[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,162,0,25,[9,43,70,95,133,171,195,219,250,279,307,329,355,390,409,432,455,488,514,533,555,580,604,638,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100471095","phase-2-the-gut-microbiome-in-type-1-diabetes-and-mechanism-of-metformin-action-100471095",false,"NCT05414409","The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action","The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin","Inclusion Criteria:\n\n1. Overweight\u002Fobese youth 11-18 years of age with T1D at time of enrollment.\n2. Lean youth 11-18 years of age with T1D at time of enrollment.\n\nExclusion Criteria:\n\n1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic\u002Fantibody testing).\n2. History of ongoing infection or antibiotic treatment within the past month;\n3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.\n4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.\n5. Participation in any research intervention trials within the past 3 months.\n6. History of treatment or use of metformin, a type 2 diabetes medication.","ALL","11 Years","18 Years",{"count":21,"type":22},114,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with overweight and obesity as well as potential mechanisms to modify disease.",[28,29],"Type 1 Diabetes","Obesity","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2022-09-30",{"date":38,"type":22},"2027-03-01",{"name":40,"class":41},"Heba M. Ismail","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100645360","phase-1-encrt-103-hpi-evaluation-of-an-immune-protected-encrt-103-hpi-containing-primary-human-islets-in-adults-with-type-1-diabetes-with-and-without-standard-of-care-portal-vein-islet-infusion-100645360","NCT07680673","ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.","Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.","Inclusion Criteria:\n\n* follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).\n\nExclusion Criteria:\n\n* \\- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).","75 Years",{"count":52,"type":22},10,[54],"PHASE1","This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.",[28],[58],"islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism","NOT_YET_RECRUITING","2026-08-19",{"date":31,"type":34},{"date":63,"type":22},"2027-01-06",{"date":65,"type":22},"2029-01",{"name":67,"class":68},"Encellin","INDUSTRY",2,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100597675","phase-1-a-randomized-phase-12-trial-of-low-dose-anti-thymocyte-globulin-atg-with-subsequent-adalimumab-or-verapamil-in-new-onset-type-1-diabetes-100597675","NCT07061574","A Randomized Phase 1\u002F2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes","WAVE T1D","Key Inclusion Criteria:\n\n1. Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.\n2. At least one positive T1D auto-antibody.\n\n   * If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.\n   * Insulin auto-antibodies are only considered if exogenous insulin use is \\\u003C10 days when blood is drawn.\n3. Must have stimulated C-peptide levels ≥0.2 pmol\u002FmL measured during MMTT conducted prior to randomization.\n4. Age 9 to \\\u003C21 years at the time of randomization.\n5. Body weight \\>30kg.\n6. BMI \\\u003C95th percentile for age and gender.\n7. Willing to comply with intensive diabetes management.\n8. Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.\n9. Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral\u002Finjection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.\n10. Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.\n11. Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.\n12. Willing to provide informed consent and child assent as applicable.\n13. Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.\n14. Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).\n15. Must be fully vaccinated for age.\n16. Must have been vaccinated for flu (if currently in flu season).\n17. Must be willing to not receive live vaccines throughout the treatment period.\n18. Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ATG or known allergy to ATG or rabbit-derived products.\n2. Local lab draw at screening:\n3. Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\\\u003C3,000 leukocytes \u002FμL), neutropenia (\\\u003C1,500 neutrophils\u002FμL), lymphopenia (\\\u003C800 lymphocytes\u002FμL).\n4. Thrombocytopenia (\\\u003C100,000 platelets\u002FμL) or anemia (hemoglobin \\\u003C 10g\u002FdL).\n5. Leukocytosis (\\>14,000\u002FmL)\n6. Infections:\n7. Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization.\n8. Have active signs or symptoms of acute infection at the time of randomization.\n9. Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON), or a positive test for latent tuberculosis.\n10. Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n11. History of serious bacterial, viral, fungal, or other opportunistic infections.\n12. Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization.\n13. Have positive CMV and\u002For EBV PCR test within 30 days prior to randomization.\n14. Have positive COVID-19 self-antigen test within 3 days of randomization.\n15. History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology).\n16. Blood pressure (either systolic or diastolic) \\\u003C5th percentile for age, gender, and height on two out of three measurements.\n17. Pulse \\\u003C2nd percentile for age and gender on two out of three measurements.\n18. History of vasovagal syncopal episodes related to hypotension.\n19. History of malignancies other than of skin.\n20. Use of medications likely to interfere with study results:\n21. Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only).\n22. Current or previous use of Teplizumab.\n23. Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed.\n24. Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine.\n25. Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization.\n26. Any known hypersensitivity reaction to any of the study medications or their components.\n27. Unable to swallow pills (tested with an inert imitation tablet in clinic at screening).\n28. History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing.\n29. Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor).\n30. Established history of allergy or severe reaction to adhesive or tape that must be used in the study.\n31. Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm.\n32. Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:\n33. Alcohol or drug abuse\n34. Untreated or inadequately treated mental illness\n35. Liver disease or LFTs \\>2x ULN.\n36. Renal disease or creatinine greater than 1.5x ULN.\n37. Other autoimmune diseases except for stable and treated hypothyroidism\n38. Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet).\n39. Nervous system disorder including but not limited to Guillain-Barre\n40. Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy.\n\n41 .History of multiple abdominal surgeries and\u002For at increased risk for bowel obstruction.\n\n42\\. Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease).\n\nAny lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\n\\-","9 Years","20 Years",{"count":80,"type":22},120,[54,25],"This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\\u003C21 with recent-onset stage 3 T1D.",[28,84],"New Onset",[86],"ATG, Verapamil, Adalimumab",{"date":33,"type":34},{"date":89,"type":34},"2026-03-10",{"date":91,"type":22},"2031-04-15",{"name":93,"class":41},"City of Hope Medical Center",11,{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100576285","phase-1-cnp-103-in-adolescent-and-adult-subjects-ages-12-35-with-recently-diagnosed-within-6-months-stage-3-type-1-diabetes-t1d-100576285","NCT06783309","CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)","A Phase 1b\u002F2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.\n2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.\n3. Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.\n4. Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.\n5. Participants with a peak stimulated C-peptide of \\>0.2 nmol\u002FL measured from a screening mixed meal tolerance test (MMTT).\n6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.\n7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.\n8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).\n9. Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.