[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-mellitus-type-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-mellitus-type-i":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,63,87,118,144,169],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100593800","primary-care-pragmatic-real-world-experience-for-automated-insulin-delivery-100593800",false,"NCT07011147","Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery","PREPARE 4 AID","Inclusion Criteria:\n\n1. Age at time of consent \\>18 and \\\u003C89 years\n2. Either 2.a. or 2.b.:\n\n   1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year\n   2. Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)\n3. Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1\u002FGIP RA agents\n4. Stable doses of weight loss medications (including GLP-1 RA and GLP-1\u002FGIP RA agents) over the preceding 4 weeks as determined by the investigator.\n5. For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and\u002For indirectly, except for a dose reduction or discontinuation.\n6. Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study\n7. Willing to comply with all study procedures for the duration of the study\n8. Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP\n9. Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)\n10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol\n11. Willing and able to sign and date the Informed Consent Form (ICF)\n12. If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period\n\n    a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).\n\n    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).\n\n    iii. Placement of an intrauterine device or intrauterine hormone-releasing system.\n\n    iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository).\n\n    v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.\n\n    vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study.\n13. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration\n14. Have hardware and internet access capable of 2-way video and audio communication\n\nExclusion Criteria:\n\n1. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)\n2. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only\n3. Diagnosis of maturity-onset diabetes of the young (MODY)\n4. Plan to change usual diabetes regimen between screening and study randomization\n\n   1. This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1\u002FGIP RA medication\n   2. This would NOT include changes to any insulin doses, including pump settings, short- and\u002For long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1\u002FGIP RA); or changing type of type 2 diabetes medication within the same class\n5. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface\n6. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation\n7. Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. \"DIY Loop\", \"AAPS\", \"iAPS\" or \"Open APS\")\n8. Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy\n9. Planned use of hydroxyurea at any dose and\u002For of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.\n10. Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment\n11. Current participation in another diabetes-related clinical trial\n12. History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy\n13. Have a history of intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)\n14. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the 6 months prior to screening, unrelated to an intercurrent illness or to a kinked, dislodged, or occluded cannula\n15. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n16. Treated currently or within the past 30 days prior to enrollment, or plan to begin treatment, with sulfonylurea, pramlintide, or SGLT-2 inhibitor medication\n17. Any planned surgery during the study that would be considered major in the opinion of the investigator\n18. Pregnant or lactating, or planning to become pregnant in the next 6 months\n19. Renal failure on dialysis or chronic renal disease with a GFR or eGFR \\\u003C30mL\u002Fmin (values within the last two years will be accepted; if none available or \\>2 years prior, participant will be instructed to obtain GFR or eGFR through their usual care provider and to make copy of result available to study team)\n20. Any condition or circumstance that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study or which could compromise the results of the study c. Conditions to be considered by the investigator may include, but are not limited to, the following: i. Active clinical diagnosis of substance use disorder ii. Chronic use of opiates and\u002For benzodiazepines which, in the opinion of the investigator, might make it difficult for the participant to follow study procedures iii. Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening, a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting iv. Known history of prolonged QTc interval, malignant arrhythmia, or severe congenital heart disease v. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV vi. History of TIA or stroke in the last 12 months vii. Untreated or inadequately treated mental illness viii. History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia, or omission of insulin to manipulate weight ix. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n21. Plans to travel outside of the US and its territories for more than four weeks consecutively\n22. Plans not to have internet\u002Fvideo\u002Fphone access for more than one week consecutively\n23. