[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-mellitus-type-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-mellitus-type-1":24},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,38,65,86,111,135,160,184,206,229,248,270,298,330,350,378,410,443,475,499,523,549,573,593,613],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100578122","general-use-results-surveillance-with-awiqli-in-patients-with-diabetes-mellitus-100578122",false,"NCT06807190","General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus","A Multi-centre, Prospective, Open Label, Non-interventional, Single-armed, 52 Weeks Post-marketing Study to Investigate Safety and Clinical Parameters of Awiqli Once Weekly in Patients With Diabetes Mellitus Under Real-world Clinical Practice Setting in Japan","Inclusion Criteria:\n\n* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).\n* The decision to initiate treatment with commercially available Awiqli has been made by the patient\u002FLegally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.\n* Male or female with no age limitation.\n* Diagnosis of diabetes mellitus. There is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus.\n\nExclusion Criteria:\n\n* Previous participation in this study. Participation is defined as having given informed consent in this study.\n* Treatment with any investigational drug within 30 days prior to enrolment into the study.\n* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.\n* Contraindication described in Japanese package insert.\n* Participants showing hypoglycaemic symptoms.\n* Participants with a history of hypersensitivity to any ingredients of this drug.","ALL",{"count":19,"type":20},630,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.",[24],"Diabetes Mellitus, Type 1","RECRUITING","2026-06-26",{"date":28,"type":29},"2026-06-29","ACTUAL",{"date":31,"type":29},"2025-04-15",{"date":33,"type":20},"2028-01-31",{"name":35,"class":36},"Novo Nordisk A\u002FS","INDUSTRY",112,{"id":39,"slug":40,"hasResults":12,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100422855","phase-3-a-safety-tolerability-and-efficacy-study-of-vx-880-in-participants-with-type-1-diabetes-100422855","NCT04786262","A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes","A Phase 1\u002F2\u002F3 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia","Key Inclusion Criteria:\n\n* Clinical history of T1D with \\> 5 years of duration of insulin dependence\n* At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment\n* Stable diabetic treatment\n* Consistent use of continuous glucose monitor (CGM) for at least 3 months before Screening and willingness to use CGM for the duration of the study\n\nKey Exclusion Criteria:\n\n-Prior islet cell transplant, organ transplant, or cell therapy\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","18 Years","65 Years",{"count":48,"type":20},52,"INTERVENTIONAL",[51],"PHASE3","This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.",[24,54,55],"Impaired Hypoglycemic Awareness","Severe Hypoglycemia",{"date":57,"type":29},"2026-06-30",{"date":59,"type":29},"2021-03-29",{"date":61,"type":20},"2030-06-30",{"name":63,"class":36},"Vertex Pharmaceuticals Incorporated",29,{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":49,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100598800","phase-3-a-research-study-to-see-how-a-weekly-insulin-insulin-icodec-helps-in-reducing-the-blood-sugar-compared-to-daily-insulin-glargine-both-in-combination-with-insulin-aspart-in-adults-with-type-1-diabetes-100598800","NCT07076199","A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes","A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes","ONWARDS 11","Inclusion Criteria:\n\n* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.\n* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.\n* HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol\u002Fmol)), both inclusive, at screening confirmed by central laboratory analysis.\n* Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Previous participation in this study. Participation is defined as signed informed consent.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n* Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.\n* Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).\n* Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.\n* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.",{"count":74,"type":20},877,[51],"This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.",[24],"2026-06-25",{"date":28,"type":29},{"date":81,"type":29},"2025-08-11",{"date":83,"type":20},"2027-03-01",{"name":35,"class":36},196,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":49,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":97,"type":20},150,[51],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[24],"2026-06-19",{"date":103,"type":29},"2026-06-23",{"date":105,"type":29},"2026-01-12",{"date":107,"type":20},"2031-07",{"name":109,"class":36},"Eli Lilly and Company",107,{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":118,"targetDuration":4,"studyType":49,"phases":120,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100610034","phase-3-a-study-of-baricitinib-ly3009104-to-preserve-beta-cell-function-in-children-and-adults-newly-diagnosed-with-type-1-diabetes-baricade-preserve-100610034","NCT07222332","A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Preserve Beta Cell Function in Participants Newly Diagnosed With Type 1 Diabetes Aged ≥1 to \u003C36 Years","Inclusion Criteria:\n\n* Have a new diagnosis of type 1 diabetes within 100 days prior to starting study intervention\n* Have at least one diabetes-related autoantibody found at screening\n* Show signs of remaining beta-cell function\n\n  * stimulated (peak or 90 min) C-peptide ≥0.2 nmol\u002FL (0.6 ng\u002FmL) at screening\n* Weigh at least 8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes including gestational\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious medical condition or infection",{"count":119,"type":20},300,[51],"The purpose of this study is to find out if baricitinib can preserve beta-cell function in participants newly diagnosed with type 1 diabetes. Participation in the study will last about 60 weeks.",[24],[124,125,126,127],"T1DM","Children","New-onset","Beta-cell Function",{"date":103,"type":29},{"date":130,"type":29},"2026-02-05",{"date":132,"type":20},"2028-07",{"name":109,"class":36},132,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":49,"phases":144,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"100463650","early-phase-1-regulation-of-brain-glucose-metabolism-in-type-1-diabetes-100463650","NCT05317455","Regulation of Brain Glucose Metabolism in Type 1 Diabetes","Inclusion Criteria:\n\nT1DM subjects with:\n\n* a history of severe hypoglycemia and\u002For hypoglycemia unawareness or\n* a history of severe hypoglycemia with a blood glucose \\\u003C54 mg\u002FdL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or\n* at least 2 values \\\u003C54mg\u002Fdl during 2 weeks of CGMS testing during the week prior to study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\>55 years.