\n10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.\n11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.\n12. Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.\n13. Participants must weigh \\>35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh \\>50 kg at Screening for Cohort 3 (600 mg).\n14. Body mass index (BMI):\n\n    1. Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)\n    2. Participants 18-35 years: 18.0-30.0 (not inclusive)\n\nExclusion Criteria:\n\n1. Participants unable to comply with prohibited medication outlined in the protocol.\n2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.\n3. Participants with a history of tuberculosis or positive Quantiferon test.\n4. Participants who received vaccinations in the following time frame:\n\n   1. Any live vaccine within 28 days prior to Screening.\n   2. Any subunit vaccine within 14 days prior to Screening.\n   3. Any COVID-19 vaccine series within 14 days prior to Screening.\n   4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)\n5. Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.\n6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.\n7. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen\u002Fantibody as determined at Screening.\n8. Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.\n9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.\n10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.\n11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.\n12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.\n13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.\n14. Known sensitivity to any components of CNP-103.","12 Years","35 Years",{"count":105,"type":22},72,[54,25],"This study is a Phase 1b\u002F2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).",[109,110,111,112,113,114,115,28,116,117],"Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes in Adolescence","Type 1 Diabetes in Children","Type 1 Diabetes (Juvenile Onset)","Type 1 Diabetes Patients","Type 1 Diabetes Mellitis",[119,110,120,121,122,111,123,124],"Diabetes","Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed",{"date":31,"type":34},{"date":127,"type":34},"2025-05-12",{"date":129,"type":22},"2027-06",{"name":131,"class":68},"COUR Pharmaceutical Development Company, Inc.",38,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":103,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":42},"100560306","phase-1-a-study-to-investigate-safety-and-effectiveness-of-porcine-pancreatic-cells-opf-310-in-patients-with-type-1-diabetes-mellitus-100560306","NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM) (in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII For subjects aged 65 to \\\u003C70 years who do not meet Exclusion Criterion 12 but have a history of cardiovascular or cerebrovascular disease related to the conditions above, a cardiology consultation (and consultation with other relevant specialists, as appropriate) will be required during the screening period to confirm suitability for general anesthesia and laparoscopic surgery.\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","70 Years",{"count":142,"type":22},13,[54,25],"This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[146,147,148,28,109,110,111,112,149,150,151,152,153,154,155,156,157],"Diabetes Mellitus, Type 1","Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases","Metabolic Disease",[159,160,111,147,161,162,151,163,109,28],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation",{"date":33,"type":34},{"date":166,"type":34},"2025-06-10",{"date":168,"type":22},"2027-06-30",{"name":170,"class":68},"Otsuka Pharmaceutical Factory, Inc.",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":17,"minAge":179,"maxAge":19,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100595901","early-detection-of-type-1-diabetes-in-first-degree-relatives-of-type-1-diabetes-patients-detect-t1d-gulf-100595901","NCT07038473","Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)","Islet Autoantibody Early Detection in At-risk Children\u002FAdolescents to Predict Type 1 Diabetes: a Cohort Study in Gulf Countries","Inclusion Criteria:\n\n* Children and adolescents, age 1.5 years to 18 years\n* First degree relatives of T1D probands\n* Parent or legal guardian signing an informed consent\n\nExclusion Criteria:\n\n* Already developed clinical overt T1D\n* Known diabetes of any kind (type 1, type 2, Maturity Onset Diabetes of the Young - MODY)\n* Have a previous history of being treated with insulin\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"18 Months",{"count":181,"type":22},3500,[183],"NA","The aim of this research is to identify pre-symptomatic Type 1 Diabetes (T1D) in young children and adolescents who have first degree relatives with T1D. This protocol has been developed to address the growing need for standardized T1D screening, monitoring, and data collection in alignment with international recommendations. The study's estimated duration is 13 months and will consist of two visits: Visit 1 (screening visit) and Visit 2 (confirmatory visit).",[28],"2026-08-18",{"date":60,"type":34},{"date":189,"type":34},"2025-12-17",{"date":191,"type":22},"2026-12-25",{"name":193,"class":68},"Sanofi",7,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":178,"sex":17,"minAge":78,"maxAge":140,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":206,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":69},"100652377","oral-galactose-as-a-substrate-for-post-exercise-skeletal-muscle-glycogen-repletion-in-individuals-with-type-1-diabetes-100652377","NCT07774780","Oral Galactose as a Substrate for Post-Exercise Skeletal Muscle Glycogen Repletion in Individuals With Type 1 Diabetes","Inclusion Criteria:\n\n* Healthy or T1D\n* BMI 18,5-30 kg\u002Fm2\n* Singed informed consent\n\nExclusion Criteria:\n\n* Clinically significant heart, lung, kidney, liver, endocrine, or malignant disease based on information collected during the initial screening visit as well as blood tests\n* Lack of awareness of hypoglycemia episodes\n* Blood donation within the last 3 months\n* Smoking\n* Alcohol or substance abuse\n* Participation in other studies involving ionizing radiation within the last 6 months\n* Claustrophobia\n* Inability to train one leg for one hour",{"count":202,"type":22},16,[183],"This Ph.D. project investigates whether orally ingested galactose can be taken up by skeletal muscle and the heart in response to exercise or hyperinsulinemia, and whether it may serve as a viable nutritional strategy for individuals with type 1 diabetes (T1D).\n\nAlthough exercise provides significant health benefits for people with T1D, it is often associated with substantial glucose fluctuations and an increased risk of hypoglycemia. Conventional carbohydrate strategies based on glucose may further exacerbate glycemic instability due to the rapid increase in blood glucose levels. In contrast, galactose is metabolized more slowly and may therefore provide a more stable energy source during and after exercise.\n\nPrevious research has demonstrated that intravenously administered galactose is taken up by human skeletal muscle, with uptake increasing during exercise, suggesting a mechanism that may be at least partly insulin-independent. Building on these findings, this project aims to determine whether similar uptake occurs when galactose is ingested orally.