[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type1diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type1diabetes":638},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,46,67,103,130,154,183,206,234,254,276,294,320,347,374,393,419,439,468,489,514,538,563,592,621],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100633144",false,"NCT07522866","Thrive With Type 1 Diabetes 2026","Intervention to Thrive With Type 1 Diabetes 2026","Inclusion Criteria:\n\n* Aged 31 to 75 years\n* Type 1 Diabetes for at least 1 year\n* One or more sleep health dimensions are out of range\n\nExclusion Criteria:\n\n* Non-English speaking\n* Recent night shift work or transmeridian travel\n* Life-limiting illness",true,"ALL","31 Years","75 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.",[28],"Type1diabetes",[30,31,32],"Glycemia","A1C","Sleep","RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":22},"2026-07",{"date":41,"type":22},"2028-04",{"name":43,"class":44},"Emory University","OTHER",2,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100600074","NCT07092761","Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagonsed with T1DM or T2DM\n* Venous blood sampling access can be established in the forearm\n* Capable of independently reading instructions and complying with the clinical trial requirements\n* Willing to sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Severe hypoglycemia within the past 6 month\n* Heart failure or hemiplegic sequelae due to prior cerebrovascular disease\n* Severe skin conditions at the sensor wear site\n* Extensive systemic skin disorders\n* Coagulation disorders confirmed by the investigator\n* Anemia or abnormal hematocrit\n* Blood donation within the past 6 months\n* Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days\n* Current or recent (≤1 month) participation in other clinical trials\n* Planned MRI\u002FCT scans during sensor wear\n* Allergy to medical adhesives or alcohol\n* Conditions impairing comprehension of informed consent or study procedures\n* Other exclusionary conditions per investigator's discretion","18 Years",{"count":53,"type":22},82,[25],"The study is to evaluate the accuracy and safety of a novel real-time CGM system among adult patients with type 1 diabetes mellitus with respect to YSI reference venous plasma sample measurements.",[28],"2026-05-27",{"date":59,"type":37},"2026-05-29",{"date":61,"type":37},"2025-04-01",{"date":63,"type":22},"2026-09-01",{"name":65,"class":44},"Henan University of Science and Technology",1,{"id":68,"slug":4,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":73,"targetDuration":75,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100637631","NCT07607015","CGM Experience, Preferences & Blood Glucose Parameters","Instara™-1 Dual Perspectives on Continuous Glucose Monitoring: Understanding Patient Experience and Healthcare Professional Preferences","Inclusion Criteria:\n\n* Subjects to provide written informed consent prior to any study procedures being performed\n* Subjects with age 18 and above both male and female\n* Diagnosed with Diabetes Miletus Type I, Type II and\u002For GDM\n* Comfortable using smart phone, access to internet along with Bluetooth connectivity throughout the study duration.\n* Subjects (Patients) on oral or injectable anti-diabetic medications, (in case of insulin, patient must be on insulin from last 3 months )\n* Subjects (HCPs) healthy, Pre-diabetes or Diabetes Miletus (any type)\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the active or inactive ingredients of the CGM device used in the trial, and\u002For history of significant allergic skin reactions.\n* Presence of severe diabetes complications e.g. retinopathy, acute metabolic crisis, etc.\n* History of active\u002F acute renal and\u002For hepatic failure.\n* Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.\n* History of critical illness or incapacitated patients\n* History of acute psychiatric disorder or exacerbation of chronic psychiatric disorder.\n* History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study.\n* Medical conditions that require patients to undergo frequent radiation\u002F imaging procedures for example CT, MRI and X rays\n* History of known hematological disorders such as Sickle Cell Disease \\& Trait, Thalassemia, Hemolytic Anemias (e.g., G6PD deficiency, autoimmune), Iron Deficiency Anemia\n* Patients on high doses of acetaminophen (\\>1 gram every 6 hours), ascorbic acid supplements (e.g., \\> 500-1000 mg\u002Fday), IV sorbitol, steroids and aspirin which can alter the readings on the CGM device.",{"count":74,"type":22},75,"3 Months","OBSERVATIONAL","This is an open-label, prospective, multicenter observational study designed to evaluate the perceived benefits, device experience, preference, and glucose-related parameters associated with the Instara-1 Continuous Glucose Monitoring device. The study will include patients with diabetes and healthcare professionals. Patients will use Instara- 1 and will be followed up to assess device experience, glucose parameters, and diabetes-related quality of life. Healthcare professionals will evaluate device experience and preference, including comparison with FreeStyle Libre 2.",[79,80,81,82,83],"Diabete Mellitus","Type2diabetes","type1diabetes","Gestational Diabetes","Pre Diabetes",[85,86,87,88,89,90,91],"CGM","Glucose monitoring","Time in range","estimated HbA1c","Time above range","Time below range","Diabetes Quality of life","NOT_YET_RECRUITING","2026-05-19",{"date":95,"type":37},"2026-05-26",{"date":97,"type":22},"2026-09-10",{"date":99,"type":22},"2027-08-10",{"name":101,"class":102},"Getz Pharma","INDUSTRY",{"id":104,"slug":4,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":66},"100326299","NCT03528226","Exercise Training and Endothelial Function in Type 1 Diabetes","Impact of Exercise Training on Endothelial Function in Adults With Type 1 Diabetes","EVaDia","Inclusion Criteria:\n\n* Covered by social security\n* With a T1Diabete, diagnosed for at least 1 year, and free from macrovascular and microvascular diabetic complications.\n\nExclusion Criteria:\n\n* type 1 diabetes diagnoses for less than 1 year\n* MODY diabetes, mitochondrial diabetes or type 2 diabetes\n* presence of macrovascular and\u002For microvascular diabetic complications (retinopathy, nephropathy, neuropathy ,…)\n* Obesity (Body Mass Index \\> 30 kg\u002Fm²\n* Smokers\n* Hypertension\n* Disabling painful discomfort for trunk, upper or lower limb movements\n* Active chronic disease or in remission (excluding type 1 diabetes)\n* Head trauma in the past","50 Years",{"count":112,"type":22},34,[25],"Endothelial dysfunction and vasoreactivity disorders are early subclinical complications of type 1 diabetes (T1D). In a preventive setting, in T1D patients still free of complications, the research of non-pharmacological interventions to improve endothelial function appears fundamental.\n\nIn this randomized controlled trial, the effects of exercise training on endothelial function will be evaluated in T1D adults. Secondary objectives are to evaluate the exercise training effects on the micro and macrovascular function and exercise-induced tissue vasoreactivity and their possible neurometabolic consequences.\n\nAn improvement in vascular function, particularly endothelium-dependent, as well as in neurometabolic profile, through this non-pharmacological strategy is expected",[28],[117,118,119,120],"Type 1 diabetes","endothelial function","exercise training","physical activity","2026-05-13",{"date":123,"type":37},"2026-05-14",{"date":125,"type":37},"2019-11-12",{"date":127,"type":22},"2028-11",{"name":129,"class":44},"University Hospital, Lille",{"id":131,"slug":4,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":66},"100597300","NCT07056699","SGLT2i, Pioglitazone, and Ketone Production in T1D","Protocol V: San Antonio Site Sub Study: Can Pioglitazone Block SGLT2 Inhibitor-induced Stimulation of Lipolysis, Ketone Production and Liver Glucose Production in Type I Diabetic Patients","Inclusion Criteria:\n\n1. Age \\>18 years\n2. T1DM\n3. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.\n4. Fasting C-peptide concentration \\\u003C0.7 ng\u002Fml\n5. Poor glycemic control (HbA1c=7.0-11.0%)\n6. Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump\n7. Total daily insulin dose ≥0.6 U\u002Fkg per day\n8. Stable insulin dose (±4 units) in the preceding three months.