[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes-t1d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes-t1d":37},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,69,0,25,[9,65,102,130,155,178,205,233,265,293,319,342,369,396,426,444,470,495,519,546,571,598,637,661,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":46,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100560306","phase-1-a-study-to-investigate-safety-and-effectiveness-of-porcine-pancreatic-cells-opf-310-in-patients-with-type-1-diabetes-mellitus-100560306",false,"NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM) (in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII For subjects aged 65 to \\\u003C70 years who do not meet Exclusion Criterion 12 but have a history of cardiovascular or cerebrovascular disease related to the conditions above, a cardiology consultation (and consultation with other relevant specialists, as appropriate) will be required during the screening period to confirm suitability for general anesthesia and laparoscopic surgery.\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","ALL","35 Years","70 Years",{"count":21,"type":22},13,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Diabetes Mellitus, Type 1","Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases","Metabolic Disease",[47,48,35,30,49,50,39,51,33,32],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","RECRUITING","2026-08-19",{"date":55,"type":56},"2026-08-21","ACTUAL",{"date":58,"type":56},"2025-06-10",{"date":60,"type":22},"2027-06-30",{"name":62,"class":63},"Otsuka Pharmaceutical Factory, Inc.","INDUSTRY",1,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":86,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":64},"100628559","integrating-new-skills-into-diabetes-education-with-cgm-100628559","NCT07463209","Integrating New Skills Into Diabetes Education With CGM","Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes","INSIDE-CGM","Participant Inclusion Criteria:\n\n* Adults 65 years and older at time of consent\n* Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as receiving care within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.\n* Using any insulin at least once daily\n* No continuous glucose monitor (CGM) use within the previous 365 days\n* Willing to use a smartphone to access glucose readings using CGM phone app\n* Fluent in English\n\nParticipant Exclusion Criteria:\n\n* Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)\n* Currently receiving dialysis, assessed through chart review and self-report on screening visit\n* Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit\n* The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of \\\u003C1 year, assessed at screening visit\n* Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures\n* Not fluent in English\n* Unable to consent to recording of sessions\n\nCare Partner Inclusion Criteria:\n\n* Live in the same household as the study participant\n* Age 18 years or older\n* Fluent in English\n* Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes\n* Consent to recording of sessions","65 Years",{"count":75,"type":22},144,[77],"NA","This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program (\"intervention\") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches (\"comparators\").\n\nFollowing a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks.\n\nThe study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.\n\nLastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.",[80,81,82,83,84,37,85],"Insulin Dependent Diabetes","Diabetes (DM)","Diabetes (Insulin-requiring, Type 1 or Type 2)","Diabetes Education","Diabetes Care","Type 2 Diabetes Mellitus (T2DM)",[87,88,89,90,91,83],"Continuous Glucose Monitor","Diabetes","Insulin Dependent","Older Adults (65 years and older)","CGM","2026-08-12",{"date":94,"type":56},"2026-08-14",{"date":96,"type":56},"2026-08-11",{"date":98,"type":22},"2028-06",{"name":100,"class":101},"University of North Carolina, Chapel Hill","OTHER",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100649993","continuous-glucose-monitoring-in-high-risk-children-and-youth-with-type-1-diabetes-in-the-dominican-republic-100649993","NCT07742306","Continuous Glucose Monitoring in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic","The Effects of Continuous Glucose Monitoring Interventions in High-Risk Children and Youth With Type 1 Diabetes in the Dominican Republic","Inclusion Criteria:\n\n* HbA1c \\>9.0%\n* Age range: 10-19 years\n* Disposition and availability for patients and families to attend scheduled provider meetings, as well as general diabetic educational and psychological support meetings throughout the whole study. Namely, meeting every 2 weeks for the first 3 months and then every 4 weeks until completion of study for next 12 months.\n* Willingness and ability to provide signed voluntary consent form. Date and signature is requested however based on literacy levels a patient can provide consent verbally as long as there is a witness who is 18 years or older and demonstration of acknowledgement of information provided.\n\nExclusion Criteria:\n\n* Diagnosis of T1D within the past 12 months\n* Previous or current use of CGM like FreeStyle Libre 2, Dexcom (G6, G7), or similar devices from other companies not mentioned\n* Current use of continuous insulin pump in combination with CGM use at present or prior to study\n* Residence location with greater than 3 hours of travel time distance from each health center in setting of cost and feasibility for families to travel on frequent necessary basis\n* Current steroid therapy orally or intravenously.\n* Medical comorbidities including chronic renal disease, hemoglobinopathies, leukemia, hematologic or oncologic conditions that can affect glycemia\n* Pregnancy","10 Years","19 Years",{"count":112,"type":22},40,"OBSERVATIONAL","The goal of this pilot longitudinal study is to investigate whether intermittent use of the Dexcom G7 continuous glucose monitor, together with pediatric endocrinology follow-up, diabetes education, and psychological support, can improve glucose control in children and adolescents with high-risk type 1 diabetes in the Dominican Republic.\n\nThe study will include 40 participants, 10 to 19 years of age, from two pediatric diabetes care centers. Participants will use the Dexcom G7 during two short monitoring periods in the early part of the study. Each participant will use six sensors in total. Between and after these monitoring periods, participants will return to their usual finger-stick glucose monitoring with a glucometer. Participants and their families will also attend scheduled medical visits, diabetes education sessions, and psychological support sessions.\n\nStudy information will be collected from medical records, laboratory results, Dexcom Clarity reports, participant glucose logs, study forms, and questionnaires.\n\nThe study will assess changes in HbA1c, time in range, average glucose, glucose variability, low and high blood glucose episodes, adverse events, diabetes-related distress, fear of hypoglycemia, and satisfaction with glucose monitoring.",[37],[117,118,119,120],"Continous glucose monitoring (CGM)","Youth","Dominican Republic","Intermittent CGM",{"date":122,"type":56},"2026-08-13",{"date":124,"type":56},"2025-11-14",{"date":126,"type":22},"2027-12",{"name":128,"class":101},"Life for a Child Program, Diabetes Australia",3,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100586744","a-study-of-gnti-122-in-adults-recently-diagnosed-with-t1d-100586744","NCT06919354","A Study of GNTI-122 in Adults Recently Diagnosed With T1D","POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)","POLARIS","Inclusion Criteria:\n\n1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.\n2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol\u002FL.\n3. Positive for at least one T1D-associated autoantibody.\n4. Able and willing to provide written, informed consent as approved by the IRB.\n5. Is confirmed positive for the HLA-DRB1\\*04:01 allele.\n6. Has adequate vascular access to undergo leukapheresis with no known contraindications.\n\n8\\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.\n\n9\\. Male participants of childbearing potential must agree to protocol specified contraception.\n\n10\\. Other than T1D, participant is in good general health.\n\nExclusion Criteria:\n\n1. Type 2 diabetes.\n2. Experienced DKA within 4 weeks prior to or during Screening.\n3. Unwilling or unable to comply with study procedures or schedule.\n4. Chronic or uncontrolled medical condition.\n5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.\n6. Participation in another clinical study or active follow-up in a prior study.","18 Years","55 Years",{"count":141,"type":22},16,[25],"This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https:\u002F\u002Fwww.polarisstudy.com to learn more!",[37,33],"2026-08-07",{"date":147,"type":56},"2026-08-10",{"date":149,"type":56},"2025-09-03",{"date":151,"type":22},"2028-02",{"name":153,"class":63},"GentiBio, Inc",10,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":64},"100651185","no-meal-announcement-in-automated-insulin-delivery-open-source-and-commercial-systems-100651185","NCT07758647","NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems","NOMAD","Inclusion Criteria:\n\n* Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA)\n* Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.)\n* Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM.\n* If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage).\n* Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period.