[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-hypoglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-hypoglycemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,89,112],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100422855","phase-3-a-safety-tolerability-and-efficacy-study-of-vx-880-in-participants-with-type-1-diabetes-100422855",false,"NCT04786262","A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes","A Phase 1\u002F2\u002F3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Key Inclusion Criteria:\n\n* Clinical history of T1D with \\> 5 years of duration of insulin dependence\n* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment\n* Stable diabetic treatment\n* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study\n\nKey Exclusion Criteria:\n\n-Prior islet cell transplant, organ transplant, or cell therapy\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","ALL","18 Years","65 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.",[27,28,29],"Diabetes Mellitus, Type 1","Impaired Hypoglycemic Awareness","Severe Hypoglycemia","RECRUITING","2026-06-26",{"date":33,"type":34},"2026-06-30","ACTUAL",{"date":36,"type":34},"2021-03-29",{"date":38,"type":21},"2030-06-30",{"name":40,"class":41},"Vertex Pharmaceuticals Incorporated","INDUSTRY",29,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":56,"conditions":57,"keywords":73,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"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","35 Years",{"count":52,"type":21},13,[54,55],"PHASE1","PHASE2","This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[27,58,59,60,61,62,63,64,65,29,66,67,68,69,70,71,72],"Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases","Metabolic Disease",[74,75,63,58,76,77,66,78,61,60],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","2026-02-26",{"date":81,"type":34},"2026-03-02",{"date":83,"type":34},"2025-06-10",{"date":85,"type":21},"2027-06-30",{"name":87,"class":41},"Otsuka Pharmaceutical Factory, Inc.",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":88},"100602696","phase-1-a-safety-tolerability-and-efficacy-study-of-e-islet-01-in-participants-with-type-1-diabetes-100602696","NCT07126873","A Safety, Tolerability, and Efficacy Study of E-islet 01 in Participants With Type 1 Diabetes","A Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, and Efficacy of E-islet 01 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Inclusion Criteria:\n\n* Clinical history of Type 1 Diabetes with \\> 5 years of duration\n* 2-hour C-peptide level \\\u003C0.3 ng\u002FmL after a mixed meal stimulation test\n* Under continuous insulin therapy, Participants have at least one of the following conditions:\n\n  1. At least one episode of documented severe hypoglycemia in the 12 months prior to enrollment;\n  2. Unaware hypoglycemia evaluated using the Clarke scoring system\n* Willing and able to conduct self-blood glucose monitoring as required, with good compliance\n* Voluntarily participate and sign the informed consent form\n\nExclusion Criteria:\n\n* Uncontrolled systemic infections, including but not limited to pulmonary tuberculosis, active hepatitis, a history of positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab).\n* History of malignancy within the past 5 years or undergoing antitumor treatment\n* Participation in other clinical trials in the 3 months or islet cell transplant, organ transplant, or cell therapy in the 12 months prior to enrollment\n* Other situations judged by the investigator as unsuitable for participation in the trial","75 Years",{"count":98,"type":21},21,[54,55],"This study will evaluate the safety, tolerability and efficacy of E-islet 01 in participants with Type 1 diabetes mellitus (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia",[27,28,29],"2025-08-17",{"date":104,"type":34},"2025-08-22",{"date":106,"type":21},"2025-08-11",{"date":108,"type":21},"2029-12-31",{"name":110,"class":111},"EndoCell Therapeutics, Inc.","OTHER",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":16,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":88},"100575310","longitudinal-study-of-the-glucagon-response-to-hypoglycemia-in-children-and-adolescents-with-new-onset-type-1-diabetes-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.",true,"2 Years","30 Years",{"count":124,"type":21},1000,[126],"NA","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.",[29,129],"Type1diabetes",[131,58,132],"Pediatric","Diabetes","2025-01-07",{"date":135,"type":34},"2025-01-13",{"date":137,"type":34},"2022-05-25",{"date":139,"type":21},"2025-10-25",{"name":141,"class":111},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain"]