[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,80,0,25,[9,47,92,118,148,172,194,220,246,275,299,320,342,363,385,406,428,449,476,507,526,553,584,616,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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",false,"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","ALL","1 Year","35 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Diabetes Mellitus, Type 1",[30,31,32,33],"T1DM","Children","New-onset","Beta-cell Function","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2026-02-05",{"date":42,"type":22},"2028-07",{"name":44,"class":45},"Eli Lilly and Company","INDUSTRY",138,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":60,"conditions":61,"keywords":77,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100560306","phase-1-a-study-to-investigate-safety-and-effectiveness-of-porcine-pancreatic-cells-opf-310-in-patients-with-type-1-diabetes-mellitus-100560306","NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 70 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM) (in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII For subjects aged 65 to \\\u003C70 years who do not meet Exclusion Criterion 12 but have a history of cardiovascular or cerebrovascular disease related to the conditions above, a cardiology consultation (and consultation with other relevant specialists, as appropriate) will be required during the screening period to confirm suitability for general anesthesia and laparoscopic surgery.\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","70 Years",{"count":56,"type":22},13,[58,59],"PHASE1","PHASE2","This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[28,62,63,64,65,66,30,67,68,69,70,71,72,73,74,75,76],"Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases","Metabolic Disease",[78,79,30,62,80,81,70,82,65,64],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","2026-08-19",{"date":37,"type":38},{"date":86,"type":38},"2025-06-10",{"date":88,"type":22},"2027-06-30",{"name":90,"class":45},"Otsuka Pharmaceutical Factory, Inc.",1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":91},"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.","65 Years",{"count":100,"type":22},30,[102],"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",[105,28],"Diabetes Mellitus, Type 2",[107],"Diabetes self management","2026-08-14",{"date":110,"type":38},"2026-08-17",{"date":112,"type":22},"2026-09",{"date":114,"type":22},"2027-03",{"name":116,"class":117},"Emory University","OTHER",{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":91},"100476036","phase-2-therapeutic-strategies-for-microvascular-dysfunction-in-type-1-diabetes-100476036","NCT05478707","Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes","MCD-1","Inclusion criteria:\n\n* History of type 1 diabetes, duration \\> 5 years\n* Age 18-40 years\n* HbA1c \\\u003C 8.5%\n* BMI 19-34.9 kg\u002Fm2\n* Using insulin for diabetes treatment only (multiple daily injections or insulin pump with or without sensor augmentation)\n* On stable regimen of non-diabetic medications for the last 6 months\n* All screening labs within normal limits or not clinically significant - English or Spanish speaking\n\nExclusion criteria:\n\n* Pregnancy or currently breastfeeding\n* Smoking history within 6 months\n* History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) as well as clinically significant cardiac arrhythmias or conduction disorders\n* Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers).\n* Known hypersensitivity to perflutren (contained in Definity© contrast)\n* Screening O2 saturation \\\u003C90%\n* Musculoskeletal condition preventing participation in exercise testing or exercise training\n* Acute or unstable disease other than T1D\n* Hypoglycemia unawareness\n* History of gastroparesis, severe gastroesophageal reflux, pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2\n* Anemia (hemoglobin \\\u003C12 g\u002FdL in women, hemoglobin \\\u003C13 g\u002FdL in men), eosinophilia (absolute eosinophil count \\>500 cells\u002Fmicroliter) leukopenia (total white blood cells \\\u003C4,000 cells\u002Fmicroliter)\n* Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days\n* Hospital admission for DKA within 1 year","18 Years","40 Years",{"count":128,"type":22},47,[59],"The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) enhances insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.",[28,132],"Endothelial Dysfunction",[134,135,136,137,138],"microvessels","oxidative stress","Dulaglutide","Glucagon-like peptide-1","Exercise therapy","2026-08-10",{"date":141,"type":38},"2026-08-12",{"date":143,"type":38},"2023-10-05",{"date":145,"type":22},"2028-07-30",{"name":147,"class":117},"AdventHealth