[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-mellitus-type-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-mellitus-type-2":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,244,0,25,[9,51,75,98,127,152,177,227,261,292,317,335,356,379,416,439,459,478,504,529,553,568,587,627,650],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053367","phase-4-ai-assisted-lifestyle-intervention-versus-tirzepatide-for-obesity-and-newly-diagnosed-type-2-diabetes-100053367",false,"NCT07697391","AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes","A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes","AI-LIFE-T2D-OB","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 65 years.\n2. Newly diagnosed type 2 diabetes mellitus, defined as diagnosis within 3 years and no use of glucose-lowering medications within the past 3 months. Diagnosis should meet the 1999 World Health Organization criteria, including at least one of the following: random plasma glucose ≥11.1 mmol\u002FL, fasting blood glucose ≥7.0 mmol\u002FL, 2-hour postprandial blood glucose ≥11.1 mmol\u002FL, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation.\n3. Body mass index ≥28 kg\u002Fm² and \\\u003C40 kg\u002Fm².\n4. Willing to use effective contraception and have no pregnancy plan within 12 months after signing the informed consent form; female participants must have a negative pregnancy test at screening.\n5. Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.\n2. Body weight change \\>5% within 12 weeks before screening.\n3. Pregnant or breastfeeding women.\n4. Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.\n5. Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.\n6. History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \\>1.5 × upper limit of normal at screening.\n7. Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening.\n8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.\n9. Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.\n10. History of organ transplantation or acquired or congenital immune system disease.\n11. Schizophrenia or other psychiatric disorder that may interfere with participation in the study.\n12. Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.\n13. Hypertension with systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>90 mmHg after stable antihypertensive treatment.\n14. Clinically significant abnormal gastric emptying, severe chronic gastrointestinal disease, diabetic gastroparesis, long-term use of medications directly affecting gastrointestinal motility, or history of gastrointestinal surgery.\n15. Special dietary requirements or allergy to foods such as soy products or dairy products.\n16. Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.\n17. Allergic constitution, defined as allergy to two or more categories of substances.\n18. Fasting C-peptide \\\u003C0.81 ng\u002FmL.\n19. Calcitonin ≥50 pg\u002FmL.\n20. Abnormal laboratory results, including AST or ALT \\>2.5 × upper limit of normal, bilirubin \\>2.5 × upper limit of normal, triglycerides ≥5.7 mmol\u002FL, estimated creatinine clearance \\\u003C60 mL\u002Fmin using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin \\\u003C120 g\u002FL in men or \\\u003C110 g\u002FL in women.\n21. Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year before randomization, or history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or severe metabolic disorder causing neuropsychiatric dysfunction.\n22. History or risk factors of epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, torsades de pointes, hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia.\n23. Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment.\n24. Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.\n25. Positive urine drug screening and\u002For drug dependence.\n26. Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial.\n27. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.","ALL","18 Years","65 Years",{"count":22,"type":23},285,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg\u002Fm² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.\n\nParticipants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.",[29,30],"Obesity","Diabetes Mellitus, Type 2",[32,33,34,35,36,37],"AI-Assisted Lifestyle Intervention","Tirzepatide","Weight Management","Glycemic Control","Continuous Glucose Monitoring","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":23},"2026-07-20",{"date":46,"type":23},"2028-01-31",{"name":48,"class":49},"The First Affiliated Hospital of Anhui Medical University","OTHER",2,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100053272","phase-1-a-clinical-trial-of-mk-1403-in-participants-with-type-2-diabetes-mellitus-mk-1403-006-100053272","NCT07242469","A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)","A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM)\n* Has body mass index (BMI) between 18 and 40 kg\u002Fm\\^2, inclusive\n\nExclusion