERIMENTAL', 'label': 'Control-IQ 2.0 Standard Range First, then Lower Range', 'description': 'After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks.', 'interventionNames': ['Device: t:slim X2 insulin pump with Control-IQ technology 2.0']}], 'interventions': [{'name': 't:slim X2 insulin pump with Control-IQ technology 2.0', 'type': 'DEVICE', 'description': 't:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.', 'armGroupLabels': ['Control-IQ 2.0 Lower Range First, then Standard Range', 'Control-IQ 2.0 Standard Range First, then Lower Range']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center (Pediatric Clinic)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'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, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}