[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,88,0,25,[9,59,99,131,158,191,210,244,266,301,323,348,379,403,433,455,478,500,526,550,583,603,622,641,665],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":39,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"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",false,"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.","ALL","12 Years","35 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25,26],"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).",[29,30,31,32,33,34,35,36,37,38],"Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes in Adolescence","Type 1 Diabetes in Children","Type 1 Diabetes (Juvenile Onset)","Type 1 Diabetes","Type 1 Diabetes Patients","Type 1 Diabetes Mellitis",[40,30,41,42,43,31,44,45],"Diabetes","Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed","RECRUITING","2026-08-19",{"date":49,"type":50},"2026-08-20","ACTUAL",{"date":52,"type":50},"2025-05-12",{"date":54,"type":22},"2027-06",{"name":56,"class":57},"COUR Pharmaceutical Development Company, Inc.","INDUSTRY",38,{"id":60,"slug":61,"hasResults":12,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":70,"conditions":71,"keywords":84,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100560306","phase-1-a-study-to-investigate-safety-and-effectiveness-of-porcine-pancreatic-cells-opf-310-in-patients-with-type-1-diabetes-mellitus-100560306","NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM) (in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII For subjects aged 65 to \\\u003C70 years who do not meet Exclusion Criterion 12 but have a history of cardiovascular or cerebrovascular disease related to the conditions above, a cardiology consultation (and consultation with other relevant specialists, as appropriate) will be required during the screening period to confirm suitability for general anesthesia and laparoscopic surgery.\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","70 Years",{"count":68,"type":22},13,[25,26],"This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[72,73,74,36,29,30,31,32,75,76,77,78,79,80,81,82,83],"Diabetes Mellitus, Type 1","Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases","Metabolic Disease",[85,86,31,73,87,88,77,89,29,36],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation",{"date":91,"type":50},"2026-08-21",{"date":93,"type":50},"2025-06-10",{"date":95,"type":22},"2027-06-30",{"name":97,"class":57},"Otsuka Pharmaceutical Factory, Inc.",1,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":98},"100617944","phase-2-reducing-risk-of-diabetic-ketoacidosis-in-type-1-diabetes-and-kidney-disease-using-continuous-ketone-monitoring-100617944","NCT07325201","Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.","Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report","SCOUT-CKD","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Males and females; Ages 18-75.\n4. Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening.\n5. Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)).\n6. Most recent eGFR ≥25 (and within prior 12 months).\n7. HbA1c 7-\\\u003C-9%.\n8. Have never used SGLT2i medications.\n9. Must be willing and able to wear a DGK device and willing to follow the study protocol.\n10. Must be able to read and speak English.\n11. Use of adequate contraception for the duration of the study be the women of childbearing potential.\n12. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).\n\nExclusion Criteria:\n\n1. Pregnant, lactating, or planning to become pregnant or unwillingness to be on contraception during the trial.\n2. Any form of diabetes other than T1D.\n3. Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months.\n4. Chronic systemic corticosteroids (\\>4 consecutive weeks) within 6 months before screening or planned use during the study period.\n5. History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year.\n6. History of multiple (≥ 3 infections) genital mycotic or bacterial infections within 6 months of screening or any history of necrotizing fasciitis.\n7. Hypotension at screening as defined as, systolic blood pressure \\\u003C 90 and diastolic blood pressure \\\u003C 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations).\n8. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening.\n9. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening.\n10. New York Heart Association Class IV heart failure.\n11. CKD-EPI estimated glomerular filtration rate (eGFR) \\\u003C25 mL\u002Fmin\u002F1.73m2.\n12. Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, organ transplant).\n13. Active Hepatitis B or C, or tuberculosis.\n14. Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) \\>2X upper limit of the normal reference range (ULN), ALT \\>2X ULN, serum total bilirubin (TB) \\>1.5X ULN.\n15. History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion.\n16. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis.\n17. Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.\n18. History of kidney transplant.\n19. Chronic kidney disease (CKD) from a known cause other than T1D.\n20. Current or clinically significant history of an eating disorder.\n21. BMI \\\u003C22 at time of screening.\n22. Adherence to a very low carbohydrate or ketogenic diet (\\\u003C100g carbohydrate \u002Fday) and unwilling to change during study participation.\n23. History of foot amputation.\n24. Non-healing wounds of extremities.\n25. Documented medical adhesive allergy, as evaluated by investigator.\n26. Inability to perform the study follow up or unwilling to wear the DGK device.\n27. Heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) at screening, history of alcohol use disorder or binge drinking.\n28. Participation in another treatment or intervention study within the past six weeks.