[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes-mellitus":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,91,0,25,[9,42,64,88,120,158,180,203,230,254,287,318,341,376,386,413,437,447,471,502,534,561,583,613,639],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053771","clinical-study-to-evaluate-the-impact-of-the-accu-chek-smartguide-cgm-solution-on-the-mean-change-in-time-in-range-compared-with-self-monitoring-of-blood-glucose-in-participants-with-type-1-and-type-2-diabetes-mellitus-100053771",false,"NCT06704672","Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus","Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range of 70 - 180 mg\u002Fdl Compared to SMBG","Inclusion Criteria:\n\n* Type 1 Diabetes mellitus (T1D) or Type 2 Diabetes mellitus (T2D) diagnosed at least 12 months prior to screening, using multiple daily injection (MDI) regime for at least six months prior to screening\n* Performing SMBG, no CGM\u002Fflash glucose monitoring (FGM) use during the last six months prior screening\n* HbA1c ≥8% and ≤10% based on analysis from a local laboratory\n\nExclusion Criteria:\n\n* Untreated adrenal or thyroid insufficiency\n* Severe visual impairment\n* Significant renal impairment: eGFR \\\u003C30 ml\u002Fmin within last one year\n* Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject\n* Hematocrit greater than 10% below the lower limit of normal\n* Pregnancy (lack of negative pregnancy test - except in case of menopause, sterilization or hysterectomy - self-reported), planned pregnancy, or breast feeding\n* Allergic to the adhesive (glue or tape)\n* Skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) at the sensor application sites\n* Sickle cell disease, or hemoglobinopathy\n* Elective surgery planned that requires general anesthesia during study participation\n* Current or anticipated acute uses of glucocorticoids (oral, injectable, or intravenous)\n* Medical conditions that, per investigator determination, make it inappropriate or unsafe to target an HbA1c of \\\u003C7%. Conditions may include but are not limited to: heart failure, unstable cardiovascular disease, recent myocardial infarction, ventricular rhythm disturbances, recent transient ischemic attack or cerebrovascular accident, significant malignancy\n* Chronic use of opiates, opioids, morphinomimetics more than three times per week, which has not stopped at least 30 days prior to screening and any other medication interfering with the assessment of pain, as per investigator's discretion\n* Intake of hydroxyurea (hydroxycarbamide), levodopa, methyldopa, ascorbic acid, acetylsalicylic acid (≥300mg), which has not stopped at least 30 days prior to screening\n* Magnetic resonance tomography (MRT), computed tomography (CT), X-ray, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound planned during the course of the study\n* Planned flight or high-altitude hike (\\>3000 m) during baseline and assessment periods\n* Shift-worker (night-shifts)\n* On or planning to start a diet intended for weight change\n* Currently abusing illicit and\u002For prescription drugs or alcohol as judged by the investigator\n* Any other physical or psychological disease or psychiatric disorder that could limit adherence to the required study tasks and interfere with the normal conduct of the study as judged by the investigator\n* Dependency (e.g., employee, co-worker or family member) on sponsor, investigator or companies active in the field of CGM (e.g. Dexcom, Abbott, Menarini, Medtronic) or their subsidiaries\n* Participation in another clinical study at the same time","ALL","18 Years",{"count":20,"type":21},270,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.\n\nThe goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg\u002Fdl compared with that using self-monitoring of blood glucose (SMBG).",[27,28],"Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-04-14",{"date":37,"type":21},"2027-05-30",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",18,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100053900","gateway-safety-evaluation-of-the-minimed-nmx8-aid-system-in-children-and-adults-living-with-diabetes-100053900","NCT07228117","GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes","Inclusion Criteria:\n\n1. Age at time of screening according to diabetes type:\n\n   1. T1D: Age 7-85 years\n   2. T2D: Age 18-85 years\n2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:\n\n   1. T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.\n   2. T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis\n3. Is willing to provide informed consent\u002Fassent for participation.\n4. Subject or parent\u002Fcaregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.\n5. Is willing to wear the system continuously throughout the study.\n6. Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:\n\n   1. T1D adults (Age 18-85 years):\n\n      I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.\n   2. T2D adults (Age 18-85 years):\n\n      I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.\n   3. T1D pediatric (Age 7-17 years):\n\n   I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.\n\n   II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.\n\n   Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.\n7. Is willing to upload study pump data via an app or computer.\n8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:\n\n   1. Humalog™\\* (insulin lispro injection)\n   2. NovoLog™\\* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™\\*)\n   3. NovoRapid™\\* (insulin aspart solution for injection)\n   4. Admelog™\\* (insulin lispro injection)\n   5. Merilog™\\* (insulin aspart)\n   6. Fiasp™\\* (ultra-rapid-acting insulin aspart)\n   7. Lyumjev™\\* (ultra-rapid-acting insulin lispro)\n   8. Authorized generic insulin aspart\n   9. Authorized generic insulin lispro\n\nExclusion Criteria:\n\n1. Unable to consent due to a mental or intellectual disability.\n2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:\n\n   1. Medical assistance (i.e., Paramedics, Emergency Room \\[ER\\] or Hospitalization)\n   2. Coma or\n   3. Seizures\n3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.\n4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.\n5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n6. Currently pregnant or planning to become pregnant during the time period of study participation\n\n   1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening\n   2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable\n7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.\n8. Has diagnosis of adrenal insufficiency.\n9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.\n10. T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and\u002For Glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.\n\n    1. Participants who have stopped using metformin and\u002For GLP-1\u002FGIP have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin and\u002For GLP-1\u002FGIP must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study.\n11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 \u002FGIP containing medications (e.g., Mounjaro), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.\n\n    1. Participants who have stopped using metformin, GLP-1\u002FGIP or SGLT2 have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin, GLP-1\u002FGIP or SGLT2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study\n12. Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.\n13. Is using inhalable insulin in the 8 weeks prior to screening.\n14. Is using hydroxyurea at time of screening or plans to use it during the study\n15. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study.\n16. Is, at the discretion of the investigator, abusing drugs or alcohol.\n17. Is, in the opinion of the investigator, not able to perform all study procedures safely.\n18. Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator.\n19. Has elective surgery planned that requires general anesthesia during the course of the study.\n20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.\n21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.\n22. Is diagnosed with current eating disorder such as anorexia or bulimia.\n23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c\n24. Is on dialysis.\n25. Has an estimated Glomerular Filtration Rate (eGFR) \\\u003C30.\n26. Has celiac disease that is not adequately treated as determined by the investigator.\n27. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.\n28. Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.\n29. Is a member of the research staff involved with the study.\n30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and\u002For adult siblings).","7 Years","85 Years",{"count":51,"type":21},400,[24],"The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5\u002FSimplera Sync in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Participants will use their current therapy while also wearing the DS5\u002FSimplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if participants like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.",[27,28],"2026-07-09",{"date":32,"type":33},{"date":58,"type":33},"2026-02-02",{"date":60,"type":21},"2027-01",{"name":62,"class":40},"Medtronic MiniMed, Inc.",38,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100645052","safety-and-performance-evaluation-of-the-sava-continuous-glucose-monitor-for-effective-glucose-detection-100645052","NCT07679347","Safety and Performance Evaluation of the SAVA Continuous Glucose Monitor for Effective Glucose Detection","SPEED","Inclusion Criteria:\n\n* The participant is willing and able to give informed consent to participate in the study.\n* The participant is at least 18 years of age at the time of enrolment.\n* The participant has a clinical diagnosis of Type 1 diabetes, with 7% \\\u003C HbA1C \\\u003C 10% within the last 6 months, for a minimum of 6 months duration prior to enrolment, as determined by a medical record by an individual qualified to make a medical diagnosis, and is using insulin (either by an insulin pump, subcutaneous injections, and\u002For inhaled insulin) for at least 6 months prior to enrolment.\n* If participant is using noninsulin glucose-lowering medications (such as SGLT2I Inhibitor, Metformin, or other), dose has been stable for at least 2 weeks prior to screening.\n* The participant body weight is at least 110 pounds, in accordance with U.S. Department of Health and Human Services guidance for blood collection.\n* The participant has adequate venous access as assessed by an investigator or appropriate centre staff.\n* The participant is available to attend all three up to 8-hour, clinically supervised, in-clinic sessions and to have multiple venous and capillary blood samples collected.\n* The participant agrees to not consume Vitamin C for the duration of the study.\n* The participant is prepared to record details related to their participation (e.g. meals, finger prick times, device incidents, comfort) daily.\n* The participant is prepared to wear up to three blinded investigational devices, and one unblinded investigational device for 15 days.