\n\nExclusion Criteria:\n\n* Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)\n* Participant-reported clinically significant nephropathy (eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator\n* Recent (\\\u003C3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)\n* Anticipated therapeutic change (including change of CGM sensor \\[other than Dexcom sensors\\] or AID system type, new antidiabetic drug initiation) between admission and end of the study\n* % of time spent out of automated mode exceeding 10% in last month's trial start\n* Anticipated need to use hydroxyurea during the study period (as it can interfere with CGM readings)\n* Pregnancy (ongoing or current attempt to become pregnant)\n* Breastfeeding\n* Plan to go abroad in a foreign country during the study period\n* Severe hypoglycemic episode within one month of screening\n* Severe hyperglycemic episode (including DKA) requiring hospitalization in the last 3 months\n* Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)\n* Current use of SGLT-2 inhibitors or GLP1 agonists or other antidiabetic agents (Metformin, DPP-4 inhibitors) unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed (for iSGLT2 treatment).\n* Known or suspected allergies to study products (e.g., Dexcom adhesive)\n* Other serious medical illnesses likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator\n* Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change)\n* Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI)\n* In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device.",{"count":163,"type":22},33,[77],"Automated insulin delivery (AID) systems are the current gold standard for the management of type 1 diabetes (T1D), improving glycemic control, reducing hypoglycemia, and decreasing treatment burden. Although both commercial AID (C-AID) and open-source AID (OS-AID) systems have demonstrated significant clinical benefits, direct randomized comparisons between these systems remain scarce. Moreover, an important limitation of currently available AID systems is their reliance on user-initiated meal announcements and carbohydrate counting, which remain major contributors to postprandial dysglycemia and treatment burden. While emerging evidence suggests that AID systems may partially compensate for missed meal announcements, their comparative performance under these challenging real-world conditions is unknown.\n\nThe NOMAD study is an international, multicenter, open-label, randomized, non-inferiority crossover trial designed to compare an open-source AID system with commercially available AID systems (including Tandem Control-IQ and Omnipod 5) in adults with type 1 diabetes currently using an open-source AID system. The study specifically evaluates glycemic outcomes following standardized unannounced meal challenges performed under free-living conditions.\n\nA total of 33 participants will be enrolled and complete two 4-week intervention periods, each consisting of a 2-week run-in phase followed by a 2-week data collection phase, with crossover between treatment arms. Participants will continue using their own Dexcom G6 or Dexcom G7 continuous glucose monitoring system throughout the study.\n\nThe primary outcome is the percentage of time spent in the target glucose range (3.9-10.0 mmol\u002FL) during the 4 hours following standardized unannounced meal challenges. Secondary outcomes include additional CGM metrics (time above and below range, glucose variability, mean glucose, and GMI), insulin delivery characteristics, and patient-reported outcomes evaluating treatment satisfaction, usability, and diabetes-related burden.",[37],[168],"Automated Insulin Delivery Systems","NOT_YET_RECRUITING","2026-08-06",{"date":96,"type":56},{"date":173,"type":22},"2026-10-01",{"date":175,"type":22},"2029-12-31",{"name":177,"class":101},"Institut de Recherches Cliniques de Montreal",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":73,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":64},"100649400","ai-assisted-remote-insulin-pump-optimization-in-t1dm-100649400","NCT07732777","AI-Assisted Remote Insulin Pump Optimization in T1DM","Evaluating AI-Assisted Remote Optimization of Insulin Pump Settings in Type 1 Diabetes Using CGM","Inclusion Criteria:\n\n1. Clinical diagnosis of T1D, meeting all three of the following criteria:\n\n   1. Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis;\n   2. At least one of the following: age at disease onset \\\u003C 15 years; presentation with ketosis or diabetic ketoacidosis (DKA) at onset; no overweight or obesity at onset; highest random C-peptide \\\u003C 200 pmol\u002FL;\n   3. At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody.\n2. Age 14 to 65 years, inclusive, male or female.\n3. HbA1c \\\u003C 11.0% at the screening visit.\n4. At least 3 months of documented T1D duration, and at least 3 months of treatment with either multiple daily insulin injections (MDI) or insulin pump therapy.\n5. Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro.\n6. Willing to perform at least one fingerstick blood glucose measurement per day.\n7. Willing to upload data from the study device.\n8. Willing and able to provide signed informed consent (by the participant and\u002For legally authorized representative) and to learn basic diabetes management and study device operation.\n\nExclusion Criteria:\n\n1. History of severe hypoglycemia within the 6 months prior to screening, defined as an event requiring medical assistance (i.e., physician office visit, emergency room visit, or hospitalization), coma, seizure, or hypoglycemia with loss of consciousness.\n2. Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment.\n3. Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening.\n4. Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema.\n5. Presence of significant acute or chronic complications, hepatorenal disease, or other systemic diseases at screening. Hyperthyroidism or hypothyroidism with unstable thyroid function at the time of screening, defined as thyroid-stimulating hormone outside the normal range with concurrent abnormal free triiodothyronine or free thyroxine levels.\n6. Prior pancreas or islet cell transplantation.\n7. Any of the following cardiovascular or cerebrovascular events within 1 year prior to screening: myocardial infarction, heart failure (NYHA Class III\u002FIV), unstable angina, coronary artery bypass grafting, coronary stent implantation, angina pectoris, congestive heart failure, ventricular arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or other thromboembolic disease.\n8. Diagnosis of any of the following: malignancy, tuberculosis or other chronic wasting disease, hematological disorder, psychiatric disorder, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, or clinically significant malabsorption. Diagnosis of adrenal insufficiency, or current treatment for hyperthyroidism, or planned treatment for hyperthyroidism during the study period.\n9. History of drug abuse or alcohol abuse.\n10. Use of any oral, injectable, or intravenous glucocorticoids within 8 weeks prior to screening, or planned use during the study period.\n11. Use of any of the following non-insulin glucose-lowering agents within 8 weeks prior to screening, or planned use during the study period: thiazolidinediones (TZDs), alpha-glucosidase inhibitors, sulfonylureas (SUs), glinides, dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Participants currently using any of these agents must undergo a washout period of at least 7 days prior to enrollment.\n12. Planned elective surgery requiring general anesthesia, or planned dialysis during the study period.\n13. For women of childbearing potential: pregnancy, lactation, positive pregnancy test at screening, or planned pregnancy during the study period. Women of childbearing potential who are not using an effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and who do not agree to continue using such effective contraception during the study period will be excluded.\n14. Current participation in, or treatment with an investigational drug or device within 2 weeks prior to screening (observational studies are permitted).\n15. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study, including but not limited to: history of ocular trauma or other confirmed ocular disease causing blurred vision, deafness, eating disorders, celiac disease, or being underweight (Body Mass Index \\\u003C 18 kg\u002Fm²).","14 Years",{"count":187,"type":22},50,[77],"This study evaluates an AI-assisted remote parameter optimization tool for individuals with type 1 diabetes （T1D） using insulin pump and continuous glucose monitoring (CGM). The Artificial Intelligence (AI) algorithm analyzes regularly CGM and insulin data to generate personalized recommendations for adjusting pump settings. All algorithm-generated recommendations are reviewed and approved by physicians before being transmitted to the participant's mobile application for implementation.",[33,37],[32,192,193,194,195],"Insulin Pump","Continuous Glucose Monitoring","Artificial Intelligence","Insulin Dosage Adjustment","2026-07-26",{"date":198,"type":56},"2026-07-29",{"date":200,"type":56},"2026-01-28",{"date":202,"type":22},"2028-12-31",{"name":204,"class":101},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":64},"100573906","adapting-single-sessions-interventions-for-type-1-diabetes-100573906","NCT06752369","Adapting Single Sessions Interventions for Type 1 Diabetes","Adapting Single Sessions Interventions for Type 1 Diabetes (ASSISTED): Integrated Pediatric Care to Reduce Depression and HbA1c","ASSISTED","Inclusion Criteria:\n\n* Child or adolescent age between 11-18 years, inclusive\n* Physician confirmed T1D diagnosis of at least 6 months duration prior to study enrollment\n* Positive depression screening score of \\>5 on the PHQ-9 in the last year\n* Not currently engaged in outpatient mental healthcare\n* English fluency\n\nExclusion Criteria:\n\n* Another systemic chronic medical illness except for celiac disease, autoimmune thyroiditis, microalbuminuria, hypertension, or well-managed asthma\n* Any score of 1, 2, or 3 on item 9 (indicating suicidal ideation) of the PHQ-9 in the last year.","12 Years","17 Years",{"count":216,"type":22},80,[77],"The goal of this clinical trial is to learn if implementing a single-session depression intervention for youth with type 1 diabetes (T1D) is feasible and acceptable to patients. can help improve mood and health outcomes. It will also learn about the initial efficacy of the intervention. The main questions it aims to answer are:\n\n1. Is a single-session depression intervention for youth with T1D feasible to recruit and implement?