[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,158,0,25,[9,44,83,111,136,160,179,211,232,253,281,317,342,368,398,421,450,472,497,517,540,560,579,595,613],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100617321",false,"NCT07317102","Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)","Inclusion Criteria:\n\n* Patient with T1D aged ≥ 2 years.\n* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.\n* Patient has never used the Omnipod 5 System prior to inclusion.\n* Patient has not objected to the use of their personal data for this study.\n* Patient or legal guardian has an email address and mobile phone number.\n* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.\n* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.\n* Patient is covered by the local social security system\n\nExclusion Criteria:\n\n* Patient is currently pregnant.\n* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).\n* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.\n* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.\n* Adult under guardianship, curatorship or tutorship.\n* Adult otherwise deprived of liberty.","ALL","2 Years",{"count":18,"type":19},152,"ESTIMATED","12 Months","OBSERVATIONAL","The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.",[24,25,26],"Diabetes","Type 1 Diabetes","Diabetes Mellitus",[28,29,30],"Omnipod","Automated Insulin Delivery","Post-market Registry","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-03-16",{"date":39,"type":19},"2027-11",{"name":41,"class":42},"Insulet Corporation","INDUSTRY",24,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":58,"conditions":59,"keywords":69,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100576285","NCT06783309","CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)","A Phase 1b\u002F2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.\n2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.\n3. Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.\n4. Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.\n5. Participants with a peak stimulated C-peptide of \\>0.2 nmol\u002FL measured from a screening mixed meal tolerance test (MMTT).\n6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.\n7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.\n8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).\n9. Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.\n10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.\n11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.\n12. Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.\n13. Participants must weigh \\>35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh \\>50 kg at Screening for Cohort 3 (600 mg).\n14. Body mass index (BMI):\n\n    1. Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)\n    2. Participants 18-35 years: 18.0-30.0 (not inclusive)\n\nExclusion Criteria:\n\n1. Participants unable to comply with prohibited medication outlined in the protocol.\n2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.\n3. Participants with a history of tuberculosis or positive Quantiferon test.\n4. Participants who received vaccinations in the following time frame:\n\n   1. Any live vaccine within 28 days prior to Screening.\n   2. Any subunit vaccine within 14 days prior to Screening.\n   3. Any COVID-19 vaccine series within 14 days prior to Screening.\n   4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)\n5. Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.\n6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.\n7. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen\u002Fantibody as determined at Screening.\n8. Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.\n9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.\n10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.\n11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.\n12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.\n13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.\n14. Known sensitivity to any components of CNP-103.","12 Years","35 Years",{"count":53,"type":19},72,"INTERVENTIONAL",[56,57],"PHASE1","PHASE2","This study is a Phase 1b\u002F2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).",[60,61,62,63,64,65,66,25,67,68],"Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes in Adolescence","Type 1 Diabetes in Children","Type 1 Diabetes (Juvenile Onset)","Type 1 Diabetes Patients","Type 1 Diabetes Mellitis",[24,61,70,71,72,62,73,74],"Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed",{"date":34,"type":35},{"date":77,"type":35},"2025-05-12",{"date":79,"type":19},"2027-06",{"name":81,"class":42},"COUR Pharmaceutical Development Company, Inc.",33,{"id":84,"slug":4,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":54,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100474852","NCT05463289","ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2","Implementing Digital Retinal Exams Into Comprehensive Pediatric Diabetes Care","ACCESS2","Inclusion Criteria:\n\nMeets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:\n\n* Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty\n* Diagnosis of Type 2 diabetes\n\nEnriched cohort:\n\n* Patients with Type 1 or Type 2 diabetes,\n* 8-21 years of age with known diabetic retinopathy (true positives).\n* No time limit on last diabetic eye exam.\n\nExclusion Criteria:\n\n* Known diabetic eye exam in the last 12 months","8 Years","21 Years",{"count":93,"type":19},500,[95],"NA","The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.",[25,98,99],"Type 2 Diabetes","Cystic Fibrosis-related Diabetes",[101],"Diabetic Retinopathy",{"date":34,"type":35},{"date":104,"type":35},"2022-07-11",{"date":106,"type":19},"2026-09-30",{"name":108,"class":109},"Johns Hopkins University","OTHER",1,{"id":112,"slug":4,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":54,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100645360","NCT07680673","The Purpose of the Study is to Evaluate the Safety and Performance of ENCRT-103-hPI in Patients With Type I Diabetes. ENCRT-103-hPI is an Implantable Product Shielding Primary Islets From the Immune System.","Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.","Inclusion Criteria:\n\n* follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).\n\nExclusion Criteria:\n\n* \\- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).","18 Years","75 Years",{"count":120,"type":19},10,[56],"This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.",[25],[125],"islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism","NOT_YET_RECRUITING","2026-06-29",{"date":34,"type":35},{"date":130,"type":19},"2027-01-06",{"date":132,"type":19},"2029-01",{"name":134,"class":42},"Encellin",3,{"id":137,"slug":4,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":54,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":110},"100599657","NCT07087340","Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop-Genesis","Early Feasibility Evaluation of the UniBE Hybrid Closed-loop Insulin Delivery System in Type 1 Diabetes: UBLoop - Genesis","UBLoop-Gen","Inclusion Criteria:\n\n* T1D diagnosis for at least one year.