\n29. Any condition or factor that would compromise the participant's safety or conduct of the study (for example: cognitive impairment, bipolar disorder, or eating disorder) or any other reason the PI deems that the patient should not be included.","18 Years","75 Years",{"count":110,"type":22},80,[26],"The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to:\n\n1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods.\n2. Identify potentially modifiable ketosis risk factors.\n3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable.\n4. Gather information on how participants and clinicians like and use the DGK reports.\n\nParticipants will be asked to:\n\n* Meet with study investigators to determine if they are eligible\n* Sign written informed consent\n* Take a pregnancy test, if applicable\n* Have blood taken to assess kidney function and hemoglobin A1c\n* Take the study medication, following the study team instructions\n* Wear the study provided sensor throughout participation.\n* Complete 5 in person visits, and 11 phone check ins over a nine-month period\n* Provide feedback on their experience, usefulness of CGM\u002FCKM reports, and the most valuable factors of the Ketone Action Plan (KAP).",[29,114,115,116,117],"Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)","Chronic Kidney Disease","Diabetic Ketoacidosis","Ketones",[36,115,119,116,120],"Continuous Glucose Monitoring","Continuous Ketone Monitoring","NOT_YET_RECRUITING","2026-08-18",{"date":47,"type":50},{"date":125,"type":22},"2026-09",{"date":127,"type":22},"2028-08",{"name":129,"class":130},"HealthPartners Institute","OTHER",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":18,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":98},"100624443","gamification-intervertion-in-children-with-type-1-diabetes-100624443","NCT07409701","Gamification Intervertion in Children With Type 1 Diabetes","The Effect of Education Provided to Children With Type 1 Diabetes Using Gamification Methods on Health Literacy and Quality of Life: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with type 1 diabetes\n* Aged between 8 and 12 years\n* Diagnosed with type 1 diabetes for at least 1 year and having received standard diabetes education\n* Able to read and write\n\nExclusion Criteria:\n\n* Presence of speech, hearing, or visual impairments\n* Presence of any other comorbid chronic disease\n* Presence of cognitive impairment","8 Years",{"count":140,"type":22},52,[142],"NA","Objective: This study aims to examine the effect of education provided through gamification methods on health literacy and quality of life in children diagnosed with type 1 diabetes (T1DM).\n\nMaterials and Methods: The study is planned as a randomized controlled trial with a pre-test-post-test, parallel design (1:1). The data for the study will be collected between January and April 2026 from patients diagnosed with type 1 diabetes mellitus at the Ankara Etlik City Hospital Pediatric-2 Endocrinology Service. The sample size has been determined to be 52 patients, with 26 in each of the experimental and control groups, based on data from similar studies in the literature. Data will be collected through individual interviews using a Personal Information Form, the Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12 with type 1 diabetes mellitus, and the Quality of Life Scale for Children with Diabetes Mellitus. The gamified education will be provided by a researcher who has completed a 2.5-hour training program from BTK Academy. Informed Consent Forms and other forms will be completed by patients who meet the inclusion criteria and volunteer to participate. Randomization will be performed by someone other than the researcher. The experimental group will receive gamified education in addition to standard education, while the control group will receive only standard education. Data will be analyzed using the SPSS program. The research will be conducted in accordance with the principles of the Helsinki Declaration.\n\nFindings: The findings of the study will be analyzed using SPSS after the application and data collection are completed.\n\nConclusion: The results of the study will be written after the application of the study and the collection of data, followed by the analysis of the data using SPSS and the determination of the findings.",[29],[29,146,147,148],"Gamification","Health literacy","Quality of life","2026-08-12",{"date":151,"type":50},"2026-08-13",{"date":153,"type":50},"2026-01-25",{"date":155,"type":22},"2027-04-30",{"name":157,"class":130},"KTO Karatay University",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":166,"maxAge":107,"enrollmentInfo":167,"targetDuration":4,"studyType":23,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":98},"100652011","exploring-skin-barrier-function-recurrence-of-diabetes-device-related-contact-dermatitis-and-evaluation-of-hydrocolloid-and-silicone-based-patches-for-its-prevention-in-children-and-adolescents-with-type-1-diabetes-100652011","NCT07767461","Exploring Skin Barrier Function, Recurrence of Diabetes Device-Related Contact Dermatitis and Evaluation of Hydrocolloid and Silicone-Based Patches for Its Prevention in Children and Adolescents With Type 1 Diabetes","Steno Adhesive Study 1","StenoAD1","Inclusion Criteria:\n\n* Any type of contact dermatitis due to either insulin pump or glucose sensor\n* Being between 2-18 years of age prior to inclusion\n\nExclusion Criteria:\n\n* Those who are unable to read and understand Danish and\u002For have impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and\u002For be reached by phone or videocall.","2 Years",{"count":168,"type":22},30,[142],"The goal of this clinical trial is to ensure that contact dermatitis is not prohibiting any person with diabetes the access to the optimal treatment.