\n\nThis study uses a randomized controlled design and applies non-invasive 18F-FDGal PET imaging to quantify galactose uptake in skeletal muscle and cardiac tissue. The findings may contribute to improving dietary recommendations for individuals with T1D, particularly in relation to maintaining stable blood glucose levels during and after physical activity.",[28],[207,208,209,210],"Galactose metabolism","Skeletal muscle uptake of Galactose","Hepatic galactose uptake","Cerebral galactose uptake","2026-08-17",{"date":60,"type":34},{"date":214,"type":22},"2027-02-01",{"date":216,"type":22},"2029-05-31",{"name":218,"class":41},"University of Aarhus",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":229,"conditions":230,"keywords":236,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":42},"100651981","implementation-of-networked-continuous-glucose-monitoring-with-telemetry-within-the-intensive-care-unit-icu-telecgm-100651981","NCT07769138","Implementation of Networked Continuous Glucose Monitoring With Telemetry Within the Intensive Care Unit (ICU-TeleCGM)","ICU-TeleCGM","Inclusion Criteria:\n\n* Age \\>18years inclusive\n* Hyperglycaemia requiring insulin therapy (subcutaneous injection or intravenous insulin) during admission on ICU\n* Admission to ICU within 48hours\n\nExclusion Criteria:\n\n* Known significant allergy to tape\u002F adhesives\n* Imminent death or anticipated length of stay \\\u003C24hours\n* Women who are pregnant\n* Imminent extracorporeal membrane oxygenation (ECMO)\n* Requirement for therapeutic temperature control (i.e. cooling) post cardiac arrest",{"count":227,"type":22},70,"OBSERVATIONAL","The aim of this observational study is to assess safety and implementation of continuous glucose monitors within the Intensive Care Unit. The Dexcom G7 is a continuous glucose monitoring system that shows blood glucose values in real-time and includes alarms if the glucose is very low or high.",[28,231,232,233,234,235],"Type 2 Diabetes Treated With Insulin","Hyperglycemia","Intensive Care (ICU)","Continuous Glucose Monitoring","Hypoglycaemia",[237,238,239,240,241],"diabetes","hyperglycaemia","hypoglycaemia","intensive care unit","continuous glucose monitoring","2026-08-13",{"date":211,"type":34},{"date":245,"type":22},"2026-08",{"date":247,"type":22},"2028-06",{"name":249,"class":41},"Imperial College Healthcare NHS Trust",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":257,"minAge":19,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":42},"100636063","nourish---a-healthcare-community-partnership-to-improve-nutrition-for-optimal-glycemic-control-and-pregnancy-outcomes-with-pregestational-diabetes-100636063","NCT07560813","NOURISH - A Healthcare-community Partnership to Improve Nutrition for Optimal Glycemic Control and Pregnancy Outcomes With Pregestational Diabetes","NOURISH","Inclusion criteria:\n\n* Pregnant with singleton or twin pregnancy\n* Gestational age \\>8+0 to ≤22+6 weeks at enrollment by project EDD\n* Age ≥ 18 years.\n* Type 1 or 2 diabetes.\n* Screen positive for food insecurity based on answering \"Often\" or \"Sometimes\" true to either of the two questions on the USDA Hunger Vital Sign screening questions (within 12 months of enrolling in prenatal care).\n* English or Spanish speaking.\n* Willing to participate in Mid-Ohio Farmacy program and able to provide a home address to which food delivery can be provided by the Mid-Ohio Food Collective.\n* Hemoglobin A1c criteria:\n\n  * If not taking glucagon-line peptide-1 (GLP-1) or sodium-glucose co-transporter 2 (SGLT2) medication within 12 months of enrolling in prenatal care, A1c ≥6.5% during this time period.\n  * If taking GLP-1 or SGLT2 medication within 12 months of enrolling in prenatal care, A1c≥6.5% during the 12 months prior to initiation of these medications.\n\nExclusion Criteria\n\n* Involuntarily confined or detained.\n* Considered as having a diminished decision-making capacity.","FEMALE",{"count":259,"type":22},174,[183],"Nutrition insecurity (inclusive of food insecurity + poor diet quality) is a fundamental social need that must be addressed to improve treatment and health outcomes for high-risk pregnant women with pregestational type 1 and 2 diabetes, poor glucose control, and food insecurity for whom a healthy diet is critical. The NOURISH trial will provide evidence of a scalable, integrated, and theory-based healthcare-community partnership that includes weekly nutritious produce home delivery, monthly clinic-integrated diabetes, nutrition, and culinary group education, and continuous social needs assessment and support to improve glucose control and pregnancy outcomes. Given the increasing burden and devasting consequences of nutrition insecurity among high-risk pregnant women with diabetes and unmet social needs, NOURISH-an innovative and sustainable healthcare-community partnership-will have significant public health benefit.",[263,28,264],"Type 2 Diabetes","Pregnancy, High Risk",[266,28,263,267,268,269],"Pregnancy","food insecurity","nutrition insecurity","social determinants of health","2026-08-12",{"date":272,"type":34},"2026-08-14",{"date":274,"type":34},"2026-07-06",{"date":276,"type":22},"2030-06-30",{"name":278,"class":41},"Ohio State University",{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":50,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":69},"100638900","precision-t1d-platform---new-therapies-for-cardio-renal-complications-100638900","NCT07594145","Precision T1D Platform - New Therapies for Cardio-Renal Complications","Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)","Inclusion Criteria:\n\n1. Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following:\n\n   1. presence of circulating T1D-associated autoantibodies, or\n   2. history of hospitalization for diabetic ketoacidosis, or\n   3. documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose \\>100 mg\u002FdL)\n2. Aged 18-75 years, inclusive\n3. T1D duration \\>10 years\n4. HbA1c: 7-10%\n5. Meets one of the following, either\n\n   1. UACR \\> 30 mg\u002Fdl with eGFR ≥ 60mL\u002Fmin\u002F1.73 m2 and receiving standard of care therapy for early DKD Stage 2, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated, or\n   2. Early (Stage B HF) defined as NT-proBNP ≥125 pg\u002FmL\n6. Willing and able to adhere to schedule of activities and protocol requirements, including written informed consent\n\nExclusion Criteria:\n\n1. Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease\n2. Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms\n3. Current use of GLP-1 receptor agonists or other non-glucose lowering agent\n4. Use of aldosterone inhibitors within 2 months prior to screening\n5. Immunosuppressive medications within 3 months prior to screening\n6. Systolic BP\\>160 or diastolic BP \\>95 mmHg at screening\n7. History of ≥3 severe hypoglycemic events requiring third-party assistance for correction within 3 months prior to screening\n8. Evidence of any episode of DKA or non-ketotic hyperosmolar state within 12 months prior to screening\n9. Serum potassium \\> 5.0 mmol\u002FL at screening\n10. Absolute neutrophil count \\\u003C 2.0 × 109 per L at screening\n11. Platelet count \\\u003C 120 × 109 per L at screening\n12. Known active tuberculosis, hepatitis B or C at screening, or history of HIV\n13. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and\u002For AST or ALT \\>2 times upper limit of normal, and\u002For total bilirubin \\>1.3 times upper limit of normal at screening\n14. History of severe acquired immune deficiency syndrome or severely immunocompromised status in the opinion of the study site investigator\n15. History of biopsy-proven non-diabetic CKD\n16. History of any other cause of HF (viral, congenital, valvular)\n17. History of heart or renal transplant or currently on chronic dialysis\n18. Cancer treatment, excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer, within one year prior to screening\n19. Illicit drug abuse within 6 months prior to screening in the opinion of the study site investigator\n20. Current heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week)\n21. Participation in another interventional clinical research study within 30 days prior to screening\n22. Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial\n23. Presence of a clinically significant medical history, physical examination, laboratory finding or other identified study site investigator concern that may interfere with any aspect of study conduct or interpretation of results",{"count":287,"type":22},57,[25],"Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health \\& Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.",[28,291,292,293],"T1D Heart Failure","Cardio-renal Vascular Function and Failure","Diabetic Chronic Kidney Disease",[28,110,295,296,297],"DKD","Heart Failure","Platform Trial","2026-08-05",{"date":300,"type":34},"2026-08-10",{"date":302,"type":22},"2026-11-01",{"date":304,"type":22},"2031-12-31",{"name":306,"class":41},"Oregon Health and Science University",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":42},"100650580","study-of-metabolic-dysfunction-associated-steatotic-liver-disease-masld-in-adults-with-type-1-diabetes-100650580","NCT07750210","Study of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n1. age ≥ 18years,\n2. diagnosis of T1DM\n\nExclusion Criteria\n\n(1)Type 2 diabetes mellitus (2) using glucocorticoids (3) long-term alcohol consumption (4) previous diagnosis of other chronic liver diseases (viral, autoimmune, etc.), major diseases such as liver cirrhosis or tumors\n\n\\-",{"count":314,"type":22},250,"Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.