\n* In the investigators' opinion, are suitable for participation in the study.\n* The participant is able to read and understand English.\n* The participant is willing to return the research devices at the end of the study.\n* The participant is willing to manage diabetes with insulin during study visits as they would do otherwise.\n* The participant can commit to not getting the CGMs wet for the first 12 hours after application, such as by showering or swimming.\n\nExclusion Criteria:\n\n* The participant gave birth within the last 6 months, is pregnant, is trying to conceive or is not willing and able to practice birth control during the study duration.\n* The participant has serious concomitant disorders or diseases (e.g. history of hypoglycaemia with unawareness requiring third party assistance, coagulation disorders) that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.\n* The participant has had a recent cardiovascular event or major surgery in the last 6 months that would compromise the safety of the participant or their ability to complete the study, at the discretion of the Investigator.\n* The participant has been admitted to the hospital with Diabetic Ketoacidosis in the last 6 months prior to enrolment.\n* The participant has donated more than 500mL of blood in the past 4 weeks.\n* The participant has a blood haemoglobin (Hb) that is 10% or more below the normal reference range for men and women, at the discretion of the Investigator.\n* Current use of sulfonylurea medications.\n* Current use of GLP-1 Receptor Agonist medications.\n* The participant has an implanted medical device such as a pacemaker or an implantable cardioverter-defibrillator (ICD).\n* The participant has multiple tattoos, scars, active skin condition or wound, or significant dermatitis overlying the skin where devices are likely to be placed.\n* The participant has a known allergy or sensitivity to skin adhesives or sensor materials.\n* The participant is taking part in another interventional clinical study requiring blood sampling, an investigational drug or device during the 15-day wear period of this study.\n* The participant is using a hybrid closed loop (Automated Insulin Delivery) system or not willing to suspend their AID for the clinic sessions.\n* The participant has any X-ray or MRI scheduled at any time during the participation of the study.\n* Any other reason which, in the investigator's opinion, would compromise participant safety or data integrity.",{"count":72,"type":21},20,[24],"The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes. This is a pilot study, so the main purposes are to collect preliminary data for future studies, assess comfort and safety, and explore the accuracy of the CGM against references and benchmarks.",[27],[27,77],"Continuous Glucose Monitor","NOT_YET_RECRUITING","2026-06-30",{"date":81,"type":33},"2026-07-01",{"date":83,"type":21},"2026-08",{"date":85,"type":21},"2026-09",{"name":87,"class":40},"SAVA Technologies Ltd.",{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100637152","efficacy-of-the-omnipod-6-system-compared-with-the-omnipod-5-system-100637152","NCT07579702","Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System","Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia","STRIVE 2","Inclusion Criteria:\n\n* Age at time of consent 14-75 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment\n* Basal\u002FBolus insulin delivery via multiple daily doses or insulin pump with or without automation\n* HbA1c ≥ 7.5%\n* Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user\n* Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user\n* Currently using a continuous glucose monitor\n* Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.\n* Participant agrees to provide their own insulin for the duration of the study\n* Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and\u002For caregiver can safely operate all study devices and can adhere to the protocol\n* Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and\u002For caregiver can safely operate all study devices and can adhere to the protocol\n* If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.\n* Willing to wear the system continuously throughout the study\n* Willing and able to sign the Informed Consent Form (ICF) or has a parent\u002Fguardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged \\\u003C 18 years per local regulatory requirements\n* Able to read and understand English and operate the study device in English\n* If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n* Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk\n* Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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\n* Any planned surgery during the study which could be considered major in the judgment of the investigator\n* History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and\u002For physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n* History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure\n* Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement\n* Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n* Use of hydroxyurea\n* Plans to receive blood transfusion over the course of the study\n* Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study\n* Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.\n* Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening\n* Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).\n* Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period\n* 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\n* Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned","14 Years","75 Years",{"count":99,"type":21},200,[24],"This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.",[28,27],[104,105,106,107,108,109,110],"Omnipod","Automated Insulin Delivery","T2D","T1D","Type 2 Diabetes","Type 1 Diabetes","AID",{"date":112,"type":33},"2026-07-02",{"date":114,"type":33},"2026-05-13",{"date":116,"type":21},"2027-02-01",{"name":118,"class":40},"Insulet Corporation",12,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":134,"conditions":135,"keywords":143,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100576285","phase-1-cnp-103-in-adolescent-and-adult-subjects-ages-12-35-with-recently-diagnosed-within-6-months-stage-3-type-1-diabetes-t1d-100576285","NCT06783309","CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)","A Phase 1b\u002F2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.\n2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.\n3. Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.\n4. Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.\n5. Participants with a peak stimulated C-peptide of \\>0.2 nmol\u002FL measured from a screening mixed meal tolerance test (MMTT).\n6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.\n7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.\n8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).\n9. Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.\n10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.\n11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.\n12. Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.\n13. Participants must weigh \\>35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh \\>50 kg at Screening for Cohort 3 (600 mg).\n14. Body mass index (BMI):\n\n    1. Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)\n    2. Participants 18-35 years: 18.0-30.0 (not inclusive)\n\nExclusion Criteria:\n\n1. Participants unable to comply with prohibited medication outlined in the protocol.\n2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.\n3. Participants with a history of tuberculosis or positive Quantiferon test.\n4. Participants who received vaccinations in the following time frame:\n\n   1. Any live vaccine within 28 days prior to Screening.\n   2. Any subunit vaccine within 14 days prior to Screening.\n   3. Any COVID-19 vaccine series within 14 days prior to Screening.\n   4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)\n5. Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.\n6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.\n7. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen\u002Fantibody as determined at Screening.\n8. Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.\n9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.\n10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.\n11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.\n12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.\n13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.\n14. Known sensitivity to any components of CNP-103.","12 Years","35 Years",{"count":130,"type":21},72,[132,133],"PHASE1","PHASE2","This study is a Phase 1b\u002F2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).",[27,107,136,137,138,139,140,109,141,142],"T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes in Adolescence","Type 1 Diabetes in Children","Type 1 Diabetes (Juvenile Onset)","Type 1 Diabetes Patients","Type 1 Diabetes Mellitis",[144,107,145,146,147,136,148,149],"Diabetes","Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed",{"date":112,"type":33},{"date":152,"type":33},"2025-05-12",{"date":154,"type":21},"2027-06",{"name":156,"class":40},"COUR Pharmaceutical Development Company, Inc.",33,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":165,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":179},"100585095","basic-hematological-parameters-and-coagulation-profile-in-type-1-diabetic-children-100585095","NCT06897904","Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children","Inclusion Criteria:\n\n* Age from one month to 18 year.\n* Both sexes.\n* Patients known to have type 1 diabetes.\n\nExclusion Criteria:\n\n* Patients less than one month and more than 18years.\n* history of bleeding disorders or anemia unrelated to diabetes.