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial\n24. Previous use of the iLet for more than four weeks (including use of the commercially available iLet or prior participation in a study involving wearing the iLet for more than four weeks)","ALL","18 Years","89 Years",{"count":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:\n\nCan the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?\n\nResearchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.\n\nParticipants will:\n\nUse the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks",[27,28,29,30,31,32,33,34,35,36,37],"Type 1 Diabetes (T1D)","Type 2 Diabetes","Diabetes, Autoimmune","Diabetes Mellitus","Diabetes Mellitus Type 2","Diabetes Mellitus, Type I","Diabetes, Type II","Diabetes","Diabetes Mellitus, Insulin-Dependent","Diabetes Mellitus Type II","Diabetes Type 2 on Insulin",[39,40,41,42,43,44,45,46,47,48,49],"automated insulin delivery","type 1 diabetes","type 2 diabetes","bionic pancreas","closed loop","pancreas, artificial","t1d","t2d","diabetes","insulin","primary care","RECRUITING","2026-06-10",{"date":53,"type":54},"2026-06-11","ACTUAL",{"date":56,"type":54},"2026-01-16",{"date":58,"type":21},"2029-04-01",{"name":60,"class":61},"University of Colorado, Denver","OTHER",2,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100582223","hla-demographics-study-in-adults-with-type-1-diabetes-100582223","NCT06860516","HLA Demographics Study in Adults With Type 1 Diabetes","A Non-interventional Study of HLA-DRB1*04:01 Distribution in Adults With Recently Diagnosed Type 1 Diabetes (T1D)","Inclusion Criteria:\n\n1. Male and female participants aged ≥ 18 to ≤ 55 years, with type 1 DM meeting American Diabetes Association criteria at diagnosis:\n\n   1. Fasting glucose ≥ 126 mg\u002FdL (7.0 mmol\u002FL), or\n   2. 2-hour oral glucose tolerance test plasma glucose ≥ 200 mg\u002FdL (11.0 mmol\u002FL), or\n   3. Hemoglobin A1c ≥ 6.5%, or\n   4. Random plasma glucose ≥ 200 mg\u002FdL (11.1 mmol\u002FL) (with documented classic hyperglycemia symptoms or hyperglycemic crisis).\n2. Date of T1D diagnosis within 6 months of the study visit.\n3. Able and willing to provide written, informed consent as approved by the institutional review board (IRB). Participants must be able to consent directly; no other person or guardian may consent for them in this study.\n\nExclusion Criteria:\n\n1. Participant is an employee of, or an immediate family member of an employee, of the Sponsor, study site, or of a contractor\u002Fvendor who is involved in direct study conduct for this protocol.\n2. Participant is unwilling or unable to comply with the study visit assessments.","55 Years",{"count":72,"type":21},200,"OBSERVATIONAL","This is a study to evaluate the HLA-DRB1\\*04:01 genotype in adults that have been diagnosed with type 1 diabetes",[32],"2026-04-30",{"date":78,"type":54},"2026-05-06",{"date":80,"type":54},"2025-06-06",{"date":82,"type":21},"2027-03",{"name":84,"class":85},"GentiBio, Inc","INDUSTRY",5,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100568983","phase-2-treatment-of-presymptomatic-stage-1-type-1-diabetes-pediatric-patients-with-treg-cell-preparations-and-anti-cd20-antibody-100568983","NCT06688331","Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody","A Multicenter, Randomized, Blinded, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Cell Therapy Based With Artificially Expanded CD4+CD25+CD127- Regulatory Lymphocytes and Anti-CD20 Antibody in Pediatric Patients With Presymptomatic Diabetes Type 1 (Stage 1)","PreTreg","Inclusion Criteria:\n\n1. Age 6-16\n2. 25 ≤ BMI ≤ 75 percentile (acc. to OLAF) with a lower weight threshold of 20 kg\n3. Venous plasma glucose levels \\\u003C 100mg% at fasting (70 to 100 mg\u002Fdl) and normal glucose tolerance test (at 120 minutes glycaemia \\\u003C140 mg\u002Fdl) (acc. to PTD)\n4. Insulin independence\n5. C-peptide levels ≥ 1.0 ng\u002Fml (central laboratory limit of normal) in fasting and post-stimulation tests increase ≥ 100%\n6. Participant has not yet been diagnosed with stage 2 or 3 type 1 diabetes mellitus (no history of dysglycemia, no history of clinical symptoms of type 1 diabetes mellitus)\n7. HbA1c level (%) \\\u003C5,7% (acc. to ADA)\n8. Positive autoantibody titres (ICA, IAA, GAD, IA-2\u002FICA512, ZnT8) - low titers of two or more antibodies (2-4 times the normal\\*); if high titer of one of the antibodies (≥ 4 times the norm, not applicable to ICA) re-screening allowed (the participant can be included in the trial only after confirming two or more antibodies)\n9. Ability to give informed consent by the child's legal representatives (and the child himself or herself if he or she is over the age of 13 at the time of the trial \\[according to local law\\])\n10. Ability of the child's legal representatives to manage diabetes, defined as blood glucose levels control at least three times a day and the ability to dose insulin correctly.