[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07260110":3,"trial-entities:NCT07260110":153,"trial-summary:NCT07260110":157},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":56,"sex":110,"minimum_age":111,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":112,"std_ages":122,"locations":126,"central_contacts":136,"overall_officials":147,"references":148,"see_also_links":149},"NCT07260110","OBS18679","A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States","TEPLIzumab: QUality of Life Evaluation During Stage Transition","RECRUITING","2030-12-03","2025-11","2025-12-03","2025-10-31","Sanofi","INDUSTRY",false,"This study is an observational, longitudinal, non-interventional real-world study in the United States. The study is meant to describe the experience of participants with a history of stage 2 type 1 diabetes who have been infused with teplizumab and the experience of participants with stage 2 type 1 diabetes who have not been infused with teplizumab, and to compare descriptively the experiences of the two groups.\n\nPrimary Objective:\n\n\\- To characterize health related quality of life, diabetes-related anxiety, diabetes-related burden, and ease of diabetes management, and how participants feel, form and function in those who infused and those who did not infuse with teplizumab\n\nSecondary Objectives:\n\n* To show the clinical transitions experienced by those who infused and those who did not infuse with teplizumab\n* To describe the prevalence and timing of diabetes misclassification and the temporal patterns between misclassification, antibody testing, and the correct diagnosis of type 1 diabetes in those who infused and those who did not infuse with teplizumab\n* To estimate the impact of diagnostic misclassification on the timing of progression to stage 3 type 1 diabetes in those who infused and those who did not infuse with teplizumab\n* To characterize glucose monitoring strategies in those who infused and those who did not infuse with teplizumab where possible\n* To characterize insulin use in those who infused and those who did not infuse with teplizumab where possible\n* To characterize longitudinal health care resource utilization in those who infused and those who did not infuse with teplizumab","Each participant is expected to participate in the study from the time of their enrollment through the last data delivery, which is estimated to occur five years after the first participant is enrolled.",[19],"Type 1 Diabetes",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},550,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Teplizumab","This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.",[33],"Participants with a history of teplizumab infusion",[35],"TZIELD",[37,40,42,44,47,49,52,54],{"measure":38,"timeFrame":39},"Change in participant and caregiver-reported outcomes from survey responses: ease of diabetes management questions","From baseline, repeated every 6 months up to end of study, approximately 5 years",{"measure":41,"timeFrame":39},"Change in participant and caregiver-reported outcomes from survey responses: Psychological well-being World Health Organization-5 (WHO-5)",{"measure":43,"timeFrame":39},"Change in participant and caregiver-reported outcomes from survey responses: State-Trait Anxiety Inventory (STAI)",{"measure":45,"timeFrame":46},"Change in participant and caregiver-reported outcomes from survey responses: Type 1 Diabetes Distress Assessment System-Core Scale (T1-DDAS CORE)","From baseline, repeated every 6 months, up to end of study, approximately 5 years",{"measure":48,"timeFrame":39},"Change in participant and caregiver-reported outcomes from survey responses: Diabetes constraints scale",{"measure":50,"timeFrame":51},"Sociodemographic screening characteristics","At enrollment",{"measure":53,"timeFrame":51},"Sociodemographic medical history characteristics",{"measure":55,"timeFrame":51},"Sociodemographic diabetes management characteristics",[57,60,62,65,67,69,71,73,75,77,79,81,83,85,87,89,92,94,96,98,100,102,104,106,108],{"measure":58,"timeFrame":59},"Changes in characteristics of participants: monitoring practices (e.g. continuous glucose monitor, self-monitoring blood glucose, blood drawn by clinician) across type 1 diabetes stages","From enrollment up to study end, approximately 5 years",{"measure":61,"timeFrame":59},"Changes in characteristics of participants: medical history across type 1 diabetes stages",{"measure":63,"timeFrame":64},"Time from index date to the diagnosis of stage 3 type 1 diabetes","From baseline up to end of study, approximately 5 years",{"measure":66,"timeFrame":64},"Changes in glucose parameters: HbA1c",{"measure":68,"timeFrame":64},"Changes in glucose parameters: blood glucose",{"measure":70,"timeFrame":64},"Changes in glucose parameters: post prandial glucose",{"measure":72,"timeFrame":64},"Changes in glucose parameters: c-peptide",{"measure":74,"timeFrame":64},"Changes in glucose parameters: time in range in participants with glucose monitor data",{"measure":76,"timeFrame":64},"Changes in glucose parameters: time above range in participants with glucose monitor data",{"measure":78,"timeFrame":64},"Changes in glucose parameters: time below range in participants with glucose monitor data",{"measure":80,"timeFrame":64},"Changes in glucose parameters: glucose variability percent in participants with glucose monitor data",{"measure":82,"timeFrame":64},"Changes