\n* Body weight \\>85 kg at screening visit\n* BMI \\> 30 (female) and \\>30 (male) kg\u002Fm2.\n* Untreated proliferative retinopathy\n* carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity","55 Years",{"count":143,"type":20},16,[145],"EARLY_PHASE1","This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.",[24,148],"Hypoglycemia Unawareness","2026-06-05",{"date":151,"type":29},"2026-06-09",{"date":153,"type":29},"2025-05-13",{"date":155,"type":20},"2027-06-30",{"name":157,"class":158},"Yale University","OTHER",1,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":49,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":159},"100629415","diabetes-multimorbidity-typology-trajectory-and-feasibility-of-an-audio-diary-mobile-application-to-support-self-management-100629415","NCT07474376","Diabetes Multimorbidity Typology, Trajectory, and Feasibility of an Audio Diary Mobile Application to Support Self-management","Inclusion Criteria:\n\n* Diagnosed type 1 or 2 diabetes and at least one comorbidity (eg, obesity, HIV, heart failure, polycystic ovary syndrome, obstructive sleep apnea, and prediabetes with and without hypertension)\n* Being able to fill in the Redcap surveys, and install and use the audio diary app.\n\nExclusion Criteria:\n\n•Those who cannot use (e.g., no mobile phone, incompatible system), read, type, speak, or understand English in Redcap or the audio diary mobile app.",{"count":167,"type":20},30,[169],"NA","The goal of this clinical trial is to evaluate whether an audio diary mobile application (Fabla-diabetesMM) is feasible to use and may support self-management in older adults with type 1 or 2 diabetes and multimorbidity.\n\nThe main questions it aims to answer are:\n\n* Is it feasible to adapt and implement the Fabla-diabetesMM audio diary mobile app among 30 older adults with diabetes and multimorbidity\n* Does the use of the audio diary mobile app affect self-management outcomes",[172,24],"Diabetes Mellitus, Type 2",[174],"Diabetes self management","2026-06-03",{"date":177,"type":29},"2026-06-04",{"date":179,"type":20},"2026-06",{"date":181,"type":20},"2026-11",{"name":183,"class":158},"Emory University",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":191,"minAge":45,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":49,"phases":194,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":159},"100643325","phase-1-bioavailability-biopotency-and-food-effect-study-of-scd0503-compared-to-subcutaneous-regular-human-insulin-100643325","NCT07634770","Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin","A Trial to Investigate the Relative Bioavailability, Relative Biopotency and Food Effect of SCD0503 (Oral Insulin) in Comparison to Subcutaneous Regular Human Insulin Under Euglycaemic Clamp Conditions and After Food Intake in People With Type I Diabetes","Inclusion Criteria:\n\n* Male person with type 1 diabetes mellitus\n* Age between 18 and 64 years, both inclusive\n* Body Mass Index (BMI) between 18.5 and 29.9 kg\u002Fm2, both inclusive\n* HbA1c ≤ 8.5%\n* Fasting C-peptide \\\u003C= 0.20 nmol\u002FL\n* Total insulin dose of \\\u003C1.2 (I)U\u002Fkg\u002Fday\n* Diabetes duration of at least 12 months at the time of screening\n* Stable insulin regimen for at least 2 months prior to inclusion into the trial\n\nExclusion Criteria:\n\n* Systolic blood pressure \\\u003C 90 mmHg or \\>139 mmHg and\u002For diastolic blood pressure \\\u003C 50 mmHg or \\> 89 mmHg\n* Heart rate at rest outside the range of 50- 90 beats per minute\n* Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening\n* Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\\\u003C1 year) ophthalmologic examination\n* Peripheral neuropathy\n* More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months pior to screening\n* Hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening\n* Significant history of alcoholism or drug abuse\n* Smoking more than 5 cigarettes or the equivalent per day\n* Tested positive for hepatitis Bs antigen\n* Tested positive for hepatitis C antibodies\n* Positive result to the test for HIV-1\u002F2 antibodies or HIV-1 antigen\n* Estimated glomerular filtration rate (eGFR) \\\u003C 60.0 mL\u002Fmin\u002F1.73m2","MALE","64 Years",{"count":143,"type":20},[195],"PHASE1","Reason for the study The participants have been diagnosed with type 1 diabetes and are being treated with standard insulin therapy.\n\nThe sponsor of the study is developing a new insulin-based medicine that can be taken by mouth (orally). For this reason, the investigational product named SCD0503 is to be tested in the study. The sponsor wants to investigate the course of blood concentrations and the blood sugar-lowering effect of the investigational product and to find out whether SCD0503 is safe.\n\nInvestigational product tested in this study The investigational product tested, SCD0503, is still under clinical evaluation and has not yet been approved for your treatment. The active ingredient is regular human insulin, which has been used for many years in approved medicines for the treatment of diabetes. SCD0503 is being used in humans for the first time in this study.\n\nStudy procedures The study will last for approximately 1 to 4 months. During this time, the participant will come to the investigational site 8 times for visits.\n\nDuring 4 visits the participant will undergo a clamp examination. The blood sugar-lowering effect of the investigational product is determined using a clamp device, a computer-controlled device that maintains blood sugar at a constant level within the normal range. This is achieved by infusing a sugar solution. During 2 further visits the participant will have a meal test. During the meal test, the blood sugar-lowering effect of the investigational product is determined after intake of a standardized meal as breakfast. You will have catheters in your arms to take blood, measure your blood sugar level and to infuse glucose (sugar) or insulin, if needed.\n\nSCD0503 is compared with a regular human insulin already approved for the treatment of diabetes.\n\nThe participant will receive SCD0503 and the comparator product during different visits to the investigational site. The participant will also receive a placebo together with the investigational or the comparator product. The placebo looks identical but contains no active ingredient. As the investigational product is administered orally and the comparator product is injected under the skin, two placebos are used in this study.