\n11. Venous access to guarantee blood donation\n\n    Exclusion Criteria:\n12. Refusal to participate in the trial or lack of a signed informed consent form\n13. Suspicion or diagnosis for a type of diabetes other than type 1 diabetes mellitus\n14. Age under 6 or above 16\n15. IgA deficiency or history of other diagnosed immunodeficiency (max. 7 infections\u002Fyear allowed, and the prognosis should indicate that the patient will remain in the study throughout its duration)\n16. C-peptide levels \\\u003C 1.0 ng\u002Fml fasting and in post-stimulation tests increase \\\u003C 100%\n17. Glucose levels in venous blood ≥ 100mg% fasting\n18. Glucose levels in venous blood after 1 and 2 hours in OGTT ≥ 200mg%\n19. Glycated hemoglobin level (HbA1c) in venous blood ≥ 5,7%\n20. BMI \\\u003C 25 or \\> 75th percentile for a given age or weight of less than 20 kg\n21. History of hypersensitivity to anti-CD20 or other components of the preparation\n22. History of hypersensitivity to penicillin and\u002For streptomycin\n23. Past or active infection with HBV, HCV, HIV, HTLV I\u002FII, mycobacterium tuberculosis, syphilis. Laboratory evidence of infection without the need for clinical signs and symptoms is sufficient for diagnosis.\n24. Active infection with the EBV or CMV virus (positive IgM)\n25. Any fungal, parasitic, viral, or bacterial infection\n26. History of past or active cancer\n27. Anemia, lymphopenia, neutropenia, or thrombocytopenia defined as a blood cell count below the lower limit of normal for age found within the last 6 weeks prior to trial inclusion\n28. Elevated thrombotic activity\u002Fhistory of thrombosis episode\n29. Any disease prior to inclusion in the trial currently requiring medication for more than 3 months in history\n30. Diagnosed autoimmune disease other than type 1 diabetes mellitus, including a history of Hashimoto's disease and coeliac disease\n31. Taking anti-diabetic medication (including insulin) in the last 4 weeks prior to trial inclusion\n32. History of retinopathy\n33. History of hypertension\n34. Current or history of albuminuria\n35. For women in childbearing potential\u002Fmenstruating women: pregnancy (from medical interview) or unwillingness to exercise sexual restraint or use effective forms of contraception for the duration of the trial and up to 4 months after completion, if applicable.\n\n    The following contraceptive methods are acceptable: bilateral fallopian tube closure, sterilization in men, appropriate use of hormonal contraception that inhibits ovulation, hormone-releasing IUDs, and copper IUDs, male or female condoms with spermicide; and cap, uterine disc, or sponge with spermicide.\n36. Breastfeeding\n37. For males over 15 years of age: expressed intention to have offspring or donate sperm during the trial or within 4 months after the end of the trial, if applicable\n38. Excessive anxiety of the participant or his\u002Fher legal representatives regarding the procedures used in the trial\n39. Any medical problem that, in the opinion of the investigator, may adversely affect the participant's health if included in the trial\n40. Legal representatives and\u002For children over the age of 15 with an identified alcohol and\u002For psychoactive substance addiction\n41. History of disease of unknown etiology\n42. History of Creutzfeldt-Jacob disease\n43. History of progressive dementia or degenerative neurological disease, including of unknown origin\n44. History of taking hormones derived from the human pituitary gland (e.g., growth hormone)\n45. Treatment with immunosuppressants\n46. History of corneal, scleral, and dural transplant or undocumented neurosurgery\n47. History of occurrence of risk factors related to the participant's travel, where there is a possibility of exposure to regional infectious diseases\n48. Physical signs that indicate the risk of an infectious disease\n49. History of xenogeneic transplant","6 Years","16 Years",{"count":98,"type":21},150,[100],"PHASE2","The main purpose of the study is to check:\n\n* Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and\u002For an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or delay type 1 diabetes?\n* Is therapy with a preparation of regulatory cells (Tregs lymphocytes) and\u002For a preparation of antiCD20 antibodies (rituximab) safe for children with pre-diabetes, and what side effects may be associated with it? The study will include patients at high risk for type 1 diabetes whose laboratory tests have confirmed preserved normal\u002Fhigh insulin production. First (part 1 of the study), tests will be performed to determine the risk of the disease (determination of autoantibodies that characterize the autoimmune background).\n\nIn order to confirm the effectiveness of the therapy, not all patients will receive the study treatment. The study will be a so-called blinded randomized trial. This means that in this trial, all participants will undergo the same study procedures, but the participant will be randomly assigned to one of four (4) groups that will receive different treatment regimens before entering the study.\n\nThe participant will be randomly assigned to one of four groups:\n\n* Group I will receive a preparation of regulatory cells (Tregs lymphocytes) along with a preparation of antiCD20 antibodies,\n* Group II will receive a preparation of regulatory cells (Tregs lymphocytes) together with an inert substance (placebo)\n* Group III will receive a preparation of antiCD20 antibodies along with a sham treatment (inert substance)\n* Group IV will receive an agent containing an inert substance and sham treatment.