Criteria:\n\n* Has Type 1 diabetes mellitus or secondary types of diabetes\n* Has a history of congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4)\n* Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and\u002For stroke\n* Has history of cancer (malignancy)\n* Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV)\n* Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery","75 Years",{"count":60,"type":23},52,[62],"PHASE1","The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.",[30],"RECRUITING",{"date":41,"type":42},{"date":68,"type":42},"2025-12-22",{"date":70,"type":23},"2026-08-28",{"name":72,"class":73},"Merck Sharp & Dohme LLC","INDUSTRY",5,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":82,"targetDuration":4,"studyType":24,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100624924","phase-2-a-research-study-comparing-how-well-different-doses-of-the-medicine-nnc0662-0419-lower-blood-sugar-in-people-with-type-2-diabetes-100624924","NCT07415954","A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes","Efficacy and Safety of Once-weekly Subcutaneous NNC0662-0419 in Participants With Type 2 Diabetes - a Dose-finding Study","Inclusion criteria\n\n* Male or female (sex at birth).\n* Age 18-75 years (both inclusive) at the time of signing the informed consent.\n* Glycated haemoglobin (HbA1c) of 7.0-10.0 percent (%) (53-86 millimoles per mole \\[mmol\u002Fmol\\]) (both inclusive) as assessed by central laboratory at screening.\n* Willingness to obtain a high weight loss (greater than \\[\\>\\] 25% of weight at baseline).\n\nExclusion criteria\n\n* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's Questionnaire.",{"count":83,"type":23},270,[85],"PHASE2","This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.",[30],"2026-06-26",{"date":90,"type":42},"2026-06-30",{"date":92,"type":42},"2026-04-17",{"date":94,"type":23},"2027-10-01",{"name":96,"class":73},"Novo Nordisk A\u002FS",63,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":24,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100582880","re-engineered-discharge-for-diabetes-care-transitions-100582880","NCT06869057","Re-Engineered Discharge for Diabetes Care Transitions","Re-Engineered Discharge for Diabetes Care Transitions: Screening and Addressing Social Determinants of Health Needs at Hospital Discharge","REDDCAT2","Inclusion Criteria:\n\n* adult aged 18 years or older\n* diagnosed with type 2 diabetes\n* hospitalized at Univ of Massachusetts-affiliated hospital\n* endorsed at least 1 unmet social need via screening survey\n\nExclusion Criteria:\n\n* pregnancy\n* discharge to short or long-term nursing facility or hospital\n* medical contraindication\n* cognitive impairment\n* unable to provide informed consent",{"count":107,"type":23},412,[109],"NA","The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.",[112,113,114],"Diabetes Mellitus Type 2","Social Determinants of Health (SDOH)","Hospital Readmission",[116,117,118],"diabetes","social determinants of health","hospital readmission",{"date":90,"type":42},{"date":121,"type":42},"2026-06-08",{"date":123,"type":23},"2029-05-30",{"name":125,"class":49},"University of Massachusetts, Worcester",1,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":24,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":126},"100525222","time-restricted-eating-window-timing-type-2-diabetes-status-and-sex-on-glycemic-control-100525222","NCT06118931","Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control","The Impact of Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control","Inclusion Criteria:\n\n* Aged 40 years or older\n* Body mass index \\\u003C50 kg\u002Fm2\n* Have access to an Apple or Android cellphone with Bluetooth.\n* Have type 2 diabetes or be at risk for type 2 diabetes (defined as self-report of pre-diabetes, a recent (within 12 months) measure of HbA1c between 5.7 and 6.4%, waist circumference (WC) that is BMI specific; for women: BMI \\>= 18.5-24.9, WC \\>= 80cm; BMI \\>= 25-29.9, WC \\>= 90cm; BMI \\>= 30-34.9, WC \\>= 105cm; BMI \\>= 35+, WC \\>= 115cm; for men: BMI \\>= 18.5-24.9, WC \\>= 90cm; BMI \\>= 25-29.9, WC \\>= 100cm; BMI \\>= 30-34.9, WC \\>= 110cm; BMI \\>= 35+, WC \\>= 125cm.\n\nExclusion Criteria:\n\n* Individuals with type 2 diabetes will be excluded if: (1) currently on \\>2 monotherapies for diabetes, (2) have had diabetes therapy medication or dosage changes \\\u003C3 months, (3) self-reported hemoglobin A1c \\>9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas\n* The following exclusion criteria applies to all potential participants:\n\n  1. History of or referral for bariatric surgery\n  2. Weight loss \\>3% in the last 3 months\n  3. Taking antiobesity (weight loss) medications\n  4. Body weight \\>390lbs\n  5. Diagnosed with severe cognitive disorder that precludes them from giving consent\n  6. Inability or unwillingness to change their eating window to follow those prescribed in the study\n  7. Currently consistently eating during \\\u003C11.5 hour period .