\n2. Is a single-session depression intervention for youth with T1D acceptable to patients (i.e., do they find it helpful)?\n3. Does a single-session depression intervention for youth with T1D lead to improvements in low mood?\n\nResearchers will compare a single-session depression intervention for youth with to a education control to see if a single-session depression intervention works to improve depressive symptoms.\n\nParticipants will:\n\n* Participate in a single-session depression intervention\n* Complete questionnaires and provide a sample for A1c at a baseline, 3-month, and 6-month visit\n* Complete daily questionnaires once a day for two weeks before and after the single-session depression intervention",[37],[221,222,223],"type 1 diabetes","adolescents","depression","2026-07-23",{"date":226,"type":56},"2026-07-24",{"date":228,"type":22},"2026-08-03",{"date":230,"type":22},"2029-02",{"name":232,"class":101},"Nemours Children's Health System",{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100640229","safety-evaluation-of-modi-an-insulin-titration-algorithm-in-adults-with-diabetes-100640229","NCT07599982","Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes","MODIUS","Inclusion Criteria:\n\n1. Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent\n2. Insulin therapy as follows:\n\n   1. If T1D, using MDI insulin therapy for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) meal-size-based dosing (small, normal, large); and taking\n\n      1 basal insulin injection per day for at least 1 week prior to screening\n   2. If T2D, either:\n\n   i. not using insulin in the 3 months prior to screening, but require initiation of a basal-only insulin regimen based on investigator assessment ii. using only basal insulin for at least 3 months prior to screening and taking 1 basal insulin injection per day for at least 1 week prior to screening iii. using MDI for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either\n\n   (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) mealsize-based dosing (small, normal, large); and taking 1 basal insulin injection per day for at least 1 week prior to screening\n3. Age at time of consent 18-80 years\n4. HbA1c \\>7.5% and \\\u003C12% as measured by point-of-care device or local lab at the time of screening\n5. Using only injected insulin types that are specified in the MODI Instructions for Use materials\n6. Stable doses of non-insulin glucose lowering medications over the 4 weeks preceding screening as determined by Investigator and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons\n7. Stable doses of weight loss medications that may have a meaningful effect on glycemic control over the 4 weeks preceding screening and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons\n8. Weight between 80 - 440 lb at the time of screening\n9. Willing to use FSL 3 System according to manufacturer instructions and to avoid use of any other personal CGM system during the period of study participation\n10. Willing to document insulin delivery, meals, and daily activities in the Diary mobile app\n11. Has a smartphone compatible with study requirements: either iOS version 17.0 or higher, or Android version 10.0 or higher, and willing to install required apps and use them as instructed during the period of study participation, with internet connectivity for a data upload at least once per day.\n12. Is deemed an appropriate candidate for automatic insulin guidance therapy per Investigator assessment\n13. Investigator has confidence that the participant has the cognitive ability necessary for study participation, can successfully operate all study devices, and can adhere to the protocol\n14. Has a sufficient understanding of written\u002Fspoken English for legally effective informed consent and successful use of the study mobile apps\n15. If woman of childbearing potential, is willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n1. Use of an insulin pump within 3 months prior to informed consent\n2. Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening\n3. Taking more than 128 units of daily basal insulin or more than 79 units in a single bolus insulin injection in the 7 days prior to screening\n4. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and\u002For eating disorders (i.e. anorexia\u002Fbulimia)\n5. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening\n6. Any planned surgery during the study which could be considered major in the judgment of the investigator\n7. History of more than 1 severe hypoglycemic event in the 6 months prior to screening\n8. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening\n9. Blood disorder or dyscrasia within 3 months prior to screening which in the investigator's opinion could interfere with determination of HbA1c\n10. Any condition or intervention that may affect red blood cell turnover, in the 3 months prior to the study and during the study, such as blood transfusion or donation\n11. Has taken oral or injectable corticosteroids within 2 weeks prior to screening or plans to take oral or injectable corticosteroids during the study\n12. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n13. Is an employee of DreaMed Diabetes, is a study Investigator or a member of the Investigator's study team, or is immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned\n14. Participation in another clinical study using an investigational drug or device in the 90 days prior to screening or intends to participate during the study period\n15. Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral\u002Finjectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months postmenopausal)\n16. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact the CGM sensor","80 Years",{"count":242,"type":22},102,[77],"A 13-week multi-center single-arm trial, preceded by a 2-week standard therapy phase, will be conducted to assess the safety of MODI, an insulin titration algorithm, in adults with type 1 diabetes (T1D) who use multiple daily insulin injections (MDI), or with type 2 diabetes (T2D) who use MDI, basal insulin only, or who are candidates to initiate basal insulin, in conjunction with continuous glucose monitoring (CGM).",[37,246],"Type 2 Diabetes (T2D)",[221,248,249,250,251,252,253,254],"insulin","titration","algorithm","adults","continuous glucose monitoring","multiple daily injections","type 2 diabetes","2026-07-21",{"date":257,"type":56},"2026-07-22",{"date":259,"type":56},"2026-05-25",{"date":261,"type":22},"2027-01",{"name":263,"class":63},"DreaMed Diabetes",4,{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":272,"maxAge":73,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":64},"100590460","building-and-sustaining-exercise-habits-for-adults-with-type-1-diabetes-100590460","NCT06967701","Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes","Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Pilot Efficacy Study","Inclusion criteria:\n\n* 30-65 years old inclusive\n* Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)\n* Less than 1.0 exercise sessions per week\n* Smartphone ownership\n* English literacy\n* Under regular care by a healthcare provider (1+ appointments per year)\n* Home Broadband wireless Internet or cell phone network\n* Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks\n* Using insulin pump or pen and sharing data with medical record for at least 6 weeks\n\nExclusion criteria:\n\n* Diabetic ketoacidosis not clearly related to pump site failure in past 6 months\n* \\>1 episode of severe hypoglycemia (altered mental and\u002For physical status requiring assistance from another person for recovery) in past 6 months\n* A1c ≥10.0%\n* Resting blood pressure \\>160mmHg systolic or \\>100 mmHg diastolic.\n* Myocardial infarction or angina in past 12 months\n* Uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, ventricular tachycardia, escape rhythms)\n* Congestive heart failure (stage 3 or 4)\n* Exercise-induced asthma (not controlled on inhalers)\n* Chronic obstructive pulmonary disease (requiring home oxygen)\n* Renal failure\n* Pregnancy\n* Cognitive impairment\n* Severe retinopathy or neuropathy.\n* Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)","30 Years",{"count":274,"type":22},60,[77],"The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This remote participation-based research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently. You do not need to live in Connecticut to participate, as there will be no required in-person visits during the study.",[37,278,279],"Latent Autoimmune Diabetes in Adult (LADA)","Pancreatitis",[281,282,283,284,285],"exercise","physical activity","mobile phone","health coaching","fitness watch",{"date":257,"type":56},{"date":288,"type":56},"2025-07-10",{"date":290,"type":22},"2027-10",{"name":292,"class":101},"Yale University",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100640000","universal-type-1-diabetes-screening-in-pediatrics-100640000","NCT07612475","Universal Type 1 Diabetes Screening in Pediatrics","Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics","Inclusion Criteria:\n\nChildren\n\n\\- Clinics will be encouraged to select screening ages or visits that align with international consensus statements for screening during early childhood, mid-childhood, and preadolescence and routine U.S. well-child visit schedules, and that minimize workflow disruption and maximize screening completion, such as visits that already include blood draws for other routine tests (e.g., lead screening at age 2). Children who have visits at their clinic's selected ages will be eligible to have their data extracted from the electronic health record (EHR)\n\nParents\u002FCaregivers - All parents or legal guardians (hereafter, parents) who attended the well-child visit, who are eligible to have their child's EHR data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.