\n9. eGFR≥60 ml\u002Fmin\n10. Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program\n\nExclusion Criteria:\n\n1. T2DM\n2. Daily insulin dose \\\u003C0.6 U\u002Fkg per day\n3. Fasting C-peptide \\>0.7 ng\u002Fml\n4. HbA1c \\\u003C7.0% or \\>11.0%\n5. eGFR\\\u003C60 ml\u002Fmin\n6. Hematuria in urine analysis\n7. Pregnancy, lactating, positive pregnancy test or planning to become pregnant in the following year. Women of child-bearing potential will be requested to use at least two barrier methods before being enrolled in the study.\n8. Major organ system disease which includes: (i) malignancy or history of malignancy including bladder cancer; (ii) Congestive heart failure or history of coronary heart disease or any other cardiac disease; (iii) chronic liver disease or LFT \\>3 times the upper normal level; (iv) History of alcohol or drug abuse; (v) History of chronic lung disease (e.g., COPD, asthma); (vi) history of rheumatic disease; (vii) History of chronic pancreatitis or pancreatic surgery; (viii) History of CVA or TIA (ix) Planned surgery during the study; (x) history of HIV infection or other immune compromised disease; and history of organ transplantation; (xi) patients who take medications, other than insulin, known to affect glucose metabolism, e.g., prednisone.\n9. Evidence of proliferative diabetic retinopathy\n10. Patients enrolled in a heavy exercise program\n11. Patients on ketogenic diet\n12. History of hospitalization for DKA, hypoglycemia or uncontrolled hyperglycemia in the preceding 6 month.\n13. Presence of symptoms of poor glycemic control, e.g. polydipsia or polyurea\n14. History of hypersensitivity to dapagliflozin or pioglitazone",{"count":137,"type":22},24,[139],"PHASE3","Participants are being asked to be in a research study. Scientists do research to answer important questions which might help change or improve treatment of participants disease in the future.\n\nIn patients with Type 1 Diabetes (T1D), Dapagliflozin a Selective Glucose Transporter 2 Inhibitor (SGLT2i) is known to increase production of glucose in the liver, increase breakdown of fats (lipolysis), and increase production of ketones (ketogenesis). Ketones are chemicals produced by the liver when the body breaks down fat for energy instead of glucose. When the level of ketones in the body becomes too high, a condition called ketoacidosis develops. In this study, the study team will investigate whether adding pioglitazone (a medication commonly used to treat type 2 diabetes), can reduce the Dapagliflozin - induced liver glucose production, fat break down (lipolysis) and ketone body production (ketogenesis) in patients with Type 1 Diabetes (T1D).",[28],[143,144,145],"Selective Glucose Cotransporter 2 inhibitors (SGLT2i)","Dapagliflozin","Pioglitazone","2026-05-12",{"date":123,"type":37},{"date":149,"type":22},"2026-07-01",{"date":151,"type":22},"2027-06-30",{"name":153,"class":44},"The University of Texas Health Science Center at San Antonio",{"id":155,"slug":4,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":160,"enrollmentInfo":161,"targetDuration":163,"studyType":76,"phases":4,"briefSummary":164,"conditions":165,"keywords":168,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":66},"100476314","NCT05482321","Pancreas Ultrasound Imaging in type1 Diabetes","Contrast Enhanced Ultrasound Imaging of Pancreas Blood Flow in type1 Diabetes","All Participants:\n\nInclusion Criteria:\n\n* Male or non-pregnant female age 18-65\n* Ability and willingness of patient to participate fully in all aspects of this clinical study\n* Written informed consent obtained and documented\n\nExclusion Criteria:\n\n* Excessive body size preventing effective scan of the pancreas as determined by sonographer\n* Evidence of exocrine pancreatic disease, including pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumor.\n* Subjects who are pregnant or breast-feeding\n* Subjects incapable of giving assent\u002Finformed written consent\n* Known or suspected hypersensitivity to perflutren\n* Known history or suspected unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)\n\nGroup 2 (control subjects, part II):\n\nInclusion criteria:\n\nNo additional inclusion criteria\n\nExclusion criteria:\n\n* Diagnosis of diabetes according to the ADA recommended criteria (blood glucose and HbA1c will be measured)\n* Use of medications used to control high blood sugar (GLP1R agonists, metformin\\*, sulfonylureas)\n\n  * \\*Participants taking metformin will be considered eligible if they are willing\u002Fable to stop taking the medication for at least two weeks prior to each scan.\n* Any person who has received immunomodulatory intervention within 3 months of enrollment\n\nGroup 3 (T1D subjects, part II)\n\nInclusion criteria:\n\n* Diagnosis of diabetes according to the ADA recommended criteria (blood glucose and HbA1c will be measured)\n* Evidence of autoantibodies to at least 1 of the following β-cell autoantigens:\n\ninsulin, IA-2, GAD65, ZnT8\n\n* Presence of insulin autoantibody will only be valid if taken within the first 14 days of diagnosis.\n\n  * Diagnosis of diabetes within 180 days prior to participation in the study\n\nExclusion criteria:\n\n* Use of medications used to control high blood sugar (GLP1R agonists, metformin\\*, sulfonylureas)\n\n  * \\*Participants taking metformin will be considered eligible if they are willing\u002Fable to stop taking the medication for at least two weeks prior to each scan.\n* Any person who has received immunomodulatory intervention within 3 months of enrollment","65 Years",{"count":162,"type":22},50,"1 Year","The overall goal of this study is to develop and test a novel method involving ultrasound imaging, in order to detect the development of type 1 diabetes. In this study the investigators will first establish a standard operating procedure for measuring pancreas blood flow speed and volume in the pancreas of human subjects. The investigators will then determine 1) whether these pancreas blood flow factors differ between healthy subjects and those who have recently developed type1 diabetes; and 2) how variable measurements are in healthy subjects and subjects that recently developed type1 diabetes, both between subjects and over time. To address these aims the investigators will perform pancreas ultrasound measurements in each subject using an approved injectable 'bubble' contrast agent that allows measurement of pancreas blood flow. The investigators will compare ultrasound measurement with characteristics of the subject's type 1 diabetes, including genetic factors, glucose levels and other circulating factors, as well as other factors that may influence blood flow in the pancreas independent of type1 diabetes. The successful conclusion of this study will indicate whether measuring pancreas blood flow speed\u002Fvolume will be helpful in monitoring whether type1 diabetes will emerge and thus will allow a large scale study to answer this question.",[28,166,167],"Insulitis","Pancreas Inflamed",[169,170,171,172,173],"ultrasound","tissue perfusion","contrast","diabetes","pancreas","2026-05-04",{"date":176,"type":37},"2026-05-06",{"date":178,"type":37},"2023-02-27",{"date":180,"type":22},"2026-09",{"name":182,"class":44},"University of Colorado, Denver",{"id":184,"slug":4,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":190,"studyType":76,"phases":4,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100477592","NCT05498974","China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes","Inclusion Criteria:\n\n* 1\\. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)\n\n  1. Clinical diagnosis of type 1 diabetes by a specialist\n  2. Age at onset \\\u003C 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide \\\u003C 200 pmol\u002FL\n  3. Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset \\\u003C= 20 years, regardless of type and duration of disease.\n\nExclusion Criteria:\n\n* For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age)\n\n  * No insulin dependence for at least 6 months after diagnosis of diabetes mellitus.\n\n    * No DKA for 1 month off insulin for those with a history of diabetes \\> 1 year. ③ C-peptide \\> 800 pmol\u002FL at any time point.",{"count":189,"type":22},20000,"10 Years","The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset \\\u003C= 20 years.