\n\nThe order of medications given will be decided by chance, using a pre-defined method called randomization (a procedure similar to flipping a coin). Neither the participant nor the study physician will know which of the 2 medicines is administered at the respective dosing occasion. However, in case of emergency, this information will be quickly available.",[24],"2026-06-02",{"date":151,"type":29},{"date":201,"type":29},"2026-05-29",{"date":203,"type":20},"2026-10",{"name":205,"class":36},"Sam Chun Dang Pharm. Co. Ltd.",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":159},"100638903","genetic-risk-score-of-type-1-diabetes-mellitus-for-progression-to-insulin-in-diabetic-patients-lack-of-predictive-value-a-multicenter-nested-case-control-study-100638903","NCT07621445","Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study","Inclusion Criteria:\n\n* Gender is not restricted.\n* Age ranges from 14 to 50 years old.\n* Diagnosis of diabetes within \\\u003C 1 year:\n\n  1. If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol\u002FL (200 mg\u002FdL), or② Fasting plasma glucose ≥ 7.0 mmol\u002FL (126 mg\u002FdL), or③ Plasma glucose 2 hours after OGTT\u002Fpost - meal ≥ 11.1 mmol\u002FL (200 mg\u002FdL), or④ HbA1c ≥ 6.5%.\n  2. If there are no diabetes symptoms, another test on a different day is required for diagnosis.\n* Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.\n\nExclusion Criteria:\n\n* Peak C-peptide \\\u003C 200 pmol\u002FL;\n* Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;\n* Those who have been under long-term treatment with hormones or immunosuppressants;\n* Pregnant or lactating women;\n* Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;\n* Those with an expected survival time of less than 3 years;\n* Those with mental disorders or unable to cooperate with the investigation for other reasons;\n* Acute phase of diabetic ketoacidosis;\n* Stress conditions such as severe infection, fever, trauma, and major surgery;\n* Patients lacking major clinical information;\n* Those considered by the researcher as unfit to participate in this study.","14 Years","50 Years",{"count":215,"type":20},2950,"The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is:\n\n1. To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency;\n2. To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort.\n\nThis study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who \"progressed to insulin deficiency\" and those who \"progressed to severe insulin deficiency\". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.",[218,24],"Diabetes Mellitus",[220],"Genetic risk score","2026-05-31",{"date":198,"type":29},{"date":224,"type":29},"2025-10-27",{"date":226,"type":20},"2029-12-31",{"name":228,"class":158},"Second Xiangya Hospital of Central South University",{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":49,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":245,"locationsCount":247},"100541766","phase-3-cadisegliatin-as-adjunctive-therapy-to-insulin-in-participants-with-type-1-diabetes-100541766","NCT06334133","Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes","Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study","CATT1","Inclusion Criteria:\n\n* Individuals ≥18 years\n* Diagnosed T1DM with a minimum of 3 years since diagnosis\n* Has had at least 1 hypoglycemic event of Level 2 (glucose level \\\u003C54 mg\u002FdL or \\\u003C3 mmol\u002FL, \\[CGM or SMBG confirmed\\]) or Level 3 (defined as a severe hypoglycemia with altered mental state and\u002For physical status requiring assistance) in the last 2 months prior to Screening\n* HbA1c value of \\\u003C9.5% at Screening\n* Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study\n* Must have been on a CGM device for at least 3 months prior to Screening\n\nExclusion Criteria:\n\n* Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease\n* Has been hospitalized for DKA within 3 months prior to Screening\n* Has uncontrolled hypothyroidism or hyperthyroidism\n* History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight\n* Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ\n* Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) or weight loss medications within 30 days prior to the Screening\n* Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study.\n* Has an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening\n* Has uncontrolled hypertension prior to Screening",{"count":97,"type":20},[51],"This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.",[24],{"date":198,"type":29},{"date":243,"type":29},"2024-06-14",{"date":203,"type":20},{"name":246,"class":36},"vTv Therapeutics",61,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":255,"sex":17,"minAge":256,"maxAge":45,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":159},"100484949","anhydroglucitol-in-children-with-type-1-diabetes-100484949","NCT05594706","Anhydroglucitol in Children With Type 1 Diabetes","Anhydroglucitol as a Measure of the Functional Beta-cell Mass in Children With Type 1 Diabetes - Pilot Study","Inclusion Criteria:\n\n* Type 1 diabetes with positive autoantibodies against islets, insulin, islet antigen 2 (IA2), glutamic acid decarboxylase (GAD) 65 or zinc transporter (ZnT)8.\n* Treatment with continuous subcutaneous insulin infusion (CSII) with or without automated insulin delivery (AID).\n* Monitoring with a continuous glucose measurement system (CGMS) or flash glucose monitor (FGM).\n* Patient willing to keep the same type of CGMS or FGM during the year of observation\n* Ability to give informed consent as documented by signature\n\nExclusion Criteria:\n\n* Patients treated with multiple daily injections (MDI) or not willing to wear a CGMS of FGM\n* Patients changing the type of CGMS during the course of the study.",true,"2 Years",{"count":258,"type":20},60,"The investigators will measure blood levels of 1,5-anhydroglucitol in children with type 1 diabetes and correlate them with parameters related to functional beta-cell mass in diabetic patients. The values will be compared to those obtained in healthy volunteers. Children with newly diagnosed diabetes as well as children with longstanding disease will be included. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in type 1 diabetes.",[24],"2026-05-14",{"date":263,"type":29},"2026-05-18",{"date":265,"type":29},"2023-01-27",{"date":267,"type":20},"2026-12-31",{"name":269,"class":158},"University Hospital, Geneva",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":141,"enrollmentInfo":278,"targetDuration":4,"studyType":49,"phases":280,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":159},"100573644","fasted-exercise-training-in-type-1-diabetes-fed-t1d-100573644","NCT06748963","Fasted Exercise Training in Type 1 Diabetes (FED-T1D)","Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 Diabetes","FED-T1D","Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes for 5 or more years.\n2. Treatment using an insulin pump with no change in treatment modality for \\> 2 continuous months and willing to share CGM data with the research team. Insulin delivery can be managed using either manual open-loop system (non-AID) or a hybrid closed loop (AID) systems.