\n\nClinicians and Other Care Team Members\n\n* All pediatric primary care clinicians (i.e., physician \\[MD, DO\\], nurse practitioner, physician assistant) at participating clinics will be eligible to complete an interview.\n* All other care team members, including nurses, medical assistants, phlebotomists, and front desk staff at participating clinics will be eligible to complete an interview.\n\nExclusion Criteria:\n\n\\- Parents who have opted-out of survey recruitment at their clinic will not be eligible for the survey\u002Finterview.","1 Year",{"count":302,"type":22},9500,"This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.",[37],[306,307,32,308,309,310],"Implementation Science","Pediatrics","Universal Screening","Islet Autoantibodies","Population-based Screening","2026-07-16",{"date":313,"type":56},"2026-07-20",{"date":313,"type":22},{"date":316,"type":22},"2027-10-19",{"name":318,"class":101},"Northwestern University",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":73,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":64},"100644045","dietary-approaches-for-the-management-of-overweight-and-obesity-in-type-1-diabetes-100644045","NCT07667504","Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes","Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study","D1ANA","Inclusion Criteria:\n\n* T1D treated with intensive insulin therapy (multiple daily insulin injections or continuous subcutaneous insulin infusion systems)\n* HbA1c 6.5-9%\n* BMI ≥ 25 and ≤ 45 kg\u002Fm2\n* Active prescription and use of CGM\n* Active prescription for glucagon\n\nExclusion Criteria:\n\n* Pregnancy, pregnancy planning, or breastfeeding\n* Forms of diabetes other than T1D, or T1D duration \\\u003C 1 year\n* Previous cardiovascular events (acute myocardial infarction or stroke), heart failure, unstable coronary artery disease, chronic kidney disease with estimated glomerular filtration rate ≤ 30 mL\u002Fmin\u002Fm², cirrhosis, or presence of active cancer\n* Unstable diabetes, episodes of glycemic decompensation (diabetic ketoacidosis) or severe hypoglycemia (level 3) within the past year.\n* Planned change in treatment during the study (switching from multiple daily insulin injections to continuous insulin infusion, or vice versa)\n* Use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1\u002FGIP agonists, or other medications that may influence weight loss\n* Having experienced a change in body weight greater than 5% within the 3 months before screening\n* Following any form of diet prior to inclusion, carbohydrate restriction, or intermittent fasting\n* History of eating disorders or alcohol abuse\n* Inability to follow the dietary recommendations\n* Presence of other conditions that, in the investigator's judgment, may compromise participation in the study.",{"count":328,"type":22},75,[77],"Although type 1 diabetes (T1D) has traditionally been considered a disease associated with a lean phenotype, it is estimated that up to 2 out of 3 people living with T1D are overweight or obese, factors linked to an increased risk of complications in these patients. The available evidence regarding nutritional strategies for weight loss in T1D is very limited, and clinical trials are needed to determine how to effectively and safely promote weight loss in this population. In recent years, low-carbohydrate diets and several intermittent fasting protocols have demonstrated efficacy in promoting weight loss both in patients with type 2 diabetes and in patients with obesity without diabetes. This study will evaluate the efficacy of moderate carbohydrate restriction, time-restricted eating, and standard calorie restriction for weight loss in adults with T1D and overweight\u002Fobesity.",[37,332],"Obesity & Overweight","2026-07-13",{"date":335,"type":56},"2026-07-15",{"date":337,"type":56},"2026-07-02",{"date":339,"type":22},"2028-07",{"name":341,"class":101},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100645986","phase-2-metabolic-modulation-to-enhance-insulin-sensitivity-and-mitochondrial-function-in-type-1-diabetes-metmod-t1d-100645986","NCT07699380","METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)","MetMod-T1D","Inclusion Criteria:\n\n1. Adults ≥18 years to \\\u003C70 years of age with established T1D (duration ≥1 year)\n2. Currently on insulin therapy (multiple daily injections or insulin pump)\n3. HbA1c \\\u003C9.5%\n4. BMI 18.5-40 kg\u002Fm2\n5. On stable dose of RASB or statin, if indicated\n6. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. History of pancreatic disease (including pancreatitis) or pancreatic surgery\n2. History of cardiovascular disease or stroke within the past 6 months\n3. History of heart failure per New York Heart Association criteria\n4. History of severe edema or salt restriction requirement\n5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids\n6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²\n7. Liver disease (ALT\u002FAST \\>3x upper limit of normal \\[ULN\\])\n8. Pregnancy, breastfeeding, or planning pregnancy during the study period\n9. Known hypersensitivity to study drug components\n10. Abnormal baseline ECG\n11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)\n12. Chronic use of anticoagulants\n13. Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3\n14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein\n15. History of severe hypoglycemia requiring assistance within the past 3 months\n16. History of diabetic ketoacidosis (DKA) within the past 3 months\n17. Personal or family history of breast cancer or ovarian cancer\n18. Current participation in another clinical trial\n19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate","69 Years",{"count":274,"type":22},[26],"The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center\u002FDiabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.",[37,354,355,356,44,43,357,358,359],"Metabolic Diseases","Glucose Metabolism Disorders","Endocrine System Diseases","Diabetes Melletus, Type 1","Nutritional and Metabolic Diseases","Combination Therapy","2026-07-09",{"date":333,"type":56},{"date":363,"type":22},"2026-06",{"date":365,"type":22},"2029-12",{"name":367,"class":101},"University of Washington",2,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":377,"minAge":138,"maxAge":139,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":129},"100583977","automated-insulin-for-management-of-intrapartum-glycemia-100583977","NCT06883344","Automated Insulin for Management of Intrapartum Glycemia","Automated Insulin for Management of Intrapartum Glycemia (AIMING): a Multicenter Randomized Controlled Trial","AIMING","Inclusion Criteria:\n\n* Currently pregnant at ≥ 34 weeks\n* Known diagnosis of type 1 diabetes ≥ 1 year\n* Use of commercially available AID system since at least 28 weeks gestation\n* Singleton pregnancy\n* English- or Spanish-speaking\n\nExclusion Criteria:\n\n* Multifetal gestation\n* Planned cesarean delivery\n* Use of medications known to interfere with glucose metabolism\n* Intrauterine fetal demise\n* Physical or psychological disease likely to interfere with the conduct of the study and\u002For the ability to participate in own healthcare","FEMALE",{"count":379,"type":22},150,[77],"The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor\u002Fdelivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are\n\n* What are the neonatal glycemic outcomes with use of AID systems during labor\u002Fdelivery?\n* Do patients report higher birth satisfaction with use of AID systems during labor\u002Fdelivery?\n* Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor\u002Fdelivery?\n\nResearchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor\u002Fdelivery) by randomly assigning participants to one or the other.",[37,383,384],"Pregnancy","Pre-Gestational Diabetes",[383,386,387,388,389],"Intrapartum glycemic management","Neonatal hypoglycemia","Perinatal care","Diabetes in pregnancy",{"date":333,"type":56},{"date":392,"type":56},"2025-12-05",{"date":202,"type":22},{"name":395,"class":101},"University of California, San Francisco",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":403,"sex":17,"minAge":300,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":407,"conditions":408,"keywords":410,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":425},"100602022","innodia-family--friends-early-stage-t1d-detection-protocol-100602022","NCT07118098","INNODIA Family & Friends Early-Stage T1D Detection Protocol","INNODIA DETECT","Inclusion Criteria:\n\n1. Have given written informed consent to participate\n2. Be aged between 1 and 45 years\n3. Have a family relative with T1D or close friend diagnosed with symptomatic T1D at age \\\u003C45 years\n\nExclusion Criteria:\n\n1. Previous diagnosis of stage 3 T1D or other forms of diabetes\n2. Unable\u002Funwilling to consent to participation",true,"45 Years",{"count":406,"type":22},30000,"The purpose of INNODIA DETECT is to identify people who are at increased risk of developing T1D. Investigators are doing this by testing for markers in the blood (autoantibodies) that tell them an individuals risk of getting T1D in the future.\n\nWhat is Type 1 Diabetes (T1D)? T1D is a serious disease where the blood glucose (sugar) level is too high because the body cannot make a hormone called insulin.\n\nThis happens when the body's immune system attacks the cells in the pancreas that make insulin (called beta cells), meaning that insulin production stops.\n\nThis is harmful to the body as insulin does an essential job. It allows the glucose in the blood to enter cells and fuel the body, resulting in a lowering of the blood glucose level.