\n\nCD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.",[28,193],"Diabetes",[195],"Type 1 diabetes; Diabetes in Young","2026-04-23",{"date":198,"type":37},"2026-04-28",{"date":200,"type":37},"2022-01-01",{"date":202,"type":22},"2035-12-31",{"name":204,"class":44},"Second Xiangya Hospital of Central South University",11,{"id":207,"slug":4,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":212,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":23,"phases":215,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":66},"100600393","NCT07096908","Tirzepatide Use in People With Obesity and Type 1 Diabetes","Treatment With Tirzepatide of the Disease of Obesity in People With Type 1 Diabetes","Inclusion Criteria:\n\n1. Informed consent obtained before any trial-related activities.\n2. Male or female, adults.\n3. Documented diagnosis of T1DM (per ADA 2024definition\u002Fcriteria) for at least 1 year before screening visit with C-peptide level of less than 0.01nm\u002FL.\n4. Body mass index (BMI) ≥ 27.0 kg\u002Fm2\n5. History of at least one self-reported unsuccessful dietary effort to lose body weight.\n6. Must be using a Continuous Glucose Monitoring (CGM) device for at least 2 months before the screening visit and be willing to wear a CGM device for the duration of the study.\n\nExclusion Criteria:\n\n1. Diabetes related:\n\n   * Glycated hemoglobin (HbA1c) ≥86 mmol\u002Fmol (10%) as measured by the central laboratory at screening.\n   * Treatment with a glucagon-like peptide-1 receptor agonist within 180 days before screening.\n   * Preproliferative or proliferative retinopathy\n   * Experienced diabetic ketoacidosis within 6 months of screening visit.\n   * Experienced severe hypoglycemia (Level 3) within 6 months of screening visit.\n2. Obesity-related:\n\n   * A self-reported change in body weight \\>5 kg (11 lbs) within 90 days before screening irrespective of medical records.\n   * Treatment with any medication for the indication of obesity within the past 90 days before screening.\n   * Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and\u002For abdominoplasty, if performed \\>1 year before screening; (2) lap banding, if the band has been removed \\>1 year before screening; (3) intragastric balloon, if the balloon has been removed \\>1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \\>1 year before screening.\n   * Uncontrolled thyroid disease, defined as thyroid stimulating hormone \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL as measured by the central laboratory at screening.\n3. Mental health:\n\n   * History of major depressive disorder within 2 years before screening.\n   * Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).\n   * A Patient Health Questionnaire-9 score of ≥15 at screening.\n   * A lifetime history of a suicidal attempt.\n   * Suicidal behavior within 30 days before screening.\n   * Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale within the past 30 days before screening.\n4. General safety:\n\n   * Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown\u002Funspecified content within 90 days before screening.\n   * Presence of acute pancreatitis within the past 180 days prior to the day of screening.\n   * History or presence of chronic pancreatitis.\n   * Calcitonin ≥100 ng\u002FL as measured by the central laboratory at screening.\n   * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.\n   * Renal impairment measured as estimated glomerular filtration rate value of \\\u003C15 mL\u002Fmin\u002F1.73m2 as defined by KDIGO 2012 by the central laboratory at screening.\n   * History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.\n   * Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.\n   * Subject presently classified as being in New York Heart Association Class IV.\n   * Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.\n   * Known or suspected abuse of alcohol or recreational drugs.\n   * Known or suspected hypersensitivity to trial product(s) or related products.\n   * Previous participation in this trial. Participation is defined as signed informed consent.\n   * Participation in another clinical trial within 90 days before screening.\n   * Other subject(s) from the same household participating in any semaglutide trial.\n   * Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.\n   * Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.","21 Years",{"count":214,"type":22},60,[216],"PHASE4","Tirzepatide, a gut hormone-based medication, has shown promising results in treating obesity, with \\~22% weight loss and mild side effects. However, patients with type 2 diabetes typically experience only about 15% weight loss with tirzepatide, despite tolerating the medication well. Its effects in people with both obesity and type 1 diabetes remain largely unknown.\n\nAlthough tirzepatide is not approved for glycemic control in type 1 diabetes, it is licensed for obesity treatment in Gulf and Europe. In Kuwait, more than a quarter of people with type 1 diabetes also have obesity, presenting a unique opportunity to study tirzepatide's impact.\n\nThis randomized, double-blind controlled trial will evaluate the safety and efficacy of tirzepatide in patients with type 1 diabetes and obesity, comparing usual care with the maximum tolerable dose of tirzepatide to assess its impact on weight loss. The findings may help address important safety concerns and have the potential to inform and influence future clinical practice.",[28,219],"Obesity",[221,222,223,224],"T1D","tirzepatide","weight loss","obesity","2026-04-15",{"date":227,"type":37},"2026-04-20",{"date":229,"type":37},"2025-07-31",{"date":231,"type":22},"2028-08-01",{"name":233,"class":44},"Dasman Diabetes Institute",{"id":235,"slug":4,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100497406","NCT05756829","Type 1 Diabetes Virtual Self-management Education and Support","T1ME","Inclusion Criteria:\n\n1. Outpatients ≥18 years of age\n2. Physician diagnosis of type 1 diabetes\n3. Currently on an insulin pump or using multiple daily insulin injections.\n4. HbA1c ≥ 7.5% on most recent laboratory report or estimated from CGM\u002FFGM\\* report, within the last 4 months\n\n   \\*14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)\n5. Has access to a mobile device or computer\u002Ftablet with a video camera\n6. Seen for at least one visit in the previous 6 months by participating certified diabetes educator at the selected diabetes clinic OR If a transitioning patient: Currently enrolled in a diabetes program below AND had at least one visit or touch-point prior in the previous 6 months by participating certified diabetes educator at on of our participating diabetes clinics\n7. OHIP coverage\n8. Currently using an active email address or be willing to obtain an email address\n9. Has consistent and reliable access to internet\n10. Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period\n\nExclusion Criteria:\n\n1. Diagnosed with non-Type 1 diabetes\n2. Unable to use a computer\u002Ftablet or mobile phone\n3. Pregnant\n4. On dialysis\n5. Unable to fluently speak or read English (self-reported)",{"count":241,"type":22},580,[25],"OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver \"high frequency, low touch\" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams.\n\nSTUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario.\n\nINTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.",[81],{"date":246,"type":37},"2026-04-21",{"date":248,"type":37},"2023-05-10",{"date":250,"type":22},"2027-03-31",{"name":252,"class":44},"Unity Health Toronto",9,{"id":255,"slug":4,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":16,"sex":17,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":273,"locationsCount":45},"100443435","NCT05054361","Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children","Crosstalk Between Mucosal-Associated Invariant T Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children","MAIT-DT1","Inclusion Criteria:\n\nRecent onset group\n\n* age \\> 12 months and \\\u003C 15 years\n* recently diagnosed type 1 diabetes according ISPAD criteria\n\nAt risk subjects:\n\n* age \\> 12 months and \\\u003C 15 years\n* siblings of type 1 diabetic patient\n* HLA DR3 and DR4 positive\n\nControl subjects:\n\n* age \\> 12 months and \\\u003C 15 years\n* no HLA associated with high risk type 1 diabetes\n* no antibodies against pancreas antigenes\n\nControl subjects for UGI endoscopy:\n\n* age \\> 12 months and \\\u003C 15 years\n* suspicion of coeliac disease or gastritis\n\nExclusion Criteria:\n\nFor all groups:\n\n* no health care insurance\n* parents or tutors unable to sign the consent\n* personal history of autoimmune disease and\u002For inflammatory disease except from T1D for RD and CE groups\n* use of corticosteroids during the month before inclusion\n* pregnant subjects\n* medical contraindication of anesthetic topics\n\nFor control subjects for UGI endoscopy control and Recent onset-endoscopy group:\n\n* age below 8 years for Recent onset-endoscopy group\n* age below 4 for UGI endoscopy control group\n* cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease, patients treated with anticoagulant or antiaggregant drug\n* history of allergy to anesthetic drug","12 Months","15 Years",{"count":264,"type":22},180,"To investigate in a prospective way changes in Mucosal-Associated Invariant T (MAIT) cells frequency, phenotype and function in link with the gut microbiota, gut integrity and the presence of Coxsackie virus B in two cohorts of pediatric patients: patients with a high genetic risk of type 1 diabetes and pediatric patients with recently diagnosed T1D by comparison with control subjects\n\nTasks:\n\n1. To measure blood MAIT cells frequency, phenotype and function in the three cohorts\n2. To analyze gut microbiota and the presence of Coxsackie B enterovirus (CVB) and their impact on MAIT cell function\n3. To evaluate gut integrity and analyze the gut mucosa\n4. To integrate all the data obtained with T1D development and evolution",[28],"2026-04-08",{"date":269,"type":37},"2026-04-13",{"date":200,"type":37},{"date":272,"type":22},"2027-08-14",{"name":274,"class":275},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":277,"slug":4,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":45},"100603691","NCT07139808","Safety and Effectiveness of A Novel Continuous Glucose and Ketone Monitoring System","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagonsed with T1DM on Continuous subcutaneous insulin infusion (CSII)\n* Venous blood sampling access can be established in the forearm\n* Capable of independently reading instructions and complying with the clinical trial requirements\n* Willing to sign the Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Severe hypoglycemia within the past 6 months\n* A diagnosed history of Diabetic ketoacidosis (DKA) in the past 3 months\n* Heart failure or hemiplegic sequelae due to prior cerebrovascular disease\n* Severe skin conditions at the sensor wear site\n* Extensive systemic skin disorders\n* Having difficulty with wound healing, bleeding disorders, and\u002For taking anticoagulant medications\n* Anemia or abnormal hematocrit\n* Blood donation within the past 6 months\n* Pregnancy (defined as positive urine test in women ≤55 years), lactation, or plans for pregnancy within ≤30 days\n* Current or recent (≤1 month) participation in other clinical trials\n* Planned MRI\u002FCT scans during sensor wear\n* Allergy to medical adhesives or alcohol\n* Conditions impairing comprehension of informed consent or study procedures\n* Other exclusionary conditions per investigator's discretion",{"count":282,"type":22},12,[25],"The study is to evaluate the accuracy and safety of a novel real-time continuous glucose and ketone monitoring system among adult patients with type 1 diabetes mellitus (T1DM) with respect to Yellow Spring Instrument (YSI) and Randox reference venous plasma sample measurements.",[28],"2026-04-01",{"date":288,"type":37},"2026-04-07",{"date":290,"type":37},"2025-08-01",{"date":292,"type":22},"2026-12-01",{"name":65,"class":44},{"id":295,"slug":4,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":16,"sex":17,"minAge":299,"maxAge":4,"enrollmentInfo":300,"targetDuration":190,"studyType":76,"phases":4,"briefSummary":302,"conditions":303,"keywords":307,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":66},"100335553","NCT03648918","Genetics Of Autoimmunity In Type I Diabetes","Inclusion Criteria (Families):\n\n* Families where at least one first-degree family member has type 1 diabetes\n* The diabetic proband in the family was diagnosed before the age of 39\n* Family members must be at least 2 years old to participate\n\nExclusion Criteria (Families):\n\n* Families with no history of type 1 diabetes\n* Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)\n\nInclusion Criteria (Controls):\n\n* No family history of type 1 diabetes or other autoimmune conditions\n* Age 2 or older\n\nExclusion Criteria (Controls):\n\n* Personal or family history of autoimmune disease","2 Years",{"count":301,"type":22},4000,"The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.",[28,304,305,306],"Diabetes Mellitus, Type 1","Type1 Diabetes Mellitus","Diabetes Mellitus",[308,309,310],"Family","Healthy Controls","Siblings","2026-03-12",{"date":313,"type":37},"2026-03-16",{"date":315,"type":37},"2001-08",{"date":317,"type":22},"2050-01",{"name":319,"class":44},"Medical College of Wisconsin",{"id":321,"slug":4,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":327,"minAge":51,"maxAge":110,"enrollmentInfo":328,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":66},"100459105","NCT05258292","Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes","Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study","GLYMETY","Inclusion Criteria:\n\n1. Females aged 18 to 50 living in Canada.\n2. Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year.\n3. Using insulin pump therapy, multiple daily injections or automated insulin delivery systems for at least 3 months.\n4. Using a continuous glucose monitoring (CGM) system.\n5. Having at least one menses in the last 40 days.\n6. Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period.\n7. Having a smartphone or tablet to follow menstrual cycles.\n8. Stable weight (less than 5% variation in the last 3 months).\n\nExclusion Criteria:\n\n1. Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill)\n2. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).\n3. Clinically significant nephropathy (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2, planned or on dialysis) or neuropathy (e.g., known uncontrolled gastroparesis) as judged by the investigator.\n4. Recent (\\\u003C 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).\n5. Anticipated therapeutic change (including change of insulin type and\u002For type of CGM sensor, insulin pump or AID (automated insulin device) system) between admission and end of the study.\n6. Anticipated change in contraception method or plan to begin or stop a contraceptive method.\n7. Anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours.\n8. Pregnancy (ongoing or current attempt to become pregnant)\n9. Breastfeeding\n10. Uncontrolled thyroid disease (TSH should be in target range and treatment stable for at least 6 weeks).\n11. Severe hypoglycemic episode within two weeks of screening\n12. Severe hyperglycemic episodes requiring hospitalization in the last 3 months.\n13. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)\n14. Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study.\n15. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed.\n16. Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.\n17. Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change).\n18. Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).\n19. In the opinion of the investigator, a participant who is unable or unwilling to complete the study.\n20. If taking medication for hypothyroidism, no change of dose (Levothyroxin) in the last 6 weeks.","FEMALE",{"count":329,"type":22},86,"In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase).\n\nOverall, despite an important proportion of women reporting glycemic and\u002For insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.",[28],[333,334,335,336,337],"Menstrual cycle","Continuous glucose monitoring","Insulin dose","Physical activity","Food intake","2026-03-03",{"date":340,"type":37},"2026-03-05",{"date":342,"type":37},"2022-05-02",{"date":344,"type":22},"2026-05-31",{"name":346,"class":44},"Institut de Recherches Cliniques de Montreal",{"id":348,"slug":4,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":262,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":356,"briefSummary":357,"conditions":358,"keywords":362,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":66},"100626354","NCT07434544","Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)","The Cardiometabolic Impact of Non-Nutritive Sweeteners in Young Adults With Type 1 Diabetes","Inclusion Criteria:\n\n1. Aged 15-24 years\n2. Clinical diagnosis of type 1 diabetes, requiring insulin therapy, of ≥ 1 to \\\u003C 10 years duration.