Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 7:17 PM
Study NCT ID:
NCT06834568
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tandem Freedom - Feasibility Trial 2
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severe Hypoglycemia events', 'timeFrame': '4 days', 'description': 'Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)'}, {'measure': 'Diabetic Ketoacidosis events', 'timeFrame': '4 days', 'description': 'Number of diabetic ketoacidosis events'}], 'secondaryOutcomes': [{'measure': 'All device-related adverse events', 'timeFrame': '4 days', 'description': 'Number of device-related adverse events'}, {'measure': 'Percent Time <54 mg/dL', 'timeFrame': '4 days', 'description': 'CGM measured percent time \\<54 mg/dL'}, {'measure': 'Percent Time <70 mg/dL', 'timeFrame': '4 days', 'description': 'CGM measured percent time \\<70 mg/dL'}, {'measure': 'Percent Time in Range 70 - 180 mg/dL', 'timeFrame': '4 days', 'description': 'CGM measured percent time in range 70 - 180 mg/dL'}, {'measure': 'Percent Time in Range > 180 mg/dL', 'timeFrame': '4 days', 'description': 'CGM measured percent time in range \\> 180 mg/dL'}, {'measure': 'Percent Time in Range > 250 mg/dL', 'timeFrame': '4 days', 'description': 'CGM measured percent time in range \\> 250 mg/dL'}, {'measure': 'Percent Time in Range 70 - 140 mg/dL', 'timeFrame': '4 days', 'description': 'CGM measured percent time in range 70 - 140 mg/dL'}, {'measure': 'Mean glucose (mg/dL)', 'timeFrame': '4 days', 'description': 'CGM measured mean glucose (mg/dL)'}, {'measure': 'Glycemic Variability as assessed by Coefficient of Variation (%)', 'timeFrame': '4 days', 'description': 'CGM measured Coefficient of Variation (%)'}, {'measure': 'Glycemic Variability as assessed by Standard Deviation (mg/dL)', 'timeFrame': '4 days', 'description': 'CGM measured Standard Deviation (mg/dL)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'T1D', 'Tandem', 't:slim X2', 'automated insulin delivery'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a one week run-in, then will use Tandem Freedom in a supervised hotel setting.', 'detailedDescription': 'After a one week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 4 nights: 1 day with boluses, and 3 days without boluses, in a supervised hotel setting. Participants will perform exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years old\n* Diagnosis of type 1 diabetes for at least 1 year\n* Current Control-IQ user, having been prescribed Control-IQ for at least 3 months\n* HbA1c ≤10%, recorded in the last 3 months\n* Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.\n* Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.\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 Novorapid\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': 'NCT06834568', 'briefTitle': 'Tandem Freedom - Feasibility Trial 2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'Tandem Freedom - Feasibility Trial 2', 'orgStudyIdInfo': {'id': 'TP-0020402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tandem Freedom', 'description': 'After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.\n\nParticipants will also perform exercise challenges.', 'interventionNames': ['Device: t:slim X2 insulin pump with Tandem Freedom Algorithm']}], 'interventions': [{'name': 't:slim X2 insulin pump with Tandem Freedom Algorithm', 'type': 'DEVICE', 'description': 't:slim X2 insulin pump with Tandem Freedom System consists of the Tandem t:slim X2 insulin pump and the Freedom algorithm embedded in the pump. Participants will also use the Dexcom G6 continuous glucose monitoring system.', 'armGroupLabels': ['Tandem Freedom']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8140', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'University of Otago', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], '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'}}}}