\n\nWhat are Autoantibodies? T1D autoantibodies are markers found in the blood that indicate that the destruction of insulin producing cells has begun. The risk of developing T1D increases with the number of autoantibodies detected.\n\nPeople who have 1 autoantibody detected in their blood are at increased risk of developing T1D. The presence of 2 or more autoantibodies indicates that T1D is present but the individual does not show any signs or symptoms yet.\n\nHowever, these autoantibodies can be present for many years before someone develops symptoms of T1D. They often appear in the first few years of life.\n\nThe investigators are asking children and adults across Europe, aged between 1 and 45 years, who have either a family member (parent, child, full or half sibling) or close friend diagnosed with T1D before 45 years of age to provided a small blood sample so they can look at these T1D autoantibodies.\n\nIf a participant's autoantibody results are negative, this means they do not have autoantibodies and are at low risk of developing T1D. No further tests will be required, and they will exit the program.\n\nIf results indicate a participant has 1 or more positive T1D autoantibodies, a member of the clinical team will contact and invite them to the hospital for a venous blood sample to confirm the result. This confirmation test will be done as part of routine clinical care by the participants clinical team. INNODIA DETECT will end here and, if confirmed positive, the participant will be invited to attend further follow-up by entering in a separate protocol (named INNODIA MONITOR).",[37,409],"Pre Diabetes",[411,412,413,414,415,416],"Type 1 diabetes","Autoantibodies","Screening","Pre-T1D","Stage 1","Stage 2","2026-07-08",{"date":419,"type":56},"2026-07-10",{"date":421,"type":56},"2025-06-25",{"date":126,"type":22},{"name":424,"class":101},"INNODIA iVZW",15,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":73,"enrollmentInfo":432,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":64},"100569462","monocytes-in-subjects-with-type-1-diabetes-and-chronic-kidney-disease-100569462","NCT06694558","Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease","Inclusion Criteria:\n\n1. T1D CKD subjects:\n\n   1. Adults, males or females diagnosed with T1D\n   2. Age 18-65 years\n   3. Diagnosed with CKD (eGFR 60-90 ml\u002Fmin\u002F1.73 m2)\n   4. Diagnosed with albuminuria (UACR 30-500 mg\u002Fg)\n   5. On insulin injections or pump\n   6. On CGM\n\n   Based on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\\\u003C60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\\>70% A1c 5.0-7.0\n2. Controls: T1D subjects without CKD\n\n   1. Adults, males or females diagnosed with T1D\n   2. Age 18-65 years\n   3. No CKD (eGFR \\>90 ml\u002Fmin\u002F1.73 m2)\n   4. No albuminuria (UACR \\\u003C30 mg\u002Fg)\n   5. On insulin injections or pump\n   6. On CGM\n\nBased on baseline CGM metrics, the investigators will stratify subjects to 2 groups Group A (Lower TIR group): TIR\\\u003C60%, A1c 7.5-9.5 Group B (Higher TIR group): TIR\\>70% A1c 5.0-7.0\n\nExclusion Criteria:\n\n1. Hemoglobin \\\u003C9\n2. On GLP-1 agonist or DPP4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days\n3. pregnancy or plans to become pregnant\n4. On steroids\n5. Diagnosed with cancer, immunosuppression\u002Fautoimmune conditions\n6. Reported heavy alcohol use or recreational drug use\n7. Any condition which jeopardizes patient safety or affects monocytes at physician's discretion",{"count":274,"type":22},"This is a cross-sectional study in patients with Type 1 diabetes (TID) and chronic kidney disease (CKD) to test if time in range (TIR) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (GLP-1) agonist treatment ex vivo.",[435,37],"Chronic Kidney Disease(CKD)","2026-07-06",{"date":417,"type":56},{"date":439,"type":56},"2025-03-01",{"date":441,"type":22},"2027-07-01",{"name":443,"class":101},"The Cleveland Clinic",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":451,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":64},"100646985","phase-2-platform-trial-in-stage-1-diabetes-comparing-golimumab-vs-placebo-100646985","NCT07683026","Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo","Adaptive Platform Trial to Delay Progression From Normoglycemia to Dysglycemia in Presymptomatic Type 1 Diabetes: Golimumab Substudy","Inclusion Criteria:\n\n1. Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \\\u003C18 years of age.\n2. Weight ≥15 kg at the time of screening.\n3. Aged ≥2 to \\\u003C45 years.\n4. A confirmed history of either IA2A alone or at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. Confirmed autoantibody result means that the presence of the antibody has been verified on more than one occasion. For multiple autoantibody positivity, the same autoantibodies do not need to be present on the different tests. Confirmation must occur within the six months prior to screening. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this study.\n5. Oral glucose tolerance test (OGTT) results demonstrating normal glucose tolerance within 7 weeks (52 days) prior to randomization. If a participant has known previous abnormal glucose tolerance, the two most recent OGTTs must demonstrate normal glucose tolerance to be eligible.\n6. CMV and\u002For EBV seronegative participants must be CMV and EBV PCR negative within 60 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.\n7. CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have EBV PCR \\\u003C 2,000 IU\u002FmL within 60 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.\n8. Be at least 4 weeks from last live immunization.\n9. Be willing to forgo live vaccines during treatment and for 3 months after study drug treatment period.\n10. Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).\n11. Negative Coccidioides serology testing for those who have in the past resided in for at least 2 months, currently reside in, or within the past 2 months have visited an endemic area (as defined in Protocol MOO Appendix B).\n12. If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through up to 3 months after last study drug administration and undergo pregnancy testing at each study visit.\n\nExclusion Criteria:\n\n1. One or more screening laboratory values as stated:\n\n   1. Leukocytes \\\u003C3,500\u002FμL or \\>14,000\u002FμL\n   2. Neutrophils \\\u003C1,500\u002FmL\n   3. Platelet count \\\u003C100,000 \u002FμL\n   4. Hemoglobin \\\u003C6.2 mmol\u002FL (10.0 g\u002FdL)\n   5. AST or ALT ≥ 2 times the upper limits of normal (2x ULN)\n2. Abnormal Glucose Tolerance or Diabetes\n\n   1. Fasting plasma glucose ≥100 mg\u002FdL (6.1 mmol\u002FL), or\n   2. 2 hour plasma glucose ≥140 mg\u002FdL (7.8 mmol\u002FL), or\n   3. 30, 60, or 90 minute plasma glucose during OGTT ≥200 mg\u002FdL (11.1 mmol\u002FL)\n3. History of treatment with insulin except transient use during acute illness or hospitalization.\n4. Vaccination with a live vaccine within the last 4 weeks or killed\u002Finactivated vaccine within the last 2 weeks prior to randomization.\n5. A history of confirmed infectious mononucleosis within the 3 months prior to randomization, as documented by EBV serology (EBV VCA-IgM and VCA-IgG; PCR would be confirmatory).\n6. Evidence of prior or current tuberculosis (TB) infection through any one or more of the following:\n\n   1. A history of latent or active TB\n   2. Signs and\u002For symptoms of TB\n   3. Recent close contact with a person with known or suspected active TB unless appropriate prophylaxis for TB was given\n   4. A history of a chest X-ray consistent with active TB or old, inactive TB\n   5. A history of a positive purified protein derivative (PPD) skin test result (\\>10 mm induration), or positive\u002Frepeatedly indeterminate on an interferon-gamma release assay (IGRA; e.g., QuantiFERON-TB test).\n7. Prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, or an open, draining, or infected non-healing skin wound or ulcer.\n8. Known active infection or active signs or symptoms of acute or chronic infection at the time of randomization including SARS-Cov-2.\n9. Have or had a demyelinating disorder such as multiple sclerosis or Guillain-Barré syndrome.\n10. Current diagnosis of other autoimmune diseases except stable and\u002For adequately treated hypothyroidism and\u002For celiac disease (participants must be well controlled for the previous 6 months).\n11. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of the screening visit.\n12. Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment.\n13. History of blastomycosis, histoplasmosis, or coccidioidomycosis.\n14. A history of malignancies other than fully treated basal cell or squamous cell carcinoma of the skin.\n15. Have or had moderate to severe congestive heart failure.\n16. Ongoing or anticipated future use of any medications known to impact T1D progression.\n17. Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n18. Be pregnant or lactating or anticipate becoming pregnant during the study.\n19. Any condition, prior treatment, or laboratory abnormality that in the investigator's opinion may adversely affect study participation or confound study results.","2 Years","44 Years",{"count":454,"type":22},255,[26],"The goal of this clinical trial is to learn if golimumab is effective at preventing progression to Stage 2 diabetes in participants with presymptomatic Type 1 Diabetes. The expected duration of this study is approximately 6 years.