\n* Otherc types of diabetes .",true,{"count":166,"type":21},110,"OBSERVATIONAL","Diabetes mellitus is a group of chronic metabolic diseases characterized by hyperglycemia .Type 1 diabetes is a heterogeneous disease related to the destruction of pancreatic beta cells and is a result of absolute lack of insulin\n\n* Diabetes mellitus has been traditionally looked upon as a disease of adults (except Type I diabetes), however it can affect individuals of any age. Given the peculiarities and problems that it carries, diabetes in children and adolescents poses special challenges to the entire society. Diabetes is the second commonest chronic disease occurring in 1 in every 1500 children by age 5 and in 1 in 350 children by age 8 . Microvascular (retinopathy, neuropathy, and nephropathy) Aim of the research to assess basic hematological parameters and coagulation profiles among type 1 diabetic children and compare them with healthy controls and macrovascular (coronary artery disease, peripheral vascular disease, and cerebrovascular disease) atherothrombotic complications may occur in children and adolescents, depending on the duration of diabetes, the degree of metabolic control, and other factorssuch as genetics . Diabetes mellitus can cause blood disorders such as deformity of red blood cells and increase their adhesion \\[6\\].It has an effect on the function of red blood cells through the interaction with the membrane and intracellular components . Red blood cell distribution width (RDW) is a measure of the difference in the size of red blood cells. An increase in RDW can be caused by anemia or nutritional deficiencies related to anemia\n* Studies have shown that the average number of red blood cells, hemoglobin and hematocrit in diabetic patients is lower than the control group, which indicates the presence of anemia in diabetic patients .",[27],"2026-06-29",{"date":79,"type":33},{"date":173,"type":33},"2025-04-01",{"date":175,"type":21},"2026-08-01",{"name":177,"class":178},"Assiut University","OTHER",1,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100576899","phase-2-efficacy-and-safety-of-teplizumab-in-japanese-participants-with-stage-2-type-1-diabetes-100576899","NCT06791291","Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes","Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.","KIBOU-T1D","Inclusion Criteria:\n\n* Male or female Japanese participant, 1 (inclusive) to 34 years (inclusive) of age, at the time of signing the informed consent. Japanese: born in Japan or ethnic Japanese born outside of Japan, and a descendent of 4 ethnic Japanese grandparents who were all born in Japan.\n* Confirmed diagnosis of Stage 2 T1D based on following criteria:\n* Participant is positive for 2 or more T1D related auto-antibodies (confirmed by written medical history and\u002For obtained at study screening). The autoantibodies that are to be confirmed are anti-GAD (glutamic acid decarboxylase), anti-IA2 (insulinoma-associated antigen 2), anti-insulin, anti-ZnT8 (zinc transporter 8), and\u002For ICA (islet cell antibody).\n* Oral glucose tolerance test (OGTT) or blood HbA1c confirms the participant has dysglycemia without overt hyperglycemia.\n* Participant must be in good health (except for being Stage 2 T1D) as determined by medical e)valuation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG) XE \" ECG \" \\\\f Abbreviation \\\\t \"electrocardiogram\" .\n* Participant is up to date with routine age-appropriate immunizations according to current local specific guideline prior to randomization.\n* Female participants should use contraceptives consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is considered fertile (woman of childbearing potential - WOCBP) from the time of menarche until becoming postmenopausal unless permanently sterile. Female participants are eligible to participate if one of the following conditions applies:\n* Is a woman of nonchildbearing potential (WONCBP) OR\n* Is a WOCBP and agrees to keep abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent, or use other highly effective contraceptive method, from signing of the informed consent to at least 3 months and 2 weeks after randomization and agrees not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction during this period.\n\nA WOCBP must have at least a negative highly sensitive pregnancy test within 48 hours before the administration of study intervention.\n\nIf a urine test cannot be confirmed as negative (eg, an ambiguous result), a blood pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Any presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, dermatologic, hepatic, renal, metabolic (except Stage 2 T1D), hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.\n* Participant has clinical signs and symptoms consistent with COVID19, eg, fever, dry cough, dyspnea, loss of taste and smell, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening. Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, mechanically ventilated).\n* For participant ≥18 years, blood donation of 400 mL within 12 weeks (male) or 16 weeks (female), 200 mL within 4 weeks or apheresis donation within 2 weeks before randomization; for participant \\\u003C18 years, blood donation of any volume within 16 weeks before randomization; for any participant, blood transfusion (any volume) within 2 months before randomization.\n* Presence or history of drug hypersensitivity to any biologic medication, or clinically significant allergic disease as diagnosed and treated by a physician. Participants with known hypersensitivity to teplizumab or components of the teplizumab injection (including sodium phosphate, sodium chloride, polysorbate 80).\n* Participants with a history of active or latent or inactive tuberculosis (TB), including chest X-ray consistent with TB, regardless of treatment, or have a positive QuantiFERON-TB Gold test or T-SPOT TB test at screening.\n* At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein Barr virus (EBV), or history of infectious mononucleosis within 3 months before enrollment.\n* At screening, participant has laboratory or clinical evidence of acute or clinically active infection with cytomegalovirus (CMV).\n* Participants with a history of invasive opportunistic infections, such as histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, aspergillosis, irrespective of resolution.\n* Participants have other autoimmune diseases, except clinically stable autoimmune thyroid disease, or celiac disease.\n* Participants with a history of malignancy occurring within 5 years before randomization (except successfully treated carcinoma in situ of the cervix, or adequately treated nonmetastatic squamous cell or basal cell carcinoma of the skin).\n* Participants with fever (temperature ≥38.0°C) within 48 hours before randomization; or with chronic persistent or recurring infection(s) requiring active treatment with antibiotics, antiviral or antifungals within 4 weeks before randomization; or with other frequent recurrent infections deemed unacceptable as per Investigator's judgement.\n* If female, pregnancy (defined as positive blood or urine pregnancy test) or breast-feeding.\n* Participant has recent or planned vaccinations as follows:\n* Live vaccines: within 8 weeks before randomization, and\u002For within 54 weeks after randomization.\n* Non-live vaccines: any initial non-live vaccination within 2 weeks before randomization, and\u002For within 8 weeks after randomization.\n* Participant has a current or prior (within 30 days before randomization) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high dose, inhaled, extensive topical, or systemic glucocorticoids.\n* Participant has a current or prior (within 30 days before randomization) treatment that is known to significantly influence glucose tolerance (anti-hyperglycemic agents, atypical antipsychotics, diphenylhydantoin, niacin etc.).\n* Participant has received any anti-CD3 (cluster of differentiation 3) antibody treatment (including teplizumab) before randomization.\n* Participant who has received any biologic therapy within five half-lives of the therapy or within 6 months before randomization whichever is longer, or plan to receive any biologic therapy within 6 weeks after randomization.\n* Any participant enrolled or having participated, in this or any other clinical study involving an investigational medicinal product (IMP) or in any other type of medical research and is still in the exclusion period according to applicable regulations (eg, having received an IMP of new active pharmaceutical ingredient (API) within 4 months or that of an approved API within 3 months before the administration of this study's IMP).\n* Participant has any of the following hematologic parameters before randomization:\n* Lymphocyte count \\\u003C1.0 ×109\u002FL.\n* Neutrophil count \\\u003C1.5 ×109\u002FL.\n* Platelet count \\\u003C150 ×109\u002FL.\n* Hemoglobin \\\u003C100 g\u002FL.\n* Participant has any of the following liver function test abnormalities before randomization:\n* AST \\>2 × ULN (upper limit normal).\n* ALT \\>2 × ULN.\n* Total bilirubin \\>1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia.\n* Positive result on any of the following tests:\n* Hepatitis B surface antigen or hepatitis B core antibody confirmed by positive HBV-DNA (hepatitis B virus DNA).\n* Anti-hepatitis C virus antibody confirmed by positive HCV-RNA (hepatitis C virus RNA).\n* Human immunodeficiency virus antigen\u002F antibodies.\n* Positive SARS-CoV-2 test.\n* Participant who has contraindications or known allergy to both nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, or anti-histamines and in the opinion of the Investigator, cannot participate in the study.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","1 Year","34 Years",{"count":191,"type":21},10,[133],"This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment.\n\nTeplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA.\n\nGiven prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.",[27],{"date":81,"type":33},{"date":197,"type":33},"2025-07-25",{"date":199,"type":21},"2028-03-06",{"name":201,"class":40},"Sanofi",11,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":229},"100644587","feasibility-and-effectiveness-of-an-ai-powered-carbohydrate-counting-educational-platform-to-support-parents-of-children-with-type-1-diabetes-100644587","NCT07671053","Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes","Feasibility and Effectiveness of an AI-Powered Carbohydrate Counting Educational Platform to Support Parents of Children With Type 1 Diabetes: A Multicentre Randomized Controlled Trial","CARB-AI","Inclusion Criteria:\n\n* Primary responsibility for carbohydrate counting and insulin dosing decisions for the child\n* English-speaking\n* Access to a smartphone (iOS or Android) with internet connectivity\n* Willing and able to provide informed consent and complete study procedures\n* Diagnosis of type 1 diabetes for at least 1 month\n* Receiving intensive insulin therapy (multiple daily injections or insulin pump)\n* Using carbohydrate counting for insulin dosing\n\nExclusion Criteria:\n\n* Child has significant developmental delay or a medical condition that substantially alters nutritional requirements or carbohydrate metabolism (e.g., celiac disease, cystic fibrosis)\n* Parent or caregiver has significant cognitive impairment that would preclude participation\n* Family plans to relocate from the study area during the study period\n* Participation in another diabetes intervention study",{"count":212,"type":21},80,[24],"The goal of this clinical trial is to learn whether an AI-powered carbohydrate counting educational platform can help parents of children with type 1 diabetes improve their carbohydrate counting skills and diabetes management. The study will include parents or primary caregivers of children aged 2-12 years with type 1 diabetes.\n\nThe main questions it aims to answer are:\n\n* Is the AI-powered educational platform feasible, acceptable, and easy for parents to use?\n* Can the platform improve carbohydrate counting accuracy, parental confidence in diabetes management, and diabetes outcomes compared with usual education alone?