Translational Research Institute",{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":91},"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":156,"type":22},160,[102],"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.",[105,160,28],"Food Insecurity",[162],"inpatient","2026-08-07",{"date":165,"type":38},"2026-08-11",{"date":167,"type":38},"2024-10-07",{"date":169,"type":22},"2027-01-15",{"name":171,"class":117},"Stanford University",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"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",{"count":181,"type":22},150,[25],"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.",[28],"2026-08-05",{"date":187,"type":38},"2026-08-06",{"date":189,"type":38},"2026-01-12",{"date":191,"type":22},"2031-07",{"name":44,"class":45},111,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":91},"100519690","continuous-glucose-metrics-in-patients-with-gastroparesis-in-type-1-or-type-2-diabetes-100519690","NCT06046833","Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes","Glucose Metrics Using Freestyle Libre 3 Real-Time Continuous Glucose Monitor (rtCGM) in Patients With Gastroparesis in Type 1 or Type 2 Diabetes: Investigator Initiated Pilot Study","Inclusion Criteria:\n\n* Over the age of 18 years.\n* Hemoglobin A1c ≤11% within the last 6 months.\n* Patients with diagnosis of type 1 Diabetes or type 2 Diabetes for at least one year.\n* Normal thyroid-stimulating hormone (TSH) within the last year.\n* No episodes of diabetic ketoacidosis (DKA), Hyperosmolar Hyperglycemic Status (HHS), or hypoglycemia in the past 2 weeks requiring ER visit or hospitalization.\n* Symptoms of gastroparesis have been present for at least the past 3 months, in patients with gastroparesis.\n* In patients with gastroparesis, documented delayed gastric emptying on scintigraphy and\u002For wireless motility capsule (Smart Pill) as defined by greater than 10% retention at 4 hours or greater than 4-hour gastric transit time (GTT) in the past five years.\n* Patients using a Smartphone (iPhone or Android) compatible with LibreView App.\n\nExclusion Criteria:\n\n* Hemoglobin A1c of \\>11% at enrollment.\n* Advanced chronic kidney disease (serum creatinine of \\>2 mg\u002FdL or estimated glomerular filtration rate (eGFR) \\\u003C30mL\u002Fmin\u002F1.73m² using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula).\n* Advanced and significant cardiovascular disease or unstable angina.\n* Advanced liver disease that may affect glucose profiles.\n* Post-transplant patients.\n* History of gastric surgery.\n* Patients with symptoms secondary to celiac disease (e.g. diarrhea, nausea, vomiting, abdominal pain) at the time of the enrollment.\n* Pregnancy or women of reproductive age group not taking adequate precautions for pregnancy for 28 days.\n* Patients on steroids or immunomodulators or chemoradiation that might affect glucose profiles.\n* Patients on opiates or glucagon-like peptide-1 (GLP-1) agonists (Ozempic, Wegovy, Mounjaro, Trulicity). If previously taking these medications, patients can be enrolled after 2 weeks of the last dose.\n* Patient on recreational or illicit drugs (i.e., marijuana, opiates, cocaine, etc.).\n* Patients on motility medications such as Reglan (Metoclopramide), Motegrity (Prucalopride), Cisapride, Domperidone, Erythromycin. If previously taking any of these medications, patients can be enrolled after 1 week of the last dose.\n* Clinically significant abnormalities on upper GI endoscopy.\n* Presence of imaging evidence of gastric or intestinal obstruction.\n* Patient previously participated in the study.",{"count":202,"type":22},50,[102],"A pilot study to evaluate and compare glucose metrics using a real-time continuous glucose monitor (FreeStyle Libre 3 sensor) between patients with diabetes and gastroparesis and those with diabetes without gastroparesis.",[105,28,206],"Gastroparesis With Diabetes Mellitus",[208,209,210],"Gastroparesis","Diabetes","Continuous Glucose Monitor","2026-07-31",{"date":213,"type":38},"2026-08-03",{"date":215,"type":38},"2024-01-08",{"date":217,"type":22},"2026-12",{"name":219,"class":117},"Samita Garg",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100504547","breaking-disparities-in-access-to-advanced-diabetes-technologies-in-children-with-type-1-diabetes-100504547","NCT05849753","Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes","Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes","Inclusion Criteria:\n\nDiagnosis of T1D for at least 1 year based on clinical presentation (polyuria, polydipsia, weight loss, and\u002For ketoacidosis, or with