protocolSection identificationModule nctId: NCT06273124, orgStudyIdInfo id: 150-1261-00, briefTitle: Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-01-15, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Tandem Diabetes Care, Inc., class: INDUSTRY, collaborators name: Jaeb Center for Health Research, descriptionModule briefSummary: The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).Participants will be asked to:1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour, conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: SteadiSet Extended Wear Infusion Set, outcomesModule primaryOutcomes measure: Primary Outcome Measure, primaryOutcomes measure: Primary Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hoag Memorial Hospital Presbyterian, status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Brittany Dennis, role: CONTACT, phone: 949-764-6896, email: brittany.dennis@hoag.org, contacts name: David Ahn, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Stanford University, status: NOT_YET_RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, contacts name: Rayhan Lal, role: CONTACT, phone: 925-727-1317, email: inforay@stanford.edu, contacts name: Rayhan Lal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.42411, lon: -122.16608, locations facility: Barbara Davis Center, status: NOT_YET_RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Samantha Lange, role: CONTACT, phone: 303-724-7514, email: samantha.lange@cuanschutz.edu, contacts name: Erin Cobry, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Endocrine Research Solutions, status: RECRUITING, city: Roswell, state: Georgia, zip: 30076, country: United States, contacts name: Jessica Tapia, role: CONTACT, phone: 678-878-4750, email: jtapia.ers@gmail.com, contacts name: John C Reed, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.02316, lon: -84.36159, locations facility: Rocky Mountain Clinical Research, status: NOT_YET_RECRUITING, city: Idaho Falls, state: Idaho, zip: 83404, country: United States, contacts name: Wyatt Larson, role: CONTACT, phone: 208-525-3736, email: Wyatt.larson@idahomed.com, contacts name: David Liljenquist, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46658, lon: -112.03414, locations facility: Northwestern University, status: NOT_YET_RECRUITING, city: Evanston, state: Illinois, zip: 60208, country: United States, contacts name: Grazia Aleppo, role: CONTACT, phone: 312-926-5431, email: aleppo@northwestern.edu, contacts name: Grazia Aleppo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.04114, lon: -87.69006, locations facility: Massachusetts General Hospital, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Amy Sabean, role: CONTACT, phone: 617-726-1729, email: asabean@mgh.harvard.edu, contacts name: Melissa Putman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Henry Ford Health System, status: NOT_YET_RECRUITING, city: Detroit, state: Michigan, zip: 48202, country: United States, contacts name: Davida Kruger, role: CONTACT, phone: 313-916-3906, email: dkruger1@hfhs.org, contacts name: Davida Kruger, NP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33143, lon: -83.04575, locations facility: International Diabetes Center - HealthPartners Institute, status: NOT_YET_RECRUITING, city: Minneapolis, state: Minnesota, zip: 55416, country: United States, contacts name: Kathryn Leet, RD,LD, CDCES, role: CONTACT, phone: 952-993-9793, email: kathryn.leet@parknicollet.com, contacts name: Richard Bergenstal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Mayo Clinic, status: NOT_YET_RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Corey Kurek, role: CONTACT, phone: 507-255-0316, email: reid.corey@mayo.edu, contacts name: Yogish Kudva, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Icahn School of Medicine at Mt. Sinai, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10029, country: United States, contacts name: Denisa Tamarez, role: CONTACT, phone: 212-241-9089, email: denisa.tamarez@mssm.edu, contacts name: Camilla Levister, MS, ANCP-C, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: SUNY Upstate Medical University, status: RECRUITING, city: Syracuse, state: New York, zip: 13210, country: United States, contacts name: Suzan Bzdick, RN, CDCES, role: CONTACT, phone: 315-464-9006, email: bzdicks@upstate.edu, contacts name: Ruth Weinstock, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.04812, lon: -76.14742, locations facility: Texas Diabetes and Endocrinology, status: NOT_YET_RECRUITING, city: Austin, state: Texas, zip: 78731, country: United States, contacts name: Emmanuel Lopez, role: CONTACT, phone: 512-334-3505, email: elopez@texasdiabetes.com, contacts name: Jean Chen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Rainier Clinical Research Center, status: NOT_YET_RECRUITING, city: Renton, state: Washington, zip: 98057, country: United States, contacts name: Tina Mitchell, role: CONTACT, phone: 425-251-1720, email: TMitchell@rainier-research.com, contacts name: Frances Broyles, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.48288, lon: -122.21707, locations facility: University of Washington, status: NOT_YET_RECRUITING, city: Seattle, state: Washington, zip: 98109, country: United States, contacts name: Dori Khakpour, role: CONTACT, phone: 206-945-4965, email: dorik@uw.edu, contacts name: Irl Hirsch, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False