\n\nResearchers will compare parents who receive access to the AI-powered carbohydrate counting educational platform plus usual diabetes education with parents who receive usual diabetes education alone to see whether the AI-supported approach provides additional benefits.\n\nParticipants will:\n\n* Complete baseline assessments, including questionnaires and a carbohydrate counting test.\n* Be randomly assigned to either the AI-supported education group or the usual education group.\n* Use the assigned educational resources for 12 weeks.\n* Complete a follow-up assessment at 6 weeks and a final assessment at 12 weeks.\n* Provide information about their child's diabetes management, including HbA1c and glucose monitoring data.\n* Complete questionnaires about confidence, usability, and satisfaction with the educational support they receive.\n\nThe AI platform is designed to provide educational support only and does not replace medical advice, insulin dosing decisions, or routine diabetes care provided by healthcare professionals.",[27],[109,217,218,219,220],"Carbohydrate Counting","Artificial Intelligence","AI-Powered Education","Digital Health","2026-06-26",{"date":79,"type":33},{"date":224,"type":21},"2026-09-01",{"date":226,"type":21},"2027-12-31",{"name":228,"class":178},"Sultan Qaboos University",3,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":237,"maxAge":128,"enrollmentInfo":238,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":119},"100265401","type-1-diabetes-extension-study-100265401","NCT02734277","Type 1 Diabetes Extension Study","T1DES","Inclusion Criteria:\n\n* Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.\n* Ability to sign informed consent\u002Fassent (as applicable for children).\n\nExclusion Criteria:\n\n* Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or\n* Inability to comply with the study visit schedule and required assessments.","8 Years",{"count":239,"type":21},111,"This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D).\n\nThis observational study will:\n\n* follow participants to determine how long they continue to produce insulin, and\n* will also assess how changes in the immune system over time relate to the ability to produce insulin.\n\nThis information could help design better therapies for type 1 diabetes in the future.",[27,136,107],[243,244],"Insulin","Glucose Intolerance","2026-06-25",{"date":170,"type":33},{"date":248,"type":33},"2016-08-18",{"date":250,"type":21},"2028-08",{"name":252,"class":253},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":264,"conditions":265,"keywords":270,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":179},"100624978","validation-of-hemoglobin-a1c-in-patients-with-inflammatory-arthritis-treated-with-sulfasalazine-100624978","NCT07416656","Validation of Hemoglobin A1c in Patients With Inflammatory Arthritis Treated With Sulfasalazine","How Can We Prevent the Underdiagnosis of Diabetes and the Undertreatment of Known Diabetes in Patients With Inflammatory Arthritis Treated With Sulfasalazine?","DIA2SULFA","Inclusion Criteria:\n\n* Age ≥18 years\n* Treatment with sulfasalazine for at least 2 months prior to inclusion\n* Inflammatory arthritis diagnosis (Reumatoid Arthritis, Reaktive Arthritis, Axial spa, Psoriatic spondylitis, and Juvenil artrit)\n* HbA1c ≥38 mmol\u002Fmol obtained at least 2 months after sulfasalazine initiation OR a diabetes mellitus diagnosis (Type 1 diabetes mellitus, Type 2 diabetes mellitus, Malnutrition-related diabetes mellitus, Other specified diabetes mellitus (andre specificerede former for diabetes), and Unspecified diabetes mellitus (uspecificeret diabetes))\n* Can communicate in Danish\n* Informed consent including permission to upload glucose data and study ID to the Libreview Platform.\n\nExclusion Criteria:\n\n* Systemic treatment or local injections with glucocorticoids within the previous 2 months or planned within the following 4 weeks\n* Clinical conditions interfering with the interpretation of HbA1c expect for sulfasalazine alterations in red cell lifespan (etc. Dapson treatment)\n* Allergy towards the adhesive used in the CGM\n* Considered ineligible for participating (e.g. patients without decision-making capacity, , malignancy, terminal illness, ect.)",{"count":263,"type":21},75,"The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels.\n\nThis may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values.\n\nThe study aims to answer two main questions:\n\n1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold?\n2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol\u002Fmol)?",[266,267,268,27,269],"Inflammatory Arthritis","Diabetes (DM)","Rheumatoid Arthritis (RA)","Type 2 Diabetes (T2DM)",[271,272,273,274,275,108,144,276,277,109,278],"Validation of HbA1c","Sulfasalazine","Salazopyrin","Continuous glucose monitoring","CGM","Hemoglobin A1c","HbA1c","Fasting blood glucose","2026-06-22",{"date":245,"type":33},{"date":282,"type":33},"2026-03-10",{"date":284,"type":21},"2026-10",{"name":286,"class":178},"Klavs Würgler Hansen",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":179},"100641160","early-phase-1-simultaneous-measurement-and-responsive-treatment---part-2-100641160","NCT07655076","Simultaneous Measurement and Responsive Treatment - Part 2","SMART02","Inclusion Criteria Part A:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Total daily insulin dose (TDD) between 30 and 100 IU.\n\nInclusion Criteria Part B:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Totally daily insulin dose (TDD) between 30 and 100 IU.\n\nExclusion Criteria (A and B):\n\n* Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Failure to comply with the study protocol or with the team's recommendations.\n* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).\n* Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study. Pregnancy will be verified by urine dipstick testing at the time of admission visit.\n* Severe hypoglycemic episode within one month of admission.\n* Severe diabetic ketoacidosis episode within one month of admission.\n* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.\n* Recent (\\\u003C6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.\n* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Current or ≤ one month use of supraphysiological doses of systemic glucocorticoids\n* Pronounced lipohypertrophy in the abdominal subcutaneous adipose tissue, which may impair sensor function or insulin infusion.\n* Insufficient abdominal surface area to support the wearing of three DPP systems in Part A.",{"count":295,"type":21},40,[297],"EARLY_PHASE1","This research study is testing an investigational dual-port insulin patch pump that integrates a continuous glucose monitor (CGM) in adults with type 1 diabetes. The goal of the study is to better understand how insulin delivery near a CGM sensor affects glucose readings and to collect data to support development of a combined insulin pump and CGM system.\n\nPeople with type 1 diabetes require lifelong insulin therapy. Many use insulin pumps and CGMs, but these systems usually involve wearing multiple devices at different body sites. Managing several devices can increase treatment burden and may contribute to skin irritation, device failures, and challenges with glucose control.\n\nThis study is conducted in two in-patient parts. In Part A, participants will wear three investigational devices at the same time while glucose levels are closely monitored using laboratory blood tests and a commercial CGM. This part of the study is designed to measure how basal and bolus insulin delivery near the CGM sensor affects sensor accuracy and how quickly the sensor signal recovers after insulin delivery.\n\nIn Part B, participants will wear one investigational device while trained study staff use CGM information from the integrated sensor to guide insulin delivery recommendations generated by an automated glucose control algorithm. Insulin delivery decisions will be closely supervised, and glucose levels will be frequently monitored.\n\nParticipants will stay at the clinical research center for short, controlled study visits. Safety will be monitored throughout the study, with predefined procedures for treating low or high blood sugar. The information collected will be used to support further development of an integrated insulin pump and CGM system for people with type 1 diabetes.",[27,107,109,136],[27,301,302,303,304,305,109,306,307],"Hybrid closed-loop system","Closed-loop insulin delivery","Automated insulin delivery","Continuous Glucose Monitoring","Insulin Pump","Insulin Patch Pump","Dual-port Insulin Patch Pump","2026-06-19",{"date":310,"type":33},"2026-06-23",{"date":312,"type":33},"2026-05-19",{"date":314,"type":21},"2026-12-01",{"name":316,"class":317},"ClinSurge Research","NETWORK",{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":17,"minAge":237,"maxAge":324,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":191},"100603879","phase-2-rezpegaldesleukin-nktr-358-in-new-onset-type-1-diabetes-mellitus-100603879","NCT07142252","Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n* Provide informed consent or assent as appropriate and if \\\u003C 18 years of age have a parent or legal guardian provide informed consent.\n* Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A.\n* Diagnosis of T1D within 100 days of randomization.\n* Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A.\n* Stimulated C-peptide of ≥ 0.2 pmol\u002FmL measured during MMTT conducted at least 21 days from diagnosis of diabetes.\n* Participants ≥ 18 years old to have body weight ≥ 35 kg and ≤ 130kg.\n* Participants \\\u003C 18 years old to have body weight \\> 5th and \\\u003C98th percentile for age and sex.\n* Willing to comply with intensive diabetes management.\n* All CMV and\u002For EBV seronegative participants must be CMV and EBV PCR negative within 30 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.\n* All CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have a EBV PCR viral load \\\u003C 2,000 IU\u002FmL within 30 days of randomization. All participants may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.\n* Must meet \"TrialNet Eligibility Minimum Immunization Recommendations\" found in Appendix A of the MOO.\n* Be at least 4 weeks from last live vaccination prior to randomization.\n* Participants that are not already immunized against the current year's influenza are required to receive non-live influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available.\n* Be willing to forgo vaccines (other than killed influenza and COVID-19) during the treatment phase and the 3 months after study drug treatment period.\n* If a female participant with reproductive potential, must be willing to avoid pregnancy (abstinence or highly effective contraceptive method) through the completion of the study and undergo pregnancy testing prior to each study visit.\n* Males of reproductive age must use an adequate contraceptive method during the treatment phase and for 3 months following the last dose of study drug.