positive diabetes autoantibodies) on insulin, including injections or open-loop pumps\n\n* HbA1C ≥ 8.0% at least twice within the last 12 months before study initiation, upper limit of HbA1C \\\u003C14%\n* Be of lower SES, defined based on \\\u003C 200% above published US levels of poverty by family size and income, or based on exceptional circumstantial needs in the opinion of the investigators\n* Approximately 1\u002F3 AA, 1\u002F3 Hispanic\u002FLatinos, 1\u002F3 non-Hispanic whites. Asians, Pacific Islanders and other ethnic groups however will not be excluded from participation if other criteria met\n* History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed\n\nExclusion Criteria:\n\n* Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices\n* Chronic medications\u002Fmedical conditions that could interfere with diabetes management (ADHD medications allowed)\n* Chronic seizures, or severe neurodevelopmental delay\n* Current use of hybrid closed-loop, automated insulin delivery system\n* Significant mental health disorder that in opinion of the investigator would hinder device use","6 Years","17 Years",{"count":202,"type":22},"OBSERVATIONAL","50 children\u002Fadolescents (ages 6 to \\\u003C18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours \\~ 1\u002F3 each AA, Hispanic\u002FLatino, non-Hispanic whites. All families that qualify and agree to transition to closed-loop technologies will be recruited to allow data to be gathered before and after use of devices. They will go through the process of approval with the assistance of an insurance navigator in clinic. Those not a CGM will be prescribed one as well. Diabetes care will be 'real life', devices will be prescribed, and care per clinic routine with periodic device downloads. Principal outcome, time-in-range, will be analyzed at 3-months compared to baseline, each participant their own control. Secondary outcomes including HbA1c, other glucose metrics and questionnaires related to use of technology and diabetes distress will be also analyzed. All outcomes will also be collected at 6-months. Results could have important and fast applicability to the field and help better inform decision makers, including payers, clinicians, and patients and families and could serve to decrease health care disparities in this needy population.",[28,233,234,235],"Child","Delivery of Health Care","Equipment and Supplies","2026-07-16",{"date":238,"type":38},"2026-07-20",{"date":240,"type":38},"2023-07-26",{"date":242,"type":22},"2026-12-31",{"name":244,"class":117},"Nemours Children's Clinic",2,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":17,"minAge":254,"maxAge":125,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":256,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100568983","phase-2-treatment-of-presymptomatic-stage-1-type-1-diabetes-pediatric-patients-with-treg-cell-preparations-and-anti-cd20-antibody-100568983","NCT06688331","Treatment of Presymptomatic (Stage 1) Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody","A Multicenter, Randomized, Blinded, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Cell Therapy Based With Artificially Expanded CD4+CD25+CD127- Regulatory Lymphocytes and Anti-CD20 Antibody in Pediatric Patients With Presymptomatic Diabetes Type 1 (Stage 1)","PreTreg","Inclusion Criteria:\n\n1. Age 3-18\n2. 5 ≤ BMI ≤ 95 percentile (acc. to OLAF, or WWF in the case of children under six years old) with a lower weight threshold of 20 kg\n3. Venous plasma glucose levels \\\u003C 100mg% at fasting (70 to 100 mg\u002Fdl) and normal glucose tolerance test (at 120 minutes glycaemia \\\u003C140 mg\u002Fdl) (acc. to PTD)\n4. Insulin independence\n5. C-peptide levels ≥ 1.0 ng\u002Fml (central laboratory limit of normal) in fasting and post-stimulation tests increase ≥ 100%\n6. Participant has not yet been diagnosed with stage 2 or 3 type 1 diabetes mellitus (no history of dysglycemia, no history of clinical symptoms of type 1 diabetes mellitus)\n7. HbA1c level (%) \\\u003C5,7% (acc. to ADA)\n8. Positive autoantibody titres (ICA, IAA, GAD, IA-2\u002FICA512, ZnT8) - low titers of two or more antibodies (2 times the normal\\* or higher); if high titer of one of the antibodies (≥ 4 times the norm, not applicable to ICA) re-screening allowed (the participant can be included in the trial only after confirming two or more antibodies)\n9. Ability to give informed consent by the child's legal representatives (and the child himself or herself if he or she is over the age of 13 at the time of the trial \\[according to local law\\])\n10. Ability of the child's legal representatives to manage diabetes, defined as blood glucose levels control at least three times a day and the ability to dose insulin correctly.