\n\nThe main questions this study aims to answer are:\n\n1. How many pediatric patients with contact dermatitis due to diabetes devices experience recurrence of contact dermatitis depending on which type of patch they use under their device.\n2. Is one type of patch (silicone-based vs. hydrocolloid patch) better than the other at preventing contact dermatitis? The group being investigated is children and adolescents aged 2-18 years with contact dermatitis caused by either an insulin pump or a continuous glucose monitor.\n\nThe participants will be asked to do different surveys on well-being and they will go to three physical visits. At the visits the the following will happen:\n\n* clinical skin examination\n* skin picture (of last used pump and sensor site as well as reportet skin reactions)\n* height and weight\n* blodsample (HbA1c and fillagrin mutations)\n* interview on skin reactions etc.\n* ultrasound of the skin\n* tape strips of the skin\n* EIS (transmit harmless electrical signal through the skin)",[172,29],"Contact Dermatitis",[174,175,30,29,176,177,178,179,180,181],"skin barrier","contact dermatitis","Hydrocolloid patch","silicone-based patch","pediatric","device-related contact dermatitis","adhesive","children and adolescents","2026-08-11",{"date":184,"type":50},"2026-08-17",{"date":186,"type":22},"2026-09-04",{"date":188,"type":22},"2027-05",{"name":190,"class":130},"Steno Diabetes Center Copenhagen",{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":98},"100625793","phase-4-the-postprandial-hypo-avoid-study-100625793","NCT07427251","The Postprandial Hypo-Avoid Study","Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People With Type 1 Diabetes","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Type 1 diabetes ≥ 2 years\n* Using an automated insulin delivery system for ≥ 3 months\n* NovoRapid or Fiasp use ≥1 week\n* Proficiency in carbohydrate counting\n\nExclusion Criteria:\n\n* Allergies to lactose or glucagon\n* Known or suspected allergies to glucagon or related products\n* History of hypersensitivity or allergic reaction to glucagon or lactose\n* Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis\n* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation\n* Lack of compliance with key study procedures at the discretion of the investigator\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrolment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (\\>12 months since last period) are not required to use contraception)\n* Inability to understand the individual information and to give informed consent",{"count":199,"type":22},18,[201],"PHASE4","The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system.\n\nThe primary endpoint is the difference in the change in plasma glucose (PG) from exercise initiation to the nadir during exercise and through the 2-hour post-exercise period between the glucagon (GCN) and carbohydrate (CHO) visits.",[29],{"date":151,"type":50},{"date":206,"type":50},"2026-04-27",{"date":208,"type":22},"2028-05-01",{"name":190,"class":130},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"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 6 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","6 Years","17 Years",{"count":221,"type":22},100,[26],"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 6 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.",[29],[85,226,227,228,229,230,231,36,232,233,234,235],"Insulin","Inhaled","Afrezza","Technosphere","Pediatric","Inhaled Insulin","Newly diagnosed type 1 diabetes","Technosphere Insulin","rapid-acting inhaled insulin","Meal-time inhaled insulin",{"date":151,"type":50},{"date":238,"type":50},"2026-02-04",{"date":240,"type":22},"2027-09",{"name":242,"class":57},"Mannkind Corporation",10,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":58},"100610479","gateway-safety-evaluation-of-the-minimed-nmx8-aid-system-in-children-and-adults-living-with-diabetes-100610479","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 until the end of the study period.\n    3. During continued access, starting\u002Fstopping the medication and\u002For modifying doses will be permitted.\n    4. 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), DPP-4 Inhibitors, thiazolidinedione (TZD), 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, DPP-4 Inhibitors, TZD, or SGLT2 have done so at least 8 weeks prior to screening.\n    2. Participants currently taking metformin, GLP-1\u002FGIP, DPP-4 Inhibitors, TZD, or SGLT2 must be on a steady dose and remain on the same dose during study participation, until the end of the study period.\n    3. During continued access, starting\u002Fstopping the medication and\u002For modifying doses will be permitted.\n    4. 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. For T1D subjects who are within the first 5 years after diagnosis, a new eGFR test is not required for screening; however, if an eGFR value taken during the first 5 years from diagnosis is available, and if it is \\\u003C30, the subject will be excluded.\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":253,"type":22},400,[142],"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.",[29,257],"Type 2 Diabetes Mellitus","2026-08-10",{"date":182,"type":50},{"date":261,"type":50},"2026-02-02",{"date":263,"type":22},"2027-01",{"name":265,"class":57},"Medtronic MiniMed, Inc.",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":274,"sex":17,"minAge":107,"maxAge":275,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":98},"100610361","using-a-personalized-decision-support-tool-to-help-people-with-type-1-diabetes-manage-exercise-100610361","NCT07226583","Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise","Net-IOB & Exercise Toolkit Pilot Trial: Randomized, Crossover Evaluation of a Behavioral Decision Support Advisor to Improve Glycemic Safety During and After Exercise in Adults With Type 1 Diabetes (NEXT)","NEXT","Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups)\n\n* Adults between the age of 18-60 years\n* Able to perform moderate intensity walking for 60 minutes (target 40-60% age-predicted maximal heart rate).