[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610187":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":215,"collaborators":217,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":223,"sex":229,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":31,"studyType":235,"phases":236,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"Mannkind Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Afrezza (Technosphere Insulin) + Basal Insulin","EXPERIMENTAL","Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.",[13,14],"Drug: Technosphere Insulin","Drug: Basal insulin",[16,23,27],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Technosphere Insulin","2 unit",[9],[22],"Afrezza",{"type":17,"name":18,"description":24,"armGroupLabels":25,"otherNames":26},"4, 8, 12 units",[9],[22],{"type":17,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Basal insulin","subcutaneously-injected basal insulin",[9],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Jennifer Pleitez","CONTACT","818-661-5032","jpleitez@mannkindcorp.com",[39,61,78,95,112,129,146,163,181,198],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Children's Hospital Los Angeles","NOT_YET_RECRUITING","Los Angeles","California","90027","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-118.24368,34.05223,{"lat":51,"lon":50},[54,58],{"name":55,"role":35,"phone":56,"phoneExt":31,"email":57},"Pamela Parcon","323-203-8744","pparcon@chla.usc.edu",{"name":59,"role":60,"phone":31,"phoneExt":31,"email":31},"Roshi Monzavi, MD","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":63,"city":64,"state":43,"zip":65,"country":45,"countryCode":46,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of California San Francisco","RECRUITING","San Francisco","94158",{"type":48,"coordinates":67},[68,69],-122.41942,37.77493,{"lat":69,"lon":68},[72,76],{"name":73,"role":35,"phone":74,"phoneExt":31,"email":75},"Avani Narayan","415-530-8047","Avani.Narayan@ucsf.edu",{"name":77,"role":60,"phone":31,"phoneExt":31,"email":31},"Laya Ekhlaspour, MD",{"facility":79,"status":63,"city":80,"state":81,"zip":82,"country":45,"countryCode":46,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Barbara Davis Center for Diabetes Young Adult Clinic","Aurora","Colorado","80045",{"type":48,"coordinates":84},[85,86],-104.83192,39.72943,{"lat":86,"lon":85},[89,93],{"name":90,"role":35,"phone":91,"phoneExt":31,"email":92},"Cari Berget","303-724-8977","cari.berget@cuanschutz.edu",{"name":94,"role":60,"phone":31,"phoneExt":31,"email":31},"Gregory Forlenza, MD",{"facility":96,"status":41,"city":97,"state":98,"zip":99,"country":45,"countryCode":46,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Yale University","New Haven","Connecticut","06511",{"type":48,"coordinates":101},[102,103],-72.92816,41.30815,{"lat":103,"lon":102},[106,110],{"name":107,"role":35,"phone":108,"phoneExt":31,"email":109},"Amy Steffen, BSN","203-737-8852","Amy.steffen@yale.edu",{"name":111,"role":60,"phone":31,"phoneExt":31,"email":31},"Jennifer Sherr, MD",{"facility":113,"status":41,"city":114,"state":115,"zip":116,"country":45,"countryCode":46,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"University of Florida","Gainesville","Florida","32610",{"type":48,"coordinates":118},[119,120],-82.32483,29.65163,{"lat":120,"lon":119},[123,127],{"name":124,"role":35,"phone":125,"phoneExt":31,"email":126},"Sarah Peeling","352-273-5275","smpeeling@peds.ufl.edu",{"name":128,"role":60,"phone":31,"phoneExt":31,"email":31},"Brittany Bruggeman, MD",{"facility":130,"status":63,"city":131,"state":132,"zip":133,"country":45,"countryCode":46,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Indiana University","Indianapolis","Indiana","46202",{"type":48,"coordinates":135},[136,137],-86.15804,39.76838,{"lat":137,"lon":136},[140,144],{"name":141,"role":35,"phone":142,"phoneExt":31,"email":143},"Sana