\n3. Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.\n4. HbA1c 7.0-9.9%.\n5. Have BMI of 25 kg\u002Fm2 or above\n6. Have waist circumference associated with central obesity\u002Fmetabolic syndrome as per Diabetes Canada definition\n\n   * 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent\n   * 90cm for males of South Asian, Chinese, Japanese, South and Central American descent\n   * 80cm for females\n7. No history of stroke, myocardial infarction, or coronary artery disease\n8. Not wearing implantable device such as a pacemaker, neurostimulators, aneurysm clips, metal fragments, epicardial electrodes, cochlear implants, magnetic ocular implants, penile implants, magnetic tissue expander, some types of breast implants, magnetic orthopedic implants, magnetic dental implants, hearing Aids, intravascular implants, for example VCI filters, coils, stents, cardiac septum implants, ventricular bypass devices.\n9. Use a CGM in routine diabetes management.\n\nExclusion Criteria:\n\n1. Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).\n2. Restriction in aerobic or resistance exercise due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.).\n3. Uncontrolled hypertension (e.g., blood pressure \\>160 mmHg systolic or \\>100 mmHg diastolic).\n4. Implanted device, material, or having a condition contraindicated to MRI.\n5. Ongoing pregnancy or breastfeeding.\n6. Inability to give consent.\n7. Use of an injection-based insulin therapy (ex. multiple daily injections or combined pump and injection-based delivery).",{"count":279,"type":20},20,[169],"This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 1 diabetes. Training will take place over 12 weeks.",[24],[284,285,286,287,288],"Exercise","Continuous glucose monitoring","total daily insulin dose","Muscle fat","Liver fat","2026-05-07",{"date":291,"type":29},"2026-05-08",{"date":293,"type":29},"2025-01-01",{"date":295,"type":20},"2027-04",{"name":297,"class":158},"University of Alberta",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":308,"conditions":309,"keywords":310,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100609174","the-real-world-control-iq-glycemic-control-and-quality-of-life-study-in-type-1-diabetes-in-france-100609174","NCT07211126","The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France","RECORD-IQ","Inclusion Criteria:\n\n* Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor.\n* Age ≥ 6 years at enrollment.\n* Using an insulin approved for use in the pump.\n* Ability for patient or parent\u002Fguardian to respond to alerts and alarms, and to provide basic diabetes self-management.\n* Reside full-time in mainland France.\n* Have an email address and mobile phone number\n* Participant or participant's parent\u002Fguardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to :\n\n  1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.\n  2. the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months.\n  3. complete questionnaires per the study protocol.\n\nExclusion Criteria:\n\n* A medical or other condition, or medications being taken that, in the investigator's judgement would be a safety concern for participation in the study.\n* Patients considered vulnerable under French law.","6 Years",{"count":307,"type":20},350,"This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.",[24],[311,312,313,314,315,316,317,318,319],"Control-IQ","t:slim X2 insulin pump","Control-IQ technology","DKA","severe hypoglycemia","automated insulin dosing","automated insulin delivery","quality of life","type 1 diabetes","2026-04-29",{"date":322,"type":29},"2026-05-01",{"date":324,"type":29},"2026-03-03",{"date":326,"type":20},"2027-12",{"name":328,"class":36},"Tandem Diabetes Care, Inc.",21,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":49,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":159},"100622647","gemini-study-a-prospective-multicenter-evaluation-of-performance-and-safety-of-the-eversense-gemini-system-with-flash-glucose-measurement-feature-100622647","NCT07386340","Gemini Study: A Prospective, Multicenter Evaluation of Performance and Safety of the Eversense Gemini System With Flash Glucose Measurement Feature","Inclusion Criteria:\n\nSubjects meeting all of the following inclusion criteria will be included in this study:\n\n1. Subjects ≥18 years of age\n2. Clinically confirmed diagnosis of diabetes mellitus for ≥1 year\n3. Subject has signed an informed consent form (ICF) and is willing to comply with protocol requirements\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:\n\n1. History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure.\n2. History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months.\n3. Subjects with gastroparesis.\n4. Female subjects of childbearing capacity (defined as of childbearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.\n5. A condition preventing or complicating the placement, operation, or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition.\n6. Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic\\>160 mm Hg or diastolic \\>100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.\n7. Hematocrit \\\u003C38% or \\>60% at screening\n8. History of hepatitis B, hepatitis C, or HIV\n9. Current treatment for a seizure disorder unless written clearance by neurologist to participate in study.\n10. History of adrenal insufficiency\n11. Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant\u002Fantithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only; antibiotic for chronic infection (e.g., osteomyelitis, endocarditis)\n12. A condition requiring or likely to require magnetic resonance imaging (MRI)\n13. Known topical or local anesthetic allergy\n14. Known allergy to glucocorticoids\n15. Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion\n16. Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period\n17. The presence of any other active implanted device (as defined further in the protocol)",{"count":337,"type":20},80,[169],"A prospective, multicenter evaluation of performance and safety of the Eversense Gemini System with flash glucose measurement feature. The purpose of this clinical investigation is to evaluate the accuracy of the Gemini System with new technological flash glucose monitoring (FGM) feature enhancements compared to reference glucose measurements and the Eversense 365 CGM System. The investigation will also evaluate safety of the Gemini System usage.",[218,24,172],"2026-04-16",{"date":343,"type":29},"2026-04-21",{"date":345,"type":29},"2025-12-29",{"date":347,"type":20},"2028-05",{"name":349,"class":36},"Senseonics, Inc.",{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":95,"enrollmentInfo":358,"targetDuration":4,"studyType":49,"phases":360,"briefSummary":361,"conditions":362,"keywords":365,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100588045","type-1-diabetes-and-diabetes-distress-100588045","NCT06936280","Type 1 Diabetes and Diabetes Distress","A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress","ACTnow","Inclusion Criteria:\n\n* Type 1 diabetes for at least 6 months\n* Age between 18 and 35\n* T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2\n* Treated in a diabetes clinic in the Region of Southern Denmark\n* Proficient in Danish\n\nExclusion Criteria:\n\n* Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention\n* Cognitive disorders such as brain injury\n* Complex challenges best suited to individual treatment\n* Current therapeutic treatment for depression, anxiety or stress\n* Not stable medication for anxiety\u002Fdepression for the past two months or planned change in medication for anxiety\u002Fdepression during the project period",{"count":359,"type":20},100,[169],"The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.