Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:15 AM
Study NCT ID:
NCT07325461
Status:
RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2026-01-06', 'studyFirstSubmitQcDate': '2026-01-06', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7 Day Survival of Infusion Set for Primary Outcome Measure', 'timeFrame': '6 weeks', 'description': '7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \\>1.0 mmol/L, or Investigator advised)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['type 1 diabetes', 'T1D', 'Tandem', 't:slim X2', 'Tandem Mobi', 'automated insulin delivery', 'SteadiSet'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.', 'detailedDescription': 'All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.\n\nThe 2 treatment arms are:\n\nExisting t:slim X2 Users:\n\n* t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)\n* t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)\n\nExisting Mobi Users:\n\n* Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)\n* Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 to 80 years old inclusive\n* Generally in good health, as determined by the investigator\n* Living in the United States with no plans to move outside the United States during the study\n* Diagnosis of T1D for at least 12 months\n* Currently using a Tandem pump\n* Current Dexcom CGM user\n* HbA1c \\<9.0% in the last 6 months.\n* Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study\n* Willing to wear each investigational infusion set for up to 7 days during each of the wear periods in the study\n* Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips\n* If using Tandem Mobi, has a compatible cellular phone that can run the Tandem Mobi Mobile App\n* BMI in the range 18-35 kg/m2, both inclusive\n* Currently using one of the following insulins with no expectation of a need to change insulin type during the study:\n\n 1. Humalog™ (or generic insulin lispro)\n 2. NovoLog™ (or generic insulin aspart)\n* Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study\n* Has the ability to understand and comply with protocol procedures and to provide informed consent\n\nExclusion Criteria:\n\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* Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception\n* Episodes of severe hypoglycemia in the last 6 months resulting in:\n\n 1. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)\n 2. Loss of consciousness\n 3. Seizures\n* One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization\n* Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period\n* Known history of any of the following conditions:\n\n 1. Cushing's Disease\n 2. Adrenal insufficiency\n 3. Pancreatic islet cell tumor\n 4. Insulinoma\n 5. Lipodystrophy\n 6. Extensive lipohypertrophy, as assessed by the investigator\n* Undergoing treatment with systemic oral or intravenous corticosteroids, at or within the last 8 weeks from screening. Inhaled glucocorticoids are allowed.\n* Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:\n\n 1. Alcoholism\n 2. Drug abuse\n* Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results\n* Current participation in another clinical drug or device study\n* Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care"}, 'identificationModule': {'nctId': 'NCT07325461', 'briefTitle': 'Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'TP-0023728'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 't:slim X2 Users', 'description': '* t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)\n* t:slim X2 with and SteadiSet (43 inches) with no side ports (3 wear periods)', 'interventionNames': ['Device: SteadiSet Infusion Set']}, {'type': 'EXPERIMENTAL', 'label': 'Mobi Users', 'description': '* Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)\n* Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)', 'interventionNames': ['Device: SteadiSet Infusion Set']}], 'interventions': [{'name': 'SteadiSet Infusion Set', 'type': 'DEVICE', 'description': 'Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.', 'armGroupLabels': ['Mobi Users', 't:slim X2 Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kailee Kingston', 'role': 'CONTACT', 'email': 'kaileek@stanford.edu', 'phone': '650-725-2908'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Jordan Pinsker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tandem Diabetes Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}