[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes-mellitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes-mellitis":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,58,99,133,163,186],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100576285","phase-1-cnp-103-in-adolescent-and-adult-subjects-ages-12-35-with-recently-diagnosed-within-6-months-stage-3-type-1-diabetes-t1d-100576285",false,"NCT06783309","CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)","A Phase 1b\u002F2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.\n2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.\n3. Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.\n4. Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.\n5. Participants with a peak stimulated C-peptide of \\>0.2 nmol\u002FL measured from a screening mixed meal tolerance test (MMTT).\n6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.\n7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.\n8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).\n9. Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.\n10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.\n11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.\n12. Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.\n13. Participants must weigh \\>35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh \\>50 kg at Screening for Cohort 3 (600 mg).\n14. Body mass index (BMI):\n\n    1. Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)\n    2. Participants 18-35 years: 18.0-30.0 (not inclusive)\n\nExclusion Criteria:\n\n1. Participants unable to comply with prohibited medication outlined in the protocol.\n2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.\n3. Participants with a history of tuberculosis or positive Quantiferon test.\n4. Participants who received vaccinations in the following time frame:\n\n   1. Any live vaccine within 28 days prior to Screening.\n   2. Any subunit vaccine within 14 days prior to Screening.\n   3. Any COVID-19 vaccine series within 14 days prior to Screening.\n   4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)\n5. Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.\n6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.\n7. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen\u002Fantibody as determined at Screening.\n8. Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.\n9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.\n10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.\n11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.\n12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.\n13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.\n14. Known sensitivity to any components of CNP-103.","ALL","12 Years","35 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a Phase 1b\u002F2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).",[28,29,30,31,32,33,34,35,36,37],"Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes in Adolescence","Type 1 Diabetes in Children","Type 1 Diabetes (Juvenile Onset)","Type 1 Diabetes","Type 1 Diabetes Patients","Type 1 Diabetes Mellitis",[39,29,40,41,42,30,43,44],"Diabetes","Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed","RECRUITING","2026-06-30",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2025-05-12",{"date":53,"type":21},"2027-06",{"name":55,"class":56},"COUR Pharmaceutical Development Company, Inc.","INDUSTRY",33,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":16,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100610361","using-a-personalized-decision-support-tool-to-help-people-with-type-1-diabetes-manage-exercise-100610361","NCT07226583","Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise","Net-IOB & Exercise Toolkit Pilot Trial: Randomized, Crossover Evaluation of a Behavioral Decision Support Advisor to Improve Glycemic Safety During and After Exercise in Adults With Type 1 Diabetes (NEXT)","NEXT","Inclusion Criteria Inclusion Criteria: All Participants (Type 1 Diabetes and Healthy Control Groups)\n\n* Adults between the age of 18-60 years\n* Able to perform moderate intensity walking for 60 minutes (target 40-60% age-predicted maximal heart rate).\n* Willing and able to comply with study procedures, including supervised exercise visits and device wear\n* Able to provide written informed consent\n\nInclusion Criteria: Type 1 Diabetes Group Only\n\n* Clinical diagnosis of type 1 diabetes for \\>1 year, based on the investigator's clinical judgement\n* Current use of continuous subcutaneous insulin infusion with Tandem Control-IQ and a compatible continuous glucose monitor (CGM) for \\>1 month prior to enrollment\n* Stable insulin delivery regimen, with no planned changes to insulin pump settings or insulin dosing strategy during the study period\n* Consistent CGM use during the month prior to enrollment (\\>80% data availability)\n\nInclusion Criteria: Health Control Group Only\n\n* No diagnosis of diabetes or other disorders of glucose metabolism\n* Not using insulin or glucose-lowering