\n\nThe expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.\n\nThe intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.\n\nThe main research questions are:\n\n* Does a group-based psychological intervention reduce diabetes distress?\n* Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?\n\nResearchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).\n\nParticipants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.",[363,364],"Diabetes Distress","Diabetes Mellitus Type 1",[366,319,367,356],"RCT study","diabetes distress","2026-04-08",{"date":370,"type":29},"2026-04-09",{"date":372,"type":29},"2025-04-01",{"date":374,"type":20},"2027-05-31",{"name":376,"class":158},"Odense University Hospital",3,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":400,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":159},"100630847","home-ahcl-home-based-implementation-of-an-advanced-hybrid-closed-loop-system-with-telemonitoring-in-type-1-diabetes-100630847","NCT07492992","HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes","Safety, Effectiveness, Quality of Life, Costs, and Efficiency of the Home Setup of the Hybrid Closed-Loop System in People With Type 1 Diabetes: Application of a Value-Based Diabetes Management Model","HOME-AHCL","Inclusion Criteria:\n\n* Diagnosis of type 1 diabetes.\n* Aged 18 years or older.\n* Candidate to initiate an Advanced Hybrid Closed-Loop (AHCL) system based on standard clinical criteria.\n* Access to the internet and\u002For a compatible smartphone to connect to the system.\n* Willingness to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Currently participating in another diabetes-related clinical trial.\n* Pregnant or planning to become pregnant during the study.\n* Inability to use the system autonomously (e.g., severe cognitive impairment or severe psychiatric disorders without support).\n* Medical contraindication for the use of insulin pumps or continuous glucose monitors (CGM).",{"count":337,"type":20},"The goal of this observational study is to evaluate a new home-based setup and care model for an advanced hybrid closed-loop insulin pump system (Tandem with Control-IQ). The study will look at the safety, effectiveness, costs, and impact on quality of life in adults with type 1 diabetes.\n\nThe main questions it aims to answer are:\n\n* Is it safe for participants to start using the insulin pump system at home instead of the hospital? (Measured by the amount of time blood sugar is very low, under 54 mg\u002FdL).\n* Does this home-based care model help participants keep their blood sugar in a healthy range?\n* How does this model affect the participants' quality of life, device satisfaction, and overall experience?\n* Does this model reduce healthcare costs and the need for hospital visits?\n\nParticipants will:\n\n* Complete an online technical training course before the setup.\n* Receive a home visit from a specialized nurse to configure and start the insulin pump system.\n* Have their device data monitored remotely every 14 days by the nursing team to manage any health alerts.\n* Attend scheduled clinical follow-up visits at 1, 3, 6, and 12 months.\n* Answer surveys about their quality of life, their experience with the healthcare service, and their satisfaction with the new device.",[364],[390,391,392,393,394,395,396,397,398,399],"Type 1 Diabetes","Advanced Hybrid Closed Loop","Insulin Pump","Continuous Glucose Monitoring","Telemonitoring","Remote Patient Monitoring","Value-Based Healthcare","Home Care Services","Quality of Life","Cost-Effectiveness","NOT_YET_RECRUITING","2026-04-07",{"date":403,"type":29},"2026-04-13",{"date":405,"type":20},"2026-04",{"date":407,"type":20},"2028-04",{"name":409,"class":36},"Air Liquide Healthcare Spain",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":49,"phases":419,"briefSummary":420,"conditions":421,"keywords":423,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100534267","hybrid-closed-loop-effectiveness-trial-in-adults-with-type-1-diabetes-100534267","NCT06236607","Hybrid Closed Loop Effectiveness Trial in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Clinical diagnosis of T1D for at least 12 months, on MDI for at least 6 months;\n* A1c ≥7.0% with no upper limit at screening (The investigator will consider the participant A1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on A1c specified for eligibility);\n* Able to understand, speak and read English (Given the language limitations in currently available pump interfaces, subjects who are not able to understand written English will not be eligible);\n* Willingness to use either lispro or aspart insulin and no other insulin or new non-insulin diabetes pharmacotherapy during the study;\n* Total daily dose of insulin of at least 10 units\u002Fday;\n* Investigator believes that the participant will be able to successfully adhere to the study protocol.\n\nExclusion Criteria:\n\n* Current use of insulin pump or closed loop insulin pump system;\n* Unable to provide informed consent;\n* Currently taking hydroxyurea or have medical condition that may necessitate use of hydroxyurea;\n* Current use of SGLT-2 inhibitors or sulfonylureas (If using GLP-1RA, pramlintide or metformin, must be on a stable dose for 3 months prior to enrollment);\n* Tape allergy or skin condition precluding use of pump or CGM;\n* Females who are pregnant or intending to become pregnant (since automated algorithm adaption for some of the HCL systems used in the trial cannot be configured to adjust to changing insulin demands of pregnancy);\n* Current renal dialysis or plan to begin renal dialysis during study. Most recent eGFR \\\u003C30 ml\u002Fmin is exclusionary (within last 2 years is acceptable);\n* Active cancer treatment;\n* Extreme visual or hearing impairment that would impair ability to use CGM and pump;\n* Cognitive concerns;\n* Significant psychiatric diagnosis or substance abuse disorder that in the investigator's opinion impairs ability of the individual to participate.","75 Years",{"count":418,"type":20},140,[169],"Minoritized individuals with type 1 diabetes (T1D) have approximately 2% higher average A1c levels and twice the rate of hospitalizations, complications, and mortality as their white counterparts. However, the efficacy trials establishing the benefits of hybrid closed loop (HCL) pump therapy in T1D have been in more socially advantaged and predominantly non-Hispanic white patients. Use of this technology by individuals with T1D from underserved communities remains very low.