[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602492":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":82,"collaborators":25,"id":84,"slug":25,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":25,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":25,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":104,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"First Institute of All Medicines","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","The same size, shape, and weight of the devices without emitting biophotons will be provided and used during the first 4 weeks of the randomized study period.",[13],"Device: Biophoton Generators",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment","EXPERIMENTAL","Eight Tesla Biophotonizer-A will be packed in 4 sleeves and used during the study. The Placebo will be packed the same way without emitting biophotons.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Biophoton Generators","Biophoton Generators will be placed around the subject's bed and used during the night sleep during the entire study period.",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"James Z Liu, MD, PhD","STUDY_CHAIR",[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Mariola A Smotrys, Principal Investigator, MD, MBA, MSc","CONTACT","302-300-3010","mariola.smotrys@firstammmed.org",[37,62],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Tesla BioHealing Medical Center in Butler-FL","Tampa","Florida","33614","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-82.45843,27.94752,{"lat":48,"lon":47},[51,55,59],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Laura Poirier, BS","813-293-9984","laura.Poirier@teslabiohealing.com",{"name":56,"role":33,"phone":57,"phoneExt":25,"email":58},"Helen Y Gu, MBA","302-300-5412","helen.gu@firstallmed.org",{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Leonard Luria, MD","SUB_INVESTIGATOR",{"facility":63,"status":25,"city":64,"state":65,"zip":66,"country":42,"countryCode":43,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Tesla BioHealing Medical Center in Butler-PA","Butler","Pennsylvania","16001",{"type":45,"coordinates":68},[69,70],-79.89533,40.86118,{"lat":70,"lon":69},[73,77,80],{"name":74,"role":33,"phone":75,"phoneExt":25,"email":76},"Audrey Ager, BS","724-810-1020","Audrey.ager@teslabiohealing.com",{"name":78,"role":33,"phone":25,"phoneExt":25,"email":79},"Timothy Walter, BS","Timothy.walter@teslabiohealing.com",{"name":81,"role":61,"phone":25,"phoneExt":25,"email":25},"Ben Jagiello, MD, MD",{"type":83,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100602492",false,"NCT07124208","RCT to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes","A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes","Inclusion Criteria:\n\n* Willing and able to give informed consent for participation in the trial.\n* Is able and willing to comply with all trial requirements.\n* Male or female aged 18-70 years old without major diseases.\n* An adult clinically diagnosed with DM2\n* Participants must not be heavy users of Tesla BioHealing devices; enrollment will be determined by the clinical team based on an evaluation of the participant's prior device usage.\n* Must be fluent in English.\n\nExclusion Criteria:\n\n* Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals.\n* Is participating in another investigational drug or device trial","ALL","18 Years","70 Years",{"count":94,"type":95},46,"ESTIMATED","INTERVENTIONAL",[98],"NA","Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can treat diabetes.\n\nStudy Design This is a randomized, double-blind, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in treating diabetes. Approximately 46 volunteers will participate in the study.\n\nStudy Randomization The biostatistician will prepare a randomization schedule including a serial of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. This phase lasts for 4 weeks. At the end of Week 4, the active devices will replace the placebo. Both groups will be actively participating in the study for 2 months (8 weeks).\n\nOther than the Informed Consent Form (ICF), all study information will be recorded by using the subject number.\n\nThe Principal Investigator, study physicians, study nurses, data-entry specialists, and biostatisticians, as well as the participants, will be blinded about who received which product during the first two weeks of study participation.\n\nStudy Enrollment Each potentially qualified volunteer will review the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the e-ICF and e-Criteria with the study team medical professional via telephone during the scheduled time. Each qualified volunteer will sign the e-ICF and send it to the Medical Office Coordinator. The study coordinator will assign the qualified volunteer a randomized subject number, then the volunteer will become a study participant.",[101],"Type 2 Diabetes",[103],"Diabetes, Biophotons, Ageing Marker, Stem Cells,","NOT_YET_RECRUITING","2026-05-21",{"date":107,"type":108},"2026-05-26","ACTUAL",{"date":110,"type":95},"2026-06-08",{"date":112,"type":95},"2027-08-15",{"name":5,"class":6},2]