\n* Aged between 18 and 65 years old (inclusive).\n* Currently using insulin for at least six months.\n* Currently using closed-loop insulin therapy for at least three months.\n* Willingness to suspend any personal CGM for the duration of the pilot study once the study CGM is in place.\n* Willingness not to start any new non-insulin glucose-lowering agent during the study (including metformin\u002Fbiguanides, incretin agonists \\[GIP\u002FGLP-1RAs or GLP-1RAs\\], pramlintide, DPP-4 inhibitors, sulfonylureas, Sodium-glucose cotransporter-2 inhibitors \\[SGLT2 inhibitors\\], and nutraceuticals).\n* Understanding and willingness to follow the protocol and signed informed consent.\n\nExclusion Criteria:\n\n* An HbA1C ≥10% .\n* History of diabetic ketoacidosis (DKA) in the past 12 months.\n* History of severe hypoglycaemic event (Level 3): defined as seizure or loss of consciousness in the past 12 months.\n* Current uncontrolled chronic diabetic microvascular complications (neuropathy, retinopathy, renal diabetes disease, and diabetic gastroparesis).\n* Body Mass Index (BMI) ≤18.5 or ≥ 35 kg m2\n* Estimated glomerular filtration rate (eGFR) lab value below 30 mL\u002Fmin\u002F1.73 m2\n* Pregnancy or intent to become pregnant during the study.\n* Currently breastfeeding or planning to breastfeed.\n* Currently uncontrolled seizure disorder.\n* Planned surgery during the study duration.\n* Have uncontrolled hypertension (systolic BP above or equal to 160 mmHg and\u002For diastolic BP above or equal to 100 mmHg). If a participant is on anti-hypertensive therapies, doses must be stable for 30 days before screening. For participants with uncontrolled hypertension at the screening visit, antihypertensive medication may be started or adjusted.\\*\n* Personal history of one of the following cardiovascular conditions: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) in the last three months before the screening.\n* Conditions that may increase the risk of induced hypoglycemia such as known coronary artery disease, CHF (Have NYHA Functional Classification III or IV CHF), history of any cardiac disorder or arrhythmia, history of cerebrovascular event, hypoglycemia-induced migraine within the past six months, seizure disorder, syncope, adrenal insufficiency, or neurological disease).\n* Cystic fibrosis.\n* Uncontrolled thyroid disease as judged by the investigator.\n* Have an uncontrolled psychiatric condition such as (major depressive disorder, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder, alcohol or drug abuse).\n* Treatment with a non-insulin glucose-lowering agent, except metformin, in stable doses in the last three months.\n* Participants receiving or have received systemic glucocorticoid therapy within three months before screening (Prednisolone 10mg daily or equivalent \\>2 weeks) or chronic systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, single intraarticular injection, or inhaled preparations).\n* Have current treatment with (or history of, within 3 months before screening) medications that may affect glucose metabolism, as judged by the investigator.\n* Current enrolment in another clinical trial, unless approved by the investigator of both studies, and if the clinical trial is a non-interventional registry trial.\n* Have evidence of a significant active, uncontrolled medical condition or a history of any medical problem capable of constituting a risk when using the study devices or interfering with the interpretation of data, as judged by the study physician at screening.","65 Years",{"count":145,"type":19},6,[95],"The study is investigating the early feasibility of a novel algorithm for a hybrid closed-loop (HCL) insulin delivery system in adult patients with Type 1 diabetes.\n\nParticipants will attend a study visit where the UBLoop system on a smartphone will manage insulin delivery via an insulin pump, using blood glucose values from a continuous glucose meter. Specialized staff and a remote monitoring system, which is integrated into the UBLoop system, will oversee the participants.",[149],"Type-1-Diabetes",[151,152],"Automated insulin delivery","Artificial pancreas",{"date":32,"type":35},{"date":155,"type":35},"2026-01-21",{"date":157,"type":19},"2026-08-31",{"name":159,"class":109},"University of Bern",{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":110},"100527191","NCT06144554","Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes","Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes","Inclusion Criteria:\n\n1. Self-reported type 1 diabetes\n2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks\n3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog\n4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States\n5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months\n6. Willing and able to complete registry assessments every two weeks\n7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)\n8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control\n9. Access to internet via phone, tablet and\u002For computer to use the registry online platform\n10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)\n11. Willing and able to provide informed consent (or assent) and\u002For has a parent\u002Fguardian willing and able to provide informed consent as applicable\n\nExclusion Criteria:\n\n1. Diagnosed with sickle cell anemia and\u002For hemoglobinopathy\n2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5\n3. Adults that are unable to provide informed consent",{"count":167,"type":19},2200,"This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.",[25],[25,28,29,171],"Registry",{"date":173,"type":35},"2026-07-01",{"date":175,"type":35},"2023-09-25",{"date":177,"type":19},"2028-09",{"name":41,"class":42},{"id":180,"slug":4,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":15,"minAge":90,"maxAge":50,"enrollmentInfo":185,"targetDuration":4,"studyType":54,"phases":187,"briefSummary":188,"conditions":189,"keywords":195,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":110},"100644489","NCT07670572","Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes","The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* For the child:\n\nDiagnosed with Type 1 diabetes Aged between 8 and 12 years Able to read and write Able to understand and speak Turkish Diagnosed with diabetes for at least one year Regularly attending routine three-month outpatient clinic follow-ups Having no other diseases or medical conditions aside from diabetes The child agrees to participate in the study\n\n-For the Parent: Being the mother or father of the child with Type 1 diabetes Being the primary caregiver responsible for the child Able to read and write Agrees to participate in the study\n\nExclusion Criteria:\n\nThe child uses an insulin pump\n\n\\-",{"count":186,"type":19},40,[95],"Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\\*Power based on the pilot data. Data will be collected using the \"Descriptive Information Form for Children with Diabetes\" and the \"Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms.\" The \"Find-Solve-Learn Insulin Self-Management Activity Book\" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.",[25,190,191,192,193,194],"Children","Activity","Insulin","Self Management","Parent",[196,197,198,199,200,201],"type 1 diabetes","children","activity","insulin","self management","parent","2026-06-25",{"date":204,"type":35},"2026-06-26",{"date":206,"type":19},"2026-07-15",{"date":208,"type":19},"2027-06-15",{"name":210,"class":109},"Marmara University",{"id":212,"slug":4,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":218,"targetDuration":220,"studyType":21,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100644872","NCT07676565","Safety and Efficacy of Adjunct Therapies in Adults With Type 1 Diabetes: Multicenter, Registry Study","Safety and Efficacy of Adjunct Therapies in Adults With Type 1diabetes: Multicenter, Registry Study","ATT1D","Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Clinical diagnosis of T1D\n* GLP-1RA or SGLTi (SGLT-1 and SGLT-2 inhibitors) drug prescribed by their provider for any indication as part of usual care with use for no more than 1 week\n* Use of CGM and availability of CGM data for 1 month prior to enrollment and expected to be available throughout the study\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* No exclusion criteria other than those not meeting inclusion criteria above",{"count":219,"type":19},300,"1 Year","This will be a multicenter registry-based study to evaluate safety and efficacy of GLP-1RA and SGLTi therapies in adjunct to insulin in adults with type 1 diabetes (T1D) over 1 year. This study will enroll participants who have been prescribed adjunct therapy as part of usual care.",[25],"2026-06-24",{"date":32,"type":35},{"date":226,"type":35},"2026-03-24",{"date":228,"type":19},"2028-04",{"name":230,"class":109},"Indiana University",7,{"id":233,"slug":4,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":15,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":54,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100529314","NCT06172166","Transdisciplinary Care for Young Adults With Type 1 Diabetes","Transdisciplinary Care for Young Adults With Type 1 Diabetes Transitioning to Adult Healthcare","TCT","Inclusion Criteria:\n\n* Diagnosed with type 1 diabetes for at least 6 months\n* Approaching their last visit with their pediatric type 1 diabetes healthcare provider. They will have their final visit with their pediatric T1D provider within about a month of enrollment in the study.\n* English fluency\n\nExclusion Criteria:\n\n* Another systemic chronic medical illness except celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma\n* Developmental disability limiting independent living\n\nWe are recruiting eligible individuals through Nemours and remotely.","17 Years",{"count":241,"type":19},80,[95],"The incidence of type 1 diabetes (T1D) is increasing globally with the most substantial increases occurring in the youngest age groups. A growing number of youths with T1D must therefore transition their healthcare from pediatric to adult T1D care settings as they approach young adulthood. This healthcare transition introduces many challenges because it coincides with a developmental period that is fraught with social, financial, residential, school\u002Fwork and other changes\u002Fdemands. Thus, it is not surprising that young adults (YA) with T1D are at risk for suboptimal glycemic levels, the development of diabetes-related complications, and psychosocial issues such as depression, anxiety, and disordered eating. Yet, few evidence-based interventions to assist YA with T1D with this complex healthcare transition exist.\n\nIn this study, we are testing the feasibility, acceptability, and initial efficacy of a novel transdisciplinary model of care (Transdisciplinary Care for Transition; TCT) in which a diabetes nurse educator, psychologist, and transition navigator (case manager) co-deliver transitional care. TCT addresses the psychological and systems barriers to transition and aims to improve outcomes via better assessment of YA needs and resources, better cross-discipline and YA-provider communication, and better collaboration with YA to resolve problems that cross pediatric and adult healthcare settings.\n\nWe will recruit 80 YA with T1D during their final visit in pediatric T1D specialty care to participate in a pilot randomized controlled trial during which we will randomize YA to a standard care control group (SCC) or to receive three TCT visits during the 6 months post discharge from pediatric T1D care. In SCC, participants will transition to adult T1D care as usual per their clinic's standard transition procedures.\n\nAll study procedures can be completed remotely. This includes enrollment, study evaluations, and TCT visits for those randomized to TCT. Thus, we are recruiting individuals from across the United States.\n\nAim 1: Examine the feasibility, acceptability, and fidelity of TCT in YA with T1D.\n\nAim 2: Examine the preliminary efficacy of TCT versus SCC on YA HbA1c, transition readiness and success, and continuity of care and explore for an effect on diabetes distress and acute care utilization.",[25],{"date":127,"type":35},{"date":247,"type":35},"2024-04-17",{"date":249,"type":19},"2028-04-30",{"name":251,"class":109},"Nemours Children's Clinic",2,{"id":254,"slug":4,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":54,"phases":260,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":110},"100641160","NCT07655076","Simultaneous Measurement and Responsive Treatment - Part 2","SMART02","Inclusion Criteria Part A:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Total daily insulin dose (TDD) between 30 and 100 IU.\n\nInclusion Criteria Part B:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Totally daily insulin dose (TDD) between 30 and 100 IU.\n\nExclusion Criteria (A and B):\n\n* Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Failure to comply with the study protocol or with the team's recommendations.\n* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).\n* Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study. Pregnancy will be verified by urine dipstick testing at the time of admission visit.\n* Severe hypoglycemic episode within one month of admission.\n* Severe diabetic ketoacidosis episode within one month of admission.\n* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.\n* Recent (\\\u003C6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.\n* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Current or ≤ one month use of supraphysiological doses of systemic glucocorticoids\n* Pronounced lipohypertrophy in the abdominal subcutaneous adipose tissue, which may impair sensor function or insulin infusion.\n* Insufficient abdominal surface area to support the wearing of three DPP systems in Part A.",{"count":186,"type":19},[261],"EARLY_PHASE1","This research study is testing an investigational dual-port insulin patch pump that integrates a continuous glucose monitor (CGM) in adults with type 1 diabetes. The goal of the study is to better understand how insulin delivery near a CGM sensor affects glucose readings and to collect data to support development of a combined insulin pump and CGM system.