\n\nThe investigators plan to conduct a randomized effectiveness trial - with broader eligibility criteria (including markedly elevated A1c) and longer follow up than the previous HCL efficacy trials - to evaluate the benefits, safety risks and treatment complications of HCL use in underserved adults with T1D. A comprehensive mixed-methods approach will be implemented to capture information about the user experience.\n\nParticipants will be randomized (3:1 ratio) to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy. Subjects will be followed for 9 months to collect data on effectiveness (glucose % time-in-range 70-180 mg\u002FdL and % time \\\u003C 70 mg\u002FdL), safety (diabetic ketoacidosis and severe hypoglycemia events) and patient experience using the systems (including benefits and burdens, the impact of life stressors on HCL use, and how the match between HCL system functionality and the individual's needs and expectations impacts on user experience).",[24,422],"Diabetes Complications",[424,425,426,427,428,429,430,431,432],"Hybrid closed loop (HCL)","HCL pump therapy","Multiple daily injections (MDI)","Continuous glucose monitoring (CGM)","Glucose time-in-range (TIR)","Glucose management indicator (GMI)","Diabetic ketoacidosis","Patient reported outcomes (PRO)","Ecological momentary assessment (EMA)","2026-03-30",{"date":435,"type":29},"2026-04-01",{"date":437,"type":29},"2025-02-27",{"date":439,"type":20},"2028-09",{"name":441,"class":158},"Boston Medical Center",2,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":416,"enrollmentInfo":451,"targetDuration":4,"studyType":49,"phases":452,"briefSummary":453,"conditions":454,"keywords":458,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100532783","phase-3-sotagliflozin-to-slow-kidney-function-decline-in-persons-with-type-1-diabetes-and-diabetic-kidney-disease-100532783","NCT06217302","Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease","Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease","SUGARNSALT","Inclusion Criteria:\n\n* Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.\n* Duration of T1D ≥ 8 years;\n* eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml\u002Fmin\u002F1.73 m2 at screening (with the option of a second eGFR measurement within 4 weeks from the first one if the eGFR was in the range of \\>60 to ≤65 or ≥16 to \\\u003C20 ml\u002Fmin\u002F1.73 m2);\n* a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg\u002Fg at Screening or on repeat measurement within 4 weeks from the first one, or b. First morning void urinary UACR ≥100 mg\u002Fg at Screening or on repeat measurement within 4 weeks and at least one uACR \\>=30 in the previous 2 years while treated with RASB at a stable dose;\n* HbA1c at screening \\\u003C10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);\n* Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, unless contraindicated or not tolerated.\n* Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study.\n* a. Blood pressure ≤155\u002F95 mmHg at screening, or b. BP ≤155\u002F95 mmHg at the end of the run-in period, or c. consistent BP ≤155\u002F95 mmHg on home monitoring during the run-in period, as determined by study site investigator, despite BP values \\>155\u002F95 mmHg in clinic.\n\nExclusion Criteria:\n\n* Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;\n* Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;\n* Use of any SGLT inhibitor in the previous 2 months;\n* Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);\n* Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \\> 2 months at screening (patients can be rescreened after being on stable dose for \\> 2 months);\n* Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;\n* Known allergies, hypersensitivity, or intolerance to SOTA;\n* History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;\n* History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR \\>1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;\n* Blood beta-hydroxybutyrate (BHB) \\>0.6 mmol\u002FL for \\>2 hours on \\>2 occasions during the Run-in period;\n* Inadequate beta hydroxybutyrate (BHB) testing (\\\u003C50% of the prescribed measurements) during Run-in;\n* History of primary renal glycosuria;\n* History of biopsy-proven non-diabetic chronic kidney disease (CKD);\n* History of kidney transplant or currently on chronic dialysis;\n* 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 aspartate aminotransferase (AST) or alanine transaminase (ALT) at screening \\>2 times upper limit of normal, and\u002For total bilirubin at screening \\>1.3 times upper limit of normal).\n* History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;\n* 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 of screening.\n* Illicit drug abuse within 6 months of screening;\n* Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);\n* Participation in another interventional clinical research study within 30 days of screening;\n* Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;\n* Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;\n* Any condition that may render the patient unable to comply with study requirements and\u002For complete the study.",{"count":97,"type":20},[51],"Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50\u002F50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.",[455,456,364,457],"Diabetic Nephropathies","Kidney Failure, Chronic","Heart Failure",[455,456,459,460,461,462,463,464],"Type 1 diabetes","Heart failure","Cardiovascular disease","Glomerular filtration rate","SGLT2 inhibitors","Diabetic kidney disease","2026-03-20",{"date":467,"type":29},"2026-03-24",{"date":469,"type":29},"2024-10-31",{"date":471,"type":20},"2029-05",{"name":473,"class":158},"Alessandro Doria",19,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":46,"enrollmentInfo":481,"targetDuration":4,"studyType":49,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":159},"100554801","efficacy-and-safety-of-a-ketogenic-diet-in-type-1-diabetes-100554801","NCT06503809","Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes","Inclusion Criteria:\n\n* Age ≥18 and ≤65 years\n* T1D diagnosed \\>1 year prior to screening\n* HbA1c 7.0%-9.0%\n* Stable insulin delivery method for the past 30 days\n* Ability to read all device instructions and insulin pump settings\n* eGFR ≥60 mL\u002Fmin\u002F1.73 m2\n* Use of an insulin pump or insulin delivery by multiple daily injections\n* Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products\n* Use of cellular phone with data capability for wireless connectivity to the CGM system.