\n3. Last available HbA1c ≤ 8.5% (obtained by chart review in Children's Wisconsin Diabetes Clinic patients or verbally by individuals not receiving diabetes care at Children's Wisconsin)\n4. Current use of an FDA approved automated insulin delivery (AID) system\n5. Willing to consume a 12 ounce Gatorade G Zero Glacier Cherry drink in less than 10 minutes\n6. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \\\u003C 18 years of age\n\nExclusion Criteria:\n\n1. Any disease other than type 1 diabetes that affects glucose, sex steroid, or fat metabolism such as polycystic ovary syndrome or hypercortisolism\n2. Any medication use that may affect glucose, sex steroid, or fat metabolism such as metformin or glucocorticoids\n3. Half or full sibling already participating in this study\n4. Known cardiovascular disease such as hypertension or atherosclerosis, and\u002For use of an anti-hypertensive medication\n5. Known hyperlipidemia, defined as LDL ≥ 160 mg\u002FdL, and\u002For use of lipid-lowering medication, such as statin therapy\n6. Known renal disease or microalbuminuria, and\u002For use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARBs) for microalbuminuria\n7. Known diabetic retinopathy or neuropathy\n8. Raynaud's phenomenon or other vascular disease\n9. Obesity and\u002For body habitus that precludes completion of the flow-mediated brachial ultrasound study (generally, BMI \\> 40 kg\u002Fm2 in adults) - this is at study team's discretion.\n10. Pregnancy or lactation\n11. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.","24 Years",{"count":355,"type":22},20,[25],"This project will apply a novel non-nutritive sweetener (NNS) dietary assessment tool with measurement of circulating NNS levels in a pediatric population, allowing correlation of NNS exposure to clinically meaningful cardiometabolic health outcomes.",[359,360,81,361],"Non-Nutritive Sweetener","Type 1 Diabetes","Type 1 Diabetes Mellitus",[363,360,364,365],"Non-Nutritive Sweeteners","Cardiometabolic","Long standing","2026-02-20",{"date":368,"type":37},"2026-02-25",{"date":370,"type":22},"2026-06-01",{"date":372,"type":22},"2029-12-31",{"name":319,"class":44},{"id":375,"slug":4,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":379,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":66},"100502506","NCT05823142","Health Behavior Intervention for Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Aged 18 to 40 years\n* Type 1 Diabetes at least 1 year\n* One or more sleep health dimension out of range\n\nExclusion Criteria:\n\n* Non-English speaking\n* A1C \\\u003C 7% or \\>80% time in glucose range","40 Years",{"count":381,"type":22},300,[25],"Type 1 diabetes (T1D) affects approximately 2 million Americans, and only 2 in 8 young adults ages 18-31 years achieve glycemic targets (glycated hemoglobin A1C \\\u003C7.0%). Achieving glycemic targets is associated with reduced risk of micro-and macrovascular complications. Sleep deprivation leads to impaired glucose tolerance and insulin sensitivity in adults without chronic conditions and with T1D. Promoting sleep in laboratory and natural environments contributes to improvements in insulin sensitivity, glucose levels, and distress symptoms in young adults without chronic conditions and more time in range in adolescents with T1D. Multiple dimensions of sleep health (alertness, timing, efficiency, and sleep duration) are associated with better achievement of glycemic targets in adults with T1D. Therefore, sleep health dimensions are appropriate therapeutic targets to improve glucoregulation and other diabetes self-management outcomes in this population.\n\nOur primary objective is to evaluate the immediate and short-term effects of a 12-week CB-sleep intervention compared to enhanced usual care (time balanced attention control) on actigraphy- and self-report derived sleep health dimensions and diabetes self-management outcomes (glycemia and distress symptoms) over 9-months (Stage II of the NIH Model for Behavior Change, ORBIT phase III). CB-sleep is guided by principles and practices from motivational interviewing and the Transtheoretical Model of Behavior Change with interactive stage-matched sessions.",[28],"2025-12-17",{"date":387,"type":37},"2025-12-19",{"date":389,"type":37},"2023-12-20",{"date":391,"type":22},"2028-12",{"name":43,"class":44},{"id":394,"slug":4,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":17,"minAge":399,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":23,"phases":402,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":66},"100474152","NCT05454176","Diabetes in African Youth","Diabetes in African Youth: Improving Glucose Time-In-Range (DAYTime, Randomized Clinical Trial)","Inclusion Criteria:\n\n* Children and youth in Uganda, age 4-26 years at the beginning of the baseline assessment\n* T1D (determined by clinical criteria, as autoantibody testing is not regionally available) of at least 12 months duration at the beginning of the baseline assessment\n* Receiving insulin therapy\n* Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas)\n* At least one parent or guardian (or as per local regulations) is present in clinic and able to give consent for children under 18 years of age (those age 18-26 may give consent for themselves)\n\nExclusion Criteria:\n\n* Unwilling or unable to be seen monthly at the pediatric diabetes clinic\n* Pregnant or breast-feeding; women likely to become pregnant in the next year\n* Major medical conditions which the investigator feels would interfere with study participation\n* Patient already has CGM\n* Inability during the baseline assessment period to wear the sensor for at least 7 days or return it\n* Participant deemed unlikely or unable to comply with the protocol","4 Years","26 Years",{"count":264,"type":22},[216],"This RCT aims to improve T1D care in East African children and young adults by testing the hypothesis that enabling patients to continuously monitor glucose levels with flash CGM technology will improve glucose time-in-range (glucose level 70-180 mg\u002Fdl). A second primary endpoint is to perform a cost analysis on flash glucose monitoring compared to 3x\u002Fday SMBG, to determine whether this technology is cost-effective in the setting of a less-resourced nation.\n\nAfter a 2 week assessment with blinded CGM when a potential subject's ability to wear CGM is confirmed, subjects will be enrolled for 12 months in randomized, open label study, with a primary endpoint measurement at 6 months. All subjects will receive monthly diabetes self-management education.\n\nFor the first six months, months 1-6:\n\n* Half of patients (n=90) will be randomized to an unblinded FreeStyle Libre 2 CGM.They and their care providers will be able to continuously see their CGM glucose levels to assist in insulin adjustment.\n* Half of patients (n=90) will be given sufficient test strips for 3x daily SMBG while wearing blinded CGM (control group). Neither they nor their care providers will be able to see their CGM glucose levels (the blinded CGM is simply for outcome measurement, not an intervention). As per usual clinical practice, only the SMBG glucose levels will be available to assist in insulin adjustment.\n* The change between baseline to 6 months in CGM-derived glucose percent time-in- range will be compared between groups (first primary study endpoint).\n\nFor the second six months, months 7-12:\n\n* The control group will switch to unblinded CGM months 7-12 (their data months 7-12 months will be compared to their data months 1-6 as part of the primary endpoint assessment).\n* The patients who wore the unblinded CGM months 1-6 will continue for another 6 months to assess the impact of wearing the CGM for 12 continuous months (a secondary endpoint).