\n\nPeople with type 1 diabetes require lifelong insulin therapy. Many use insulin pumps and CGMs, but these systems usually involve wearing multiple devices at different body sites. Managing several devices can increase treatment burden and may contribute to skin irritation, device failures, and challenges with glucose control.\n\nThis study is conducted in two in-patient parts. In Part A, participants will wear three investigational devices at the same time while glucose levels are closely monitored using laboratory blood tests and a commercial CGM. This part of the study is designed to measure how basal and bolus insulin delivery near the CGM sensor affects sensor accuracy and how quickly the sensor signal recovers after insulin delivery.\n\nIn Part B, participants will wear one investigational device while trained study staff use CGM information from the integrated sensor to guide insulin delivery recommendations generated by an automated glucose control algorithm. Insulin delivery decisions will be closely supervised, and glucose levels will be frequently monitored.\n\nParticipants will stay at the clinical research center for short, controlled study visits. Safety will be monitored throughout the study, with predefined procedures for treating low or high blood sugar. The information collected will be used to support further development of an integrated insulin pump and CGM system for people with type 1 diabetes.",[60,61,25,62],[60,265,266,151,267,268,25,269,270],"Hybrid closed-loop system","Closed-loop insulin delivery","Continuous Glucose Monitoring","Insulin Pump","Insulin Patch Pump","Dual-port Insulin Patch Pump","2026-06-19",{"date":273,"type":35},"2026-06-23",{"date":275,"type":35},"2026-05-19",{"date":277,"type":19},"2026-12-01",{"name":279,"class":280},"ClinSurge Research","NETWORK",{"id":282,"slug":4,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":288,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":54,"phases":291,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":110},"100642489","NCT07638345","DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions","US-based Clinical Sub-study of DASH-Obesity: Explainable AI for Family-Centric Transdiagnostic Personalized Weight Control Across Multiple Conditions","DASH-Obesity","Inclusion Criteria:\n\n* Adult caregiver (aged 18 years or older) of an adolescent or young adult aged 12 to 21 years diagnosed with Type 1 Diabetes (T1D) or asthma.\n* The caregiver is actively involved in the management of the adolescent's or young adult's condition.\n* The adolescent or young adult must meet one of the following criteria:\n* T1D and normal weight (BMI between the 10th and 85th percentile), or\n* T1D and overweight\u002Fobesity (BMI ≥85th percentile), or\n* Asthma and overweight\u002Fobesity (BMI ≥85th percentile).\n* Willingness to participate in the Adhera Caring Digital Program-Obesity (ACDP-O).\n* Access to a smartphone or internet-enabled device compatible with the study application.\n* Willingness to provide self-reported information regarding the adolescent's or young adult's health status, including disease-related and anthropometric measures.\n* For caregivers of participants with T1D, willingness to share continuous glucose monitoring (CGM) information.\n\nExclusion Criteria:\n\n* Severe psychiatric or cognitive conditions that would interfere with participation in the digital intervention.\n* Current participation in another obesity- or chronic disease-related digital health intervention study.\n* Inability or unwillingness to comply with study procedures.\n* Refusal or inability to provide informed consent.",true,{"count":290,"type":19},280,[95],"This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with overweight\u002Fobesity and chronic conditions, including type 1 diabetes (T1D) and asthma. The intervention combines personalized educational content, wearable-device monitoring, psychometric assessments, and explainable artificial intelligence (AI) to improve mental well-being, quality of life, and adherence to healthy lifestyle behaviors. A total of 280 families will participate in a 3-month intervention with remote monitoring and follow-up assessments.",[25,61,294,295,296,297],"Obesity & Overweight","Obesity Type 2 Diabetes Mellitus","Asthma Acute","Asthma (Diagnosis)",[299,25,300,301,302,303,304,305,306,307,308,309],"Pediatric Obesity","Asthma","Overweight","Digital Health","Artificial Intelligence","Explainable AI","Caregiver Burden","Quality of Life","Mental Well-being","Wearable Devices","Family-Centered Care",{"date":273,"type":35},{"date":312,"type":35},"2025-10-30",{"date":314,"type":19},"2026-09",{"name":316,"class":42},"Adhera Health, Inc.",{"id":318,"slug":4,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":288,"sex":15,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100644572","NCT07670143","M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials","Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials.","M1N0","Inclusion Criteria:\n\n* Screening is performed between the ages of 0 and 6 weeks.\n* Consent form signed by parents\u002Fguardian.\n\nExclusion Criteria:\n\n* Infants aged above 6 weeks.\n* Refusal to participate in the study","0 Weeks","6 Weeks",{"count":327,"type":19},50000,"The goal of this observational study is to identify newborns at increased genetic risk of developing type 1 diabetes-specific beta-cell autoantibodies in order to determine eligibility for participation in primary prevention randomized controlled trials aimed at preventing beta-cell autoimmunity.",[25],[25,331,332,322],"Genetic Testing","Infants","2026-06-18",{"date":204,"type":35},{"date":336,"type":19},"2026-07",{"date":338,"type":19},"2031-06",{"name":340,"class":109},"IRCCS San Raffaele",5,{"id":343,"slug":4,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":348,"minAge":117,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":54,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":364,"leadSponsor":366,"locationsCount":110},"100636063","NCT07560813","NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes","NOURISH","Inclusion criteria:\n\n* Pregnant with singleton or twin pregnancy\n* Gestational age \\>8+0 to ≤22+6 weeks at enrollment by project EDD\n* Age ≥ 18 years.\n* Type 1 or 2 diabetes.\n* Screen positive for food insecurity based on answering \"Often\" or \"Sometimes\" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).\n* English or Spanish speaking.\n* Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.\n* Hemoglobin A1c criteria:\n\n  * If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.\n  * If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.\n\nExclusion Criteria\n\n* Involuntarily confined or detained.