\n* Willing and able to comply with study procedures, including supervised exercise visits and device wear\n* Able to provide written informed consent\n\nInclusion Criteria: Type 1 Diabetes Group Only\n\n* Clinical diagnosis of type 1 diabetes for \\>1 year, based on the investigator's clinical judgement\n* Current use of continuous subcutaneous insulin infusion with Tandem Control-IQ and a compatible continuous glucose monitor (CGM) for \\>1 month prior to enrollment\n* Stable insulin delivery regimen, with no planned changes to insulin pump settings or insulin dosing strategy during the study period\n* Consistent CGM use during the month prior to enrollment (\\>80% data availability)\n\nInclusion Criteria: Health Control Group Only\n\n* No diagnosis of diabetes or other disorders of glucose metabolism\n* Not using insulin or glucose-lowering medications\n\nExclusion Criteria Exclusion Criteria: All Participants\n\n* Intercurrent illness or medical condition that precludes safe participation in moderate-intensity exercise (e.g., unstable cardiopulmonary disease, uncontrolled arrhythmia, or uncontrolled hypertension), as previously assessed by the participant's primary care physician\n* Known coronary artery disease with symptoms limiting moderate physical activity, or history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the past 12 months\n* Pregnancy, lactation, or plans to become pregnant during the study period\n* Renal insufficiency with estimated GFR \\\u003C45 mL\u002Fmin\u002F1.73 m², dialysis dependence, or adrenal insufficiency\n* Concurrent participation in another interventional drug or device study within 30 days prior to enrollment\n* Inability to comply with study procedures or safety requirements (e.g., inability to achieve target heart-rate zone, attend scheduled visits, or enable required device data access), or otherwise deemed unsuitable by the investigator\n\nExclusion Criteria: Type 1 Diabetes Group Only\n\n* Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period\n* Use of medications with potential to substantially affect glycemia (e.g., SGLT-2 inhibitors, GLP-1 receptor agonists, or GIP agonists), unless on a stable regimen with no planned changes during the study\n* Use of systemic corticosteroids within 4 weeks prior to participation\n* History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis within the prior 6 months",true,"60 Years",{"count":277,"type":22},20,[142],"This study evaluates a clinician-facing decision-support toolkit designed to assist adults with type 1 diabetes in preparing for moderate-intensity exercise. The netIOB \\& Exercise Toolkit (NEXT) integrates recent glucose data and insulin delivery history to provide individualized suggestions regarding exercise timing, insulin adjustments, and carbohydrate intake.\n\nAdults with type 1 diabetes will complete three supervised exercise sessions under different pre-exercise guidance approaches:\n\n(A) published consensus-based standard-of-care guidance, (B) usual personal care routines, and (C) guidance informed by the NEXT Toolkit.\n\nA healthy adult control group will complete a single supervised exercise session to provide comparative physiologic data.",[29,281],"Exercise Physiology",[36,30,31,119,283,284,285,286,287,288,289,290,120,291,292,293],"Insulin Dosing","CGM","Insulin Pump","Exercise","carbohydrate Intake","closed-loop system","hybrid closed-loop","CKM","Glucose Metabolism","Ketone Metabolism","Exercise Metabolism",{"date":149,"type":50},{"date":296,"type":22},"2026-10",{"date":298,"type":22},"2027-02",{"name":300,"class":130},"Stanford University",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":243},"100586744","a-study-of-gnti-122-in-adults-recently-diagnosed-with-t1d-100586744","NCT06919354","A Study of GNTI-122 in Adults Recently Diagnosed With T1D","POLARIS: A Phase 1, Single Dose, Open-label Study of GNTI-122 in Adults With Recently Diagnosed Type 1 Diabetes (T1D)","POLARIS","Inclusion Criteria:\n\n1. Male and female participants aged ≥18 to ≤55 years with recently diagnosed (within 180 days of Screening) T1D according to American Diabetes Association criteria.\n2. Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol\u002FL.\n3. Positive for at least one T1D-associated autoantibody.\n4. Able and willing to provide written, informed consent as approved by the IRB.\n5. Is confirmed positive for the HLA-DRB1\\*04:01 allele.\n6. Has adequate vascular access to undergo leukapheresis with no known contraindications.\n\n8\\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.\n\n9\\. Male participants of childbearing potential must agree to protocol specified contraception.\n\n10\\. Other than T1D, participant is in good general health.\n\nExclusion Criteria:\n\n1. Type 2 diabetes.\n2. Experienced DKA within 4 weeks prior to or during Screening.\n3. Unwilling or unable to comply with study procedures or schedule.\n4. Chronic or uncontrolled medical condition.\n5. Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.