\n\nRecent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (\\> F2) is observed 'in 13.2% and advanced fibrosis (\\> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.\n\nRecent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (\\> F2) is observed 'in 13.2% and advanced fibrosis (\\> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.\n\nRecent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (\\> F2) is observed 'in 13.2% and advanced fibrosis (\\> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways Type 1 diabetes (T1D) is a disease characterized by an absolute deficiency of insulin secondary to autoimmune destruction of pancreatic beta cells , historically individuals with T1D are not liable for metabolic complications.\n\nRecent evidence suggests a prevalence of MASLD in approximately 22.2% of adults with T1D; moreover, significant fibrosis (\\> F2) is observed 'in 13.2% and advanced fibrosis (\\> F3) in 5.12% of them (1) The development of MASLD is related to a persistence of inflammatory state and is favored by lipotoxicity due to the accumulation of free cholesterol(2) In individuals with T1D, MASLD risk may be influenced by disease-specific factors, including lifelong exposure to exogenous insulin, peripheral hyperinsulinemia with relative portal hypoinsulinemia, chronic hyperglycemia, marked glycemic variability, recurrent hypoglycemia, and progressive alterations in body composition. Even in the absence of classical insulin resistance, these factors may promote hepatic denovo lipogenesis, oxidative stress, and lipid accumulation through alternative metabolic pathways",[317,28],"MASLD",[317,319],"TYPE 1 DIABETES","2026-08-01",{"date":322,"type":34},"2026-08-06",{"date":324,"type":22},"2026-08-22",{"date":326,"type":22},"2028-08-22",{"name":328,"class":41},"Sohag University",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":338,"studyType":228,"phases":4,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":354},"100617321","omnipod-5-a-french-prospective-multicentric-study-in-real-world-optimal-b-100617321","NCT07317102","Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)","Inclusion Criteria:\n\n* Patient with T1D aged ≥ 2 years.\n* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.\n* Patient has never used the Omnipod 5 System prior to inclusion.\n* Patient has not objected to the use of their personal data for this study.\n* Patient or legal guardian has an email address and mobile phone number.\n* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.\n* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.\n* Patient is covered by the local social security system\n\nExclusion Criteria:\n\n* Patient is currently pregnant.\n* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).\n* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.\n* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.\n* Adult under guardianship, curatorship or tutorship.\n* Adult otherwise deprived of liberty.","2 Years",{"count":337,"type":22},152,"12 Months","The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.",[119,28,159],[342,343,344],"Omnipod","Automated Insulin Delivery","Post-market Registry","2026-07-31",{"date":347,"type":34},"2026-08-03",{"date":349,"type":34},"2026-03-16",{"date":351,"type":22},"2027-11",{"name":353,"class":68},"Insulet Corporation",24,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":373,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":42},"100624764","telehealth-music-therapy-for-adults-with-endocrine-disorder-and-depression-100624764","NCT07413874","Telehealth Music Therapy for Adults With Endocrine Disorder and Depression","Telehealth Music Therapy for Adults With Endocrine System Based Autoimmune Disease and a Depressive Disorder: An Intervention Development Study","Inclusion Criteria:\n\n* self-reported depression\n* self-reported autoimmune endocrine disease\n* 18-65 years of age\n* have a device that supports the Zoom platform (camera and audio)\n\nExclusion Criteria:\n\n* intellectual or developmental disability\n* no auto-immune disease\n* no depression\n* lack of access to device\n* under the age of 18 years\n* over the age of 65 years","65 Years",{"count":52,"type":22},[183],"The goal of this clinical trial is to explore if a telehealth music therapy intervention helps with quality of life, depression symptoms, anxiety symptoms. It will also explore the participants' relationship to music. The main questions it aims to answer are:\n\n* Refine and tailor the music therapy intervention to fit the specific needs of adults living with an autoimmune disease and depression.\n* Examine the feasibility of the study protocol to support a future full-scale trial\n* Examine how music therapy impacts quality of life, depression symptoms, and anxiety symptoms\n* Explore how music therapy impacts one's relationship to music\n\nParticipants will:\n\n* have a short interview to fill out a questionnaire with some basic information, answers about depression, quality of life, and potential anxiety, and a question about how they feel about music at the start and end of the sessions\n* attend 8 weekly sessions, approximately 30-45 minutes each, with a board certified music therapist over telehealth\u002FZoom\n* answer a few questions about the music therapy intervention",[28,367,368,369,370,371,372],"Hashimoto Disease","Graves Disease","Addison Disease","Autoimmune Polyglandular Syndrome Type III","Depression","Endocrine System Diseases",[374,375,376,377,237,378,379,380],"type 1 diabetes","music therapy","behavioral health","psychosocial","behavioral intervention","quality of life","telehealth","2026-07-29",{"date":383,"type":34},"2026-07-30",{"date":385,"type":34},"2026-07-16",{"date":387,"type":22},"2026-12-31",{"name":389,"class":41},"Appalachian State University",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":335,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":194},"100649706","evaluating-the-occurrence-of-dka-in-people-with-type-i-diabetes-100649706","NCT07739342","Evaluating the Occurrence of DKA in People With Type I Diabetes","Evaluating the Occurrence of DKA in People With Type 1 Diabetes","Inclusion Criteria:\n\n1. Aged at least 2 years old at the time of study enrollment.\n2. Diagnosis of type 1 diabetes with at least 12 months of diabetes medical history.\n3. In the investigator's opinion, the participant is willing to wear the sensor, follow study specific instructions, and perform all study tasks.\n4. Willing and able to provide written signed and dated informed consent (adults) or participant's parent\u002Flegal guardian must be willing and able to provide written signed and dated informed consent along with assent form completed by the participant for those mature enough to make their own decisions per investigator assessment (those less than 16 years of age).\n\nExclusion Criteria:\n\n1. In the investigator's opinion, the participant has a known (or suspected) allergy to medical grade adhesives at enrollment that would interfere with participant completing study required activities.\n2. In the investigator's opinion, the participant has concomitant medical condition(s) which could interfere with the study or present a risk to the safety or welfare of the participant or study staff.\n3. Participant is currently in another clinical study which may affect glucose or ketone management (or does so during the study).\n4. Participant is unsuitable for participation due to any other cause as determined by the investigator.