\n11. Venous access to guarantee blood donation\n\n    \\* Standard defined depending on the method used\n\n    Exclusion Criteria:\n12. Refusal to participate in the trial or lack of a signed informed consent form\n13. Suspicion or diagnosis for a type of diabetes other than type 1 diabetes mellitus\n14. Age under 3 or above 18\n15. IgA deficiency or history of other diagnosed immunodeficiency (max. 7 infections\u002Fyear allowed, and the prognosis should indicate that the patient will remain in the study throughout its duration)\n16. C-peptide levels \\\u003C 1.0 ng\u002Fml fasting and in post-stimulation tests increase \\\u003C 100%\n17. Glucose levels in venous blood ≥ 100mg% fasting\n18. Glucose levels in venous blood after 1 and 2 hours in OGTT ≥ 200mg%\n19. Glycated hemoglobin level (HbA1c) in venous blood ≥ 5,7%\n20. BMI \\\u003C 5th percentile or \\> 95th percentile for age, or body weight \\\u003C 20 kg\n21. History of hypersensitivity to anti-CD20 or other components of the preparation\n22. History of hypersensitivity to penicillin and\u002For streptomycin\n23. Past or active infection with HBV, HCV, HIV, HTLV I\u002FII, mycobacterium tuberculosis, syphilis. Laboratory evidence of infection without the need for clinical signs and symptoms is sufficient for diagnosis.\n24. Active infection with the EBV or CMV virus (positive IgM)\n25. Any fungal, parasitic, viral, or bacterial infection\n26. History of past or active cancer\n27. Anemia, lymphopenia, neutropenia, or thrombocytopenia defined as a blood cell count below the lower limit of normal for age found within the last 6 weeks prior to trial inclusion\n28. Elevated thrombotic activity\u002Fhistory of thrombosis episode\n29. Any disease prior to inclusion in the trial currently requiring medication for more than 3 months in history\n30. Diagnosed autoimmune disease other than type 1 diabetes mellitus, including a history of Hashimoto's disease and coeliac disease\n31. Taking anti-diabetic medication (including insulin) in the last 4 weeks prior to trial inclusion\n32. History of retinopathy\n33. History of hypertension\n34. Current or history of albuminuria\n35. For women in childbearing potential\u002Fmenstruating women: pregnancy (from medical interview) or unwillingness to exercise sexual restraint or use effective forms of contraception for the duration of the trial and up to 4 months after completion, if applicable.\n\n    The following contraceptive methods are acceptable: bilateral fallopian tube closure, sterilization in men, appropriate use of hormonal contraception that inhibits ovulation, hormone-releasing IUDs, and copper IUDs, male or female condoms with spermicide; and cap, uterine disc, or sponge with spermicide.\n36. Breastfeeding\n37. For males over 15 years of age: expressed intention to have offspring or donate sperm during the trial or within 4 months after the end of the trial, if applicable\n38. Excessive anxiety of the participant or his\u002Fher legal representatives regarding the procedures used in the trial\n39. Any medical problem that, in the opinion of the investigator, may adversely affect the participant's health if included in the trial\n40. Legal representatives and\u002For children over the age of 15 with an identified alcohol and\u002For psychoactive substance addiction\n41. History of disease of unknown etiology\n42. History of Creutzfeldt-Jacob disease\n43. History of progressive dementia or degenerative neurological disease, including of unknown origin\n44. History of taking hormones derived from the human pituitary gland (e.g., growth hormone)\n45. Treatment with immunosuppressants\n46. History of corneal, scleral, and dural transplant or undocumented neurosurgery\n47. History of occurrence of risk factors related to the participant's travel, where there is a possibility of exposure to regional infectious diseases\n48. Physical signs that indicate the risk of an infectious disease\n49. History of xenogeneic transplant","3 Years",{"count":181,"type":22},[59],"The main purpose of the study is to check:\n\n* Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and\u002For an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or delay type 1 diabetes?\n* Is therapy with a preparation of regulatory cells (Tregs lymphocytes) and\u002For a preparation of antiCD20 antibodies (rituximab) safe for children with pre-diabetes, and what side effects may be associated with it? The study will include patients at high risk for type 1 diabetes whose laboratory tests have confirmed preserved normal\u002Fhigh insulin production. First (part 1 of the study), tests will be performed to determine the risk of the disease (determination of autoantibodies that characterize the autoimmune background).