[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t1d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t1d":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,58,85,118,156,191,231],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"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":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24,25],"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).",[28,29,30,31,32,33,34,35,36,37],"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",[39,29,40,41,42,30,43,44],"Diabetes","Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed","RECRUITING","2026-06-30",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2025-05-12",{"date":53,"type":21},"2027-06",{"name":55,"class":56},"COUR Pharmaceutical Development Company, Inc.","INDUSTRY",33,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":18,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100265401","type-1-diabetes-extension-study-100265401","NCT02734277","Type 1 Diabetes Extension Study","T1DES","Inclusion Criteria:\n\n* Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.\n* Ability to sign informed consent\u002Fassent (as applicable for children).\n\nExclusion Criteria:\n\n* Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or\n* Inability to comply with the study visit schedule and required assessments.","8 Years",{"count":67,"type":21},111,"OBSERVATIONAL","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.",[28,30,29],[72,73],"Insulin","Glucose Intolerance","2026-06-25",{"date":76,"type":49},"2026-06-29",{"date":78,"type":49},"2016-08-18",{"date":80,"type":21},"2028-08",{"name":82,"class":83},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",12,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":117},"100641160","early-phase-1-simultaneous-measurement-and-responsive-treatment---part-2-100641160","NCT07655076","Simultaneous Measurement and Responsive Treatment - Part 2","SMART02","Inclusion Criteria Part A:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing multiple daily injection or continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Total daily insulin dose (TDD) between 30 and 100 IU.\n\nInclusion Criteria Part B:\n\n* Males and females ≥ 18 years of age.\n* Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.\n* Undergoing continuous subcutaneous insulin infusion therapy for at least 3 months. Those using an automated insulin delivery system can also participate.\n* Totally daily insulin dose (TDD) between 30 and 100 IU.\n\nExclusion Criteria (A and B):\n\n* Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Failure to comply with the study protocol or with the team's recommendations.\n* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).\n* Female participants of childbearing potential who are pregnant, breastfeeding, or unwilling to use effective contraception during the study. Pregnancy will be verified by urine dipstick testing at the time of admission visit.\n* Severe hypoglycemic episode within one month of admission.\n* Severe diabetic ketoacidosis episode within one month of admission.\n* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.\n* Recent (\\\u003C6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.\n* Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.\n* Current or ≤ one month use of supraphysiological doses of systemic glucocorticoids\n* Pronounced lipohypertrophy in the abdominal subcutaneous adipose tissue, which may impair sensor function or insulin infusion.\n* Insufficient abdominal surface area to support the wearing of three DPP systems in Part A.","18 Years",{"count":94,"type":21},40,[96],"EARLY_PHASE1","This research study is testing an investigational dual-port insulin patch pump that integrates a continuous glucose monitor (CGM) in adults with type 1 diabetes. The goal of the study is to better understand how insulin delivery near a CGM sensor affects glucose readings and to collect data to support development of a combined insulin pump and CGM system.\n\nPeople with type 1 diabetes require lifelong insulin therapy. Many use insulin pumps and CGMs, but these systems usually involve wearing multiple devices at different body sites. Managing several devices can increase treatment burden and may contribute to skin irritation, device failures, and challenges with glucose control.\n\nThis study is conducted in two in-patient parts. In Part A, participants will wear three investigational devices at the same time while glucose levels are closely monitored using laboratory blood tests and a commercial CGM. This part of the study is designed to measure how basal and bolus insulin delivery near the CGM sensor affects sensor accuracy and how quickly the sensor signal recovers after insulin delivery.\n\nIn Part B, participants will wear one investigational device while trained study staff use CGM information from the integrated sensor to guide insulin delivery recommendations generated by an automated glucose control algorithm. Insulin delivery decisions will be closely supervised, and glucose levels will be frequently monitored.\n\nParticipants will stay at the clinical research center for short, controlled study visits. Safety will be monitored throughout the study, with predefined procedures for treating low or high blood sugar. The information collected will be used to support further development of an integrated insulin pump and CGM system for people with type 1 diabetes.",[28,29,35,30],[28,100,101,102,103,104,35,105,106],"Hybrid closed-loop system","Closed-loop insulin delivery","Automated insulin delivery","Continuous Glucose Monitoring","Insulin Pump","Insulin Patch Pump","Dual-port Insulin Patch Pump","2026-06-19",{"date":109,"type":49},"2026-06-23",{"date":111,"type":49},"2026-05-19",{"date":113,"type":21},"2026-12-01",{"name":115,"class":116},"ClinSurge Research","NETWORK",1,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":137,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":117},"100642489","dash-obesity-explainable-ai-for-family-centric-personalized-weight-control-in-adolescents-and-young-adults-with-obesity-and-chronic-conditions-100642489","NCT07638345","DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions","US-based Clinical Sub-study of DASH-Obesity: Explainable AI for Family-Centric Transdiagnostic Personalized Weight Control Across Multiple Conditions","DASH-Obesity","Inclusion Criteria:\n\n* Adult caregiver (aged 18 years or older) of an adolescent or young adult aged 12 to 21 years diagnosed with Type 1 Diabetes (T1D) or asthma.