\n5. Participant has implanted medical devices such as pacemakers or requires dialysis or is critically ill.",{"count":398,"type":22},1200,"This study will evaluate the occurrences of Diabetes-related Ketoacidosis (DKA) in adult and pediatric individuals living with Type I diabetes while managing diabetes with Abbott's Continuous Monitoring Systems.",[28],"2026-07-28",{"date":345,"type":34},{"date":404,"type":22},"2026-09",{"date":406,"type":22},"2027-12",{"name":408,"class":68},"Abbott Diabetes Care",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":419,"briefSummary":420,"conditions":421,"keywords":422,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100556427","phase-1-denosumab-for-type-1-diabetes-100556427","NCT06524960","Denosumab for Type 1 Diabetes","A Phase 1\u002F2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients With Type 1 Diabetes","Main Inclusion Criteria\n\n* Age: Females 18-50 years; males 21-50 years (minimum age based on skeletal maturity)\n* Diagnosis of type 1 diabetes (T1D) based on ADA Criteria:\n\n  * Hyperglycemia (glycosylated hemoglobin (HbA1c) ≥ 6.5%; OR\n  * fasting plasma glucose ≥ 126 mg\u002Fdl (7.0 mmol\u002FL); OR\n  * 2-hour plasma glucose ≥ 200 mg\u002FdL (11.1 mmol\u002FL) during an oral glucose tolerance test; OR\n  * In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg\u002Fdl (11.1 mmol\u002FL)\n* Documented history of at least one type 1 diabetes associated autoantibody\n\n  * GAD specific autoantibodies (GADA);\n  * Islet-antigen 2 specific autoantibody (IA-2A); and\u002For\n  * Zinc Transporter 8 specific autoantibody (ZNT8A)\n* Time from T1D diagnosis to screening MMTT must be ≥ 12 months but ≤ 5 years\n* Non-fasting C-peptide concentrations of at least 0.2 nmol\u002FL (0.6 ng\u002Fml) at pre-screening and confirmed during a MMTT done at screening visit.\n* Serum calcium (corrected for albumin)\\* within normal limits per site's local lab\n* Agreement by women of childbearing potential (WOCBP) and males of childbearing potential to use a highly effective method of birth control for the course of the study through at least 5 months from the last dose of protocol therapy\n\nMain Exclusion Criteria\n\n* History of delayed puberty unless there is radiologic evidence of skeletal maturity\n* Use of other investigational agents within 3 months of enrollment\n* Vitamin D3 deficiency (\\\u003C 30 ng\u002Fml)\n* History of anorexia and\u002For eating disorder\n* BMI \\> 32 kg\u002Fm2\n* HbA1c \\> 9.5%\n* Severe hypoglycemia or diabetic ketoacidosis (DKA) within 3 months prior to screening. Subjects who had such episodes within 3-6 months prior to screening, must have written clearance from their treating physician.\n* Use of any of the diabetes medications other than insulin within 3 months of enrollment (e.g., metformin, sulfonylurea, GLP-1 agonists, DPP4 inhibitors, Symlin, SGLT2-inhibitors, amylin)\n* Treatment with any of the following drugs in past year: immunosuppressants, anticonvulsant therapy, adrenal or anabolic steroids, calcitonin, selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment.\n* Bone fractures (excluding skull, facial bones, metacarpals, fingers, toes and spontaneous fractures associated with severe trauma) within the past 12 months\n* Disorders associated with altered skeletal structure or function (Paget's disease, chronic liver disease (liver enzymes \\> twice the upper limit of normal), malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake \\> 3 units\u002Fday)\n* Significant dental\u002Foral disease, including prior history or current evidence of osteonecrosis\u002Fosteomyelitis of the jaw, active dental or jaw condition requiring oral surgery, non-healed dental\u002Foral surgery, or planned invasive dental procedures for the course of the study\n* Pregnancy or actively breastfeeding (within 6 months prior to screening), or planning to become pregnant with 5 months after last dose of protocol therapy","50 Years",{"count":418,"type":22},45,[54,25],"Type 1 diabetes (T1D) arises from abnormal immune cell-mediated injury to beta cells that make insulin. The injured beta cells can then no longer make the needed amount of insulin to stay healthy. However, in the early stages of T1D, some beta cells are still alive and functioning. Treatment to protect the beta cells against injury at this time could slow the progress of disease. Denosumab is an approved treatment for osteoporosis (a disease that thins and weakens the bones), high blood calcium levels, bone cancer, and other bone problems in patients who have cancer. The research team has found that the bone pathway that denosumab works on to treat these bone conditions also has effects on the health of the beta cells. Lab studies suggest that denosumab may protect and\u002For increase the number of beta cells and improve how well they work. This study will test whether denosumab is safe and improves beta cell function and blood sugar control in people with early T1D.",[28],[423],"Type 1 diabetes, denosumab, HbA1c, beta cell function","2026-07-27",{"date":401,"type":34},{"date":427,"type":34},"2024-09-03",{"date":429,"type":22},"2027-10-11",{"name":93,"class":41},3,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":257,"minAge":19,"maxAge":4,"enrollmentInfo":440,"targetDuration":442,"studyType":228,"phases":4,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":42},"100566402","commercial-or-open-source-closed-loop-impact-on-pregnancy-study-100566402","NCT06654713","Commercial or Open Source Closed Loop Impact on Pregnancy Study","Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study","COSCLIP","Inclusion criteria:\n\n* Pregnant\n* Diagnosis of type 1 diabetes (T1D) prior to pregnancy\n* Active use of automated insulin delivery (AID) system\n\nExclusion criteria:\n\n* Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)",{"count":441,"type":22},1000,"1 Year","The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:\n\n* What are the maternal and neonatal outcomes with AID system use in pregnancy?\n* What are the glycemic outcomes with AID system use in pregnancy?\n* What are the behavioral and emotional outcomes with AID system use in pregnancy?\n\nResearchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.\n\nParticipants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.",[28,264,445,446],"Insulin Dependent Diabetes","Pregnancy Related","2026-07-24",{"date":424,"type":34},{"date":450,"type":34},"2025-03-13",{"date":452,"type":22},"2029-12-31",{"name":454,"class":41},"University of California, San Francisco",{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":462,"maxAge":102,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":465,"briefSummary":466,"conditions":467,"keywords":473,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":42},"100644489","think-find-solve-activities-for-insulin-self-management-in-type-1-diabetes-100644489","NCT07670572","Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes","The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* For the child:\n\nDiagnosed with Type 1 diabetes Aged between 8 and 12 years Able to read and write Able to understand and speak Turkish Diagnosed with diabetes for at least one year Regularly attending routine three-month outpatient clinic follow-ups Having no other diseases or medical conditions aside from diabetes The child agrees to participate in the study\n\n-For the Parent: Being the mother or father of the child with Type 1 diabetes Being the primary caregiver responsible for the child Able to read and write Agrees to participate in the study\n\nExclusion Criteria:\n\nThe child uses an insulin pump\n\n\\-","8 Years",{"count":464,"type":22},40,[183],"Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\\*Power based on the pilot data. Data will be collected using the \"Descriptive Information Form for Children with Diabetes\" and the \"Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms.\" The \"Find-Solve-Learn Insulin Self-Management Activity Book\" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.",[28,468,469,470,471,472],"Children","Activity","Insulin","Self Management","Parent",[374,474,475,476,477,478],"children","activity","insulin","self management","parent","2026-07-17",{"date":481,"type":34},"2026-07-20",{"date":483,"type":22},"2026-07-15",{"date":485,"type":22},"2027-06-15",{"name":487,"class":41},"Marmara University",{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":178,"sex":17,"minAge":335,"maxAge":140,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":513,"locationsCount":42},"100638053","evaluating-glucose-control-using-a-next-generation-aid-algorithm-in-individuals-with-t1d-100638053","NCT07593625","Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D","Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Individuals With Type 1 Diabetes: EVOLUTION T1D","EVOLUTIONT1D","Inclusion Criteria:\n\n* Age at time of consent 2-70 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months, for those aged 8-70 years, or 3 months for those aged 2-7 years, based on Investigator assessment\n* Basal\u002FBolus insulin delivery via multiple daily injections or insulin pump with or without automation\n* Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents\n* Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n* If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.