\n\nOnce the clinical portion of the study is complete, study investigators who are health economists from the Uganda Ministry of Health will perform a costs analysis (second primary endpoint).",[81],[406,407,408,85,409],"Uganda","type 1 diabetes","continuous glucose monitor","resource poor nations","2025-11-24",{"date":412,"type":37},"2025-11-25",{"date":414,"type":37},"2022-08-15",{"date":416,"type":22},"2027-08-15",{"name":418,"class":44},"University of Minnesota",{"id":420,"slug":4,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":424,"maxAge":425,"enrollmentInfo":426,"targetDuration":261,"studyType":76,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":66},"100565740","NCT06646107","Adherence to Mediterranean Diet in Type 1 Diabetes Initiating Minimed 780G: Glucose Metrics vs Insulin Metrics, is There a Difference","Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes \\>1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.\n2. HbA1c \\\u003C 12.5%\n3. Age \\>7years at the initiation of the system\n4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period\n5. Clinically able to start the AHCL system\n6. History of 3 clinic visits in the last year\n\nExclusion Criteria:\n\n1\\. Diabetic Ketoacidosis in the 6 months prior to screening visits\n\n\\-","12 Years","80 Years",{"count":427,"type":22},240,"In this observaltional study, 240 patients aged \\>12 years old with T1DM who are on multiple daily injections or insulin pump and are scheduled to start using MiniMed 780G system will be included.We aim to compare patients' adherence to Mediterranean diet (MD) before and 12 weeks after initiation of MiniMed 780G and its association with CGM and insulin metrics, as well as anthropometric measurements, BMI, body composition, lipid levels, blood pressure and gut microbioma. Moreover, at baseline, at six and 12 months, markers of endothelial and cardiovascular function will be also assessed and associated with the use of Minimed 780G and the adherence to MD.",[28],"2025-11-15",{"date":432,"type":37},"2025-11-19",{"date":434,"type":37},"2025-03-01",{"date":436,"type":22},"2026-01-31",{"name":438,"class":44},"Attikon Hospital",{"id":440,"slug":4,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":17,"minAge":444,"maxAge":51,"enrollmentInfo":445,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":447,"conditions":448,"keywords":453,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":66},"100451542","NCT05159856","Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes","Inclusion Criteria:\n\n* T1D\\>12 months\n* 6-18 years old prior to inclusion\n* Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen\n* Speaks and reads Danish well enough to understanding the given oral and written information.\n* There is a written consent from the guardianship holder\u002Fholders for the child.\n\nExclusion Criteria:\n\n* T1D \\\u003C 12 months\n* Known cardiovascular disease\n* Antihypertensive treatment","6 Years",{"count":446,"type":22},400,"Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D).\n\nBackground: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed.\n\nMethods: A prospectivel study of 400 children, aged 6-18 years old, with T1D\\>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected.\n\nBlood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades.\n\nPerspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.",[449,81,450,451,452],"Diabetes Complications","Children, Only","Diabetic Neuropathies","Arterial Stiffness",[454,455,456,457,407,458],"pediatric","arteriel stiffness","pulse wave velosity","neuropathy","early diabetic complications","2025-05-28",{"date":461,"type":37},"2025-06-03",{"date":463,"type":37},"2022-05-03",{"date":465,"type":22},"2025-12",{"name":467,"class":44},"Steno Diabetes Center Copenhagen",{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":66},"100524223","NCT06105931","Physiologic Markers of Cardiometabolic Risk in People With Type 1 Diabetes","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18 to ≤30 years\n* Diagnosed T1D for at least 12 months and with BMI \\\u003C25 kg\u002Fm2.\n* HbA1c ≤10%\n* Clinical use of continuous glucose monitoring (CGM)\n* Any known laboratory safety parameter consistently outside the below extended laboratory ranges in the past year:\n\n  1. Baseline creatinine \\>1.0mg\n  2. Hypertriglyceridemia (\\>400 mg\u002Fdl)\n  3. ALT ≥3.5 times the upper normal limit (UNL)\n\nExclusion Criteria:\n\n* Current use of adjunctive diabetes medication or anti-obesity medication\n* Insulin dose \\\u003C0.5 units\u002Fkg\u002Fday\n* Use of lipid lowering prescription medication other than statins or omega-3 products\n* Doesn't meet MRI safety criteria or having claustrophobia\n* Known liver disease other than non-alcoholic steatosis or non-alcoholic fatty liver disease\n* Known renal impairment\n* Pregnancy or lactation, or planning to become pregnant during the study period.\n* Anemia or known hematologic condition impacting HbA1c reading, or another medical condition that precludes participation.\n* Treatment with another investigational drug within the past 1 month\n* Past medical history of or self-reported corn allergy","30 Years",{"count":475,"type":22},15,[477],"PHASE1","More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. Investigators aim to obtain reference data for individuals with T1D who do not have overweight obesity, to understand how close GLP-1 analogue obesity treatment in those with overweight\u002Fobesity brings physiologic markers of cardiometabolic risk to those with BMI in the normal range. Specifically, investigators will describe how drivers of gluconeogenesis and lipemia (specifically measured as visceral fat ratio, insulin resistance, and postprandial lipemia,) that contribute to cardiometabolic risk in T1D change over time.",[81,219],"2025-04-30",{"date":482,"type":37},"2025-05-04",{"date":484,"type":37},"2023-12-13",{"date":486,"type":22},"2028-06",{"name":488,"class":44},"Yale University",{"id":490,"slug":4,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":16,"sex":17,"minAge":495,"maxAge":424,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":503,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":4},"100548228","NCT06418269","The Effect of Therapeutic Play on Anxiety and Fear Levels in Children With Diabetes","The Effect of Insulin Education Given to Children With Diabetes by Therapeutic Play Method on Anxiety and Fear Levels","Inclusion Criteria:\n\n* The child must be between the ages of 9 and 12 (since the State Anxiety Inventory for Children Scale is for this age range)\n* Diagnosed with type 1 diabetes\n* Absence of mental retardation\n* Receiving subcutaneous insulin treatment for the first time\n* Voluntariness of the child and parent to participate in the study\n\nExclusion Criteria:\n\n* Visual, hearing or speech impairment\n* Illiteracy of the child\n* Having a clinical condition that prevents playing games (excessive fatigue, weakness, etc.)","9 Years",{"count":214,"type":22},[25],"The study will be conducted using a randomized controlled method. Children with type 1 diabetes who are admitted to the Pediatric Endocrinology Service will be divided into two groups by randomization method. Following randomization, children in the experimental group will play a therapeutic game before their subcutaneous insulin treatment. In the subcutaneous insulin treatment of the children in the control group, the routine practice of the clinic will be applied. Anxiety and fear levels of all children in the experimental and control groups will be evaluated before and after subcutaneous insulin treatment.",[28,500,501,502],"Therapeutic Play","Fear State","Anxiety State",[28,504,505,502],"Therapeutic play","Fear state","2025-04-29",{"date":480,"type":37},{"date":509,"type":22},"2025-07-18",{"date":511,"type":22},"2026-08-18",{"name":513,"class":44},"Istanbul University - Cerrahpasa",{"id":515,"slug":4,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":19,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":526,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":536,"locationsCount":66},"100490135","NCT05662189","Assessment of Pancreatic Beta Cell Mass and Function by Positron Emission Tomography Imaging in Human Diabetes Mellitus","Assessment of Pancreatic Beta Cell Mass and Function with the Aid of Positron Emission Tomography Imaging in Human Diabetes Mellitus","Inclusion Criteria:\n\n* Age ≥18 years; ≤ 75 years\n* Both sexes\n* Good health\n* Absence of exclusion criteria\n* Able to understand methods, goals, and implications of the research and of delivering a free, written informed consent\n\nExclusion Criteria:\n\n* Hemoglobin \\\u003C 12 g\u002Fdl\n* HbA1c \\> 10%\n* Pregnancy or