\n* Considered as having a diminished decision-making capacity.","FEMALE",{"count":350,"type":19},174,[95],"Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.",[98,25,354],"Pregnancy, High Risk",[356,25,98,357,358,359],"Pregnancy","food insecurity","nutrition insecurity","social determinants of health","2026-06-17",{"date":362,"type":35},"2026-06-22",{"date":173,"type":19},{"date":365,"type":19},"2030-06-30",{"name":367,"class":109},"Ohio State University",{"id":369,"slug":4,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":348,"minAge":117,"maxAge":374,"enrollmentInfo":375,"targetDuration":4,"studyType":54,"phases":377,"briefSummary":378,"conditions":379,"keywords":383,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":110},"100538987","NCT06297980","Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes","MERIT","Inclusion Criteria:\n\n* Women 18-45 who have had type 1 diabetes for at least 12 months\n* Premenopausal with either menstrual cycles or currently using oral contraceptives\n\nExclusion Criteria:\n\n* Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy","45 Years",{"count":376,"type":19},150,[95],"The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.",[25,380,381,382],"Hypoglycemia","Hyperglycaemia Due to Type 1 Diabetes Mellitus","Menstruation Disturbances",[196,384,385,386,387,388],"menstrual cycle","exercise","hypoglycemia","hyperglycemia","glucose control","2026-06-15",{"date":391,"type":35},"2026-06-16",{"date":393,"type":35},"2024-03-24",{"date":395,"type":19},"2027-10-31",{"name":397,"class":109},"University of Colorado, Denver",{"id":399,"slug":4,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":110},"100560338","NCT06575842","Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants will be 2 to 26 years of age at the time of enrollment.\n2. Participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period.\n3. Participant currently wearing a continuous glucose monitor (for example: Dexcom G6 or G7; Freestyle Libre 2, 2 Plus, or 3; Medtronic Guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal CGM data with the BDC clinical CGM account.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Currently using hydroxyurea.\n3. A condition that the investigator determines would prevent the patient from participation.","26 Years",{"count":405,"type":19},120,"This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.",[25],[409,410,411,412],"Anesthesia","Continuous glucose monitors","Accuracy","Pediatrics","2026-06-11",{"date":415,"type":35},"2026-06-12",{"date":417,"type":35},"2024-08-21",{"date":419,"type":19},"2027-12-01",{"name":397,"class":109},{"id":422,"slug":4,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":54,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100642876","NCT07646067","Closed Loop Glucose Control in a Simulated ICU Setting","Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes","Inclusion Criteria:\n\n* Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:\n\n  1. Are 18-70 years of age, inclusive.\n  2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.\n  3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 3 months.\n  4. Use insulin injections at home for glucose control.\n  5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.\n  6. Have a hemoglobin in the range for sex:\n\n     1. Females: 7-15.5 grams\u002FdL.\n     2. Males: 7-17.5 grams\u002Fdl.\n  7. Have adequate venous access sites in upper extremities.\n  8. Body weight between 40 - 150 kg.\n\nExclusion Criteria:\n\n1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.\n2. Have a known hypersensitivity to any of the components of study treatment.\n3. Have skin disease\u002Finjury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.\n4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.\n5. Have a medical condition that in the opinion of the investigator could affect study participation and\u002For personal well-being.\n6. Have a clinically significant history or presence of any of the following conditions:\n\n   1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.\n   2. Has an estimated GFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 or End Stage Kidney Disease on renal replacement therapy.\n   3. Have congestive heart failure greater than class 1 on the NYHA classification system.\n   4. Have a history of seizures.\n   5. Have a history of cerebrovascular accident.\n   6. Have a history of ischemic heart disease.\n7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:\n\n   1. Pregnant.\n   2. Refuse to agree to a pregnancy test at the time of enrollment.\n   3. Have a positive urine pregnancy test at the time of enrollment.\n8. Have a positive Influenza or COVID test within 14 days of visit 3.\n9. Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.\n10. Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3.\n11. Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.","70 Years",{"count":145,"type":19},[95],"This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.\n\nThe persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg\u002FdL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.",[25,98,432],"Stress Induced Hyperglycemia",[434,435,436,437,432,25,98,438,439,380,440,441,442],"Artificial Pancreas","Intensive Care Unit","ICU","Closed Loop Glucose Control","Inpatient","Hospital","Hyperglycemia","Glucose Variability","Fully Autonomous","2026-06-09",{"date":415,"type":35},{"date":336,"type":19},{"date":447,"type":19},"2027-12",{"name":449,"class":42},"Ideal Medical Technologies",{"id":451,"slug":4,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":54,"phases":458,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":110},"100643012","NCT07596160","Individualized Exercise Consultation in Type 1 Diabetes","ACTIVE-T1D","Inclusion Criteria:\n\n* Diagnosis of type 1 diabetes\n* Age ≥18 years\n* Willingness to participate\n\nExclusion Criteria:\n\n* None",{"count":457,"type":19},60,[95],"People with type 1 diabetes often experience challenges managing blood glucose levels during and around physical activity, which may reduce participation in exercise. The ACTIVE-T1D project aims to evaluate whether individualized video-based exercise consultations can improve exercise-related confidence, physical activity levels, and glycemic management in adults with type 1 diabetes. Participants will receive individualized consultations focused on exercise, glucose management, insulin adjustment, and nutrition strategies related to physical activity. Consultations are tailored to the participant's exercise habits, goals, and challenges. The study will assess self-reported exercise management, physical activity, and glucose metrics obtained from continuous glucose monitoring systems. A subgroup of participants will also complete objective physical activity measurements using accelerometers. The study is conducted as a prospective quality improvement project at Steno Diabetes Center Aarhus.",[25],[385,196,462,463],"intervention","consultations","2026-06-05",{"date":443,"type":35},{"date":467,"type":19},"2026-06-01",{"date":469,"type":19},"2028-06-01",{"name":471,"class":109},"University of Aarhus",{"id":473,"slug":4,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":15,"minAge":478,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":54,"phases":481,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100597675","NCT07061574","A Randomized Phase 1\u002F2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes","WAVE T1D","Key Inclusion Criteria:\n\nRecent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.