\n* Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol\n* Willing to wear the system continuously throughout the study\n* Willing and able to sign the Informed Consent Form (ICF) or has a parent\u002Fguardian willing and able to sign the ICF. Assent will be obtained from participants per local regulatory requirements\n* Able to read and understand English\n* If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n* Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.\n* Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening\n* Any planned surgery during the study which could be considered major in the opinion of the Investigator\n* History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions\n* History of more than 1 diabetic ketoacidosis (DKA) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement\n* Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n* Use of hydroxyurea\n* Plans to receive blood transfusion over the course of the study\n* Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study\n* Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and\u002For GLP1, in the 4 weeks prior to screening. Participants taking metformin and\u002For GLP1 should remain on a steady dose without dose increases during study participation\n* Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).\n* In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device that in the opinion of the investigator may have therapeutic impact on their diabetes management. Additionally, may not intend to participate in any other interventional clinical study during this study period\n* Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n* Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned",{"count":497,"type":22},80,[183],"Feasibility study to evaluate the safety and feasibility of Omnipod automated insulin delivery algorithms in individuals with type 1 diabetes. This study will enroll up to 80 participants to have a minimum of 48 participants to initiate the use of Omnipod. The study will include hotel and outpatient evaluation periods.",[28,109,501],"Diabetes (DM)",[28,110,342,503,504,505,506,507,508],"Omnipod M","Automated Insulin Delivery System","AID","fully closed loop","FCL","Omnipod S",{"date":481,"type":34},{"date":511,"type":34},"2026-05-25",{"date":214,"type":22},{"name":353,"class":68},{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":257,"minAge":19,"maxAge":416,"enrollmentInfo":521,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":526,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":42},"100453705","exercise-and-the-menstrual-cycle-in-type-1-diabetes-100453705","NCT05188014","Exercise and the Menstrual Cycle in Type 1 Diabetes","Effects of the Menstrual Cycle on Blood Glucose Changes During Exercise in Women With Type 1 Diabetes Using Oral Contraceptives","Inclusion Criteria:\n\n* type 1 diabetes diagnosed for at least 1 year\n* regular menses\n* using monophasic oral contraceptives\n* residing in Edmonton, Alberta and able to visit the lab at the University of Alberta\n\nExclusion Criteria:\n\n* HbA1c \\> 9.9%\n* frequent and unpredictable hypoglycemia\n* change in insulin management strategy within two months of the study\n* use of an automated insulin delivery system\n* blood pressure \\> 140\u002F95\n* history of cardiovascular disease\n* severe peripheral neuropathy\n* active proliferative retinopathy\n* use of medications (other than insulin) that would affect blood glucose levels\n* any musculoskeletal condition that would contraindicate exercise (e.g. sprain, strain, joint injury, etc.)",{"count":522,"type":22},15,[183],"Female participants with type 1 diabetes using oral contraceptives will be asked to wear a continuous glucose monitor for at least three days on two separate occasions (once during the last week of active pills and once during the no pill\u002Fplacebo pill phase of the menstrual cycle). An exercise session (45 minutes of aerobic exercise at 60% VO2peak on a cycle ergometer) will take place at 5 pm on the second day of glucose monitoring.",[28],{"date":481,"type":34},{"date":528,"type":34},"2022-03-15",{"date":530,"type":22},"2027-08-30",{"name":532,"class":41},"University of Alberta",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":23,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":551,"leadSponsor":553,"locationsCount":42},"100647414","screening-for-social-determinants-of-health-in-routine-diabetes-care-100647414","NCT07706803","Screening For Social Determinants Of Health In Routine Diabetes Care","SDOH","Inclusion Criteria:\n\n* 1\\) patients who are 0-21 years old, diagnosed with T1D, and receive T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic, and\u002For 2) parents\u002Flegal guardians of a child with T1D and whose child is 21 years old or under and receives T1D care from the UCLA Pediatric Diabetes program at the Westwood clinic.\n\nExclusion Criteria:\n\n* 1\\) patients who are over 21 years old and diagnosed with Type 2 Diabetes or prediabetes, and 2) parents\u002Flegal guardians of a child with type 2 diabetes or prediabetes and whose child is over 21 years old.","21 Years",{"count":542,"type":22},150,[183],"Social determinants of health (SDOH) exert a powerful influence on the everyday management of type 1 diabetes (T1D) and short and long term outcomes of T1D. Experts agree that identifying and addressing negative social determinants of health (SDOH) may help accomplish numerous T1D care goals and promote health equity in treatment. However, fundamental research gaps in achieving these goals remain, including optimal screening and management processes for identification of negative social determinants of health (SDOH) , and how to develop robust partnerships with community-based organizations (CBOs) that address social determinants of health (SDOH) with high potential for sustainability and scalability. This project will generate new knowledge regarding how to implement a social work-led social determinants of health (SDOH) screening and referral program designed to aid families of youth with T1D who face several vulnerabilities, including food insecurity. The team will implement a single arm, pragmatic clinical trial with contemporaneous, non- randomized controls; whereby all families with a child enrolled in the California Children's Services (CCS) program (which provides specialized medical care for low-income families of youth with a qualifying chronic medical condition) will receive access to a novel social work-led social determinants of health (SDOH) screening and referral program.\n\nOutcomes will be compared against youth with T1D who are also seen in our Westwood Pediatric Endocrinology clinic but who are not enrolled in the CCS program and will not receive access to the social determinants of health (SDOH) intervention. The study team has established partnerships with several community-based organizations (CBOs) across Los Angeles County that provide social services, including food-related services, to receive referrals for CCS families who screen positive for having a social need. The study team will assess the feasibility and acceptability of this screening and referral protocol among families, CBOs, and providers (Aim 1) by measuring key implementation outcomes (comprehensive documentation of social determinants of health (SDOH) screening, result, and referral in the patients' medical record) and acceptability outcomes (self-reported satisfaction with the program by families and barriers and facilitators by CBOs and providers). The team will additionally estimate the effect of this intervention (Aim 2) by measuring changes (pre\u002Fpost intervention) in families reported social needs, diabetes-related quality of life, and in the child's glycemic control (measured by HbA1c). Results from this work can provide a roadmap for sustainable and scalable social determinants of health (SDOH) interventions with potential to improve outcomes for youth with T1D in an equity-informed manner.",[28],[547,548],"Type 1 diabetes","Pediatric",{"date":385,"type":34},{"date":404,"type":22},{"date":552,"type":22},"2028-09",{"name":554,"class":41},"University of California, Los Angeles",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":228,"phases":4,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":576,"leadSponsor":578,"locationsCount":42},"100645697","targeting-glut1-to-control-autoimmunity-in-type-1-diabetes-100645697","NCT07695727","Targeting GLUT1 to Control Autoimmunity in Type 1 Diabetes","GLUT1D","Inclusion Criteria:\n\n* PBMC samples obtained from adult subjects aged 18 years or older at the time of sample collection.