\n\nIn order to confirm the effectiveness of the therapy, not all patients will receive the study treatment. The study will be a so-called blinded randomized trial. This means that in this trial, all participants will undergo the same study procedures, but the participant will be randomly assigned to one of four (4) groups that will receive different treatment regimens before entering the study.\n\nThe participant will be randomly assigned to one of four groups:\n\n* Group I will receive a preparation of regulatory cells (Tregs lymphocytes) along with a preparation of antiCD20 antibodies,\n* Group II will receive a preparation of regulatory cells (Tregs lymphocytes) together with an inert substance (placebo)\n* Group III will receive a preparation of antiCD20 antibodies along with a sham treatment (inert substance)\n* Group IV will receive an agent containing an inert substance and sham treatment.\n\nApproximately 150 patients aged 3-18 who are at risk of developing type 1 diabetes will be enrolled in the study, which will last up to 96 months. Each enrolled participant will remain in the study for up to five years.",[259,260,28],"Presymptomatic Diabetes Type 1 (Stage 1)","Diabetes Mellitus, Type I",[252,262,263,264],"Tregs","Prediabetes","presymptomatic","2026-07-15",{"date":267,"type":38},"2026-07-17",{"date":269,"type":38},"2025-03-12",{"date":271,"type":22},"2032-12",{"name":273,"class":45},"PolTREG S.A.",9,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":98,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":287,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":296,"locationsCount":298},"100583784","effect-of-inhaled-technosphere-insulin-vs-raa-insulin-on-exercise-induced-hypoglycemia-in-adults-with-t1d-using-automated-insulin-delivery-100583784","NCT06880835","Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery","INHALE-AIDEx: A Randomized Crossover Trial Evaluating the Effect of Inhaled Technosphere Insulin (Afrezza®) vs Rapid Acting Analogue Insulin on Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes Using Automated Insulin Delivery","INHALE-AIDEx","Inclusion Criteria:\n\n1. Ability to provide informed consent for study participation\n2. Age ≥18 years to 65 years\n3. Clinical diagnosis of T1D (per the Investigator)\n4. Using Tandem t:slim X2 or Tandem Mobi insulin pump with Control-IQ for at least 90 days prior to screening visit\n5. Using insulin aspart or insulin lispro in Tandem insulin pump\n6. Total daily insulin dose 20 to 80 units\n7. Usual RAA insulin bolus for 50 gram carbohydrate lunch meal is ≤12 units\n8. Physically active, with at least 3 moderate or vigorous exercise sessions ≥30 minutes per typical week self-reported by participant\n9. No medical, psychiatric, or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study\n10. No electrocardiogram (ECG) abnormality that in the judgment of the investigator, which will take into consideration the usual exercise performed by the participant and their overall medical condition, increases the risk of exercise\n11. Investigator believes that the participant can safely follow the protocol\n12. Able to read and understand written and spoken English or Spanish\n\nExclusion Criteria:\n\n1. Use of inhaled insulin within one week prior to screening visit\n2. History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator\n3. Smoking (includes cigarettes, cigars, pipes, marijuana, and vaping devices) within 90 days prior to screening visit and no plans to smoke during the study\n4. History or current diagnosis of lung cancer\n5. Forced expiratory volume in 1 second (FEV1) measurement of \\\u003C70% of predicted Global Lung Function Initiative value\n6. Pregnant or lactating, planning to become pregnant during the study, or is of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral\u002Finjectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal)\n\n   • A pregnancy test is required for any person of childbearing potential.