medications\n\nExclusion Criteria Exclusion Criteria: All Participants\n\n* Intercurrent illness or medical condition that precludes safe participation in moderate-intensity exercise (e.g., unstable cardiopulmonary disease, uncontrolled arrhythmia, or uncontrolled hypertension), as previously assessed by the participant's primary care physician\n* Known coronary artery disease with symptoms limiting moderate physical activity, or history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the past 12 months\n* Pregnancy, lactation, or plans to become pregnant during the study period\n* Renal insufficiency with estimated GFR \\\u003C45 mL\u002Fmin\u002F1.73 m², dialysis dependence, or adrenal insufficiency\n* Concurrent participation in another interventional drug or device study within 30 days prior to enrollment\n* Inability to comply with study procedures or safety requirements (e.g., inability to achieve target heart-rate zone, attend scheduled visits, or enable required device data access), or otherwise deemed unsuitable by the investigator\n\nExclusion Criteria: Type 1 Diabetes Group Only\n\n* Use of non-CSII insulin delivery, including long-acting injectable or inhaled insulin, during the study period\n* Use of medications with potential to substantially affect glycemia (e.g., SGLT-2 inhibitors, GLP-1 receptor agonists, or GIP agonists), unless on a stable regimen with no planned changes during the study\n* Use of systemic corticosteroids within 4 weeks prior to participation\n* History of severe hypoglycemia (requiring third-party assistance) or diabetic ketoacidosis within the prior 6 months",true,"18 Years","60 Years",{"count":70,"type":21},20,[72],"NA","This study evaluates a clinician-facing decision-support toolkit designed to assist adults with type 1 diabetes in preparing for moderate-intensity exercise. The netIOB \\& Exercise Toolkit (NEXT) integrates recent glucose data and insulin delivery history to provide individualized suggestions regarding exercise timing, insulin adjustments, and carbohydrate intake.\n\nAdults with type 1 diabetes will complete three supervised exercise sessions under different pre-exercise guidance approaches:\n\n(A) published consensus-based standard-of-care guidance, (B) usual personal care routines, and (C) guidance informed by the NEXT Toolkit.\n\nA healthy adult control group will complete a single supervised exercise session to provide comparative physiologic data.",[37,75,76,77],"Type 1 Diabetes (T1D)","Type 1 Diabetes Mellitus (T1DM)","Exercise Physiology",[35,29,30,79,80,81,82,83,84,85,86],"Continuous Glucose Monitoring","Insulin Dosing","CGM","Insulin Pump","Exercise","carbohydrate Intake","closed-loop system","hybrid closed-loop","NOT_YET_RECRUITING","2026-05-11",{"date":90,"type":49},"2026-05-14",{"date":92,"type":21},"2026-04",{"date":94,"type":21},"2026-08",{"name":96,"class":97},"Stanford University","OTHER",1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":98},"100638525","diathermy-on-diabetes-glucose-monitoring-effectiveness-100638525","NCT07583238","Diathermy On Diabetes Glucose Monitoring Effectiveness","Assessing the Impact of Intraoperative Diathermy on Accuracy and Functioning of Glucose Monitoring Systems","DODGE","Inclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus.\n* Planned admission for elective surgery at Nottingham University Hospitals NHS Trust.\n* Currently routinely using a prescribed Abbott Libre-2, Abbott Libre-3, Dexcom G6 or Dexcom G7 glucose monitoring system to monitor glucose concentrations.\n* Aged 4 years or older on the day of surgery.\n* Ability to give informed consent \u002F ability of parent\u002Fcarer to give informed consent (as appropriate).\n\nExclusion Criteria:\n\n* Use of paracetamol above maximum dose within 7 days before the scheduled date of surgery (in adults with body weight under 51kg - maximum of 60mg\u002Fkg per day, in adults with body weight 51kg and above - maximum of 4g per day, in children - maximum dose as per their age as stated in the British National Formulary for Children)\n* Any use of hydroxyurea within 7 days before the scheduled date of surgery\n* Use of more than 500mg per day of ascorbic acid \u002F vitamin C within 7 days before the scheduled date of surgery\n* Currently taking medications as part of a clinical trial.","4 Years",{"count":109,"type":21},126,"1 Day","OBSERVATIONAL","The goal of this observational study is to investigate if diathermy (a surgical tool that uses electrical energy to control bleeding) has any affect on the accuracy and functioning of continuous glucose monitoring systems in adults and young people with Type 1 Diabetes. The main questions this study aims to answer is -\n\n\\- Does the accuracy of continuous glucose monitoring systems change after use of diathermy?\n\nParticipants will:\n\n* Have their height and weight checked.\n* Provide information about their medical history including type of diabetes, other medical conditions and any current medications they take.