\n\nA Only adult participants ≥ 18 years old are permitted to be included in the first 18 enrolled participants in this study. Participants ≥ 12 and \\\u003C 18 years of age are only permitted to screen for this study if the safety review of the first 18 adult participants is assessed favorably by the TrialNet DSMB in consultation with Nektar Safety Group. Once an additional 17 participants ages 12 to 45, including at least 9 participants aged 12-17, enroll and complete through the 6-month visit and have the safety review assessed favorably by the TrialNet DSMB in consultation with Nektar Safety Group, then the trial is permitted to screen and enroll the remaining 31 enrollees ≥ 8 and ≤ 45 years old. If data at either juncture do not support expansion into the pediatric ages, the trial will enroll the remaining participants to reach the target sample size with the currently approved age thresholds. See protocol sections 2.5 and 3.5 for additional details.\n\nExclusion Criteria:\n\n* One or more screening laboratory values as stated\n\n  * Neutrophils \\\u003C 1,500 \u002FμL\n  * Lymphocytes \\\u003C 800 \u002FμL\n  * Platelets \\\u003C 100,000 \u002FμL\n  * Hemoglobin \\\u003C 6.2 mmol\u002FL (10.0 g\u002FdL)\n  * Eosinophils \\> 1,000 \u002FμL\n  * Potassium \\> 5.5 mmol\u002FL or \\\u003C 3.0 mmol\u002FL\n  * Sodium \\> 150 mmol\u002FL or \\\u003C 130 mmol\u002FL\n  * Estimated Glomerular Filtration Rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2\n  * AST or ALT or ALP \\> 2 times the upper limit of normal based on lab reference range\n  * Total Bilirubin ≥ 1.5 times upper limit of normal unless diagnosed with Gilbert's syndrome\n  * Serum creatinine \\> 2 times the upper limit of normal\n* Current or ongoing use of non-insulin pharmaceuticals that affect glycemia within 7 days of the screening visit or any prohibited concomitant medication as listed in section 3.7.\n* Concurrent treatment with systemic immunosuppressive agents (including biologics or steroids) - intranasal and inhaled corticosteroids are permitted as well as eye and ear drops containing corticosteroids.\n* Have active signs or symptoms of acute infection at the time of randomization.\n* Active acute or chronic infection requiring medical treatment (antibiotics, antiviral, antifungal) within 4 weeks of baseline visit unless approved by the Infectious Disease Committee.\n* Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history.\n* Any present malignancies or history of malignancy within the past 5 years, other than a successfully treated nonmelanoma skin cancer.\n* Be currently pregnant or lactating or anticipate becoming pregnant during the study.\n* History of severe cardiac disease (i.e. myocardial infarction, unstable ischemic heart disease, cerebrovascular accident, stroke, stage 3 or 4 heart failure).\n* Have evidence of current or past HIV or Hepatitis B infection.\n* Have evidence of active Hepatitis C infection.\n* History of organ allograft.\n* Hypersensitivity to IL-2, PEG, or any components of the active drug.\n* Had major surgery within 12 weeks before the screening visit or anticipates requiring major surgery during the study.\n* Has any autoimmune disease other than T1D, stable thyroid, stable asthma, inactive Graves' disease or celiac disease (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematous) or has any other disease that may be affected by immunotherapy.\n* Screening 12-lead electrocardiogram (ECG) with findings suggestive\u002Findicative of acute ischemia, clinically important heart disease or clinically important arrhythmias.\n* Current or history thrombotic events within six months prior to randomization\n* Known or untreated clinically significant hyperthyroidism or hypothyroidism\n* Prior treatment within 12 months of randomization with an immune modulating\u002Fimmune depleting agents, such as teplizumab (TZield), thymoglobulin (ATG) or rituximab.\n* Prior treatment within 6 months of randomization with a metabolic therapy intended to alter the disease course of T1D (e.g. teplizumab).\n* Has significant and uncontrolled disease\u002Fcondition in the investigator's opinion that may adversely affect study participation or may compromise the study results or increase participant risk.","45 Years",{"count":326,"type":21},66,[133],"This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin\u002Fplacebo once every 14 days over 26 weeks with an additional 6-month follow-up period.",[27],[331,107],"TrialNet","2026-06-17",{"date":334,"type":33},"2026-06-18",{"date":336,"type":33},"2026-05-14",{"date":338,"type":21},"2028-05-25",{"name":340,"class":253},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":349,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":354,"conditions":355,"keywords":356,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":191},"100610187","phase-2-inhale-1st-afrezza-for-youth-with-newly-diagnosed-type-1-diabetes-100610187","NCT07224321","INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st: Technosphere Insulin (Afrezza®) In Combination With Basal Insulin For Youth With Newly-Diagnosed Type 1 Diabetes","INHALE-1st","Inclusion Criteria:\n\n* Age 10 to \\\u003C18 years of age\n* Clinical diagnosis of stage 3 T1D, per the investigator. Stage 3 is defined as hyperglycemia, meeting ADA glycemic and clinical diagnostic criteria\n* Able to start the Afrezza-BI regimen within 21 days following T1D diagnosis (day 1 is based on the first insulin dose)\n* Forced Expiratory Volume in One Second (FEV1) \\>80.0% of predicted Global Lung Function Initiative (GLI) value\n* Investigator believes that participant can be expected to follow the study protocol\n* No medical, psychiatric, psychosocial conditions, or medications being taken that in the investigator's judgment would be a safety concern for participation in the study\n\nExclusion Criteria:\n\n* Prior insulin treatment for stage 2 T1D\n* In the judgment of the investigator, history of chronic lung disease, such as asthma, or chronic obstructive pulmonary disease, lung cancer, or any other clinically important pulmonary disease (e.g., cystic fibrosis, bronchopulmonary dysplasia)\n* Allergy or known hypersensitivity to human regular insulin\n* Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 3 months prior to screening and\u002For positive cotinine test for smoking\n* Positive urine pregnancy test for female subjects of childbearing potential","10 Years","17 Years",{"count":352,"type":21},100,[133],"INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \\\u003C18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent\u002Flegally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.",[27],[357,243,358,359,360,361,362,109,363,364,365,366],"Diabetes Mellitus","Inhaled","Afrezza","Technosphere","Pediatric","Inhaled Insulin","Newly diagnosed type 1 diabetes","Technosphere Insulin","rapid-acting inhaled insulin","Meal-time inhaled insulin","2026-06-15",{"date":369,"type":33},"2026-06-16",{"date":371,"type":33},"2026-02-04",{"date":373,"type":21},"2027-09",{"name":375,"class":40},"Mannkind Corporation",{"id":377,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":25,"conditions":380,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":385,"locationsCount":41},"100570240",{"count":20,"type":21},[24],[27,28],"2026-06-12",{"date":367,"type":33},{"date":35,"type":33},{"date":37,"type":21},{"name":39,"class":40},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":17,"minAge":188,"maxAge":127,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":412},"100625784","pediatric-insulin-plan-calculator-for-t1dm-management-100625784","NCT07427134","Pediatric Insulin Plan Calculator for T1DM Management","Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management","FLEXI-T1D","Inclusion Criteria:\n\n* Children and adolescents \\\u003C 12 years\n* Diagnosed with Type 1 Diabetes Mellitus (T1DM)\n* Duration of diagnosis \\> 1 year\n* Using a multiple daily injection (MDI) regimen\n* Practising carbohydrate counting for at least 1 month before enrolment\n\nExclusion Criteria:\n\n* Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months\n* Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes)\n* Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy)",{"count":395,"type":21},440,[24],"This is a multi-centre, prospective, randomized, open-label controlled trial designed to evaluate the effectiveness of a flexible digital insulin dose calculator in children under 12 years of age with Type 1 Diabetes Mellitus (T1DM) managed with multiple daily injections (MDI). Participants will be stratified by continuous glucose monitoring (CGM) use and baseline HbA1c, and randomised to receive either standard care alone or standard care plus the insulin dose calculator tool for 6 months.\n\nThe primary outcome is the change in HbA1c from baseline to 6 months. Secondary outcomes include CGM-derived glycaemic metrics (Time in Range, Time Below Range, Time Above Range, and Coefficient of Variation), total daily insulin dose (units\u002Fkg\u002Fday), healthcare provider contact frequency, and caregiver-reported usability and satisfaction. The study aims to determine whether the use of a structured digital decision-support tool improves glycaemic control and supports safer insulin dosing in paediatric patients with T1DM.",[27,399,136,137],"Type 1 Diabetes Mellitus (T1DM)",[27,401,402,403],"Clinical Decision Support Tool","Digital Health Intervention","Insulin Dose Calculator","2026-06-06",{"date":406,"type":33},"2026-06-09",{"date":408,"type":33},"2026-05-03",{"date":410,"type":21},"2026-12-31",{"name":228,"class":178},2,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":188,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":22,"phases":424,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100599713","phase-3-a-study-to-investigate-efficacy-and-safety-of-teplizumab-compared-with-placebo-in-participants-1-to-25-years-of-age-with-stage-3-type-1-diabetes-100599713","NCT07088068","A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes","A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)","βETA PRESERVE","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n* Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent.\n* Participants diagnosed with T1D Stage 3 according to American Diabetes Association 2025 criteria\n* Participants able to be randomized and initiate study drug within 8 weeks (56 days) of the Stage 3 T1D diagnosis\n* Participants must be positive for at least one T1D autoantibody at screening:\n* Glutamic acid decarboxylase (GAD-65),\n* Insulinoma Antigen-2 (IA-2),\n* Zinc-transporter 8 (ZnT8), or\n* Insulin (if obtained not later than 14 days after exogenous insulin therapy initiation).\n* Islet cell cytoplasmic autoantibodies (ICAs)\n* Have random C-peptide level ≥0.2 nmol\u002FL obtained at screening\n* Enter Inclusion Criteria Sex\n* Both male and female participants are eligible.