Kalaji","317-274-0306","skalaji@iu.edu",{"name":145,"role":60,"phone":31,"phoneExt":31,"email":31},"Linda DiMeglio, MD",{"facility":147,"status":63,"city":148,"state":149,"zip":150,"country":45,"countryCode":46,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Joslin Diabetes Center","Boston","Massachusetts","02215",{"type":48,"coordinates":152},[153,154],-71.05977,42.35843,{"lat":154,"lon":153},[157,161],{"name":158,"role":35,"phone":159,"phoneExt":31,"email":160},"Kerry Milaszewski","617-975-8209","Kerry.Milaszewski@joslin.harvard.edu",{"name":162,"role":60,"phone":31,"phoneExt":31,"email":31},"Lori Laffel, MD",{"facility":164,"status":41,"city":165,"state":166,"zip":167,"country":45,"countryCode":46,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104",{"type":48,"coordinates":169},[170,171],-97.51643,35.46756,{"lat":171,"lon":170},[174,179],{"name":175,"role":35,"phone":176,"phoneExt":177,"email":178},"Deidre Graham, RN","405-271-8001","34284","deidre-graham@ou.edu",{"name":180,"role":60,"phone":31,"phoneExt":31,"email":31},"David Sparling, MD",{"facility":182,"status":41,"city":183,"state":184,"zip":185,"country":45,"countryCode":46,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Baylor College of Medicine","Houston","Texas","77030",{"type":48,"coordinates":187},[188,189],-95.36327,29.76328,{"lat":189,"lon":188},[192,196],{"name":193,"role":35,"phone":194,"phoneExt":31,"email":195},"Anh Nguyen","832-822-3870","anh.nguyen2@bcm.edu",{"name":197,"role":60,"phone":31,"phoneExt":31,"email":31},"Daniel DeSalvo, MD",{"facility":199,"status":63,"city":200,"state":201,"zip":202,"country":45,"countryCode":46,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"University of Virginia","Charlottesville","Virginia","22903",{"type":48,"coordinates":204},[205,206],-78.47668,38.02931,{"lat":206,"lon":205},[209,213],{"name":210,"role":35,"phone":211,"phoneExt":31,"email":212},"Sara Prince","434-320-5599","SP4SA@uvahealth.org",{"name":214,"role":60,"phone":31,"phoneExt":31,"email":31},"Melissa Schoelwer, MD",{"type":216,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[218],{"name":219,"class":220},"Jaeb Center for Health Research","OTHER","100610187","phase-2-inhale-1st-afrezza-for-youth-with-newly-diagnosed-type-1-diabetes-100610187",false,"NCT07224321","INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st","Inclusion Criteria:\n\n* Age 10 to \\\u003C18 years of age\n* Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria\n* Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)\n* Forced Expiratory Volume in One Second (FEV1) \\>80.0% of predicted Global Lung Function Initiative (GLI) value\n* Investigator believes that participant can be expected to follow the study protocol\n* No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study\n\nExclusion Criteria:\n\n* Prior insulin treatment for stage 2 T1D\n* In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia)\n* Allergy or known hypersensitivity to human regular insulin\n* Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and\u002For positive cotinine test for smoking\n* Positive urine pregnancy test for female subjects of childbearing potential","ALL","10 Years","17 Years",{"count":233,"type":234},100,"ESTIMATED","INTERVENTIONAL",[237],"PHASE2","INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \\\u003C18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent\u002Flegally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.",[240],"Type 1 Diabetes Mellitus",[242,243,244,22,245,246,247,248,249,18,250,251],"Diabetes Mellitus","Insulin","Inhaled","Technosphere","Pediatric","Inhaled Insulin","Type 1 Diabetes","Newly diagnosed type 1 diabetes","rapid-acting inhaled insulin","Meal-time inhaled insulin","2026-06-15",{"date":254,"type":255},"2026-06-16","ACTUAL",{"date":257,"type":255},"2026-02-04",{"date":259,"type":234},"2027-09",{"name":5,"class":6},10]