\n* The caregiver is actively involved in the management of the adolescent's or young adult's condition.\n* The adolescent or young adult must meet one of the following criteria:\n* T1D and normal weight (BMI between the 10th and 85th percentile), or\n* T1D and overweight\u002Fobesity (BMI ≥85th percentile), or\n* Asthma and overweight\u002Fobesity (BMI ≥85th percentile).\n* Willingness to participate in the Adhera Caring Digital Program-Obesity (ACDP-O).\n* Access to a smartphone or internet-enabled device compatible with the study application.\n* Willingness to provide self-reported information regarding the adolescent's or young adult's health status, including disease-related and anthropometric measures.\n* For caregivers of participants with T1D, willingness to share continuous glucose monitoring (CGM) information.\n\nExclusion Criteria:\n\n* Severe psychiatric or cognitive conditions that would interfere with participation in the digital intervention.\n* Current participation in another obesity- or chronic disease-related digital health intervention study.\n* Inability or unwillingness to comply with study procedures.\n* Refusal or inability to provide informed consent.",true,{"count":128,"type":21},280,[130],"NA","This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with overweight\u002Fobesity and chronic conditions, including type 1 diabetes (T1D) and asthma. The intervention combines personalized educational content, wearable-device monitoring, psychometric assessments, and explainable artificial intelligence (AI) to improve mental well-being, quality of life, and adherence to healthy lifestyle behaviors. A total of 280 families will participate in a 3-month intervention with remote monitoring and follow-up assessments.",[35,29,133,134,135,136],"Obesity & Overweight","Obesity Type 2 Diabetes Mellitus","Asthma Acute","Asthma (Diagnosis)",[138,35,139,140,141,142,143,144,145,146,147,148],"Pediatric Obesity","Asthma","Overweight","Digital Health","Artificial Intelligence","Explainable AI","Caregiver Burden","Quality of Life","Mental Well-being","Wearable Devices","Family-Centered Care",{"date":109,"type":49},{"date":151,"type":49},"2025-10-30",{"date":153,"type":21},"2026-09",{"name":155,"class":56},"Adhera Health, Inc.",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":190},"100614816","phase-2-a-clinical-trial-using-tirzepatide-to-help-adults-with-type-1-diabetes-automatically-control-their-blood-sugar-100614816","NCT07284511","A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar","Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial","TZP","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required).\n* A BMI ≥ 27 kg\u002Fm2.\n* HbA1c \\> 6.5%, and \\\u003C 12%.\n* Current therapy: multiple daily injections or insulin pump.\n* Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible)\n* Active carbohydrate counting for prandial insulin dosing.\n* Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.\n\nExclusion Criteria:\n\n* Use of GLP1-RAs within the last four weeks.\n* Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.\n* Diabetic ketoacidosis within the last 2 months.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe renal impairment with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI), measured within the last four months.\n* Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.\n* Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.\n* History of bariatric surgery within the last 6 months.\n* Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.\n* Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.\n* Any safety concern that, in the investigator's judgment, precludes participation.",{"count":165,"type":21},105,[25,167],"PHASE3","This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals.\n\nPeople with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose.\n\nTirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises.\n\nThis study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups:\n\nTirzepatide group:\n\nParticipants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals.\n\nControl group:\n\nParticipants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses.\n\nThe main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart\u002Ffitness, or body-composition tests.\n\nAs with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial.\n\nOverall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.",[35,28,29,30,31],[35,171,102,172,173,174,175,176,177,178,179,100,101,180],"Overweight or obesity in type 1 diabetes","Insulin pump","Continuous glucose monitoring","Tirzepatide","Mounjaro","GIP\u002FGLP-1 receptor agonist","Dual incretin therapy","Adjunctive tirzepatide therapy","Tandem Control-IQ","Dexcom G7","2026-05-22",{"date":183,"type":49},"2026-05-27",{"date":111,"type":49},{"date":186,"type":21},"2029-01",{"name":188,"class":189},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",4,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":216,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":117},"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 65 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. In addition, patients with transiently abnormal TSH levels may undergo rescreening only once during the screening period.