\n* Documented diagnosis of Type 1 Diabetes.\n* PBMC samples already collected and stored in the institutional Biobank of IRCCS Ospedale San Raffaele.\n* PBMC samples obtained from subjects who had previously provided written informed consent for the collection, storage, and research use of biological material and associated data.\n\nExclusion Criteria:\n\n* PBMC samples obtained from subjects younger than 18 years at the time of sample collection.\n* Presence of relevant concomitant diseases or clinical conditions that, in the Investigator's judgment and based on available records, may interfere with the interpretation of immunological analyses or with the study objectives.\n* Insufficient sample availability, inadequate sample quality, or missing essential sample-related information preventing use of the PBMC sample for the planned research activities.",{"count":563,"type":22},84,"Type 1 Diabetes is an autoimmune disease in which immune cells contribute to the destruction of insulin-producing pancreatic beta cells. This study investigates whether targeting glucose transporter 1 (GLUT1), a transporter involved in immune cell metabolism, may help modulate autoimmune responses associated with Type 1 Diabetes.\n\nThe study uses previously collected and biobanked peripheral blood mononuclear cells (PBMCs) from individuals with Type 1 Diabetes. No additional visits, blood draws, or study-specific procedures will be performed on human participants.",[28,566],"Autoimmunity",[566,28,568,569,570,571],"GLUT1","Humanized mice","Immunometabolism","T cells","2026-07-10",{"date":574,"type":34},"2026-07-14",{"date":404,"type":22},{"date":577,"type":22},"2029-09",{"name":579,"class":41},"IRCCS San Raffaele",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":588,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":23,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":603},"100607359","phase-2-safety-and-efficacy-of-human-anti-thymocyte-immunoglobulin-sab-142-arresting-progression-of-type-1-diabetes-100607359","NCT07187531","SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset of Type 1 Diabetes (NOT1D)","SAFEGUARD","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian must have given written informed consent and\u002For assent according to local, regional and\u002For country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.\n2. Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\\*, inclusive, at the time of randomisation in Part B.\n3. Weight ≥16.0 kg at time of randomisation.\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: The date of diagnosis is defined as the date of the first insulin dose or any other glucose lowering medication. An extension of no more than 14 days is permitted if a participant has planned and\u002For is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.\n5. Participant has random C-peptide levels of ≥0.2 nmol\u002FL, measured during Screening. One random C-peptide retest during screening period is allowed.\n6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.\n7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:\n\n   * Glutamic acid decarboxylase 65 (GAD65)\n   * Islet antigen 2 (IA-2)\n   * Zinc transporter 8 (ZnT8)\n   * Insulin autoantibodies (if testing within the first 14 days of insulin treatment)\n8. Female participants:\n\n   a. Must be of nonchildbearing potential, i.e., pre-pubertal\\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative result on a serum (beta human chorionic gonadotropin \\[β-HCG\\]) at screening and a negative urine β-HCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.\n\n   ii. Agree not to become pregnant or donate ova from signing the consent form until the end of study visit.\n\n   iii. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from signing the consent and for the duration of the study.\n\n   \\* Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)\u002Fguardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.\n9. Male participants, if not biologically or surgically sterilised, must:\n\n   1. Agree not to donate sperm from signing the consent form until EOS.\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the consent form until EOS.\n   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.\n10. Prior to receiving study drug, participant must agree to receive locally, regionally and\u002For country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and\u002For country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.\n11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and\u002For stimulate pancreatic β cell regeneration or insulin secretion.\n12. Participant has suitable venous access for blood sampling.\n13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nExclusion Criteria:\n\n1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications).\n2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.\n3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.\n4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.\n5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and\u002For efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.\n6. Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematous) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.\n7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.\n8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.\n9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus \\[CMV\\], Epstein-Barr Virus \\[EBV\\] as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I\u002FE are met. Participants who have an active infection and\u002For fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.\n11. Participant has a diagnosis of significant liver disease or at screening ALT and\u002For AST \\>2× or total bilirubin of \\>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant maybe eligible for randomization. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and\u002For indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.\n12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:\n\n    * Lymphocyte count: \\\u003C1000\u002FμL\n    * Neutrophil count: \\\u003C1500\u002FμL\n    * Platelet count: \\\u003C100 000 platelets\u002FμL\n    * Haemoglobin: \\\u003C10 g\u002FdL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and\u002For is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the normal ranges.\n13. Current or prior (within 5× half-lives before SV2) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.\n14. Current or prior (within 5× half-lives before SV2) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \\[glucagon-like peptide-1\\], dipeptidyl peptidase-4 \\[DPP-IV\\] inhibitors, or amylin).\n15. Current or prior (within 5× half-lives before SV2) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).\n16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n18. Female is lactating and\u002For plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.\n19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and\u002For country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit\u002Fhyperactivity disorder (ADHD) or others are allowed to participate in the study.\n20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.