\n\nExclusion Criteria:\n\n* Body mass index \\\u003C20.0 or \\>34.9 kg\u002Fm2\n* Severe gastroparesis or history of bariatric surgery\n* Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening\n* Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)\n* Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)\n* Structured exercise \\>210 minutes per week\n* Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period\n* Unstable weight (\\>4% change in the last 2 months)\n* Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease)\n* Anemia (Hgb \\\u003C10 g\u002FdL)\n* Major psychiatric illness\n* Active tobacco use (\\>8 cigarettes\u002Fday) or illegal drug use\n* Regular alcohol consumption (\\>10 standard drinks per week)\n* Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study\n* Familial hypercholesterolemia\n* Active eating disorder\n* Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion\u002Fsensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy\n* Already consuming a low-carbohydrate (\\\u003C130 g\u002Fday) diet\n* Persons who are not able to grant voluntary informed consent\n* Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.",{"count":482,"type":20},58,[169],"Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.",[24],[459,487,488,285,489],"Ketogenic diet","Insulin sensitivity","Hypoglycemia","2026-03-17",{"date":492,"type":29},"2026-03-19",{"date":494,"type":29},"2024-08-12",{"date":496,"type":20},"2030-03-31",{"name":498,"class":158},"Washington University School of Medicine",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":45,"enrollmentInfo":506,"targetDuration":4,"studyType":49,"phases":508,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":159},"100349861","sequential-transplantation-of-ucbscs-and-islet-cells-in-children-and-adolescents-with-monogenic-immunodeficiency-t1dm-100349861","NCT03835312","Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM","Sequential Transplantation of Umbilical Cord Blood Stem Cells and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1.Type 1 diabetes mellitus children with genetic immunodeficiency\n\n1. Meet the diagnostic criteria of type 1 diabetes mellitus: clinical manifestations of typical diabetes mellitus include polyphagia, polyuria, weight loss, or diabetic ketoacidosis, confirmed by blood sugar level, islet function and autoimmune antibody.\n2. Existence of extrapancreatic organ damage: (1) inflammatory bowel disease, (2) impairment of renal function, (3) repeated infection of mouth, skin, anus or whole body, (4) immune hepatitis, (5) persistent chronic immune iridocyclitis, (6) immune adrenalinitis leading to adrenocortical dysfunction, (7) pituitary inflammation leading to hypophysis, (8) rheumatoid disease, (9) immune vasculitis, (10) systemic lupus erythematosus, (11) other organs besides thyroid function damage. Suffering from one or more of above diseases. Recurrence after receiving regular clinical treatment, including symptomatic treatment of organ protective drugs.\n3. Gene mutation was found according to gene diagnosis: gene mutation was found by gene sequencing. Literature searches at home and abroad confirmed that the defect of the gene resulted in autoimmune or immune dysfunction, resulting in multiple organ dysfunction and poor prognosis.\n\nExclusion Criteria:\n\n1. Mature and effective treatment methods are available.\n2. HIV, HBV and HCV were positive.\n3. A the active period of infection.\n4. At the active stage of malignant tumors.\n5. Combination of other fatal diseases.\n6. Existence of mental and psychological diseases.",{"count":507,"type":20},50,[169],"This study evaluates the efficacy of sequential transplantation of umbilical cord blood stem cells and islet cells in children with monogenic immunodeficiency type 1 diabetes mellitus. Umbilical cord blood stem cell transplantation will be performed first. Children with stable immune reconstruction will than receive islet cell transplantation.",[24,511],"Immunologic Deficiency Syndromes",[513,514],"Islets of Langerhans Transplantation","Cord Blood Stem Cell Transplantation","2026-03-15",{"date":490,"type":29},{"date":518,"type":29},"2019-02-20",{"date":520,"type":20},"2030-12-31",{"name":522,"class":158},"Children's Hospital of Fudan University",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":255,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":529,"targetDuration":531,"studyType":21,"phases":4,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":159},"100335553","genetics-of-autoimmunity-in-type-i-diabetes-100335553","NCT03648918","Genetics Of Autoimmunity In Type I Diabetes","Inclusion Criteria (Families):\n\n* Families where at least one first-degree family member has type 1 diabetes\n* The diabetic proband in the family was diagnosed before the age of 39\n* Family members must be at least 2 years old to participate\n\nExclusion Criteria (Families):\n\n* Families with no history of type 1 diabetes\n* Families with a history of diabetes that is not type 1 (LADA, MODY, type 2 etc.)\n\nInclusion Criteria (Controls):\n\n* No family history of type 1 diabetes or other autoimmune conditions\n* Age 2 or older\n\nExclusion Criteria (Controls):\n\n* Personal or family history of autoimmune disease",{"count":530,"type":20},4000,"10 Years","The purpose of this study is to gain more information about the step-by-step process that causes someone to develop type 1 diabetes. Scientists think that a person's own immune system, directed by genetic and environmental factors play a major role in its development. Participation involves a blood draw, a brief medical history questionnaire and measurements of height and weight. Some participants will be asked to return for annual follow-up visits for 10 years.",[534,24,535,218],"Type1diabetes","Type1 Diabetes Mellitus",[537,538,539],"Family","Healthy Controls","Siblings","2026-03-12",{"date":542,"type":29},"2026-03-16",{"date":544,"type":29},"2001-08",{"date":546,"type":20},"2050-01",{"name":548,"class":158},"Medical College of Wisconsin",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":49,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":159},"100541400","food-insecurity-reduction--strategy-team-100541400","NCT06329375","Food Insecurity Reduction & Strategy Team","FIRST","Inclusion Criteria:\n\n* Diagnosis of Type 1 or Type 2 Diabetes Mellitus\n* Admitted to Stanford Healthcare inpatient unit\n* Residence in California at time of enrollment\n* Positive Screening for Food Insecurity\n* On a Healthcare Plan covered by Mom's Meals.\n\nExclusion Criteria:\n\n* Plans to be discharged to a skilled nursing facility.\n* Patients who prefer a language for which a short-form consent is not available.\n* No Home Address\n* Pregnant Participants.