breast-feeding\n* If not in menopause, women not using effective birth control methods or not willing to undergo a pregnancy test\n* History of severe psychiatric disorder or alcohol abuse\n* Recent head traumas (\\\u003C6 months)\n* Active neurologic diseases\n* Claustrophobia\n* Active malignant neoplasms\n* Severe kidney and\u002For liver disease\n* Recent (\\\u003C6 months) major adverse cardiovascular events\n* Heart failure (class NYHA 3-4)\n* Drugs known to affect beta cell function and\u002For insulin sensitivity\n* Current or past treatment with GLP1R-agonists\n* Intolerance to exenatide\n* Endocrine diseases, other than diabetes mellitus, known to affect beta cell function and\u002For insulin sensitivity, except well controlled hypothyroidism or adrenal insufficiency\n* COPD on day time oxygen therapy\n* Any current acute disease",{"count":521,"type":22},70,[25],"The goals of this project are to build an experimental tool to dissect out in vivo pancreatic beta cell mass (BCM) and beta cell function (BCF) and to assess for the first time these two determinants of beta cell functional mass (BCFxM) in obesity and in various stages of type 1 and type 2 diabetes mellitus.",[28,80,83,525],"Hyperinsulinism",[172,527,528,529],"beta-cell","exendin","PET-CT","2025-03-14",{"date":532,"type":37},"2025-03-18",{"date":534,"type":37},"2022-03-15",{"date":465,"type":22},{"name":537,"class":44},"Azienda Ospedaliero-Universitaria di Parma",{"id":539,"slug":4,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":16,"sex":17,"minAge":299,"maxAge":473,"enrollmentInfo":545,"targetDuration":4,"studyType":23,"phases":547,"briefSummary":548,"conditions":549,"keywords":551,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":66},"100575310","NCT06770621","Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes","Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes (GLUREDIA Study): Characteristics and Predictive Biomarkers.","GLUREDIA","WP1 :\n\n* Inclusion criteria:\n\n  * De novo type 1 diabetic patient, as per ISPAD criteria;\n  * Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +\u002F- Acido ketosis.\n  * Fasting blood glucose ≥126 mg\u002FdL AND\u002FOR blood glucose ≥200 mg\u002FdL at 120 minutes of an OGTT AND\u002FOR HbA1c ≥6.5% AND\u002FOR a patient with symptoms of hyperglycemia\u002Fhyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg\u002FdL.\n\nPresence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)\n\n* Patients aged between 2 and 30 years\n* Minimum weight: 17 kg (for blood samples)\n* Male - female patients\n* Free, written and oral consent.\n\n  * Exclusion criteria:\n* Child under 2 years of age.\n* Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n* Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.\n* Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n* Obesity defined as a BMI with a z-score \\>+3 SD.\n* Hepatic, renal or adrenal insufficiency.\n* History of bone marrow transplantation.\n* History of diabetes after hemolytic-uremic syndrome.\n* Epileptic patient\n* Absence of anti-islet autoantibodies.\n* Dysmorphia with suspicion of underlying genetic syndrome.\n* Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.\n\nWP2 :\n\n* Inclusion Criteria:\n\n  * De novo type 1 diabetic patient, as per ISPAD criteria;\n  * Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +\u002F- Acido ketosis.\n  * Fasting blood glucose ≥126 mg\u002FdL AND\u002FOR blood glucose ≥200 mg\u002FdL at 120 minutes of an OGTT AND\u002FOR HbA1c ≥6.5% AND\u002FOR a patient with symptoms of hyperglycemia\u002Fhyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg\u002FdL.\n  * Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)\n  * Patients aged between 2 years and 18 years (\\\u003C18 years).\n  * Male - female patients\n  * Free, written and oral consent.\n* Exclusion criteria:\n\n  * Child under 2 years of age.\n  * Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n  * Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.\n  * Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n  * Obesity defined as a BMI with a z-score \\>+3 SD.\n  * Hepatic, renal or adrenal insufficiency.\n  * History of bone marrow transplantation.\n  * History of diabetes after hemolytic-uremic syndrome.\n  * Absence of anti-islet autoantibodies.\n  * Dysmorphia with suspected underlying genetic syndrome.\n  * Participation in another study within the previous 3 months with administration of blood derivatives or potentially immunomodulatory treatments.\n\nWP3 :\n\n* Inclusion Criteria:\n\n  * Adult older than 18 years.\n  * Absence of blood marker of diabetes (Absence of antibodies, HbA1C \\\u003C6.5%, C-peptide \\> 0.18 nmol\u002FL, Fasting blood glucose \\\u003C 100 mg\u002FdL, blood glucose at any time \\\u003C 200 mg\u002FdL).\n  * Be a first-degree relative with a patient being followed for diabetes (meeting ISPAD criteria).\n  * Male - Female\n  * Free written and oral consent\n* Exclusion criteria:\n\n  * Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n  * Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.\n  * Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n  * Obesity defined as a BMI with a z-score \\>+3 SD.\n  * Hepatic, renal or adrenal insufficiency.\n  * History of bone marrow transplantation.\n  * History of diabetes after hemolytic-uremic syndrome.\n  * Ischemic cardiomyopathy\n  * Pregnant participant\n  * Epileptic patient\n\nWP4 :\n\n* Inclusion Criteria:\n\nCohort of patients followed for cystic fibrosis:\n\n* Pediatric patient between 2 and 18 years of age.\n* Diagnosed with cystic fibrosis with impaired pancreatic endocrine function.\n* Presents glucose homeostasis disorders (regular hypo\u002Fhyper-glycemia).\n* Male - female patient\n* Free, written and oral consent\n\nCohort of patients with (sub)total pancreatectomy:\n\n* Pediatric patients between 2 and 18 years of age.\n* Follow-up for total pancreatectomy or caudal pancreatectomy\n* Presents disorders of carbohydrate homeostasis (regular hypo-\u002Fhyper-glycemia)\n* Male - female patient\n* Free, written and oral consent\n\n  * Exclusion criteria:\n* Child under 2 years of age.\n* Body weight less than 17 kg.\n* Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n* Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.\n* Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n* Obesity defined as a BMI with a z-score \\>+3 SD.\n* Hepatic, renal or adrenal insufficiency.\n* History of bone marrow transplantation.\n* History of diabetes after hemolytic-uremic syndrome.\n* Dysmorphia with suspected underlying genetic syndrome.\n* Participation in another study within the last 3 months, with administration of blood derivatives or potentially immunomodulatory treatments.\n\nWP5 :\n\n* Inclusion Criteria:\n\n  * Patient who has undergone insulin testing due to suspected growth hormone deficiency or adrenal insufficiency or hypopituitarism.\n  * Patients between the ages of 2 years and 18 years (\\\u003C18 years).\n  * Male - female patient.\n  * Free written and oral consent.\n* Exclusion criteria:\n\n  * Child under 2 years of age.\n  * Body weight less than 17 kg.\n  * Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n  * Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.\n  * Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n  * Obesity defined as a BMI with a z-score \\>+3 SD..\n  * History of bone marrow transplantation.\n  * History of diabetes after hemolytic-uremic syndrome.\n  * Participation in another study within the last 3 months, with administration of blood derivatives or potentially immunomodulatory treatments.\n\nWP6 :\n\n* Inclusion Criteria:\n\n  * Type 1 diabetic patient, as per ISPAD criteria;\n  * Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +\u002F- Acido ketosis.\n  * Fasting blood glucose ≥126 mg\u002FdL AND\u002FOR blood glucose ≥200 mg\u002FdL at 120 minutes of an OGTT AND\u002FOR HbA1c ≥6.5% AND\u002FOR a patient with symptoms of hyperglycemia\u002Fhyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg\u002FdL.\n  * Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)\n  * Patients aged between 2 and 18 years (\\\u003C18 years).\n  * Male - female patients\n  * Free, written and oral consent.\n* Exclusion criteria:\n\n  * Child under 2 years of age.\n  * Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n  * Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n  * Obesity defined as a BMI with a z-score \\>+3 SD.