\n\nParticipants will:\n\n* Take golimumab or placebo injections monthly for the duration of the study or until they are diagnosed with either stage 2 or stage 3 Type 1 Diabetes\n* Visit a study clinic every 6 months for Oral Glucose Tolerance Tests (OGTTs) and other tests until the end of the study",[37],[459,34,460],"TrialNet","Golimumab","2026-06-30",{"date":436,"type":56},{"date":464,"type":22},"2026-08-08",{"date":466,"type":22},"2032-09-01",{"name":468,"class":469},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":478,"maxAge":479,"enrollmentInfo":480,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":264},"100644549","phase-3-prise-personalized-response-and-immunologic-surveillance-of-endogenous-c-peptide-preservation-in-new-recent-and-established-onset-type-1-diabetes-treated-with-human-anti-thymocyte-globulin-h-atg-study-100644549","NCT07670650","PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study","A Phase 3, Randomized, Double-Blind, Placebo-Controlled 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 T1D, Recent Onset T1D, and Established T1D","PRISE-hATG","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian for participants below the legal age of consent 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. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.\n2. Males and females 5-40 years old\\*, inclusive, at the time of randomisation.\n\n   \\* Note: Age step-down rules apply, as described in protocol Section 6.1.\n3. Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) between 16 to 32 (inclusive).\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria (refer Section 22.1) as following:\n\n   * For Cohort 2: within \\>100 days but \\\u003C1 year (365 days) of randomisation;\n   * For Cohort 3: within ≥1 year (365 days) but \\\u003C2 years (730 days) of randomisation. For participants who were initially misdiagnosed with Type 2 diabetes (T2D), time from misdiagnosis with T2D to randomisation is up to 1 and 2 years.\n\n   Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy the time of randomisation.\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   1. 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\n   2. If of childbearing potential, must:\n\n   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 the time of signing the consent form until the end of the 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 \\[Section 11.3.1\\]) from the time of 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 the time of signing the consent form until End of Study (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 \\[refer to Section 11.3.1\\]) from the time of 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 the time of 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). This includes participants with Hereditary Fructose Intolerance.\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 erythaematosis) 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 hospitalisation or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active CMV, 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 (defined as PCR \\\u003C1000 copies\u002FmL or its equivalent in plasma or serum based on the site-specific PCR assay) 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 site laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant may be eligible for randomisation. 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\n\n    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 references 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 on the investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    Countries within the EU member states only:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): from 30 days before dosing through 6 months following administration of SAB-142 for each TP;\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: from 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    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of each TP.\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. Note: Investigators should ensure that all study inclusion criteria and no study exclusion criteria have been met at screening. If a participant's clinical status changes (including any available laboratory results or receipt of additional medical records) after screening but before the first dose of study drug is given such that he or she no longer meets all eligibility criteria, then the participant should be excluded from participation in the study.\n22. An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI or if participation in the study may place the participant at risk.\n23. An individual who has been placed in an institution by official or court order.","5 Years","40 Years",{"count":481,"type":22},108,[483],"PHASE3","This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of SAB-142, a fully human anti-thymocyte globulin (h-ATG), in participants aged 5 to 40 years with Stage 3 type 1 diabetes (T1D). The study will enroll participants with recent-onset T1D (\\>100 days to \\\u003C1 year from diagnosis) and established-onset T1D (≥1 year to ≤2 years from diagnosis) who retain residual beta-cell function as demonstrated by stimulated C-peptide levels \\>0.2 nmol\u002FL. Participants will be randomized in a 2:1 ratio to receive SAB-142 or placebo in addition to standard diabetes care. The primary objective is to determine whether SAB-142 preserves beta-cell function over 12 months as measured by stimulated C-peptide response during a mixed meal tolerance test (MMTT). External data from the SAB-142-201 SAFEGUARD study will be incorporated to include participants with new-onset T1D (\\\u003C100 days from diagnosis) in the primary efficacy analysis.",[37],"2026-06-25",{"date":488,"type":56},"2026-06-26",{"date":490,"type":22},"2026-09-01",{"date":492,"type":22},"2030-09-01",{"name":494,"class":101},"University of Florida",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":502,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":64},"100564044","circadian-mechanisms-glucose-and-cv-risks-in-t1d-100564044","NCT06624046","Circadian Mechanisms, Glucose, and CV Risks in T1D","Circadian Mechanisms of Glycemic Control and Cardiovascular Risk in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Adults 18-50 years with a clinical diagnosis of T1D for at least one year\n* Report habitual sleep irregularity ≥1 hour\u002Fweek\n* Desire to improve sleep, and own a smartphone (Android or iPhone)\n\nExclusion Criteria:\n\n* Self-reported A1C within the past 6 months ≥10%\n* insomnia symptoms defined as Insomnia Severity Index score ≥15\n* history of restless leg syndrome\n* history of severe hypoglycemia (defined as hypoglycemic episode that results in loss of consciousness, seizure, or requiring emergency room visit or hospitalization) within the past 6 months\n* rotating shift or night work or routinely sleeping after 3 AM.\n* use of sleep medications\u002Faids, significant medical comorbidities (such as heart failure, cirrhosis, chronic obstructive pulmonary disease requiring oxygen, active treatment for cancer, on renal replacement therapy \\[dialysis\\])\n* depression (Patient Health Questionnaire 8 \\[PHQ-8\\] score ≥15)\n* history of stroke with neurological deficits\n* pregnant, breast feeding, or planning pregnancy, as sleep and glucose are known to change during pregnancy and breastfeeding.\n* Allergy to lidocaine Participants who passed the first screen by phone will be scheduled for a consenting visit at UIC","50 Years",{"count":504,"type":22},100,[77],"People with type 1 diabetes are disproportionately affected by cardiovascular disease (CVD). Short and irregular sleep have been associated with cardiovascular risk in this population. Improving sleep regularity has been associated with improved glycemic markers however mechanisms by which improving sleep regularity improves metabolic and cardiovascular health is not known. The investigators propose to conduct a mechanistic study using a sleep stability manipulation. This proposal will advance the understanding of mechanisms by which improving sleep regularity influences glycemic control and cardiovascular risk in T1D.",[37],[509,510,511],"sleep","cardiovascular disease risk","glycemic control",{"date":461,"type":56},{"date":514,"type":56},"2025-03-13",{"date":516,"type":22},"2029-08-31",{"name":518,"class":101},"University of Illinois at Chicago",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":64},"100644212","efficacy-of-islet-re-transplantation-after-failure-of-beta-cell-replacement-100644212","NCT07666789","Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement","Efficacy and Safety of Islet Re-transplantation After Failure of Beta-cell Replacement","MULT-ILOT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of type 1 diabetes\n* Prior beta-cell replacement therapy : islet transplantation or pancreas transplantation\n* Islet re-transplantation performed after 2005\n* Islet re-transplantation performed after documented beta cell graft failure, defined by undetectable C-peptide and\u002For recurrence of severe hypoglycemia on insulin therapy\n* Availability of clinical and biological data required for assessment of study outcomes\n\nExclusion Criteria:\n\n* Missing or incomplete data preventing assessment of the primary outcome\n* Patients who did not meet inclusion criteria",{"count":528,"type":22},20,"Islet transplantation and pancreas transplantation are established therapeutic options for selected individuals with type 1 diabetes experiencing severe glycemic instability and recurrent hypoglycemia. Although these approaches significantly improve glycemic management and quality of life, long-term graft survival remains limited, with a progressive decline in beta-cell function over time.\n\nThe clinical benefit-risk profile of islet re-transplantation after graft failure remains poorly defined, and outcomes following repeat islet transplantation after prior islet graft failure have not been specifically evaluated.\n\nRepeated exposure to multiple donors may increase the risk of alloimmunization, including the development of donor-specific antibodies , which may adversely affect graft survival and limit access to future transplantation.