\n6. Participation in another clinical study or active follow-up in a prior study.","55 Years",{"count":311,"type":22},16,[25],"This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https:\u002F\u002Fwww.polarisstudy.com to learn more!",[75,29],"2026-08-07",{"date":258,"type":50},{"date":318,"type":50},"2025-09-03",{"date":320,"type":22},"2028-02",{"name":322,"class":57},"GentiBio, Inc",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":331,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100599713","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 systemic corticosteroids (ie, oral, high doses of inhaled or injectable) 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 (\\\u003C 1000 \u002FµL in participants with documented Duffy-null genotype),\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.","1 Year","25 Years",{"count":334,"type":22},723,[336],"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.",[29],"2026-08-06",{"date":258,"type":50},{"date":342,"type":50},"2025-08-06",{"date":344,"type":22},"2028-12-12",{"name":346,"class":57},"Sanofi",162,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":362,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":98},"100579129","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":358,"type":22},44,[26],"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.",[29],[72,85,82,363,364,365,366,367,368,369,370],"Incretins","Physiological Effects of Drugs","Tirzepatide","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Diseases","Overnutrition","Insulin Resistance",{"date":258,"type":50},{"date":373,"type":50},"2026-07-07",{"date":375,"type":22},"2027-12-31",{"name":377,"class":378},"Victor Chang Cardiac Research Institute","OTHER_GOV",{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":4},"100600591","ultrasound-enhanced-propolis-therapy-for-healing-diabetic-foot-wounds-100600591","NCT07099482","\"Ultrasound-Enhanced Propolis Therapy for Healing Diabetic Foot Wounds\"","Effectiveness of Propolis Phonophoresis on Wound Healing in Diabetic Ulcer: a Randomized Controlled Trial","PEARL","Inclusion Criteria:\n\nAdults aged 18 to 75 years\n\nDiagnosed with type 1 or type 2 diabetes mellitus\n\nPresence of a diabetic foot ulcer classified as Grade 1 or 2 (Wagner classification)\n\nUlcer size between 1 cm² and 5 cm²\n\nAble and willing to provide informed consent\n\nExclusion Criteria:\n\nSevere infection or presence of osteomyelitis at the ulcer site\n\nUse of systemic immunosuppressants or corticosteroids\n\nKnown allergy or hypersensitivity to propolis\n\nPregnant or breastfeeding women\n\nParticipation in another clinical trial within the past 30 days",{"count":110,"type":22},[142],"This study aims to evaluate whether using ultrasound (phonophoresis) can help deliver propolis-a natural compound made by bees-more effectively into the skin to speed up wound healing in people with diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and often take a long time to heal. Propolis has natural anti-inflammatory and antimicrobial properties that may promote healing, but it does not easily penetrate the skin. By using ultrasound to enhance absorption, this study tests whether combining propolis with phonophoresis is more effective than standard wound care alone. Participants will be randomly assigned to receive either the propolis ultrasound therapy or standard care. The study will measure wound size, healing time, pain, infection rates, and quality of life.",[391,29,257,392,393],"Diabetic Foot Ulcer t","Wound Management","Chronic Wound Healing","2026-08-01",{"date":396,"type":50},"2026-08-04",{"date":398,"type":22},"2026-08-30",{"date":400,"type":22},"2027-09-25",{"name":402,"class":130},"Sinai University",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":411,"maxAge":108,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"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",{"count":413,"type":22},200,[142],"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.",[257,29],[418,419,420,30,421,36,422],"Omnipod","Automated Insulin Delivery","T2D","Type 2 Diabetes","AID","2026-07-31",{"date":425,"type":50},"2026-08-03",{"date":427,"type":50},"2026-05-13",{"date":429,"type":22},"2027-03-24",{"name":431,"class":57},"Insulet Corporation",11,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100570240","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-100570240","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",{"count":441,"type":22},270,[142],"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).",[29,257],"2026-07-28",{"date":447,"type":50},"2026-07-29",{"date":449,"type":50},"2025-04-14",{"date":451,"type":22},"2027-05-30",{"name":453,"class":57},"Hoffmann-La Roche",19,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":411,"maxAge":356,"enrollmentInfo":462,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":98},"100649400","ai-assisted-remote-insulin-pump-optimization-in-t1dm-100649400","NCT07732777","AI-Assisted Remote Insulin Pump Optimization in T1DM","Evaluating AI-Assisted Remote Optimization of Insulin Pump Settings in Type 1 Diabetes Using CGM","Inclusion Criteria:\n\n1. Clinical diagnosis of T1D, meeting all three of the following criteria:\n\n   1. Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis;\n   2. At least one of the following: age at disease onset \\\u003C 15 years; presentation with ketosis or diabetic ketoacidosis (DKA) at onset; no overweight or obesity at onset; highest random C-peptide \\\u003C 200 pmol\u002FL;\n   3. At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody.\n2. Age 14 to 65 years, inclusive, male or female.\n3. HbA1c \\\u003C 11.0% at the screening visit.\n4. At least 3 months of documented T1D duration, and at least 3 months of treatment with either multiple daily insulin injections (MDI) or insulin pump therapy.\n5. Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro.\n6. Willing to perform at least one fingerstick blood glucose measurement per day.\n7. Willing to upload data from the study device.\n8. Willing and able to provide signed informed consent (by the participant and\u002For legally authorized representative) and to learn basic diabetes management and study device operation.