\n  8. Physician-diagnosed eating disorder\n  9. Having a pacemaker or receiving dialysis.\n  10. Not having access to a Lifelabs location.","40 Years",{"count":136,"type":23},123,[109],"This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.",[30,29,140,141],"Prediabetic State","Hyperglycemia",[143,144,29,35],"Time-restricted eating","Type 2 Diabetes",{"date":90,"type":42},{"date":147,"type":42},"2025-06-28",{"date":149,"type":23},"2027-06-28",{"name":151,"class":49},"University of Toronto",{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":24,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100597898","phase-3-easi-protkt---a-study-to-test-vicadrostat-bi-690517-taken-together-with-empagliflozin-in-people-with-type-2-diabetes-high-blood-pressure-and-cardiovascular-disease-100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":160,"type":23},11800,[162],"PHASE3","This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[30,165,166],"Hypertension","Cardiovascular Diseases","2026-06-23",{"date":169,"type":42},"2026-06-24",{"date":171,"type":42},"2025-07-22",{"date":173,"type":23},"2029-12-21",{"name":175,"class":73},"Boehringer Ingelheim",1155,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":24,"phases":186,"briefSummary":187,"conditions":188,"keywords":206,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":50},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":185,"type":23},132,[109],"Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[29,189,190,191,192,193,194,195,196,197,198,199,200,201,30,202,203,204,205],"Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[207,208,209,210,211,34,212,213,214,215,216,217,218],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)",{"date":220,"type":42},"2026-06-25",{"date":222,"type":42},"2025-06-24",{"date":224,"type":23},"2028-06",{"name":226,"class":49},"Pichamol Jirapinyo, MD, MPH",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":235,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":24,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100643997","phase-3-a-study-of-orforglipron-ly3502970-compared-with-dulaglutide-in-pediatric-participants-with-type-2-diabetes-100643997","NCT07668336","A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes","A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Once-Daily Oral Orforglipron Compared With Once-Weekly Dulaglutide in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes","ACHIEVE-PEDS","Inclusion Criteria:\n\n* Have type 2 diabetes treated with diet and exercise and metformin and\u002For basal insulin\n* Have HbA1c \\> 6.5% to ≤ 11.0% at screening\n* Have a body weight ≥50 kilograms (kg) (110 pounds) and a body mass index (BMI) of \\>85th percentile\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* After the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome\n* Have had at least one episode of severe hypoglycemia and\u002For at least one episode of hypoglycemic unawareness within the last 6 months before screening\n* Have a history of pancreatitis or gallbladder disease\n* Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or (SGLT2) inhibitors within 90 days prior to screening\n* Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 90 days prior to screening","10 Years","17 Years",{"count":238,"type":23},170,[162],"This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.\n\nParticipation in the study will last about 61 weeks.",[30],[243,244,245,246,247,248,249,250,251],"Pediatric trial","GLP-1 receptor agonist","Oral GLP-1","Small molecule GLP-1","Youth-onset type 2 diabetes","Glycemic control","Continuous glucose monitoring","Non-inferior","Active-controlled","2026-06-22",{"date":220,"type":42},{"date":255,"type":23},"2026-09",{"date":257,"type":23},"2030-03",{"name":259,"class":73},"Eli Lilly and Company",71,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":270,"briefSummary":271,"conditions":272,"keywords":277,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":289,"locationsCount":291},"100507429","phase-2-a-randomised-controlled-trial-of-a-low-energy-diet-for-improving-functional-status-in-heart-failure-with-preserved-ejection-fraction-preserved-ejection-fraction-100507429","NCT05887271","A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction","A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)","AMEND","Inclusion Criteria:\n\n1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse\n2. Clinically stable for ≥ 3 months (no admissions to hospital)\n3. Obesity (BMI ≥30kg\u002Fm2 if white European or ≥27kg\u002Fm2 if Asian, Middle Eastern or Black ethnicity)\n4. Age ≥18\n\nExclusion Criteria:\n\n1. Inability to walk\u002Fundertake 6-minute walk test\n2. Inability to follow a low-energy MRP\n3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy\u002Fpericardial disease or congenital heart disease.