in glucose parameters: percent coefficient of variation in participants with glucose monitor data",{"measure":84,"timeFrame":64},"Changes in glucose paremeters: glucose management indicator in participants with glucose monitor data",{"measure":86,"timeFrame":64},"Number of complications (including micro- and macrovascular occurrences and hypoglycemia occurrences)",{"measure":88,"timeFrame":51},"The frequency of glycemic vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis",{"measure":90,"description":91,"timeFrame":51},"The sequence (first or second) of glycemic testing vs. autoantibody testing related to stage 2 type 1 diabetes diagnosis","Sequence describes if glycemic testing or autoantibody testing took place first in stage 2 type 1 diabetes diagnosis",{"measure":93,"timeFrame":51},"The frequency of misclassification with type 2 diabetes",{"measure":95,"timeFrame":51},"The time between misclassification with type 2 diabetes and autoantibody testing",{"measure":97,"timeFrame":51},"The time between misclassification with type 2 diabetes and the correct diagnosis of stage 2 type 1 diabetes",{"measure":99,"timeFrame":64},"Time from index date to the diagnosis of stage 3 type 1 diabetes for those misclassified with type 2 diabetes where diagnosis is confirmed by HbA1c and\u002For glycemic measures",{"measure":101,"timeFrame":64},"Proportion (%) of participants using home glycemic monitoring assessments (Continuous Glucose Monitor, self-monitoring blood glucose, urine glucose monitoring) vs in-clinic assessments (HbA1c, fasting blood glucose, c-peptide)",{"measure":103,"timeFrame":64},"Proportion (%) of participants using insulin characterized by insulin dosing, type, regimen, and mode of administration",{"measure":105,"timeFrame":64},"Annualized rate of hospitalizations due to type 1 diabetes complications",{"measure":107,"timeFrame":64},"Annualized rate of emergency room visits due to type 1 diabetes complications",{"measure":109,"timeFrame":64},"Annualized rate of specialist (including endocrinologist) visits","ALL","8 Years",{"inclusion":113,"exclusion":120,"raw_text":121},[114,115,116,117,118,119],"History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record","At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 months prior to enrollment","Aged 8 or older at the time of enrollment","Aged 8 or older at the time of teplizumab infusion (if infused)","Receipt of medical care in the United States","Able to and does give written informed consent",[],"Inclusion Criteria:\n\n* History of stage 2 type 1 diabetes with the presence of one or more diabetes-related autoantibodies and dysglycemia confirmed in the medical record\n* At the time of enrollment either not yet diagnosed with stage 3 type 1 diabetes, or the progression occurred in the last 18 months prior to enrollment\n* Aged 8 or older at the time of enrollment\n* Aged 8 or older at the time of teplizumab infusion (if infused)\n* Receipt of medical care in the United States\n* Able to and does give written informed consent\n\nExclusion Criteria:\n\n\\- Failure to complete the baseline survey",[123,124,125],"CHILD","ADULT","OLDER_ADULT",[127],{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":132,"geoPoint":133},"Investigational Site","San Francisco","California","94107","United States",{"lat":134,"lon":135},37.77493,-122.41942,[137,143],{"name":138,"role":139,"phone":140,"phoneExt":141,"email":142},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",{"name":144,"role":139,"phone":145,"email":146},"PicnicHealth For potential study participants","415-680-3085","hello@picnichealth.com",[],[],[150],{"label":151,"url":152},"OBS18679 Tepli-QUEST website for potential participants","https:\u002F\u002Fpicnichealth.com\u002Fcare\u002Fprograms\u002Ftepli-quest",{"nct_id":4,"conditions":154,"biomarkers":156},[155],"Type 1 Diabetes Mellitus",[],{"nct_id":4,"found":158,"summary":159,"prompt_version":169},true,{"design":160,"status":161,"heading":162,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This is an observational study involving about 550 participants. It compares the experiences of people who have received Teplizumab with those who have not, without administering any treatment.","completed","Observational Study of Teplizumab in Stage 2 Type 1 Diabetes","This study is looking at the real-world experiences of people with Stage 2 Type 1 Diabetes. It compares those who have received Teplizumab (a drug) with those who have not. Researchers want to understand how Teplizumab affects daily life, including how easy it is to manage diabetes, overall well-being, and anxiety. This is an observational study, meaning you won't receive any new treatment through the study; instead, researchers will gather information from your regular medical care over about five years. You may be eligible if you are 8 years or older, have Stage 2 Type 1 Diabetes (meaning you have certain antibodies and abnormal blood sugar levels), and have not yet been diagnosed with Stage 3 Type 1 Diabetes, or progressed within the last 18 months.","Participants will be followed for approximately 5 years, with survey responses collected every 6 months during this period.",126,"You would participate in surveys every 6 months for up to approximately 5 years. These surveys will ask about your diabetes management, psychological well-being, and anxiety.","Not stated in the trial record.",[30],"v2"]