\n7. An event of severe hypoglycemia, as judged by the Investigator, within the 90 days prior to screening visit\n8. An episode of diabetic ketoacidosis (DKA) as defined in section 5.2 within the 90 days prior to screening visit\n9. Any disease other than diabetes or current use (or anticipated use during the study) of any medication (e.g., beta blocker) that, in the judgment of the Investigator, may substantially impact glucose metabolism\n10. Use of a non-insulin glucose-lowering medication (or weight-reduction medication with glucose-lowering effect) within 4 weeks prior to screening visit\n11. Exposure to any investigational drug in the 90 days prior to the screening visit\n12. Current or anticipated acute uses of oral, inhaled, or injectable glucocorticoids during the time period of the study (topical or intranasal glucocorticoid use is acceptable)\n13. Current use of Hydroxyurea medication\n14. Current or anticipated use of a low carbohydrate diet (\\\u003C50 grams\u002Fday) or low calorie diet (\\\u003C800 kcal\u002Fday) during the time period of the study\n15. Current treatment for diabetic retinopathy\n16. Known stage 4\u002F5 chronic kidney disease or on dialysis\n17. Having a direct supervisor at place of employment who is directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the study",{"count":100,"type":22},[102],"This investigator-initiated study will enroll about 30 adults 18 to 65 years of age with type 1 diabetes (T1D) who are using the Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ or Control-IQ+ technology (\"Control-IQ\" which will refer to either Control-IQ or Control-IQ+). The study is being done to find out if inhaled insulin given for a meal is safer and better to use than a bolus of insulin through your pump when you exercise following a meal. Participants are asked to complete three study exercise visits in the clinic.",[28],[28,288,289,290],"Exercise","Technosphere Insulin","Automated Insulin Delivery","2026-07-14",{"date":236,"type":38},{"date":294,"type":38},"2025-06-05",{"date":242,"type":22},{"name":297,"class":117},"Jaeb Center for Health Research",3,{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"100578122","general-use-results-surveillance-with-awiqli-in-patients-with-diabetes-mellitus-100578122","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.",{"count":307,"type":22},630,"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.",[28],"2026-06-26",{"date":312,"type":38},"2026-06-29",{"date":314,"type":38},"2025-04-15",{"date":316,"type":22},"2028-01-31",{"name":318,"class":45},"Novo Nordisk A\u002FS",112,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":98,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"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",{"count":328,"type":22},52,[25],"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.",[28,332,69],"Impaired Hypoglycemic Awareness",{"date":334,"type":38},"2026-06-30",{"date":336,"type":38},"2021-03-29",{"date":338,"type":22},"2030-06-30",{"name":340,"class":45},"Vertex Pharmaceuticals Incorporated",29,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":362},"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":351,"type":22},877,[25],"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.",[28],"2026-06-25",{"date":312,"type":38},{"date":358,"type":38},"2025-08-11",{"date":360,"type":22},"2027-03-01",{"name":318,"class":45},196,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":91},"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":371,"type":22},16,[373],"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.",[28,376],"Hypoglycemia Unawareness","2026-06-05",{"date":379,"type":38},"2026-06-09",{"date":381,"type":38},"2025-05-13",{"date":88,"type":22},{"name":384,"class":117},"Yale University",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":392,"minAge":125,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":91},"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":371,"type":22},[58],"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.",[28],"2026-06-02",{"date":379,"type":38},{"date":401,"type":38},"2026-05-29",{"date":403,"type":22},"2026-10",{"name":405,"class":45},"Sam Chun Dang Pharm. Co. Ltd.",{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":17,"minAge":412,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":416,"conditions":417,"keywords":418,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":91},"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":415,"type":22},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.",[78,28],[419],"Genetic risk score","2026-05-31",{"date":398,"type":38},{"date":423,"type":38},"2025-10-27",{"date":425,"type":22},"2029-12-31",{"name":427,"class":117},"Second Xiangya Hospital of Central South University",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":435,"sex":17,"minAge":436,"maxAge":125,"enrollmentInfo":437,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":447,"locationsCount":91},"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":438,"type":22},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.",[28],"2026-05-14",{"date":443,"type":38},"2026-05-18",{"date":445,"type":38},"2023-01-27",{"date":242,"type":22},{"name":448,"class":117},"University