\n* No access to refrigerator.",{"count":557,"type":20},160,[169],"This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include:\n\n1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.\n2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options.\n3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.",[172,561,24],"Food Insecurity",[563],"inpatient","2026-03-11",{"date":566,"type":29},"2026-03-13",{"date":568,"type":29},"2024-10-07",{"date":570,"type":20},"2026-08-31",{"name":572,"class":158},"Stanford University",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":255,"sex":17,"minAge":45,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":49,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":159},"100588746","phase-1-a-study-of-ly4057996-in-healthy-participants-and-participants-with-type-1-and-type-2-diabetes-100588746","NCT06945406","A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes","A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes","YKAA","Inclusion Criteria:\n\nPart A for Healthy Participants:\n\n* Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment\n\nPart A for Type 2 Diabetes (T2DM) Participants:\n\n* Are participants with T2DM diagnosed greater than 1 year before enrollment,\n* On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)\n* Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening\n\nPart B\n\n* Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol\u002FL) or less or non-fasting C-peptide level of 0.30 nmol\u002FL or less at screening\n* HbA1c 6% to 8.5% inclusive at screening\n\nPart C\n\n* Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol\u002FL) or less or non-fasting C-peptide level of 0.30 nmol\u002FL or less at screening\n* HbA1c 6 to 8.5% inclusive at screening\n\nAll Parts\n\n* Have blood pressure of less than 140\u002F90 millimeters of mercury (mmHg) for healthy participants or 150\u002F90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)\n* No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants\n\nExclusion Criteria:\n\n* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening\n* Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening\n\nAll Parts\n\n* Cardiovascular: no significant history of cardiovascular disease (CVD)\n* Gastrointestinal: have gastroparesis or have undergone gastric surgery\n* Hepatic: have acute or chronic hepatitis",{"count":582,"type":20},124,[195],"The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.\n\nThe study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.",[24,172],"2026-03-09",{"date":564,"type":29},{"date":589,"type":29},"2025-05-16",{"date":591,"type":20},"2026-12",{"name":109,"class":36},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":49,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":442},"100502198","phase-3-type-1-diabetes-impacts-of-semaglutide-on-cardiovascular-outcomes-100502198","NCT05819138","Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes","T1-DISCO","Inclusion Criteria:\n\n* Age 18-49 years\n* 1\\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis\n* Insulin pump or automated insulin delivery systems\n* Estimated glomerular filtration rate (eGFR) ≥ 45 ml\u002Fmin\u002F1.73m2\n* Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics)\n* BMI 20-45 kg\u002Fm2\n* Adequate contraceptive method for females\n\nExclusion Criteria:\n\n* HbA1c \\>9%, recent diabetic ketoacidosis (DKA) or hospitalization\n* Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy\n* History\u002Ffamily history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis\n* Current\u002Fplanned pregnancy or nursing\n* Uncontrolled thyroid disease or hypertension (HTN) (≥ 160\u002F100 mm Hg despite optimal therapy)\n* Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months\n* Use of atypical antipsychotics\n* Significant systemic illness such as cancer\n* Shellfish\u002Fiodine allergy (only exclusionary to iohexol clearance procedure)\n* MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy","49 Years",{"count":258,"type":20},[51],"This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.",[24],{"date":606,"type":29},"2026-03-04",{"date":608,"type":29},"2023-06-21",{"date":610,"type":20},"2027-12-01",{"name":612,"class":158},"University of Colorado, Denver",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":45,"maxAge":416,"enrollmentInfo":621,"targetDuration":4,"studyType":49,"phases":623,"briefSummary":624,"conditions":625,"keywords":626,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100541080","closed-loop-and-education-for-hypoglycemia-awareness-restoration-100541080","NCT06325202","Closed Loop and Education for Hypoglycemia Awareness Restoration","Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)","CLEAR","Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes\n* Gold Score or Clarke Score ≥ 4 (highly associated with IAH)\n* Random non-fasting C-peptide \\\u003C 200 pmol\u002FL\n* Diabetes duration ≥ 10 years\n* HbA1c \\\u003C 10.5%\n* Total Daily Insulin Dose of \\\u003C 1 unit\u002Fkg\n* Ability to read and speak English (because validated non-English versions of the cognitive tests and the educational interventions are not available)\n\nExclusion Criteria:\n\n* Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)\n* Active alcohol or drug abuse (as defined by DSM criteria of either 1) recurrent use of alcohol\u002Fdrugs resulting in a failure to fulfill major role obligations at work, school, or home, 2) recurrent alcohol\u002Fdrug use in situations in which it is physically hazardous, or 3) recurrent alcohol or drug-related legal problems)\n* Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, inadequate social support)\n* Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for \\>12 months and on a stable regimen of anti-convulsant therapy\n* Skin conditions that would preclude the use of a CGM\n* Super-physiologic exposure to steroids within one month of enrollment\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2\n* History of bariatric surgery that irreversibly alters gut innervation and structure\n* Hyper- or hypokalemia (serum potassium \\>5.5 or \\\u003C3.5 mmol\u002FL)\\*\n* Hemoglobin \\\u003C 10 g\u002FdL\\*\n* Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses\n* Pregnancy, plan for pregnancy, or breast feeding\n* Abnormal thyroid function tests of clinical significance, as determined by PI\\*\n* Liver transaminases \\> 3 times the upper limit of normal\\*\n* Hospitalization for mental illness in last year\n* History of adrenalectomy\n\n  * At discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant. The participant may be screened again.",{"count":622,"type":20},324,[169],"The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.",[24],[627,628,629],"impaired awareness of hypoglycemia","hybrid closed loop device","continuous glucose monitor","2026-02-27",{"date":324,"type":29},{"date":633,"type":29},"2025-10-03",{"date":635,"type":20},"2029-07-31",{"name":637,"class":158},"Milton S. Hershey Medical Center",8]