\n21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.","5 Years","40 Years",{"count":591,"type":22},159,[25],"This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).",[28],"2026-07-08",{"date":572,"type":34},{"date":598,"type":34},"2025-11-25",{"date":600,"type":22},"2028-12",{"name":602,"class":68},"SAb Biotherapeutics, Inc.",71,{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":612,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":626,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":4},"100646492","effect-of-a-structured-educational-intervention-through-mobile-app-on-hemoglobin-a1c-hba1c-self-efficacy-and-self--care-in-adolescent-with-type-1-diabetes-t1dm-100646492","NCT07689318","Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes (T1DM)","Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes A Pilot RCT","(T1DM)","Inclusion Criteria:\n\nAdolescents aged 10 to 19 years. Diagnosed with Type 1 Diabetes Mellitus (T1DM) by a physician for at least 6 months.\n\nHbA1c greater than or equal to 7%. Have access to a smartphone or tablet (owned by the participant or parent\u002Fguardian).\n\nExclusion Criteria:\n\nUse of an insulin pump. Current use of any smartphone application for diabetes self-management. Presence of comorbid conditions that may interfere with participation in the study.\n\nDiagnosis of intellectual disability or other cognitive impairment documented in the medical record that may limit the participant's ability to complete questionnaires or comply with intervention requirements.","10 Years","19 Years",{"count":563,"type":22},[183],"This study aims to evaluate the effectiveness of a mobile health (mHealth) educational intervention for adolescents with Type 1 Diabetes Mellitus (T1DM). Adolescents often face challenges in maintaining optimal blood glucose control and performing regular self-care. In this study, participants will receive structured diabetes education through a mobile application designed to improve their knowledge, self-efficacy (SE), and self-management skills. The impact of the intervention will be assessed by measuring changes in HbA1c levels, diabetes self-efficacy, and self-care (SC)behaviors over time. These findings may help determine whether mobile app-based education can support better diabetes management among adolescents.",[115,28,109,618,619,620,621,622,623,624,625],"HbA1c","HbA1c Level","Self Care","Self Efficacy","Mobile Application","MOBILE WEB-BASED INTERVENTION PROGRAM","Mobile Apps","Nurse Led Intervention",[627,628,629],"type 1 diabetes Mellitus, educational intervention , mobile app, HbA1c","Self Efficacy , Self Care","adolescents","2026-07-07",{"date":595,"type":34},{"date":633,"type":22},"2026-07-01",{"date":635,"type":22},"2026-11-30",{"name":637,"class":41},"Shifa Tameer-e-Millat University",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":645,"maxAge":646,"enrollmentInfo":647,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":650,"conditions":651,"keywords":652,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":42},"100553621","behavioural-problems-and-cognition-in-children-with-hypoglycemia-unawareness-in-type-1-diabetes-mellitus-100553621","NCT06488469","Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus","The Effect of a Multi-domain Intervention on the Behaviour Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus- A Pilot Study","Inclusion Criteria:\n\n* Children should be between 6-16 years of age.\n* Children must be having Hypoglycemia Unawareness as documented by Continuous Glucose Monitoring. (Blood sugar \\\u003C70 mg\u002Fdl without symptoms)\n* Children must be on treatment with Insulin for a minimum period of 6 months\n* The care giver\u002Fparent must give written informed consent for the child and himself\u002Fherself and the child should give assent.\n\nExclusion Criteria:\n\n* Children with known psychiatric disorders.\n* Children who are on steroids and\n* Children with documented Learning Disability from a certified psychologist.","6 Years","16 Years",{"count":648,"type":22},50,[183],"The study is designed to explore if a multi-pronged intervention strategy comprising of Psychological Interventions, Dietary Modifications, Targeted therapy and Counselling on Parental Attitude would bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.",[28],[147,28,653],"Parent management techniques",{"date":630,"type":34},{"date":656,"type":22},"2026-12-01",{"date":658,"type":22},"2028-07-31",{"name":660,"class":41},"University of Pittsburgh",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":50,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":42},"100646838","butyrate-or-intensive-lifestyle-modification-in-type-1-diabetes-and-metabolic-dysfunction-associated-steatotic-liver-disease-100646838","NCT07684248","Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease","Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Factorial Randomized Clinical Trial","Inclusion Criteria:\n\n* Age 18-75 years.\n* Type 1 diabetes.\n* MASLD: Defined by a Controlled Attenuation Parameter (CAP) measured by Fibroscan® ≥248 dB\u002Fm (40).\n* Signed informed consent.\n\nExclusion Criteria:\n\n* History of alcohol consumption \\> 50 g\u002Fday in men or \\> 30 g\u002Fday in women for 3 consecutive months in the last year.\n* Patients with impaired liver function (total bilirubin \\> 2.0 mg\u002FdL).\n* Hemochromatosis, Wilson's disease, or autoimmune hepatitis.\n* History of cancer (except basal cell carcinoma) in the past 5 years or active cancer of any type.\n* Known infection with HIV, HBV, HCV, or any other infection that may cause liver disease.\n* Severe underlying diseases that, in the investigators' judgment, constitute an exclusion criterion for study participation.\n* Reduced life expectancy.\n* Pregnant or breastfeeding women.\n* Documented history of intolerance\u002Fallergy to butyrate.\n* Participation in another clinical trial within 30 days prior to study entry.\n* Inability to comply with scheduled visits.\n* Use of antibiotics, prebiotics, or probiotics (in pharmacological form or as supplements, not as part of usual diet) in the month prior to inclusion in the study.",{"count":669,"type":22},200,[183],"Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in individuals with type 1 diabetes (T1D) and is associated with increased cardiovascular and metabolic risk. However, evidence regarding effective therapeutic strategies for MASLD in T1D remains scarce. Lifestyle modification has shown benefits in obesity and type 2 diabetes, whereas butyrate, a microbiota-derived short-chain fatty acid, has emerged as a potential therapeutic approach because of its anti-inflammatory and metabolic effects. This study aims to evaluate the efficacy of intensive lifestyle modification, butyrate supplementation, or their combination on hepatic steatosis in individuals with T1D and MASLD.\n\nMethods: BEAM-T1D is a factorial, randomized, 6-month, parallel-group, placebo-controlled clinical trial conducted at the Regional University Hospital of Malaga. A total of 200 adults with T1D and MASLD will be randomized (1:1:1:1) to receive: (1) standard lifestyle recommendations plus placebo; (2) intensive lifestyle modification plus placebo; (3) standard lifestyle recommendations plus butyrate; or (4) intensive lifestyle modification plus butyrate. Intensive lifestyle modification includes a hypocaloric Mediterranean diet and promotion of physical activity. Participants randomized to butyrate will receive 2.25 g\u002Fday of microencapsulated sodium butyrate. The primary endpoint will be the change in controlled attenuation parameter (CAP) measured by transient elastography (FibroScan®). Secondary outcomes include changes in liver fat content, insulin resistance, metabolic control, body composition, inflammatory markers, gut microbiota composition, and short-chain fatty acid concentrations.\n\nResults: Participant recruitment is expected to begin in October 2025. The study will evaluate the independent and combined effects of butyrate supplementation and intensive lifestyle modification on hepatic steatosis and metabolic outcomes in individuals with T1D and MASLD.\n\nConclusion: The BEAM-T1D study will provide novel evidence regarding the potential role of butyrate and intensive lifestyle modification in the management of MASLD in T1D. If effective, these interventions could represent feasible and scalable therapeutic strategies for a population with limited evidence-based treatment options.",[28],[674,675,676,149],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Short-Chain Fatty Acids (SCFAs)","Sodium Butyrate",{"date":274,"type":34},{"date":679,"type":22},"2026-09-15",{"date":681,"type":22},"2028-02-15",{"name":683,"class":41},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud"]