Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-15 @ 7:37 PM
Study NCT ID:
NCT06717451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PS230005 Control-IQ 1.5 Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-08', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score', 'timeFrame': '12 months', 'description': 'DIDS satisfaction score at baseline, and after 6 and 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.'}, {'measure': 'Diabetes Impact and Satisfaction Scale (DIDS), Impact Score', 'timeFrame': '12 months', 'description': 'DIDS impact score at baseline, and after 6 and 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.'}, {'measure': 'EQ-5D (inclusive of the Visual Analogue Scale (VAS))', 'timeFrame': '12 months', 'description': 'Questionnaire score at baseline, and after 6 and 12 months of Control-IQ use.'}, {'measure': 'Hypoglycemia Fear Survey - Parent for Young Children Version (HFS-P-YC)', 'timeFrame': '12 months', 'description': 'Questionnaire score at baseline, and after 6 and 12 months of Control-IQ use.'}], 'primaryOutcomes': [{'measure': 'Incidence Rates of Severe Hypoglycemia (SH)', 'timeFrame': '12 months', 'description': 'Overall incidence rate of SH events per 100 patient years during 12 months of Control-IQ use'}, {'measure': 'Incidence Rates of Diabetic Ketoacidosis (DKA)', 'timeFrame': '12 months', 'description': 'Overall incidence rate of DKA events per 100 patient years during 12 months of Control-IQ use'}], 'secondaryOutcomes': [{'measure': 'Percent Time in Range 70 - 180 mg/dL', 'timeFrame': '12 months', 'description': 'CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use'}, {'measure': 'Percent Time Greater Than 180 mg/dL', 'timeFrame': '12 months', 'description': 'CGM measured percent time \\>180 mg/dL during 12 months of Control-IQ use'}, {'measure': 'Percent Time Greater Than 250 mg/dL', 'timeFrame': '12 months', 'description': 'CGM measured percent time \\>250 mg/dL during 12 months of Control-IQ use'}, {'measure': 'Percent Time Less Than 70 mg/dL', 'timeFrame': '12 months', 'description': 'CGM measured percent time \\<70 mg/dL during 12 months of Control-IQ use'}, {'measure': 'Percent Time Less Than 54 mg/dL', 'timeFrame': '12 months', 'description': 'CGM measured percent time \\<54 mg/dL during 12 months of Control-IQ use'}, {'measure': 'Mean Glucose mg/dL', 'timeFrame': '12 months', 'description': 'CGM measured mean glucose during 12 months of Control-IQ use'}]}, 'oversightModule': {'isPpsd': True, 'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'Control-IQ', 'Control-IQ 1.5', 'Tandem', 'mobi', 't:slim X2', 'automated insulin delivery'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to \\<6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.', 'detailedDescription': 'The study will recruit participants age 2 to \\<6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Enrollment in the study will be available to all individuals age 2 to \\<6 years of age at time of screening who start therapy with Control-IQ Technology v1.5.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system in the t:slim X2 or Mobi insulin pump\n* Age 2 to \\<6 years at time of screening\n* Using an insulin approved for use in the pump\n* Using an iCGM sensor approved for use with the pump\n* Agreement to use Control-IQ technology 1.5, and to continue use for at least 12 consecutive months after study enrollment.\n* Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.\n* Ability for parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management.\n* Reside full-time in the United States.\n* Willingness to download the t:connect Mobile application to their smartphone and keep it active throughout the study if using a Tandem t:slim X2 pump. Participants who are unable to use the t:connect mobile application must be willing to manually upload their insulin pump data to Tandem Source every three months and at the completion of the study.\n* Participant's parent/guardian has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Use of any glucose-lowering therapy other than insulin.\n* A medical or other condition, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study."}, 'identificationModule': {'nctId': 'NCT06717451', 'briefTitle': 'PS230005 Control-IQ 1.5 Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'PS230005 Control-IQ 1.5 Post-Approval Study', 'orgStudyIdInfo': {'id': 'TP-0017060'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control-IQ Technology v1.5', 'description': 'Real-world use of Control-IQ technology v1.5 for 12 months.', 'interventionNames': ['Device: Control-IQ Technology v1.5']}], 'interventions': [{'name': 'Control-IQ Technology v1.5', 'type': 'DEVICE', 'description': 'Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5.\n\nEvery month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months.', 'armGroupLabels': ['Control-IQ Technology v1.5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92130', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Tandem Diabetes Care', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Jordan Pinsker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Medical Officer, Tandem Diabetes Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}