\n* Have paired glucose meter and sensor glucose measurements taken every 15-75 minutes from up to 4 hours before surgery until up to 4 hours after the end of surgery.\n* Have two blood samples taken to measure glucose levels, The first one will be before the use of diathermy and the second will be after the use of diathermy.",[37],[115,116,28,117,118,119,120,121,122,123],"Continuous Glucose Monitoring Systems","Diathermy","Capillary blood glucose","Sensor blood glucose","Peri-operative care","Intra-operative T1DM management","pre-operative","post-operative","intraoperative","2026-05-06",{"date":126,"type":49},"2026-05-13",{"date":128,"type":21},"2026-05",{"date":130,"type":21},"2027-02",{"name":132,"class":97},"University of Nottingham",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":98},"100632752","effectiveness-of-artificial-intelligence-ai-bolus-priming-added-to-an-existing-fully-automated-control-algorithm-aidanet-100632752","NCT07517770","Effectiveness of Artificial-Intelligence (AI) Bolus Priming Added to an Existing Fully Automated Control Algorithm (AIDANET)","AIDANET AI","Inclusion Criteria:\n\n1. Age ≥18.0 years old at time of consent\n2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes (T1D) for at least one year.\n3. Currently using an automated insulin delivery (AID) system.\n4. Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.\n5. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either live with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.\n6. Participant not currently known to be pregnant or breastfeeding.\n7. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.\n8. Willingness to use the study AIDANET system (CGM, insulin pump, and phone) during the study period.\n9. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.\n10. Willingness to participate in all study procedures.\n11. Access to internet at home and willingness to upload data during the study as needed.\n12. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.\n13. Participant is proficient in reading and writing English.\n\nExclusion Criteria:\n\n1. Plans to start a new non-insulin glucose-lowering agent (e.g., Glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.\n2. Current use of an sodium-glucose transport protein 2 (SGLT-2) or SGLT-1\u002F2 inhibitor due to risk of euglycemic diabetic ketoacidosis (DKA).\n3. Hemophilia or any other bleeding disorder.\n4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.\n5. History of DKA event in the last 12 months.\n6. Unstable Stage 4 chronic renal disease or currently on peritoneal or hemodialysis.\n7. Currently being treated for adrenal insufficiency.\n8. Currently being treated for a seizure disorder.\n9. Hypothyroidism or hyperthyroidism that is not adequately treated.\n10. Use of oral or injectable steroids at the time of enrollment or within the last 2 weeks.\n11. Planned surgery during the study period that results in prolonged disconnection from study devices.\n12. Known ongoing adhesive intolerance that is not well managed.\n13. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.\n14. Participation in another interventional trial at the time of enrollment.\n15. Participant with a direct supervisor involved in the conduct of the trial.",{"count":141,"type":21},50,[72],"Bolus Priming (BP) based on Artificial Intelligence (AI) learning of meal patterns, added to our established Automated insulin delivery as Adaptive Network (AIDANET) algorithm and running on iPhone Diabetes Assistant (iDiAs) phone wirelessly connected to Tandem Mobi insulin pump and Dexcom Continuous Glucose Monitor (CGM).",[37],[75,146,147,148,149,150,151,152,153],"Artificial-Intelligence (AI)","Hybrid Closed Loop (HCL)","Fully Closed Loop (FCL)","Mobi insulin pump","iPhone Diabetes Assistant (iDiAs)","Automated insulin delivery as Adaptive Network (AIDANET) algorithm","Bolus Priming System (BPS)","Mobi Research App (MRA)","2026-04-03",{"date":156,"type":49},"2026-04-08",{"date":158,"type":21},"2026-05-01",{"date":160,"type":21},"2027-04-30",{"name":162,"class":97},"Sue Brown",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100611598","phase-1-clamp-study-to-estimate-the-relative-potency-of-gzr33-versus-insulin-degludec-at-steady-state-100611598","NCT07242664","Clamp Study to Estimate the Relative Potency of GZR33 Versus Insulin Degludec at Steady State","A Trial to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Insulin GZR33 Compared With Insulin Degludec at Steady State in Participants With Type 1 Diabetes","Inclusion Criteria: type 1 diabetes for at least 12 months\n\n* 18-64 years of age\n* HbA1c \\\u003C= 9.0%.