Hospital, Geneva",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":369,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":91},"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":458,"type":22},20,[102],"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.",[28],[288,463,464,465,466],"Continuous glucose monitoring","total daily insulin dose","Muscle fat","Liver fat","2026-05-07",{"date":469,"type":38},"2026-05-08",{"date":471,"type":38},"2025-01-01",{"date":473,"type":22},"2027-04",{"name":475,"class":117},"University of Alberta",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":227,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":485,"conditions":486,"keywords":487,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":506},"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.",{"count":484,"type":22},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.",[28],[488,489,490,491,492,493,494,495,496],"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":499,"type":38},"2026-05-01",{"date":501,"type":38},"2026-03-03",{"date":503,"type":22},"2027-12",{"name":505,"class":45},"Tandem Diabetes Care, Inc.",21,{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":91},"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":5,"type":22},[102],"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.",[78,28,105],"2026-04-16",{"date":519,"type":38},"2026-04-21",{"date":521,"type":38},"2025-12-29",{"date":523,"type":22},"2028-05",{"name":525,"class":45},"Senseonics, Inc.",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":19,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":541,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":298},"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":535,"type":22},100,[102],"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.",[539,540],"Diabetes Distress","Diabetes Mellitus Type 1",[542,496,543,532],"RCT study","diabetes distress","2026-04-08",{"date":546,"type":38},"2026-04-09",{"date":548,"type":38},"2025-04-01",{"date":550,"type":22},"2027-05-31",{"name":552,"class":117},"Odense University Hospital",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":574,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":91},"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":5,"type":22},"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.",[540],[64,565,566,567,568,569,570,571,572,573],"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":577,"type":38},"2026-04-13",{"date":579,"type":22},"2026-04",{"date":581,"type":22},"2028-04",{"name":583,"class":45},"Air Liquide Healthcare Spain",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":597,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":245},"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":592,"type":22},140,[102],"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).",[28,596],"Diabetes Complications",[598,599,600,601,602,603,604,605,606],"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":609,"type":38},"2026-04-01",{"date":611,"type":38},"2025-02-27",{"date":613,"type":22},"2028-09",{"name":615,"class":117},"Boston Medical Center",{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":622,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":590,"enrollmentInfo":624,"targetDuration":4,"studyType":23,"phases":625,"briefSummary":626,"conditions":627,"keywords":631,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"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":181,"type":22},[25],"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.",[628,629,540,630],"Diabetic Nephropathies","Kidney Failure, Chronic","Heart Failure",[628,629,632,633,634,635,636,637],"Type 1 diabetes","Heart failure","Cardiovascular disease","Glomerular filtration rate","SGLT2 inhibitors","Diabetic kidney disease","2026-03-20",{"date":640,"type":38},"2026-03-24",{"date":642,"type":38},"2024-10-31",{"date":644,"type":22},"2029-05",{"name":646,"class":117},"Alessandro Doria",19,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":17,"minAge":125,"maxAge":98,"enrollmentInfo":654,"targetDuration":4,"studyType":23,"phases":656,"briefSummary":657,"conditions":658,"keywords":659,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":91},"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":655,"type":22},58,[102],"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.",[28],[632,660,661,463,62],"Ketogenic diet","Insulin sensitivity","2026-03-17",{"date":664,"type":38},"2026-03-19",{"date":666,"type":38},"2024-08-12",{"date":668,"type":22},"2030-03-31",{"name":670,"class":117},"Washington University School of Medicine"]