\n\nExclusion Criteria:\n\n1. History of severe hypoglycemia within the 6 months prior to screening, defined as an event requiring medical assistance (i.e., physician office visit, emergency room visit, or hospitalization), coma, seizure, or hypoglycemia with loss of consciousness.\n2. Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment.\n3. Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening.\n4. Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema.\n5. Presence of significant acute or chronic complications, hepatorenal disease, or other systemic diseases at screening. Hyperthyroidism or hypothyroidism with unstable thyroid function at the time of screening, defined as thyroid-stimulating hormone outside the normal range with concurrent abnormal free triiodothyronine or free thyroxine levels.\n6. Prior pancreas or islet cell transplantation.\n7. Any of the following cardiovascular or cerebrovascular events within 1 year prior to screening: myocardial infarction, heart failure (NYHA Class III\u002FIV), unstable angina, coronary artery bypass grafting, coronary stent implantation, angina pectoris, congestive heart failure, ventricular arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or other thromboembolic disease.\n8. Diagnosis of any of the following: malignancy, tuberculosis or other chronic wasting disease, hematological disorder, psychiatric disorder, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, or clinically significant malabsorption. Diagnosis of adrenal insufficiency, or current treatment for hyperthyroidism, or planned treatment for hyperthyroidism during the study period.\n9. History of drug abuse or alcohol abuse.\n10. Use of any oral, injectable, or intravenous glucocorticoids within 8 weeks prior to screening, or planned use during the study period.\n11. Use of any of the following non-insulin glucose-lowering agents within 8 weeks prior to screening, or planned use during the study period: thiazolidinediones (TZDs), alpha-glucosidase inhibitors, sulfonylureas (SUs), glinides, dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Participants currently using any of these agents must undergo a washout period of at least 7 days prior to enrollment.\n12. Planned elective surgery requiring general anesthesia, or planned dialysis during the study period.\n13. For women of childbearing potential: pregnancy, lactation, positive pregnancy test at screening, or planned pregnancy during the study period. Women of childbearing potential who are not using an effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and who do not agree to continue using such effective contraception during the study period will be excluded.\n14. Current participation in, or treatment with an investigational drug or device within 2 weeks prior to screening (observational studies are permitted).\n15. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study, including but not limited to: history of ocular trauma or other confirmed ocular disease causing blurred vision, deafness, eating disorders, celiac disease, or being underweight (Body Mass Index \\\u003C 18 kg\u002Fm²).",{"count":463,"type":22},50,[142],"This study evaluates an AI-assisted remote parameter optimization tool for individuals with type 1 diabetes （T1D） using insulin pump and continuous glucose monitoring (CGM). The Artificial Intelligence (AI) algorithm analyzes regularly CGM and insulin data to generate personalized recommendations for adjusting pump settings. All algorithm-generated recommendations are reviewed and approved by physicians before being transmitted to the participant's mobile application for implementation.",[29,75],[36,285,119,468,469],"Artificial Intelligence","Insulin Dosage Adjustment","2026-07-26",{"date":447,"type":50},{"date":473,"type":50},"2026-01-28",{"date":475,"type":22},"2028-12-31",{"name":477,"class":130},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":356,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":497,"leadSponsor":498,"locationsCount":98},"100635154","phase-2-open-label-study-of-dimethyl-fumarate-in-adults-with-type-1-diabetes-100635154","NCT07548996","Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes","Non-Randomized, Parallel-Controlled, Single-Center, Open-Label Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Pancreatic β-Cell Function in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Willing and able to participate in the study and provide signed informed consent\n* Aged 18 to 65 years\n* Diagnosed with type 1 diabetes mellitus according to ADA 2024 criteria\n* Positive for at least 2 islet autoantibodies among insulin autoantibody (IAA), glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), islet cell antibody (ICA), and zinc transporter 8 autoantibody (ZnT8A)\n* Random C-peptide level greater than or equal to 200 pmol\u002FL\n\nNote:\n\n\\- For participants who have used insulin for more than 14 days, a positive IAA result must be accompanied by at least 2 additional positive autoantibodies other than IAA\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy in the opinion of the investigator\n* Good glycemic control with oral antidiabetic drugs alone\n* Participation in other studies involving diabetes treatment or immunomodulation\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal\n* Patients with renal insufficiency or evidence of renal impairment:\n\neGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²; or other renal diseases considered by the investigator to be unsuitable for study enrollment\n\n* History of malignancy, uncontrolled immune system disease, or uncontrolled infection\n* Alcohol abuse, drug abuse, psychiatric disorder, or other conditions considered unsuitable for participation in a drug trial\n* Use of other immunosuppressive agents within 12 weeks before enrollment\n* Participation in any other drug trial within 12 weeks before enrollment\n* History of multiple drug allergies, allergic diseases, hypersensitivity constitution, or drug dependence\n* Any disease or condition that, in the opinion of the investigator, may interfere with study participation or evaluation",{"count":486,"type":22},96,[26,336],"This is a non-randomized, parallel-controlled, single-center, open-label clinical trial designed to evaluate the efficacy of dimethyl fumarate in preserving pancreatic beta-cell function in adults with type 1 diabetes, as well as its safety and tolerability in this population.