\n\nApproximately 150 patients aged 6-16 who are at risk of developing type 1 diabetes will be enrolled in the study, which will last up to 96 months. Each enrolled participant will remain in the study for up to five years.",[103,32,104],"Presymptomatic Diabetes Type 1 (Stage 1)","Diabetes Mellitus, Type 1",[93,106,107,108],"Tregs","Prediabetes","presymptomatic","2026-01-14",{"date":56,"type":54},{"date":112,"type":54},"2025-03-12",{"date":114,"type":21},"2032-12",{"name":116,"class":85},"PolTREG S.A.",8,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":126,"minAge":17,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":143},"100572128","influence-of-menstrual-cycle-phases-on-the-glycemic-control-of-aerobic-or-hiit-exercise-in-adult-women-with-type-1-diabetes-100572128","NCT06729242","Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes","Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX\u002F2)","DIABETEXX\u002F2","Inclusion Criteria:\n\nAge between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) \\\u003C 8.5% (\\\u003C69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.\n\nExclusion Criteria:\n\nClinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral\u002Fparenteral steroids or metformin, among others).","FEMALE","45 Years",{"count":129,"type":21},40,[24],"Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.",[32,133],"Menstruation","2025-07-05",{"date":136,"type":54},"2025-07-08",{"date":138,"type":54},"2025-01-10",{"date":140,"type":21},"2026-06",{"name":142,"class":61},"University of Valencia",1,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":143},"100586719","effect-of-advanced-hybrid-closed-loop-system-minimed-780g-in-newly-diagnosed-children-and-adolescents-with-type-1-diabetes-on-glycemic-control-and-patient-reported-outcomes-compared-to-standard-insulin-therapy-historical-data-ahcl-in-new-onset-t1d-children-study-100586719","NCT06919029","Effect of Advanced Hybrid Closed Loop System, MiniMed 780G in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study)","Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study): a Single Arm Open- Label Prospective Observational Study Protocol","Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetes is based on international criteria and the investigator's judgment; C peptide level and antibody determinations are not required.\n2. Age range 7 to 17 years.\n3. Literate in Greek or English.\n4. Willing to wear study devices.\n5. Willing to follow study-specific instructions.\n6. Total daily insulin dose greater than 8.0 units over 1 week period\n7. Willing and able (access to internet from home) to download information into the Medtronic CareLink software\n8. Clinically eligible to start the AHCL system\n\nExclusion Criteria:\n\n* Type 2 diabetes mellitus or MODY diabetes\n* Any untreated comorbidities of type 1 diabetes\n* Medication affecting metabolic control or interfering in the interpretation of HbA1c\n* Pregnancy\n* Untreated diabetes retinopathy, or other causes that in the investigator's opinion, precludes the individual from participating in the trial.\n* Known or suspected allergy to insulin.\n* Regular use of acetaminophen.\n* Lack of reliable telephone facility for contact.\n* Living alone.\n* Severe visual or hearing impairment.\n* Medically documented allergy to the adhesive of plasters or unable to tolerate tape adhesive around sensor placement.\n* Serious skin lesions at areas of the body used for insertion of the glucose sensor.\n* Illicit drugs abuse.\n* Alcohol abuse.\n* Sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion or erythropoietin within 3 months prior to time of enrollment.\n* Eating disorder including anorexia\u002Fbulimia.\n* Milk protein allergy.","7 Years","17 Years",{"count":154,"type":21},30,"The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. After the initial study period there will be a 3month extension phase of the study.",[32],[40,158,159],"advanced hybrid closed loop","diabetes onset","2025-04-02",{"date":162,"type":54},"2025-04-09",{"date":164,"type":21},"2025-04",{"date":166,"type":21},"2026-04",{"name":168,"class":61},"National and Kapodistrian University of Athens",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":176,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":143},"100581385","auto-antibody-dosage-from-blood-spots-for-diagnosis-of-type-1-diabetes-and-celiace-disease-100581385","NCT06849622","Auto-antibody Dosage From Blood Spots for Diagnosis of Type 1 Diabetes and Celiace Disease","CELDI","Inclusion Criteria:\n\n* Patients aged 2-13 years\n* Patients with a confirmed diagnosis of type 1 diabetes or celiac disease (positive controls) and children who do not have type 1 diabetes or celiac disease or autoantibodies associated with these pathologies (controls)\n* Obtained informed consent\n\nExclusion Criteria:\n\n* none","2 Years","13 Years",{"count":179,"type":21},1500,[24],"Early diagnosis of type 1 diabetes and celiac disease is very useful, allows early therapy and prevents deaths from the onset of diabetic ketoacidosis. This is a pilot study on screening of autoantibodies of type 1 diabetes and celiac disease in tuscany patients. The study aims to evaluate the concordance between the screening results obtained using two different matrix (blood drop spots on card and serum) in the search for autoantibodies for celiac disease and for type 1 diabetes. Moreover, it will be evaluated the feasibility and acceptability of the screening on a sample of the population enrolled in the territory through the participation of pediatricians.",[183,32,184],"Celiac Disease in Children","Screening","2025-02-25",{"date":187,"type":54},"2025-02-27",{"date":189,"type":54},"2024-11-04",{"date":191,"type":21},"2026-03-30",{"name":193,"class":61},"Meyer Children's Hospital IRCCS"]