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is eligible to participate if she is not pregnant, and one of the following conditions applies:\n* Is a woman of nonchildbearing potential (WONCBP) OR\n* Is a woman of childbearing potential (WOCBP) and agrees to use a contraceptive method that is highly effective, with a failure rate of \\\u003C1% during the study intervention period (to be effective before starting the intervention) and for at least 30 days after the last administration of study intervention.\n* A WOCBP must have a negative highly sensitive pregnancy test at screening (serum) and within 24 hours (urine or serum as required by local regulations) before the first administration of study intervention.\n* Lactating woman must interrupt breastfeeding and pump and discard breast milk during and for 20 days after last administration of study intervention.\n* Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n\nNote: For minor participants, a specific ICF must also be signed by the participant's legally authorized representative (LAR).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Participant has diabetes other than autoimmune T1D that includes but is not limited to genetic forms of diabetes, maturity-onset diabetes of the young (MODY), diabetes secondary to medications or surgery and type 2 diabetes by judgement of the Investigator.\n* Participant has an active serious infection and\u002For fever ≥38.5°C (101.3°F) within the 48 hours prior to the first dose (except if localized skin infection), or has chronic, recurrent or opportunistic infectious disease.\n* At screening, participant has laboratory or clinical evidence of acute or clinically active infection with Epstein-Barr virus (EBV), cytomegalovirus (CMV).\n* At screening, participant has positive serology for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).\n* Participant has 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. Blood testing (eg, QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n* Has other autoimmune diseases, (eg, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus etc), except clinically stable autoimmune thyroid disease, or controlled celiac disease (at discretion of Investigator).\n* Any clinically significant abnormality identified either in medical\u002Fsurgical history or during screening evaluation (eg, physical examination, laboratory tests, vital signs), or any adverse event (AE) during screening period which, in the judgment of the investigator, would preclude safe completion of the study or constrains efficacy assessment.\n* Participant has recent or planned vaccinations as follows:\n* Live-attenuated (live) vaccines (eg, varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) within the 8 weeks before first dose of the investigational medicinal product (IMP) or planned\u002Frequired administration during treatment or up to 26 weeks after last IMP administration in any treatment course\n* Inactivated or mRNA vaccines within 2 weeks before the first dose of IMP or planned required administration during treatment or up to 6 weeks after last IMP administration in any treatment course.\n* Current or prior use (within 30 days before screening) of any anti-hyperglycemic agents other than insulin\n* Past (within 30 days prior to screening) or current administration of any treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status (including but not limited to oral, inhaled or systemically injected steroids with duration \\>14 days, adrenocorticotropic hormone, verapamil).\n* Past systemic immunosuppression medicine or immune modulatory biologic therapy (such as monoclonal antibodies), within 3 months or 5 half-lifes (whichever is longer) prior to dosing.\n* Current or prior (within 30 days before screening) use of any medication known to significantly influence glucose tolerance (eg, atypical antipsychotics, diphenylhydantoin, niacin).\n* Participant has previously received teplizumab or other anti-CD3 treatment.\n* Other medications not compatible or interfering with IMP at discretion of Investigator.\n* Current enrollment OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within the last 8 weeks or 5 half-lifes, whichever is longer, prior to screening.\n* Participant has any of the following laboratory parameters, at screening prior to first dose:\n* Lymphocyte count: \\\u003C1000\u002FµL,\n* Neutrophil count: \\\u003C1500\u002FµL,\n* Platelet count: \\\u003C150,000 platelets\u002FµL,\n* Hemoglobin: \\\u003C10 g\u002FdL,\n* Aspartate aminotransferase (AST) \\>2.0 × upper limit of normal (ULN),\n* Alanine aminotransferase (ALT) \\>2.0 × ULN,\n* Total bilirubin \\>1.5 × ULN with the exception of participants with the diagnosis of Gilbert's syndrome who may be eligible provided they have no other causes leading to hyperbilirubinemia\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","25 Years",{"count":423,"type":21},723,[425],"PHASE3","This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment.\n\nThe purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.",[27],"2026-06-05",{"date":430,"type":33},"2026-06-08",{"date":432,"type":33},"2025-08-06",{"date":434,"type":21},"2028-12-12",{"name":201,"class":40},159,{"id":438,"slug":4,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":53,"conditions":441,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":445,"leadSponsor":446,"locationsCount":63},"100610479",{"count":51,"type":21},[24],[27,28],"2026-06-04",{"date":430,"type":33},{"date":58,"type":33},{"date":60,"type":21},{"name":62,"class":40},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":96,"maxAge":18,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":179},"100570631","a-hybrid-effectiveness-implementation-trial-to-reduce-diabetes-distress-in-teenagers-100570631","NCT06709755","A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers","A Hybrid Effectiveness-implementation Trial of an Intervention to Reduce Diabetes-specific Emotional Distress in Teenagers","Inclusion Criteria: Eligibility criteria includes:\n\n* T1D diagnosis for at least 1-year,\n* using daily basal\u002Fbolus insulin,\n* fluent in English,\n* able to provide caregiver consent and teen assent to participate\n* able to access telehealth via a digital device. We will focus recruitment on participants from populations under-represented in diabetes research (e.g., racial and ethnic minorities, families of low SES, using public aid, or living in rural communities).\n\nExclusion Criteria: To increase generalizability into typical clinical practice, exclusion criteria are minimal and include:\n\n* cognitive or developmental disorders,\n* participants cannot be a ward of the state.",{"count":455,"type":21},360,[24],"The investigators will assess both effectiveness (primary) and implementation (secondary) outcomes for a distress-reducing intervention, Supporting Teen Problem Solving (STePS). STePS has already undergone an efficacy trial. The current study allows for evaluating the outcomes of STePS by delivering it in real-world settings, using real-world providers. The investigators will train these behavioral health providers who are already embedded in diabetes clinics to use the STePS intervention. The investigators will also compare two approaches to intervention delivery: in-person versus telehealth. The investigators have recruited 6 different study sites across the country, representing diversity in rural vs. urban, public vs private insurance, as well as in ethnic and racial background of the participants. 360 teens will be enrolled and randomized to either STePS or an educational control group on a 1:1:1 basis at each of our 6 study sites: STePS in-person (n=120), STePS telehealth (n=120), or educational control via telehealth (n=120).\n\nAll 3 groups will be delivered as 4.5-month interventions, consisting of 9 sessions offered twice per month. Quantitative data (surveys) will be collected for all participants at baseline, immediately post-intervention, and 6 \\& 12 months post-intervention. Qualitative data will also be collected post-intervention through focus groups.\n\nAim 1. To test, in 360 teens across 6 clinical sites, the effectiveness of STePS in improving diabetes- specific emotional distress and preventing worsening glycemic control, both immediately post intervention and over time. Hypothesis 1a: STePS will lead to clinically meaningful and statistically significant improvements in diabetes distress. Hypothesis 1b: STePS will prevent the worsening of glycemic control (A1C and Time in Range). These hypotheses are consistent with the efficacy trial and will prove effectiveness when implemented in real- world settings.\n\nAim 2. To assess the implementation of STePS among key stakeholders (teen participants, interventionists). Recruitment, enrollment, representativeness, feasibility, acceptability, appropriateness, fidelity, and costs will be assessed as well as preferred implementation approaches. Hypothesis 2a. Stakeholders will find few perceived barriers to implementing STePS and many perceived facilitators for adopting it in their clinical settings. Hypothesis 2b. Implementation strategies will be plausible in diabetes clinics across the country.",[27],[460,461],"diabetes distress","adolescents","2026-05-27",{"date":464,"type":33},"2026-05-29",{"date":466,"type":33},"2024-07-10",{"date":468,"type":21},"2029-03-15",{"name":470,"class":178},"Jill Weissberg-Benchell, Ph.D.",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":497,"leadSponsor":499,"locationsCount":501},"100614816","phase-2-a-clinical-trial-using-tirzepatide-to-help-adults-with-type-1-diabetes-automatically-control-their-blood-sugar-100614816","NCT07284511","A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar","Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial","TZP","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required).\n* A BMI ≥ 27 kg\u002Fm2.\n* HbA1c \\> 6.5%, and \\\u003C 12%.\n* Current therapy: multiple daily injections or insulin pump.\n* Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible)\n* Active carbohydrate counting for prandial insulin dosing.\n* Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.\n\nExclusion Criteria:\n\n* Use of GLP1-RAs within the last four weeks.\n* Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.\n* Diabetic ketoacidosis within the last 2 months.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe renal impairment with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI), measured within the last four months.\n* Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.\n* Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.\n* History of bariatric surgery within the last 6 months.\n* Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.\n* Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.\n* Any safety concern that, in the investigator's judgment, precludes participation.",{"count":480,"type":21},105,[133,425],"This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals.\n\nPeople with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose.\n\nTirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises.\n\nThis study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups:\n\nTirzepatide group:\n\nParticipants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals.\n\nControl group:\n\nParticipants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses.\n\nThe main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart\u002Ffitness, or body-composition tests.\n\nAs with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial.\n\nOverall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.",[109,27,107,136,137],[109,485,303,486,274,487,488,489,490,491,492,301,302,493],"Overweight or obesity in type 1 diabetes","Insulin pump","Tirzepatide","Mounjaro","GIP\u002FGLP-1 receptor agonist","Dual incretin therapy","Adjunctive tirzepatide therapy","Tandem Control-IQ","Dexcom G7","2026-05-22",{"date":462,"type":33},{"date":312,"type":33},{"date":498,"type":21},"2029-01",{"name":500,"class":178},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",4,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":510,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":179},"100637908","phase-2-shield-t1d-shingrix-and-glp-1-agonist-for-beta-cell-preservation-in-recent-onset-type-1-diabetes-100637908","NCT07614412","SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.","Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.","SHIELD-T1D","Inclusion Criteria:\n\n1. Diagnosis of Type 1 Diabetes (T1D) according to American Diabetes Association (ADA) criteria.\n2. Age 18 to 50 years (inclusive) at the time of screening.\n3. Randomization within 100 days of the first insulin injection.\n4. Confirmed residual beta-cell function, defined as a peak stimulated C-peptide level ≥0.2 nmol\u002FL during a Mixed Meal Tolerance Test (MMTT) performed at screening.\n5. Presence of at least one T1D-related autoantibody (GADA, IA-2A, ZnT8A, or ICA).\n6. Willingness to comply with intensive insulin therapy and glucose monitoring.\n7. Females of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis (DKA) within 4 weeks of screening.\n2. Prior use of any immunotherapy or investigational agents for T1D.\n3. Current or prior use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.\n4. History of pancreatitis or medullary thyroid carcinoma.\n5. Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis).\n6. Pregnancy or breastfeeding.\n7. Significant renal, hepatic, or cardiovascular disease.\n8. History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide.\n9. Current use of systemic corticosteroids or other immunosuppressive medications.","50 Years",{"count":512,"type":21},240,[133],"Type 1 diabetes (T1D) is a chronic autoimmune disease characterized by progressive destruction of pancreatic beta cells mediated by autoreactive T lymphocytes, resulting in absolute insulin deficiency. Preservation of residual beta-cell function at the time of diagnosis is a critical therapeutic window, as even marginal endogenous insulin secretion - reflected by detectable C-peptide levels - is associated with improved glycemic control, reduced hypoglycemia burden, and decreased long-term vascular complication rates.\n\nThis study evaluates the hypothesis that combinatorial immunomodulation - using the AS01B adjuvant system within the Recombinant Zoster Vaccine (RZV; Shingrix, GSK) alongside metabolic and cytoprotective support via a GLP-1 receptor agonist (semaglutide) - can synergistically preserve residual beta-cell function in adults within 100 days of T1D diagnosis. The AS01B adjuvant system activates innate immune pathways that promote regulatory T-cell (Treg) expansion and shift the immunological milieu toward tolerance, while GLP-1 receptor agonism provides direct beta-cell cytoprotection, reduces glucotoxicity, and may suppress autoimmune cytokine signaling.\n\nSHIELD-T1D is a randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial enrolling 240 adults (18-50 years) diagnosed with T1D within 100 days, with confirmed residual beta-cell function (stimulated C-peptide ≥0.2 nmol\u002FL). Participants are randomized 1:1:1:1 to one of four arms: (1) Shingrix alone, (2) Semaglutide alone, (3) Shingrix + Semaglutide combination, or (4) dual placebo. The primary endpoint is change in 2-hour stimulated C-peptide AUC during a Mixed Meal Tolerance Test (MMTT) from baseline to 12 months.\n\nThis phase II randomized, double-blind, placebo-controlled multicenter trial will evaluate the efficacy and safety of the recombinant zoster vaccine (Shingrix) and a glucagon-like peptide-1 (GLP-1) receptor agonist, alone and in combination, for preservation of residual beta-cell function in adults with recent-onset type 1 diabetes. The working hypothesis is that combining AS01 adjuvant-mediated immunomodulation with the metabolic and cytoprotective actions of a GLP-1 receptor agonist will provide dual protection for pancreatic beta cells, slowing autoimmune destruction and improving functional insulin secretion compared with placebo.",[27],[109,517,518,519,520,521,522,523,524],"Beta-cell preservation","C-peptide","GLP-1 receptor agonist","Recombinant zoster vaccine","Shingrix","AS01 adjuvant","Immunomodulation","Autoimmunity","2026-05-21",{"date":464,"type":33},{"date":528,"type":21},"2027-01-01",{"date":530,"type":21},"2028-12-31",{"name":532,"class":533},"Ministry of Health, Saudi Arabia","OTHER_GOV",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":324,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":557,"leadSponsor":559,"locationsCount":179},"100637548","phase-1-sequential-immune-modulation-and-antigen-specific-tolerance-induction-for-disease-modification-in-recent-onset-type-1-diabetes-100637548","NCT07610213","Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes","MATIN-2: Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes - A Mechanistic Framework and Phase I\u002FII Protocol Proposal","MATIN-2","Inclusion Criteria:\n\n* Age 18-45 years\n* Clinical diagnosis of Type 1 diabetes mellitus within 6 months of enrolment\n* Positive for at least one diabetes-related autoantibody (GAD65, IA-2, ZnT8, or IAA)\n* Detectable fasting or stimulated C-peptide ≥ 0.2 nmol\u002FL\n* HbA1c ≤ 10% (86 mmol\u002Fmol)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior immunosuppressive therapy within 3 months\n* Active or chronic infection (HIV, hepatitis B\u002FC, tuberculosis)\n* Current or prior malignancy within 5 years (except non-melanoma skin cancer)\n* Pregnancy or breastfeeding\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic impairment (Child-Pugh C)\n* Known hypersensitivity to teplizumab or any excipient\n* Participation in another interventional trial within 30 days\n* Current systemic corticosteroid or immunomodulatory agent use\n* History of other autoimmune disease requiring immunosuppression\n* Absolute lymphocyte count \\\u003C 1.0 × 10⁹\u002FL\n* ALT or AST \\> 3× upper limit of normal\n* Haemoglobin \\\u003C 100 g\u002FL\n* Unwillingness to use contraception during study period",{"count":543,"type":21},60,[132],"This study tests a three-phase immune treatment for people recently diagnosed with Type 1 diabetes (within 6 months, with some insulin production remaining).\n\nPhase 1 (weeks 1-2): Teplizumab, an anti-CD3 antibody, is given by infusion to slow immune attack on insulin-producing beta cells.\n\nPhase 2 (months 2-9): Insulin is injected directly into a lymph node (intralymphatic immunotherapy, ILIT) alongside low-dose interleukin-2 to teach the immune system to tolerate insulin and expand protective regulatory T cells.\n\nPhase 3 (months 10-24): Low-dose interleukin-2 is continued to maintain immune tolerance.\n\nThe main goal is to preserve the body's remaining insulin production (measured by C-peptide). Sixty adults aged 18-45 will be randomly assigned to the MATIN-2 protocol or standard care. Safety, immune markers, and HbA1c will also be monitored.",[399,27,547],"Autoimmune Diabetes",[549,550,551,552,518,553],"teplizumab","intralymphatic immunotherapy","regulatory T cells","immune tolerance","beta cell preservation","2026-05-20",{"date":462,"type":33},{"date":528,"type":21},{"date":558,"type":21},"2030-06-01",{"name":560,"class":178},"Abdullah Kars",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":569,"maxAge":189,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":179},"100609577","phase-2-platform-trial-to-delay-stage-3-diabetes-comparing-teplizumab-with-atg-100609577","NCT07216391","Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG","Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A","TN40A","Inclusion Criteria:\n\n* Willing to provide informed consent or have a parent or legal guardians provide informed consent when the participant is \\\u003C18 years of age.\n* Aged ≥4 to \\\u003C35 years\n* A history of at least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this trial.\n* Participants must meet ADA stage 2 T1D glycemic criteria\\* by TrialNet testing within 100 days of the baseline visit.\n\n  \\*The ADA definition of stage 2 T1D is characterized by glucose intolerance or dysglycemia in the presence of two or more islet autoantibodies, impaired fasting glucose (≥ 100mg\u002FdL), impaired glucose tolerance (2-hour post 75g glucose load ≥ 140mg\u002FdL), high glucose levels at intermediate time points on OGTT (30, 60, 90 min timepoints of ≥ 200 mg\u002FdL), and\u002For HbA1c between 5.7% and 6.4% or ≥ 10% increase in HbA1c within a two year window, with the most recent HbA1c value obtained within 100 days of the baseline visit.\n* CMV and\u002For EBV seronegative participants must be CMV and EBV PCR negative within 30 days prior to 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 the baseline visit.\n* CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have EBV PCR \\\u003C 2,000 IU\u002FmL within 30 days prior to randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days prior to the baseline visit.\n* Be at least 8 weeks from last live immunization at the time of the baseline visit.\n* Be willing to forgo vaccines (other than non-live influenza and COVID-19) during the 3 months after study drug treatment period and forgo live vaccines for 12 months after study drug treatment period.\n* Must meet TrialNet eligibility minimum immunization recommendations found in Appendix A of the manual of operations (MOO).\n* With the exception of stage 2 T1D, participants must be healthy, as defined by absence of any other untreated diagnoses that the investigator deems to be a potential confounder.\n* If a female participant with reproductive potential, willing to avoid pregnancy (abstinence or adequate contraceptive method) through the completion of the study infusions and up to 3 months after study drug administration and undergo pregnancy testing prior to each study visit.\n* Must be residing or have accommodations within 1 hour of the infusion site during study drug infusions and must be within 1 hour of a medical care facility for 1 day after completion of infusions.\n* Participants must live in a location with rapid access to emergency medical services.\n\nExclusion Criteria:\n\n* Immunodeficiency or clinically significant chronic lymphopenia: (Leukopenia (\\\u003C3,000 leukocytes\u002FμL), neutropenia (\\\u003C1,500 neutrophils\u002FμL), lymphopenia (\\\u003C800 lymphocytes\u002FμL), thrombocytopenia (\\\u003C100,000 platelets\u002FμL).