[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-melletus-type-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-melletus-type-1":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100054307","phase-2-metabolic-modulation-to-enhance-insulin-sensitivity-and-mitochondrial-function-in-type-1-diabetes-metmod-t1d-100054307",false,"NCT07699380","METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D)","MetMod-T1D","Inclusion Criteria:\n\n1. Adults ≥18 years to \\\u003C70 years of age with established T1D (duration ≥1 year)\n2. Currently on insulin therapy (multiple daily injections or insulin pump)\n3. HbA1c \\\u003C9.5%\n4. BMI 18.5-40 kg\u002Fm2\n5. On stable dose of RASB or statin, if indicated\n6. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. History of pancreatic disease (including pancreatitis) or pancreatic surgery\n2. History of cardiovascular disease or stroke within the past 6 months\n3. History of heart failure per New York Heart Association criteria\n4. History of severe edema or salt restriction requirement\n5. Biliary disease or pathologies that may alter enterohepatic circulation of bile acids\n6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²\n7. Liver disease (ALT\u002FAST \\>3x upper limit of normal \\[ULN\\])\n8. Pregnancy, breastfeeding, or planning pregnancy during the study period\n9. Known hypersensitivity to study drug components\n10. Abnormal baseline ECG\n11. Use of off label medications that affect insulin sensitivity within the past 1 month (e.g., metformin, GLP-1RA, SGLT2i, pioglitazone)\n12. Chronic use of anticoagulants\n13. Use of bile acid sequestering agents, inhibitors of bile acid transporters, bile acid derivatives, aluminum-based antacids, probenecid, pan-HDAC inhibitors, phase 2 metabolizing enzymes (e.g., uridine diphosphate glucuronosyl transferases), phase 1 metabolizing enzymes other than cytochrome P450 enzymes (CYPs), and OATP1B3\n14. Use of substrates of CYP1A2, CYP2C8, CYP2B6, CYP3A4, Organic Anion transporter 1, P-glycoprotein, and Breast Cancer Resistance Protein\n15. History of severe hypoglycemia requiring assistance within the past 3 months\n16. History of diabetic ketoacidosis (DKA) within the past 3 months\n17. Personal or family history of breast cancer or ovarian cancer\n18. Current participation in another clinical trial\n19. Any condition(s) found by the study team and confirmed with the Investigator that make it unsafe to participate","ALL","18 Years","69 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study is a randomized, double-blind, parallel-group clinical trial to examine the effects of 24 weeks of oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo in 60 adults with Type 1 Diabetes (T1D) (n=30 per arm). Enrollment will be distributed equally between the University of Washington and Amsterdam University Medical Center\u002FDiabetes Center Amsterdam. Participants will be recruited through diabetes research registries, local T1D clinics, and community outreach.",[27,28,29,30,31,32,33,34,35],"Type 1 Diabetes (T1D)","Metabolic Diseases","Glucose Metabolism Disorders","Endocrine System Diseases","Autoimmune Diseases","Immune System Diseases","Diabetes Melletus, Type 1","Nutritional and Metabolic Diseases","Combination Therapy","RECRUITING","2026-07-09",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-06",{"date":44,"type":21},"2029-12",{"name":46,"class":47},"University of Washington","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100632770","rome-gs-system-study-100632770","NCT07518004","ROME GS System Study","ROME GS System Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the ROME GS System","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 unexplained 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 within 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; antibiotics 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 study period\n17. The presence of another active implanted device\\* \\*An example of an active implanted device includes but is not limited to an implantable defibrillator. Passive implantable devices are allowed. An example of a passive implantable device includes, but is not limited to, a cardiac stent. The use of commercial transcutaneous CGM devices (e.g. Dexcom G6\u002FG7 CGM and Abbott Libre) are allowed and not exclusionary. Note that FDA-approved Eversense CGM System (not study provided) use will not be allowed.",{"count":20,"type":21},[57],"NA","The purpose of this clinical investigation is to demonstrate that the proposed physical changes to the ROME GS Sensor do not have any adverse impact on safety and performance when compared to the Eversense 365 Sensor.",[60,33,61],"Diabetes","Diabetes Mellitus, Type 2","2026-04-16",{"date":64,"type":40},"2026-04-21",{"date":66,"type":40},"2026-02-12",{"date":68,"type":21},"2028-12",{"name":70,"class":71},"Senseonics, Inc.","INDUSTRY",4]