\n\nThis multicenter retrospective cohort study aims to evaluate the efficacy and safety of islet re-transplantation in adults with type 1 diabetes after failure of initial beta-cell replacement (islet or pancreas transplantation), with outcomes assessed at 3 months, 1 year, and 5 years.",[37,531],"Islets of Langerhans Transplantation",[533,534,221,535,536,511],"islet transplantation","pancreas transplantation","beta cell replacement","graft survival","2026-06-21",{"date":539,"type":56},"2026-06-24",{"date":541,"type":56},"2025-07-31",{"date":543,"type":22},"2026-09-30",{"name":545,"class":101},"University Hospital, Montpellier",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":403,"sex":17,"minAge":300,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":561,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":567,"leadSponsor":569,"locationsCount":64},"100644409","finding-immune-nascent-type-1-diabetes-100644409","NCT07663136","Finding Immune Nascent Type 1 Diabetes","Finding Immune Nascent Type 1 Diabetes (FIND T1D)","FIND T1D","Inclusion Criteria:\n\n* Participant must be in Indiana Biobank\n* Participant must be able to provide consent\n* Ages 1-99 including pregnant women\n\nExclusion Criteria:\n\n* Refusal to sign informed consent for home screening is exclusionary for the home screening portion of the study\n* While other medical conditions are allowable prior diabetes diagnosis is exclusionary for home autoantibody screening","99 Years",{"count":556,"type":22},3800,[77],"The goal of this clinical trial is to understand how many individuals who previously participated in the Indiana Biobank will return a type 1 diabetes home screening kit based upon different methods of recruitment communication. The main question it aims to answer is:\n\nWhat form of recruitment communication is most effective for completing a type 1diabetes home screening kit?\n\nResearchers will compare two types of recruitment contact: email and mail based communication (low-touch) versus phone contact and follow-up by a research team member (high-touch).\n\nParticipants will be contacted either via email\u002Fmail or by phone and asked if they want to complete a type 1 diabetes home screening kit.",[560,37],"Healthy Adult",[562,221],"type 1 diabetes home screening kit","2026-06-17",{"date":565,"type":56},"2026-06-23",{"date":363,"type":22},{"date":568,"type":22},"2029-06",{"name":570,"class":101},"Indiana University",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":64},"100631978","insulin-delivery-with-self-adjusting-closed-loop-and-behavioral-glycemic-control-enhanced-by-prediction-100631978","NCT07507708","Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction","Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)","INSIGHT","Participant Inclusion Criteria\n\n1. Age ≥18.0 years old at time of consent\n2. Clinical diagnosis, based on investigator assessment, of T1D for \\> 1 year.\n3. Having used an FDA approved AID system within the last 6 months (can be intermittent use).\n4. Currently using insulin for \\>6 months.\n5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.\n6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.\n7. Participant not currently known to be pregnant or breastfeeding.\n8. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.\n9. Willingness to wear a Dexcom CGM during each of the study phases.\n10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.\n11. Willingness not to start any new non-insulin glucose-lowering agent during the trial.\n12. Willingness to participate in all study procedures including in person training.\n13. Access to internet at home and willingness to upload data during the study as needed.\n14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.\n15. Participant is proficient in reading and verbal communication in English.\n\nParticipant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.\n\n1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.\n2. Current use of sulfonylurea medications.\n3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.\n4. Current use of an SGLT-2 or SGLT-1\u002F2 inhibitor due to risk of euglycemic DKA.\n5. Hemophilia or any other bleeding disorder.\n6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.\n7. History of DKA event in the last 12 months.\n8. Currently on peritoneal or hemodialysis.\n9. Currently being treated for adrenal insufficiency.\n10. Currently being treated for a seizure disorder.\n11. Hypothyroidism or hyperthyroidism that is not adequately treated.\n12. Use of oral or injectable steroids at the time of enrollment.\n13. Known ongoing adhesive intolerance that is not well managed.\n14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.\n15. Participation in another interventional trial at the time of enrollment.\n16. Participant with a direct supervisor at work\u002Fschool who is involved in the conduct of the trial.",{"count":528,"type":22},[77],"This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.",[37],[584,585,586,587,192,588,589],"Automated insulin delivery as Adaptive Network (AIDANET)","Fully automated Closed Loop (FCL)","Hybrid Closed Loop (HCL)","Continuous subcutaneous insulin infusion (CSII)","Tandem Mobi system","Anticipatory Closed Loop (ACL)",{"date":591,"type":56},"2026-06-22",{"date":593,"type":56},"2026-05-14",{"date":595,"type":22},"2026-12-31",{"name":597,"class":101},"Sue Brown",{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":608,"briefSummary":609,"conditions":610,"keywords":619,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":368},"100593800","primary-care-pragmatic-real-world-experience-for-automated-insulin-delivery-100593800","NCT07011147","Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery","PREPARE 4 AID","Inclusion Criteria:\n\n1. Age at time of consent \\>18 and \\\u003C89 years\n2. Either 2.a. or 2.b.:\n\n   1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year\n   2. Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)\n3. Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1\u002FGIP RA agents\n4. Stable doses of weight loss medications (including GLP-1 RA and GLP-1\u002FGIP RA agents) over the preceding 4 weeks as determined by the investigator.\n5. For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and\u002For indirectly, except for a dose reduction or discontinuation.\n6. Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study\n7. Willing to comply with all study procedures for the duration of the study\n8. Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP\n9. Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)\n10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol\n11. Willing and able to sign and date the Informed Consent Form (ICF)\n12. If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period\n\n    a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).\n\n    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).\n\n    iii. Placement of an intrauterine device or intrauterine hormone-releasing system.\n\n    iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository).\n\n    v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.\n\n    vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study.\n13. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration\n14. Have hardware and internet access capable of 2-way video and audio communication\n\nExclusion Criteria:\n\n1. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)\n2. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only\n3. Diagnosis of maturity-onset diabetes of the young (MODY)\n4. Plan to change usual diabetes regimen between screening and study randomization\n\n   1. This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1\u002FGIP RA medication\n   2. This would NOT include changes to any insulin doses, including pump settings, short- and\u002For long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1\u002FGIP RA); or changing type of type 2 diabetes medication within the same class\n5. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface\n6. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation\n7. Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. \"DIY Loop\", \"AAPS\", \"iAPS\" or \"Open APS\")\n8. Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy\n9. Planned use of hydroxyurea at any dose and\u002For of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.\n10. Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment\n11. Current participation in another diabetes-related clinical trial\n12. History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy\n13. Have a history of intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)\n14. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the 6 months prior to screening, unrelated to an intercurrent illness or to a kinked, dislodged, or occluded cannula\n15. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n16. Treated currently or within the past 30 days prior to enrollment, or plan to begin treatment, with sulfonylurea, pramlintide, or SGLT-2 inhibitor medication\n17. Any planned surgery during the study that would be considered major in the opinion of the investigator\n18. Pregnant or lactating, or planning to become pregnant in the next 6 months\n19. Renal failure on dialysis or chronic renal disease with a GFR or eGFR \\\u003C30mL\u002Fmin (values within the last two years will be accepted; if none available or \\>2 years prior, participant will be instructed to obtain GFR or eGFR through their usual care provider and to make copy of result available to study team)\n20. Any condition or circumstance that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study or which could compromise the results of the study c. Conditions to be considered by the investigator may include, but are not limited to, the following: i. Active clinical diagnosis of substance use disorder ii. Chronic use of opiates and\u002For benzodiazepines which, in the opinion of the investigator, might make it difficult for the participant to follow study procedures iii. Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening, a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting iv. Known history of prolonged QTc interval, malignant arrhythmia, or severe congenital heart disease v. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV vi. History of TIA or stroke in the last 12 months vii. Untreated or inadequately treated mental illness viii. History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia, or omission of insulin to manipulate weight ix. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n21. Plans to travel outside of the US and its territories for more than four weeks consecutively\n22. Plans not to have internet\u002Fvideo\u002Fphone access for more than one week consecutively\n23. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial\n24. Previous use of the iLet for more than four weeks (including use of the commercially available iLet or prior participation in a study involving wearing the iLet for more than four weeks)","89 Years",{"count":607,"type":22},240,[77],"The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:\n\nCan the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?\n\nResearchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.\n\nParticipants will:\n\nUse the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks",[37,611,612,47,613,614,615,88,616,617,618],"Type 2 Diabetes","Diabetes, Autoimmune","Diabetes Mellitus Type 2","Diabetes Mellitus, Type I","Diabetes, Type II","Diabetes Mellitus, Insulin-Dependent","Diabetes Mellitus Type II","Diabetes Type 2 on Insulin",[620,221,254,621,622,623,624,625,626,248,627],"automated insulin delivery","bionic pancreas","closed loop","pancreas, artificial","t1d","t2d","diabetes","primary care","2026-06-10",{"date":630,"type":56},"2026-06-11",{"date":632,"type":56},"2026-01-16",{"date":634,"type":22},"2029-04-01",{"name":636,"class":101},"University of Colorado, Denver",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":4,"eligibilityCriteria":643,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":139,"enrollmentInfo":644,"targetDuration":4,"studyType":23,"phases":646,"briefSummary":647,"conditions":648,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":64},"100640346","phase-1-a-research-study-investigating-the-effect-of-nnc0497-0040-in-healthy-participants-participants-with-overweight-or-obesity-and-participants-with-type-1-diabetes-with-overweight-or-obesity-100640346","NCT07578584","A Research Study Investigating the Effect of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and Participants With Type 1 Diabetes With Overweight or Obesity","Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Weekly Doses of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and in Participants With Type 1 Diabetes With Overweight or Obesity","For SAD cohorts\n\nInclusion Criteria:\n\n* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.\n* Body mass index between 18.5 kilogram per m\\^2 and 29.9 kilogram per m\\^2 (both inclusive) at screening.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Glycated haemoglobin (HbA1c) above or equal to 6.5 percentage (48 millimoles per mole) at screening.\n* Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.\n\nFor MAD1-3 cohorts\n\nInclusion Criteria:\n\n* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.\n* Body mass index between 27.0 kilogram per m\\^2 and 39.9 kilogram per m\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.\n* HbA1c above or equal to 6.5 percentage (48 millimoles per mole) at screening.\n* Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.\n\nFor MAD4 cohorts\n\nInclusion Criteria:\n\n* Male aged 18-55 years (both inclusive) at screening.\n* Body mass index between 27.0 kilogram per m\\^2 and 34.9 kilogram per m\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Diagnosed with type 1 diabetes mellitus above or equal to 1 year before screening.\n* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) more than 90 days prior to the day of screening.\n* Use of continuous glucose monitoring (CGM) device more than 90 consecutive days prior to the day of screening.\n* HbA1c in the range of 7.2percentage - 9.5percentage (both inclusive).\n\nExclusion Criteria:\n\n* Any disorder, unwillingness or inability, except for mild conditions under stable treatment associated with type 1 diabetes (T1D), which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).\n* Use of any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening or in the period between screening and randomisation.\n* Current treatment with systemically effective corticosteroids, monoamine oxidase (MAO) inhibitors, systemic non-selective beta-blockers or growth hormone.\n* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids).\n* Unwilling or unable to refrain from use of prescription medicinal products or non-prescription drugs, including use of herbal products and non-routine vitamins, within 14 days prior to the first day of dosing. Occasional use of paracetamol and ibuprofen to treat acute pain is permitted until 24 hours prior to dosing.",{"count":645,"type":22},146,[25],"The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.",[37,649,650,651],"Overweight","Obesity","Healthy Volunteers","2026-06-01",{"date":654,"type":56},"2026-06-04",{"date":656,"type":56},"2026-05-07",{"date":658,"type":22},"2028-02-18",{"name":660,"class":63},"Novo Nordisk A\u002FS",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":185,"maxAge":110,"enrollmentInfo":669,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":679,"locationsCount":64},"100564309","type-1-diabetes-rest-for-metabolic-health-100564309","NCT06627504","Type 1 Diabetes REst for Metabolic Health","Mechanisms Underlying the Relationship Between Sleep and Circadian Health and Cardiometabolic Risk in Adolescents With Type 1 Diabetes","T1DREaM","Inclusion Criteria:\n\n* High school students between the ages of 14-19 years;\n* Diagnosed with T1D for ≥1 year;\n* Using an insulin pump or other automated insulin delivery system;\n* Have typically insufficient sleep, defined by ≤ 7 h per night on school days (assessed by actigraphy);\n* With or at risk for obesity based on either above-average weight (BMI ≥50th percentile) or parental history of obesity (BMI ≥ 30 kg\u002Fm2);\n* Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.\n\nExclusion Criteria:\n\n* Prior diagnosis of a sleep disorder (e.g., insomnia, obstructive sleep apnea) or an elevated screening score on the OSA subscale of the Sleep Disorders Inventory for Students-Adolescents measure\n* Regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids);\n* Regular use of medications affecting IR (systemic steroids, adjunctive diabetes medications);\n* HbA1c ≥12%;\n* Severe illness or DKA within 60 days;\n* IQ\\\u003C70 or severe mental illness impacting sleep or ability to participate in the study;\n* Night-shift employment or other obligations that would preclude adherence to the intervention.",{"count":187,"type":22},[77],"Research has shown a link between poor sleep health and late circadian timing with cardiometabolic health in adolescents with type 1 diabetes (T1D). Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in T1D, which begins as early as adolescence, and current therapies are limited. Therefore, this study plans to investigate whether cardiometabolic health can be improved with increased sleep duration and advanced circadian timing in adolescents with T1D with habitually insufficient sleep. To answer this question, investigators will study adolescents with T1D who get \\<7h sleep on school nights and measure changes in insulin sensitivity, glycemic control, and vascular function after one month of a sleep and circadian intervention (1+ hour longer time in bed each night plus evening melatonin and morning light therapy) compared to one month of typical sleep (usual school schedule).",[37,673],"Sleep Health",{"date":675,"type":56},"2026-06-03",{"date":677,"type":56},"2025-08-12",{"date":516,"type":22},{"name":636,"class":101},{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":23,"phases":689,"briefSummary":690,"conditions":691,"keywords":692,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":64},"100637915","phase-2-cadisegliatin-as-adjunctive-therapy-to-insulin-in-participants-with-type-1-diabetes-who-are-using-hybrid-closed-loop-hcl-systems-100637915","NCT07616206","Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems","Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study","Hybrid CATT1","Key Inclusion Criteria:\n\n* Participants \\>= 18 years of age\n* Fasting plasma C-peptide levels \\\u003C0.6 ng\u002Fml\n* Average TIR \\\u003C 70% at the end of the screening period\n* Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration\n* Willing to wear a study provided CGM for study duration\n* Capable of participating in a 30-minute lasting exercise test\n\nKey Exclusion Criteria:\n\n* Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.\n* Have been hospitalized for DKA within 3 months\n* Have uncontrolled hypothyroidism or hyperthyroidism\n* Have QTcF interval \\> 450 msec for males or \\> 470 msec for females\n* Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias\n* Have persistent, uncontrolled hypertension\n* Have clinically significant cardiovascular or cerebrovascular disease\n* Have proliferative retinopathy or maculopathy requiring acute treatment\n* Have a serious concomitant systemic disorder incliuding but not limited to HIV or active Hep B or Hep C\n* Diagnosed and\u002For treated for malignancy within 3 years\n* Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,",{"count":112,"type":22},[26],"TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manager their diabetes. Patients using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 1-2 weeks followed by the second double-blind treatment period of 6 weeks where the patient will cross-over to the treatment arm that they did not receive in the first treatment period.",[37],[693],"Hybrid Closed Loop","2026-05-22",{"date":652,"type":56},{"date":697,"type":22},"2026-07",{"date":699,"type":22},"2027-05",{"name":701,"class":63},"vTv Therapeutics"]