\n* Body Mass Index (BMI) between 18.5 and 29.0 kg\u002Fm\\^2\n* treated with a stable insulin regimen for at least 2 months, in a dose \\> 0.2 and \\\u003C 1.2 U\u002Fkg\u002Fday\n\nExclusion Criteria:\n\n* blood pressure outside the range 90 to 140 mmHg (systolic) or 50 to 99 mmHg (diastolic)\n* clinically significant concomitant diseases\n* recurrent severe hypoglycemia (more than 1 severe hypoglycemic episode requiring assistance from another person within 180 days before screening)\n* hypoglycemia unawareness\n* estimated glomerular filtration rate (eGFR) \\\u003C60.0 mL\u002Fmin\u002F1.73 m2","64 Years",{"count":172,"type":21},12,[24],"This trial intends to investigate the pharmacodynamics, pharmacokinetics, safety, and tolerability of insulin GZR33 (hereafter referred to as GZR33) and estimate its potency in comparison with insulin degludec.",[37],"2025-11-17",{"date":178,"type":49},"2025-11-21",{"date":180,"type":49},"2025-10-13",{"date":182,"type":21},"2026-04-15",{"name":184,"class":56},"Gan and Lee Pharmaceuticals, USA",2,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":98},"100599391","phase-2-faecal-autologous-capsule-transplantation-for-type-1-diabetes-mellitus-100599391","NCT07083882","Faecal Autologous Capsule Transplantation for Type 1 Diabetes Mellitus","FACT-T1D","Inclusion Criteria:\n\n1. Male or female recently diagnosed (\\\u003C100 days) with type 1 diabetes mellitus.\n2. Age:18-45 years\n3. BMI: 18-30 kg\u002Fm2\n4. Remaining residual beta cell function: detectable plasma C-peptide or urinary C-peptide at inclusion of the study.\n\nExclusion Criteria:\n\n1. Major systemic illness\n2. (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic chemotherapy or human immunodeficiency virus(HIV) infection with a CD4 count \\\u003C 240\u002Fmm3).\n3. History of a severe disease of the digestive tract, such as celiac disease, chronic diarrhoea (≥3 stools\u002Fday for \\>4 weeks), chronic obstipation (\\\u003C2 defecations\u002Fweek for \\>3 months) or Inflammatory Bowel Disease (IBD).\n4. Illicit drug use (e.g. MDMA\u002Famphetamine\u002Fcocaine\u002Fheroin\u002FGHB) in the past three months or use during the study period.\n5. Use of \\>21 units of alcohol per week on average in the past three months.\n6. Pregnancy or breast feeding.\n7. Inability to provide informed consent.","45 Years",{"count":195,"type":21},110,[25],"SUMMARY\n\nRationale:\n\nThe(small) intestinal microbiota composition has been implicated to play an important role in (human) metabolism, as well as autoimmune diseases such as type 1 diabetes mellitus. Faecal microbiota transplantation (FMT) has been shown to significantly alter the microbiota composition, without any serious side-effects. It was recently demonstrated that multiple infusions of own faeces(autologous) preserved residual beta cell function up to one year after start of the FMT. In a proof-of-principle study it was found that encapsulated autologous FMT provides a safe and feasible option for prolonged treatment on a daily basis, which might stabilize the beta-cell destruction. These exciting findings are potentially transformative for clinical practice and deserve replication in a larger placebo-controlled trial.\n\nObjective: confirm the efficacy and feasibility of daily ingested encapsulated freeze-dried autologous (own)faecal matter on the preservation of residual beta cell function as assessed by C-peptide release upon amixed meal test (MMT) in recently diagnosed type 1 diabetes mellitus (T1D).\n\nStudy design: double-blind placebo-controlled study Study population: n=110, recently diagnosed (\\\u003C100 days of diagnosis) patients with T1D, aged 18-45 years, BMI 18-30 kg\u002Fm2, male\u002Ffemale.\n\nIntervention: After inclusion and randomisation individuals will receive for 6 months either placebo or freeze-dried autologous encapsulated FMT in a 1:2 ratio. Subsequently, participants with be followed for 6 months whether beta cell preservation was durable after cessation of treatment.\n\nMain study parameters\u002Fendpoints: The primary endpoint is long-term preservation of beta cell insulin secretion capacity as assessed by stimulated C-peptide AUC0-120minresponse upon MMT (at0, 6 and 12months).The secondary endpoint pertains to changes in post-meal urinary C-peptide levels, plasma biochemistry (HbA1c levels),glucose time-in-range and subsequentexogenous insulin dose use at 0, 6 and 12months.\n\nNature and extent of the burden and risks associated with participation,benefit and group relatedness: This study is considered a low-risk study, 3MMTs will be performed, for which 70 ml of blood samples will be drawn each visit. As of today, no severe adverse events as result of FMT have been reported in this centre and in the ENCAPSULATE trial investigating the feasibility and safety of this approach participants only reported some minor and transient constipation. In addition, the use of autologous faeces comes with a lower(absent)risk for transmitting any unknown pathogens compared to an allogenic FMT. As there currently is no widely applied therapy to preserve beta cell function in type 1 diabetes, encapsulated autologous FMT can have a potential benefit for the participants.",[37,75,199],"Fecal Microbiota Therapy (FMT)",[201,202,203],"microbiome","type 1 diabetes","microbiota transplant","2025-07-22",{"date":206,"type":49},"2025-07-24",{"date":208,"type":21},"2025-09",{"date":210,"type":21},"2029-09",{"name":212,"class":97},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]