\n\nEligible participants are adults aged 18 to 65 years who meet the ADA 2024 diagnostic criteria for type 1 diabetes, have at least 2 positive islet autoantibodies, and have residual beta-cell function as evidenced by a random C-peptide level of at least 200 pmol\u002FL. A total of 96 participants are planned for enrollment, including 32 in the dimethyl fumarate treatment group and 64 in the standard-treatment control group.\n\nParticipants in the treatment group will receive dimethyl fumarate enteric-coated capsules in addition to standard insulin therapy for type 1 diabetes. Dimethyl fumarate will be initiated at 120 mg twice daily and increased after 7 days to a maintenance dose of 240 mg twice daily. Participants in the control group will receive standard insulin therapy alone. The intervention period will be 24 weeks, followed by 52 weeks of follow-up.\n\nThe primary efficacy endpoint is the baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test at Week 24. Secondary endpoints include measures of beta-cell function at multiple time points, changes in glycated hemoglobin, proportions of participants with good or poor glycemic control, insulin dose requirements, and immunologic markers including lymphocyte subsets, cytokine profiles, and islet autoantibody characteristics. Safety assessments will include the incidence of flushing, gastrointestinal adverse events, allergic reactions, opportunistic infections, liver function abnormalities, lymphopenia, renal abnormalities, hypoglycemia, severe hypoglycemia, ketosis, and ketoacidosis.\n\nThe total study duration is 36 months, from January 2026 to December 2028.",[29],[491,36,492],"Dimethyl Fumarate","Beta-Cell Function","2026-07-20",{"date":495,"type":50},"2026-07-21",{"date":206,"type":50},{"date":475,"type":22},{"name":499,"class":130},"Nanjing Medical University",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":274,"sex":17,"minAge":166,"maxAge":66,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":98},"100638053","evaluating-glucose-control-using-a-next-generation-aid-algorithm-in-individuals-with-t1d-100638053","NCT07593625","Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D","Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D","EVOLUTIONT1D","Inclusion Criteria:\n\n* Age at time of consent 2-70 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, 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) or has a parent\u002Fguardian willing and able to sign the ICF. Assent will be obtained from participants per local regulatory requirements\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) 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 that in the opinion of the investigator may have therapeutic impact on their diabetes management. 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",{"count":110,"type":22},[142],"Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.",[36,29,512],"Diabetes (DM)",[36,30,418,514,515,422,516,517,518],"Omnipod M","Automated Insulin Delivery System","fully closed loop","FCL","Omnipod S","2026-07-17",{"date":493,"type":50},{"date":522,"type":50},"2026-05-25",{"date":524,"type":22},"2027-02-01",{"name":431,"class":57},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":534,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":538,"conditions":539,"keywords":540,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":98},"100604409","pediatric-artificial-intelligence-for-retinopathy-screening-in-children-with-type-1-diabetes-100604409","NCT07149142","Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes","Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes","PAIRS-T1D","Inclusion Criteria:\n\n* Type 1 diabetes diagnosed according to the ADA criteria\n* Age over 11.0 years or duration of diabetes over 2 years\n* Signed written informed consent by both the CwD and their parent\u002Fcaregiver\n\nExclusion Criteria:\n\n* Unwillingness to sign a written informed consent by both the CwD and their parent\u002Fcaregiver","11 Years","19 Years",{"count":253,"type":22},[142],"The proposed project is a clinical intervention trial testing the feasibility and effectiveness of diabetic retinopathy screening evaluated by artificial intelligence (AI) based software in children with type 1 diabetes (CwD). Another novel method, the confocal microscopy of the retina will be used to assess the early stages of diabetic neuropathy. In parallel, we aim to assess the prevalence of diabetic retinopathy and neuropathy in a well-controlled population of CwD at a tertiary diabetes care center.\n\nEach participant will undergo an examination of diabetic retinopathy using the non-mydriatic fundus camera. The resulting photography will be evaluated by AI driven software. The participant will then follow this examinaton with fundus ophtalmoscopy in arteficial mydriasis as a standard method of diabetic retinopathy assessment. Another method, the optic coherence tomography (OCT), which is considered as the most sensitive method for diabetic retinopathy assessment, will be performed after that. The results of these methods will be compared to assess the sensitivity of each. The examination-satisfaction questionnaire will be given to the participants.