\n* Hemoglobin less than 13 g\u002FdL for adult men and less than 11.5g\u002FdL for adult females and less than 11 g\u002FdL for participants under age 18.\n* Active signs or symptoms of acute or chronic infection at the time of the baseline visit including SARS-Cov-2.\n* Uncontrolled autoimmune thyroid disease and\u002For celiac disease (participants must be well controlled for the previous 6 months).\n* Evidence of prior or current tuberculosis 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, or interferon gamma release assay IGRA (QuantiFERON) test\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).\n* Currently pregnant or lactating or anticipate getting pregnant within the study period.\n* Require use of other immunosuppressive agents including chronic use of oral or intravenous injectable steroids.\n* Evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n* Any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, neurological disease, or blood count abnormalities.\n* A history of malignancies other than of skin.\n* Evidence of liver dysfunction with AST or ALT ≥ 2 times the upper limit of the reference range.\n* Evidence of renal dysfunction with creatinine ≥ 1.5 times the upper limit of the reference range.\n* Increased bilirubin ≥ 2 times (total) or ≥ 1.5 times (direct) the normal limit (Participants with documentation of Gilbert's Disease permitted).\n* Vaccination with a live vaccine within the last 8 weeks or killed\u002Finactivated vaccine within the last 2 weeks of the baseline visit.\n* Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within 14 days of screening.\n* Prior treatment with Teplizumab or ATG (either in a previous clinical trial or clinically).\n* Has previously participated in a clinical trial for diabetes prevention and received active study agent within 6 months of treatment.\n* Known allergy to rabbits or rabbit derived products.\n* Prior adverse reactions to heparin.\n* Any condition that in the investigator's opinion may adversely affect study participation.\n* Any screening\u002Fbaseline laboratory result not otherwise stated out of normal reference range and\u002For medical history that may increase the risk of the participant's participation in this trial.\n* Previously diagnosed with Stage 3 TID according to ADA criteria.","4 Years",{"count":543,"type":21},[133],"This is a 2-arm, multi-center, open label study to learn if ATG works the same or better than teplizumab in delaying or preventing Stage 3 Type 1 diabetes. Participants will be administered either 2 infusions of ATG or 14 infusions of teplizumab and will then be followed for at least 12-48 months after administration, depending on timepoint enrolled into the study. If the primary endpoint demonstrates a positive signal and as decided by TrialNet, there is potential for a study extention. This would extend follow-up visits for a possible study duration of about 9 years among the earliest enrollees of the initial study.",[27],[331,107,575,576],"Teplizumab","ATG",{"date":494,"type":33},{"date":579,"type":21},"2026-07-30",{"date":581,"type":21},"2030-05-30",{"name":340,"class":253},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":591,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":597,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":611,"locationsCount":179},"100579129","phase-2-acute-metabolic-effects-of-tirzepatide-in-type-1-diabetes-100579129","NCT06820281","Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes","Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes: a Phase 2 Double Blinded Placebo Controlled Clinical Trial (TIRTLE2)","TIRTLE2","Inclusion Criteria:\n\n* age 18-65 years\n* BMI ≥ 27 kg\u002Fm2\n* HbA1c ≤ 9.0%\n* insulin delivery using an automated insulin delivery system\n* at least 2 years since diagnosis of type 1 diabetes\n\nExclusion Criteria:\n\n* TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; steroids, antipsychotics, immunosuppressants in the last 6 weeks.\n* Hypoglycemic unawareness or severe hypoglycemia last 6 months.\n* History of seizure disorder.\n* History of weight loss surgery.\n* eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2.\n* Liver disease (known cirrhosis, LFTs \\> 3x upper limit of normal).\n* Active malignancy.\n* Pregnant, breastfeeding, planning pregnancy within 6 months, or not using adequate contraception.\n* History of cardiovascular disease, or coronary event or stroke in last 3 months\n* Hemoglobin level \\\u003C 13.5 g\u002FdL in men, \\\u003C 12.0 g\u002FdL in women","65 Years",{"count":593,"type":21},44,[133],"This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.",[27],[598,357,599,600,601,487,602,603,604,605,606],"Diabetes Mellitus, Type 1","Autoimmune Diseases","Incretins","Physiological Effects of Drugs","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Diseases","Overnutrition","Insulin Resistance","2026-05-17",{"date":312,"type":33},{"date":81,"type":21},{"date":226,"type":21},{"name":612,"class":533},"Victor Chang Cardiac Research Institute",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":164,"sex":17,"minAge":621,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":627,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":179},"100638053","evaluating-glucose-control-using-a-next-generation-aid-algorithm-in-adults-with-t1d-100638053","NCT07593625","Evaluating Glucose Control Using a Next-Generation AID Algorithm in Adults With T1D","Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Adults With Type 1 Diabetes: EVOLUTION T1D","EVOLUTIONT1D","Inclusion Criteria:\n\n* Age at time of consent 16-70 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months, based on Investigator assessment\n* Basal\u002FBolus insulin delivery via multiple daily injections or insulin pump with or without automation\n* Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents\n* Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n* If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.\n* Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol\n* Willing to wear the system continuously throughout the study\n* Willing and able to sign the Informed Consent Form (ICF)\n* Able to read and understand English\n* If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n* Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.\n* Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening\n* Any planned surgery during the study which could be considered major in the opinion of the Investigator\n* History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions\n* History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement\n* Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n* Use of hydroxyurea\n* Plans to receive blood transfusion over the course of the study\n* Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study\n* Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and\u002For GLP1, in the 4 weeks prior to screening. Participants taking metformin and\u002For GLP1 should remain on a steady dose without dose increases during study participation\n* Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).\n* In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device. Additionally, may not intend to participate in any other interventional clinical study during this study period\n* 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\n* Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned","16 Years","70 Years",{"count":295,"type":21},[24],"Single-arm feasibility study to evaluate the safety and feasibility of the Omnipod M System in adults with type 1 diabetes. This study will enroll up to 40 adult participants to have a minimum of 24 participants to initiate the use of the study device. The study will include hotel and outpatient evaluation periods.",[109,27,267],[109,107,104,628,629,110,630,631],"Omnipod M","Automated Insulin Delivery System","fully closed loop","FCL","2026-05-15",{"date":312,"type":33},{"date":635,"type":21},"2026-05-25",{"date":637,"type":21},"2026-08-30",{"name":118,"class":40},{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":643,"acronym":644,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":646,"targetDuration":4,"studyType":22,"phases":647,"briefSummary":648,"conditions":649,"keywords":650,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":656,"lastUpdatePostDateStruct":657,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":412},"100640840","effect-of-4-weeks-of-oral-probiotic-desulfovibrio-piger-supplementation-on-immunological-and-metabolic-parameters-in-individuals-with-longstanding-type-1-diabetes-100640840","NCT07585994","Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes","PROSPER","Inclusion Criteria:\n\n* Males or females, age \\>18 years\n* A diagnosis of type 1 diabetes, with duration of more than 5 years, with minimally one of antiGAD65, IA2, ZnT8 autoantibodies present assessed at diagnosis or routine visits at Diabeter Centrum.\n* Evidence of remaining residual beta cell function with detectable UCPCR (more than 0.01 nmol\u002Fmmol C-peptide\u002Fcreatinine ratio) and or fasting plasma C-peptide more than 0.2 mmol\u002FL.\n* BMI 18-30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Use of antibiotics or proton-pump inhibitors within the last three months before screening or during study period\n* Use of other probiotic supplementation within the last month before screening or during study period\n* A history of cholecystectomy\n* Overt untreated gastrointestinal disease, inflammatory bowel disease or abnormal bowel habits\n* Absence of a large bowel (ie colostomy)\n* Evidence for comprised immunity (HIV infection, chemotherapy, other autoimmune diseases, systemic anti-inflammatory therapy)\n* History of cardiovascular disaeses (CVD) events\n* Hepatic enzymes\\>2.5 higher than the upper limit of normal range, determined during MARVEL visits\u002Froutine visits\n* Kidney failure (eGFR \\\u003C15ml.min\u002F1.73m2), dialysis, kidney transplantation,\n* Inability or unwillingness to donate feces or urine.\n* Smoking or illicit drug use (e.g. MDMA\u002Famphetamine\u002Fcocaine\u002Fheroin\u002FGHB) in the past three months or use during the study period.\n* Alcohol abuse (equal or above 21 units per week)\n* Inability or unwillingness to provide informed consent.",{"count":72,"type":21},[24],"The goal is to establish the effect of oral probiotic Desulfovibrio piger (D. piger) supplementation on immunological and metabolic parameters in individuals with longstanding type 1 diabetes with residual beta cell function. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x10 participants to measure effects of D. piger on parameters of systemic and intestinal inflammation and residual beta cell function.",[27],[651,652,653,654,655],"type 1 diabetes mellitus","gut microbiome","probiotics","immunological parameters","residual beta cell function","2026-05-10",{"date":336,"type":33},{"date":659,"type":21},"2026-05",{"date":661,"type":21},"2028-05",{"name":663,"class":178},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]