\n\n* At least one positive T1D auto-antibody.\n* If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.\n* Insulin auto-antibodies are only considered if exogenous insulin use is \\\u003C10 days when blood is drawn.\n* Must have stimulated C-peptide levels ≥0.2 pmol\u002FmL measured during MMTT conducted prior to randomization.\n* Age 9 to \\\u003C21 years at the time of randomization.\n* Body weight \\>30kg.\n* BMI \\\u003C95th percentile for age and gender.\n* Willing to comply with intensive diabetes management.\n* Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.\n* Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral\u002Finjection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.\n* Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.\n* Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.\n* Willing to provide informed consent and child assent as applicable.\n* Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.\n* Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).\n* Must be fully vaccinated for age.\n* Must have been vaccinated for flu (if currently in flu season).\n* Must be willing to not receive live vaccines throughout the treatment period.\n* Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.\n\nKey Exclusion Criteria:\n\n* Prior treatment with ATG or known allergy to ATG or rabbit-derived products.\n* Local lab draw at screening:\n* Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\\\u003C3,000 leukocytes \u002FμL), neutropenia (\\\u003C1,500 neutrophils\u002FμL), lymphopenia (\\\u003C800 lymphocytes\u002FμL).\n* Thrombocytopenia (\\\u003C100,000 platelets\u002FμL) or anemia (hemoglobin \\\u003C 10g\u002FdL).\n* Leukocytosis (\\>14,000\u002FmL)\n* Infections:\n* Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization.\n* Have active signs or symptoms of acute infection at the time of randomization.\n* Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON), or a positive test for latent tuberculosis.\n* Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n* History of serious bacterial, viral, fungal, or other opportunistic infections.\n* Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization.\n* Have positive CMV and\u002For EBV PCR test within 30 days prior to randomization.\n* Have positive COVID-19 self-antigen test within 3 days of randomization.\n* History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology).\n* Blood pressure (either systolic or diastolic) \\\u003C5th percentile for age, gender, and height on two out of three measurements.\n* Pulse \\\u003C2nd percentile for age and gender on two out of three measurements.\n* History of vasovagal syncopal episodes related to hypotension.\n* History of malignancies other than of skin.\n* Use of medications likely to interfere with study results:\n* Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only).\n* Current or previous use of Teplizumab.\n* Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed.\n* Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine.\n* Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization.\n* Any known hypersensitivity reaction to any of the study medications or their components.\n* Unable to swallow pills (tested with an inert imitation tablet in clinic at screening).\n* History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing.\n* Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor).\n* Established history of allergy or severe reaction to adhesive or tape that must be used in the study.\n* Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm.\n* Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:\n* Alcohol or drug abuse\n* Untreated or inadequately treated mental illness\n* Liver disease or LFTs \\>2x ULN.\n* Renal disease or creatinine greater than 1.5x ULN.\n* Other autoimmune diseases except for stable and treated hypothyroidism\n* Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet).\n* Nervous system disorder including but not limited to Guillain-Barre\n* Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy.\n* History of multiple abdominal surgeries and\u002For at increased risk for bowel obstruction.\n* Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease).\n\nAny lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\n\\-","9 Years","20 Years",{"count":405,"type":19},[56,57],"This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\\u003C21 with recent-onset stage 3 T1D.",[25,484],"New Onset",[486],"ATG, Verapamil, Adalimumab","2026-05-29",{"date":489,"type":35},"2026-06-02",{"date":491,"type":35},"2026-03-10",{"date":493,"type":19},"2031-04-15",{"name":495,"class":109},"City of Hope Medical Center",11,{"id":498,"slug":4,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":54,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":514,"locationsCount":516},"100502465","NCT05822609","Trial of Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes","RT1D","Inclusion Criteria:\n\n* Adults (≥18 years) with type 1 diabetes\n* Diabetes duration of ≥5 years\n* Persistent urine albumin-to-creatinine ratio (UACR) ≥ 30 mg\u002Fg, on the most recent two measurements within the prior 3 years\n* Estimated glomerular filtration rate ≥ 20 mL\u002Fmin\u002F1.73m2\n* Stable doses of drugs altering blood pressure (e.g., Angiotensin-converting enzyme inhibitor) required for at least 4 weeks prior to randomization, and requested for the duration of the trial\n* Stable doses of lipid-lowering medications required for at least 4 weeks prior to randomization, and requested for the duration of the trial\n* Adequate contraceptive method for females of child-bearing potential\n\nExclusion Criteria:\n\n* HbA1c \\>9%, recent diabetic ketoacidosis, hyperosmolar hyperglycemic state or severe illness requiring hospitalization in past 30 days\n* Other causes of diabetes mellitus, including type 2 diabetes and maturity-onset diabetes of the young (MODY)\n* Chronic kidney disease unrelated to diabetes\n* Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) or thyroid nodule palpated by endocrinologist at screening\n* Personal history of pancreatitis\n* Current\u002Fplanned pregnancy or nursing\n* Uncontrolled thyroid disease or hypertension (Systolic blood pressure \\[SBP\\] ≥ 160 mm Hg or diastolic blood pressure \\[DBP\\] ≥ 100 mm Hg despite treatment)\n* Proliferative retinopathy with treatment in the past 6 months\n* Uncontrolled or potentially unstable diabetic retinopathy or maculopathy, verified by fundus examination with pupil dilation unless performed using a digital fundus photography camera specified for non-dilated examination\n* More than 2 severe hypoglycemic episodes (requiring glucagon and\u002For assistance from another person) in the past 6 months\n* Frequent hypoglycemia during the last two weeks of the study run-in phase (time below range \\[\\\u003C70 mg\u002FdL\\] ≥4%)\n* Pramlintide and the use of glycemia treatments not approved for type 1 diabetes by the FDA, e.g., metformin, SGT-2 inhibitor, GLP-1 receptor agonist, closed loop insulin delivery using unapproved algorithms\n* Significant systemic conditions or treatment such as cancer or immunomodulators\n* Known liver disease other than