\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\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","65 Years",{"count":200,"type":21},13,[24,25],"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.",[204,205,206,35,28,29,30,31,207,208,209,210,211,212,213,214,215],"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",[217,218,30,205,219,220,209,221,28,35],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","2026-02-26",{"date":224,"type":49},"2026-03-02",{"date":226,"type":49},"2025-06-10",{"date":228,"type":21},"2027-06-30",{"name":230,"class":56},"Otsuka Pharmaceutical Factory, Inc.",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":117},"100574031","phase-1-continuous-ketone-monitoring-in-people-with-type-1-diabetes-using-sglt2-inhibitors-100574031","NCT06753994","Continuous Ketone Monitoring in People With Type 1 Diabetes Using SGLT2 Inhibitors","Continuous Ketone Monitoring in Participants With Type 1 Diabetes (T1D) Using SGLT2 Inhibitors as Adjunctive Therapy","EmpaCKM","Adults ≥ 18 years old.\n\n* A T1D diagnosis for at least one year, as per their treating physician in agreement with the investigator's judgment (confirmatory C-peptide and antibodies will not be required).\n* HbA1c level of \\\u003C 11% within the last six months.\n* Current use of intensive insulin therapy, either multi-daily injection or closed-loop insulin pump therapy, with no plan to change during the study.\n* Current use of CGM, either real-time or intermittent.\n* Active avoidance of pregnancy during the trial, which includes effective contraception for any individuals of childbearing potential, who are sexually active.\n* Ability to consume an average of more than 50 g of carbohydrates per day.\n* Use of a compatible phone to allow for download of the CKM sensor application.\n\nExclusion Criteria:\n\n* DKA or severe hypoglycemia within the last six months.\n* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).\n* Current or ≤ one-month use of supraphysiological doses of glucocorticoids.\n* Body mass index \\\u003C 20 kg\u002Fm2.\n* Glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last two months.",{"count":240,"type":21},24,[24],"Type 1 diabetes is an autoimmune disease where the body attacks the insulin-producing cells in the pancreas. In the absence of insulin, the body is unable to effectively use glucose for energy, resulting in high blood sugar levels. This leads to a lifelong need for intensive insulin therapy to manage blood sugar and prevent complications arising from elevated blood glucose levels. When insulin is low, the body produces ketone bodies. If ketone levels rise too high, they can lead to the dangerous condition known as diabetic ketoacidosis. Diabetic ketoacidosis remains a leading cause of mortality in children and young adults with type 1 diabetes.\n\nSodium\u002Fglucose cotransporter 2 inhibitors, such as empagliflozin, are effective in lowering blood sugar but can also increase ketone levels, raising the risk of diabetic ketoacidosis. Empagliflozin is approved for type 2 diabetes and has demonstrated benefits in type 1 diabetes, including improved blood sugar control at lower doses and reduced risks of chronic kidney disease and mortality at higher doses. However, its use in type 1 diabetes is still off-label due to the heightened risk of diabetic ketoacidosis. Using empagliflozin at a commercial dose safely is desirable to maximize its potential renal benefits in type 1 diabetes. While there are measures to monitor ketone levels, current methods, such as finger prick tests, often detect issues too late to prevent diabetic ketoacidosis. Continuous ketone monitoring offers real-time tracking of ketone levels, which could enable timely interventions to maintain safe levels. Moreover, there is currently no data on continuous ketone metrics in individuals with type 1 diabetes using sodium\u002Fglucose cotransporter 2 inhibitors.\n\nWe aim to understand the dynamics of ketone levels in people with type 1 diabetes using empagliflozin, including in challenging situations such as during exercise and low-carbohydrate diets while on sodium\u002Fglucose cotransporter 2 inhibitors. To this end, we will conduct an open- label, single-arm, outpatient study where 24 participants with type 1 diabetes will use continuous ketone monitoring for a 4-week run-in, followed by empagliflozin 2.5 mg for four weeks and then empagliflozin 10 mg for nine weeks. Participants will perform an exercise sub-study during the fourth week of the continuous ketone monitoring run-in and during the eighth week of empagliflozin 10 mg use. Certain participants will be invited to undergo a low-carbohydrate diet during the last week of empagliflozin 10 mg use. The results, if positive, may lead to i) novel long-term (6 months) data on ketone levels in those with type 1 diabetes using empagliflozin, including individuals on multiple daily injections and closed-loop therapy across a wide range of body mass index, ii) data on the relationship between empagliflozin, exercise, low-carbohydrate diets, and type 1 diabetes, and iii) the creation of important metrics for ketone thresholds that have not yet been characterized. Furthermore, we hope this preliminary study will inform future research to investigate the use of continuous ketone monitoring to allow for the safe use of higher doses of sodium\u002Fglucose cotransporter 2 inhibitors in people with type 1 diabetes.",[39,244,29],"Type1diabetes",[246,247,248,249,250,251,252,253],"CKM","Continous Ketone Monitoring","Empagliflozin","SGLT2i","SGLT2 inhibitors","Sodium-glucose cotransporter-2 inhibitors","Low-carb","Exercise","2024-12-20",{"date":256,"type":49},"2024-12-31",{"date":258,"type":49},"2024-12-05",{"date":260,"type":21},"2027-01-01",{"name":262,"class":189},"McGill University"]