\n  * Hepatic, renal or adrenal insufficiency.\n  * History of bone marrow transplantation.\n  * History of diabetes after hemolytic-uremic syndrome.\n  * Epileptic patient\n  * Dysmorphia with suspicion of underlying genetic syndrome.\n  * Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.\n\nWP7 :\n\n* Inclusion Criteria:\n\n  * De novo type 1 diabetic patient, as per ISPAD criteria;\n  * Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +\u002F- Acido ketosis.\n  * Fasting blood glucose ≥126 mg\u002FdL AND\u002FOR blood glucose ≥200 mg\u002FdL at 120 minutes of an OGTT AND\u002FOR HbA1c ≥6.5% AND\u002FOR a patient with symptoms of hyperglycemia\u002Fhyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg\u002FdL.\n  * Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)\n  * Patients aged between 2 and 18 years\n  * Minimum weight: 17 kg (for blood samples)\n  * Male - female patients\n  * Free, written and oral consent.\n* Exclusion criteria:\n\n  * Child under 2 years of age.\n  * Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).\n  * Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.\n  * Autoimmune\u002Fautoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.\n  * Obesity defined as a BMI with a z-score \\>+3 SD.\n  * Hepatic, renal or adrenal insufficiency.\n  * History of bone marrow transplantation.\n  * History of diabetes after hemolytic-uremic syndrome.\n  * Epileptic patient\n  * Absence of anti-islet autoantibodies.\n  * Dysmorphia with suspicion of underlying genetic syndrome.\n  * Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.",{"count":546,"type":22},1000,[25],"The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D). Hypoglycemia can lead to severe symptoms, but is normally counteracted by CRR, corresponding to the secretion of hormones to maintain normoglycemia. Hypoglycemia is common in T1DM but some patients develop severe hypoglycemia as a result of CRR dysfunction. Despite several studies in adults, the presence of CRR dysfunction remains unpredictable and not well understood. The objective of GLUREDIA is therefore to describe and predict the evolution of CRR in children with T1DM.",[550,28],"Severe Hypoglycemia",[552,553,193],"Pediatric","Hypoglycemia","2025-01-07",{"date":556,"type":37},"2025-01-13",{"date":558,"type":37},"2022-05-25",{"date":560,"type":22},"2025-10-25",{"name":562,"class":44},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain",{"id":564,"slug":4,"hasResults":11,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":66},"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":137,"type":22},[477],"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.",[193,28,221],[575,576,577,578,579,580,581,582],"CKM","Continous Ketone Monitoring","Empagliflozin","SGLT2i","SGLT2 inhibitors","Sodium-glucose cotransporter-2 inhibitors","Low-carb","Exercise","2024-12-20",{"date":585,"type":37},"2024-12-31",{"date":587,"type":37},"2024-12-05",{"date":589,"type":22},"2027-01-01",{"name":591,"class":44},"McGill University",{"id":593,"slug":4,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":379,"enrollmentInfo":598,"targetDuration":4,"studyType":23,"phases":599,"briefSummary":600,"conditions":601,"keywords":602,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":66},"100379371","NCT04219709","Effects of Ketosis on Brain Function in Patients With T1DM","Brain Function, Cognition, and Hypoglycemia Tolerance in Patients With Type 1 Diabetes Mellitus in the Setting of Nutritional Ketosis Versus Standard Carbohydrate Diet","Inclusion Criteria:\n\n* Males and females with T1D for at least 1 year\n* Age 18 to 40 years\n* Tanner stage ≥ IV\n* BMI 18.5-35 kg\u002Fm2\n* Stable glycemic control (HbA1c 6.5-9%)\n* Use of a continuous glucose monitor (CGM)\n* Use of an insulin pump\n* Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)\n\nExclusion Criteria:\n\n* Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months\n* Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies\n* Following a weight-loss or otherwise restrictive diet\n* Vigorous exercise \\>2 hours on \\>3 days a week\n* History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)\n* Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables\n* Significant psychiatric illness\n* Smoking, use of recreational drugs, or excessive alcohol consumption\n* Pregnancy or breastfeeding\n* Anemia\n* For participants who undergo MRI:\n\n  1. Standard MRI exclusion criteria\n  2. Irregular menses\n  3. Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data).",{"count":137,"type":22},[25],"The scientific goal of this study is to examine the effects of a ketogenic diet on hypoglycemia tolerance and brain function in people with type 1 diabetes mellitus (T1D) and to clarify the mechanistic role of ketones in this process. Glycemic management of T1D is typified by alternating periods of hyper- and hypo-glycemia. Because brain metabolism under usual conditions depends on glucose, acute hypoglycemia leads to immediate complications including impaired cognitive function and a counter-regulatory hormone response. Recurrent hypoglycemia is associated with functional and structural changes in the brain and contributes to the cognitive decline observed in individuals with diabetes. The state of nutritional ketosis (as it occurs during fasting or when following a ketogenic \\[very low carbohydrate\\] diet) may protect against these acute and chronic complications. As the body relies on fat metabolism, ketone bodies build up and provide an alternative fuel for the brain. Studies during hypoglycemia have shown better cognitive function and less hypoglycemia symptoms in the setting of nutritional ketosis or with ketone administration. This physiological benefit may have special relevance for people with T1D who experience hypoglycemia frequently. To date, no mechanistic studies have examined brain effects of nutritional ketosis in T1D; nor have any trials explored the potential relevance of this for diabetes care.",[28],[603,604,605,606,607,608,609,610,611],"nutrition","very low carbohydrate diet","ketogenic diet","nutritional ketosis","cognitive function","brain","metabolism","ketones","ketosis","2024-12-16",{"date":614,"type":37},"2024-12-18",{"date":616,"type":37},"2020-01-03",{"date":618,"type":22},"2026-07-31",{"name":620,"class":44},"Boston Children's Hospital",{"id":622,"slug":4,"hasResults":11,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":379,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":630,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":636,"leadSponsor":637,"locationsCount":66},"100377888","NCT04200391","Very Low Carbohydrate Diets and Glucagon Response in T1DM","Glucagon Response in Patients With Type 1 Diabetes Mellitus Following a Very Low Carbohydrate",{"count":282,"type":22},[25],"Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate (VLC) diet. Despite these promising preliminary results, the use of VLC diets for T1D remain controversial, because of their restrictive nature and theoretical concerns regarding growth, ketoacidosis and hypoglycemia risks and efficiency of glucagon treatment for hypoglycemia. Glucagon is used as a rescue medication during severe hypoglycemia and increases blood glucose levels by mobilizing liver glycogen stores. If these stores are depleted during carbohydrate restriction, glucagon response may be inadequate and put individuals at risk for refractory hypoglycemia. A physiologic study has shown a blunted but still adequate response to glucagon in n=10 participants after following a VLCD for 1 week. Longer-term studies have not been done.\n\nTo test the hypotheses that glucagon response remains adequate while following a VLC diet in the longer term, the investigators will conduct a glucagon challenge in participants who are assigned to the VLC arm of a randomized-controlled feeding study in 32 young adults with T1D who will receive a VLC vs a standard diet for 12 weeks. After an overnight fast, twelve participants in the VLC arm will receive IV insulin to lower blood glucose levels to 60 mg\u002FdL, followed by a glucagon injection and monitoring of blood glucose levels and other metabolic fuels.",[28],[603,604,605,606,631,632,633,611,610],"glucagon","hypoglycemia","glycogen",{"date":614,"type":37},{"date":616,"type":37},{"date":618,"type":22},{"name":620,"class":44},""]