non-alcoholic fatty liver disease (NAFLD) or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>100 IU\u002FL, history of severe gastrointestinal disease (e.g., gastroparesis) or gallstones\n* Body mass index \\\u003C20 kg\u002Fm2\n* Known or suspected allergy\u002Fsensitivity to semaglutide or its excipients\n* Pregnant, breast feeding, or the intention of becoming pregnant\n* The receipt of any investigational drug within 3 months prior to this trial\n* Previously randomized in this trial",{"count":457,"type":19},[57],"The primary objective of this study is to determine the effects of semaglutide on change in albuminuria from baseline to 26 weeks in type 1 diabetes. The secondary objective is to determine the effects of semaglutide on change in kidney parameters (including kidney oxygenation and function) measured by MRI from baseline to 26 weeks in type 1 diabetes. Other objectives are to determine the glycemic effects and safety of semaglutide in type 1 diabetes.",[507,25],"Diabetic Kidney Disease",[509],"Glucagon-like peptide-1 receptor agonist",{"date":489,"type":35},{"date":512,"type":35},"2024-04-05",{"date":447,"type":19},{"name":515,"class":109},"University of Washington",4,{"id":518,"slug":4,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":15,"minAge":524,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":54,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":539},"100607359","NCT07187531","SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset of Type 1 Diabetes (NOT1D)","SAFEGUARD","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian must have given written informed consent and\u002For assent according to local, regional and\u002For country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.\n2. Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\\*, inclusive, at the time of randomisation in Part B.\n3. Weight ≥16.0 kg at time of randomisation.\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: The date of diagnosis is defined as the date of the first insulin dose or any other glucose lowering medication. An extension of no more than 14 days is permitted if a participant has planned and\u002For is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.\n5. Participant has random C-peptide levels of ≥0.2 nmol\u002FL, measured during Screening. One random C-peptide retest during screening period is allowed.\n6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.\n7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:\n\n   * Glutamic acid decarboxylase 65 (GAD65)\n   * Islet antigen 2 (IA-2)\n   * Zinc transporter 8 (ZnT8)\n   * Insulin autoantibodies (if testing within the first 14 days of insulin treatment)\n8. Female participants:\n\n   a. Must be of nonchildbearing potential, i.e., pre-pubertal\\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative result on a serum (beta human chorionic gonadotropin \\[β-HCG\\]) at screening and a negative urine β-HCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.\n\n   ii. Agree not to become pregnant or donate ova from signing the consent form until the end of study visit.\n\n   iii. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from signing the consent and for the duration of the study.\n\n   \\* Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)\u002Fguardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.\n9. Male participants, if not biologically or surgically sterilised, must:\n\n   1. Agree not to donate sperm from signing the consent form until EOS.\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the consent form until EOS.\n   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.\n10. Prior to receiving study drug, participant must agree to receive locally, regionally and\u002For country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and\u002For country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.\n11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and\u002For stimulate pancreatic β cell regeneration or insulin secretion.\n12. Participant has suitable venous access for blood sampling.\n13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications).\n2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.\n3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.\n4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.\n5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and\u002For efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.\n6. Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematous) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.\n7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.\n8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.\n9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus \\[CMV\\], Epstein-Barr Virus \\[EBV\\] as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I\u002FE are met. Participants who have an active infection and\u002For fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.\n11. Participant has a diagnosis of significant liver disease or at screening ALT and\u002For AST \\>2× or total bilirubin of \\>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant maybe eligible for randomization. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and\u002For indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.\n12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:\n\n    * Lymphocyte count: \\\u003C1000\u002FμL\n    * Neutrophil count: \\\u003C1500\u002FμL\n    * Platelet count: \\\u003C100 000 platelets\u002FμL\n    * Haemoglobin: \\\u003C10 g\u002FdL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and\u002For is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the normal ranges.\n13. Current or prior (within 5× half-lives before SV2) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.\n14. Current or prior (within 5× half-lives before SV2) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \\[glucagon-like peptide-1\\], dipeptidyl peptidase-4 \\[DPP-IV\\] inhibitors, or amylin).\n15. Current or prior (within 5× half-lives before SV2) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).\n16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n18. Female is lactating and\u002For plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.\n19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and\u002For country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit\u002Fhyperactivity disorder (ADHD) or others are allowed to participate in the study.\n20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.