\n\nIn subjects over 18 years, a confocal microscopy of the retina examination will be performed to assess the status of the corneal sub-basal nerve plexus and the presence of diabetic neuropathy will be noted.\n\nThe prevalence of diabetic retinopathy and neuropathy in this group of children with diabetes will be assessed based on the results.",[29],[541,542,468],"Diabetic Retinopathy","Diabetic Neuropathy",{"date":493,"type":50},{"date":545,"type":50},"2026-07-01",{"date":547,"type":22},"2029-12-31",{"name":549,"class":130},"University Hospital, Motol",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":17,"minAge":558,"maxAge":535,"enrollmentInfo":559,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":572,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":579,"leadSponsor":581,"locationsCount":4},"100646492","effect-of-a-structured-educational-intervention-through-mobile-app-on-hemoglobin-a1c-hba1c-self-efficacy-and-self--care-in-adolescent-with-type-1-diabetes-t1dm-100646492","NCT07689318","Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes (T1DM)","Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes A Pilot RCT","(T1DM)","Inclusion Criteria:\n\nAdolescents aged 10 to 19 years. Diagnosed with Type 1 Diabetes Mellitus (T1DM) by a physician for at least 6 months.\n\nHbA1c greater than or equal to 7%. Have access to a smartphone or tablet (owned by the participant or parent\u002Fguardian).\n\nExclusion Criteria:\n\nUse of an insulin pump. Current use of any smartphone application for diabetes self-management. Presence of comorbid conditions that may interfere with participation in the study.\n\nDiagnosis of intellectual disability or other cognitive impairment documented in the medical record that may limit the participant's ability to complete questionnaires or comply with intervention requirements.","10 Years",{"count":560,"type":22},84,[142],"This study aims to evaluate the effectiveness of a mobile health (mHealth) educational intervention for adolescents with Type 1 Diabetes Mellitus (T1DM). Adolescents often face challenges in maintaining optimal blood glucose control and performing regular self-care. In this study, participants will receive structured diabetes education through a mobile application designed to improve their knowledge, self-efficacy (SE), and self-management skills. The impact of the intervention will be assessed by measuring changes in HbA1c levels, diabetes self-efficacy, and self-care (SC)behaviors over time. These findings may help determine whether mobile app-based education can support better diabetes management among adolescents.",[35,36,29,564,565,566,567,568,569,570,571],"HbA1c","HbA1c Level","Self Care","Self Efficacy","Mobile Application","MOBILE WEB-BASED INTERVENTION PROGRAM","Mobile Apps","Nurse Led Intervention",[573,574,575],"type 1 diabetes Mellitus, educational intervention , mobile app, HbA1c","Self Efficacy , Self Care","adolescents",{"date":577,"type":50},"2026-07-08",{"date":545,"type":22},{"date":580,"type":22},"2026-11-30",{"name":582,"class":130},"Shifa Tameer-e-Millat University",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":601,"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 not willing to suspend their hybrid closed loop (Automated Insulin Delivery) system during the clinic sampling session.\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":277,"type":22},[142],"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.",[29],[29,595],"Continuous Glucose Monitor","2026-07-02",{"date":373,"type":50},{"date":599,"type":22},"2026-08",{"date":125,"type":22},{"name":602,"class":57},"SAVA Technologies Ltd.",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":274,"sex":17,"minAge":4,"maxAge":107,"enrollmentInfo":609,"targetDuration":4,"studyType":611,"phases":4,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":98},"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 .",{"count":610,"type":22},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 .",[29],"2026-06-29",{"date":616,"type":50},"2026-06-30",{"date":618,"type":50},"2025-04-01",{"date":394,"type":22},{"name":621,"class":130},"Assiut University",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":331,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":23,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":432},"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.","34 Years",{"count":243,"type":22},[26],"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.",[29],{"date":545,"type":50},{"date":637,"type":50},"2025-07-25",{"date":639,"type":22},"2028-03-06",{"name":346,"class":57},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":662,"locationsCount":664},"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":110,"type":22},[142],"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.",[29],[36,654,468,655,656],"Carbohydrate Counting","AI-Powered Education","Digital Health","2026-06-26",{"date":616,"type":50},{"date":660,"type":22},"2026-09-01",{"date":375,"type":22},{"name":663,"class":130},"Sultan Qaboos University",3,{"id":666,"slug":667,"hasResults":12,"nctId":668,"briefTitle":669,"officialTitle":669,"acronym":670,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":17,"minAge":138,"maxAge":19,"enrollmentInfo":672,"targetDuration":4,"studyType":611,"phases":4,"briefSummary":674,"conditions":675,"keywords":676,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":683,"locationsCount":686},"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.",{"count":673,"type":22},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.",[29,31,30],[226,677],"Glucose Intolerance","2026-06-25",{"date":614,"type":50},{"date":681,"type":50},"2016-08-18",{"date":127,"type":22},{"name":684,"class":685},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",12]