\n21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.","5 Years","40 Years",{"count":527,"type":19},159,[57],"This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).",[25],"2026-05-27",{"date":487,"type":35},{"date":534,"type":35},"2025-11-25",{"date":536,"type":19},"2028-12",{"name":538,"class":42},"SAb Biotherapeutics, Inc.",71,{"id":541,"slug":4,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":15,"minAge":547,"maxAge":239,"enrollmentInfo":548,"targetDuration":4,"studyType":54,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":252},"100538911","NCT06296992","Type 1 Diabetes, Exercise and Mentoring Trial","Type 1 Diabetes, Exercise and Mentoring (TEAM) Trial: A Randomized Controlled Pilot Trial Using Peer Mentorship to Increase Physical Activity and Quality of Life in Adolescents With Type 1 Diabetes","TEAM","Inclusion Criteria:\n\n* want to increase their daily PA\n* currently use a continuous glucose monitor (CGM)\n\nExclusion Criteria:\n\n* were diagnosed with T1D within 12 months of randomization\n* have diabetes secondary to medications or surgery\n* have cancer\n* evidence of drug\u002Falcohol abuse\n* have an eating disorder\n* an orthopedic injury or illness that would limit their ability to engage in daily PA\n* a suicide attempt in the previous 12 months\n* are pregnant","13 Years",{"count":457,"type":19},[95],"The proposed study aims to improve the psychosocial health of adolescents living with type 1 diabetes (T1D). The study will generate knowledge and support knowledge mobilization about the effectiveness of a novel model of care for psychosocial health and self-management for adolescents living with type 1 diabetes (T1D). The novel model of care is the recruitment and training if young adult mentors to deliver a behavioural intervention that empowers adolescents with T1D to increase daily physical activity. The study will also advance the development and implementation of this peer mentoring model to improve the psychosocial health of adolescents with T1D.",[25,552],"Physical Activity",{"date":467,"type":35},{"date":555,"type":35},"2025-02-01",{"date":557,"type":19},"2027-05",{"name":559,"class":109},"University of Manitoba",{"id":561,"slug":4,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":54,"phases":567,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":110},"100434186","NCT04933851","ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Spanish or English-speaking\n* Type 1 diabetes\n* Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days\n* Screen positive for diabetes distress\n\nExclusion Criteria:\n\n* Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider\n* Plans to move out of the San Diego area in the next 12 months\n* Lack of technology capability required to complete online surveys and telemedicine visit",{"count":566,"type":19},250,[57],"This research will compare a psychological intervention (\"ACT1VATE\") versus diabetes self-management education and support (DSME\u002FS; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.",[25],[25,571],"Emotional Distress",{"date":487,"type":35},{"date":574,"type":35},"2021-10-25",{"date":576,"type":19},"2027-03-31",{"name":578,"class":109},"Scripps Whittier Diabetes Institute",{"id":580,"slug":4,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":593,"locationsCount":496},"100628126","NCT07457580","Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)","A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)","Inclusion Criteria:\n\n* Patient written or electronic informed consent or assent (for patients \\\u003C 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.\n* Patient received ≥ 1 day of teplizumab treatment as part of MAPs.\n\nExclusion Criteria:\n\n• Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product\u002Fprocedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":457,"type":19},"This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.",[25],"2026-05-22",{"date":531,"type":35},{"date":37,"type":35},{"date":592,"type":19},"2026-11-30",{"name":594,"class":42},"Sanofi",{"id":596,"slug":4,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":612},"100620627","NCT07360080","Long-Term Outcomes of Teplizumab in Routine Clinical Care","Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care","AL1GN","Inclusion Criteria -\n\n* Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.\n* Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.\n\n(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)\n\n• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent\u002Fassent as applicable for the age of the participant and as per local regulations.\n\nExclusion Criteria -\n\n* Participants who had participated in a previous clinical trial for teplizumab.\n* Participants enrolled in a clinical trial within 6 months prior to study enrollment.\n\n(Note: Participants enrolled in other observational studies may be included.)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":603,"type":19},1000,"This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.",[25],{"date":531,"type":35},{"date":608,"type":35},"2026-03-19",{"date":610,"type":19},"2035-10-29",{"name":594,"class":42},8,{"id":614,"slug":4,"hasResults":11,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":54,"phases":622,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":640,"locationsCount":516},"100614816","NCT07284511","A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar","Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial","TZP","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required).\n* A BMI ≥ 27 kg\u002Fm2.\n* HbA1c \\> 6.5%, and \\\u003C 12%.\n* Current therapy: multiple daily injections or insulin pump.\n* Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible)\n* Active carbohydrate counting for prandial insulin dosing.\n* Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.\n\nExclusion Criteria:\n\n* Use of GLP1-RAs within the last four weeks.\n* Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.\n* Diabetic ketoacidosis within the last 2 months.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe renal impairment with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI), measured within the last four months.\n* Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.\n* Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.\n* History of bariatric surgery within the last 6 months.\n* Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.\n* Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.\n* Any safety concern that, in the investigator's judgment, precludes participation.",{"count":621,"type":19},105,[57,623],"PHASE3","This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals.\n\nPeople with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose.\n\nTirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises.\n\nThis study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups:\n\nTirzepatide group:\n\nParticipants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals.\n\nControl group:\n\nParticipants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses.\n\nThe main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart\u002Ffitness, or body-composition tests.\n\nAs with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial.\n\nOverall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.",[25,60,61,62,63],[25,627,151,628,629,630,631,632,633,634,635,265,266,636],"Overweight or obesity in type 1 diabetes","Insulin pump","Continuous glucose monitoring","Tirzepatide","Mounjaro","GIP\u002FGLP-1 receptor agonist","Dual incretin therapy","Adjunctive tirzepatide therapy","Tandem Control-IQ","Dexcom G7",{"date":531,"type":35},{"date":275,"type":35},{"date":132,"type":19},{"name":641,"class":109},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",""]