\n4. Recovered EF (previous EF \\\u003C 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF\u002FAflutter).\n5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension\n6. Severe chronic obstructive pulmonary disease (FEV1\\\u003C 1.0L)\n7. Severe primary valvular heart disease\n8. Anaemia (Hb\\\u003C100g\u002FL)\n9. Severe renal disease (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2)\n10. Weight loss \\> 5kg in preceding 3 months.\n11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months\n12. Active substance abuse (drugs or alcohol)\n13. History of bariatric surgery in the last 3 years\n14. Active illness likely to cause change in weight\n15. Women who are pregnant or are considering pregnancy\n16. People currently participating in another clinical research trial that is likely to affect diet or weight change.\n17. History of a severe mental illness including an eating disorder\n\n17\\. Individuals with a diagnosis of Type 1 diabetes mellitus.",{"count":97,"type":23},[85,162],"Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.",[273,274,30,275,276],"Heart Failure With Preserved Ejection Fraction","Heart Failure, Diastolic","Diabetes Mellitus Type 2 in Obese","Obesity Adult Onset",[278,279,280,29,281,282,283,284],"Heart failure with preserved ejection fraction","Diastolic heart failure","Type 2 diabetes mellitus","Meal replacement plan","Cardiac magnetic resonance imaging","Exercise intolerance","Diabetes remission",{"date":220,"type":42},{"date":287,"type":42},"2023-12-05",{"date":90,"type":23},{"name":290,"class":49},"University of Leicester",3,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":299,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":300,"targetDuration":4,"studyType":24,"phases":302,"briefSummary":303,"conditions":304,"keywords":305,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":126},"100640678","phase-1-a-trial-evaluating-amg-127-in-healthy-participants-and-participants-with-type-2-diabetes-mellitus-100640678","NCT07590193","A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus","Inclusion Criteria for Part A and B\n\n* Participant must be 18-65 years of age\n* Participant must be overtly healthy\n\nInclusion Criteria for Part C\n\n* Participant must be 40-75 years of age\n* Confirmed diagnoses of T2DM\n\nExclusion Criteria for Part A and B\n\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>140 millimeters of mercury (mmHg) or diastolic blood pressure \\>90 mmHg\n\nExclusion Criteria for Part C\n\n* Hemoglobin A1c (HbA1c) \\>10% within the last 3 months\n* History of hypotension, syncope, or orthostatic intolerance\n* Systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg",true,{"count":301,"type":23},162,[62],"The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).",[30],[306,307,308],"AMG 127","healthy participants","type 2 diabetes mellitus","2026-06-19",{"date":167,"type":42},{"date":312,"type":42},"2026-06-11",{"date":314,"type":23},"2027-10-02",{"name":316,"class":73},"Amgen",{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":324,"targetDuration":4,"studyType":24,"phases":326,"briefSummary":327,"conditions":328,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100643855","phase-2-a-research-study-comparing-how-well-different-doses-of-the-medicine-ubt251-lower-blood-sugar-in-people-with-type-2-diabetes-100643855","NCT07668388","A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes","Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study","Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18-75 years (both inclusive) at the time of signing the informed consent.\n* Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening.\n* Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:\n\nmetformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor.\n\n* HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol\u002Fmol)) (both inclusive) as assessed by central laboratory at screening.\n* Body mass index between 25.0 kg\u002Fm\\^2 and 50.0 kg\u002Fm\\^2 (both inclusive) at screening.\n\nExclusion Criteria:\n\n* Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.",{"count":325,"type":23},300,[85],"The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.",[30],{"date":220,"type":42},{"date":252,"type":23},{"date":332,"type":23},"2027-11-15",{"name":96,"class":73},69,{"id":336,"slug":4,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100609494","NCT07215312","A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin","A Phase 2, Randomized, Open-Label, Comparator-Controlled Trial to Evaluate the Efficacy and Safety of LY3938577 in Study Participants, With Type 2 Diabetes Previously Treated With Basal Insulin","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Are receiving ≥20 units of basal insulin per day and ≤55 units\u002Fday and ≤1.5 units\u002Fkg\u002Fday at screening\n* Have hemoglobin A1c (HbA1c) 7.5% to 10.5% inclusive\n* Have a body mass index (BMI) of 20 or higher and less than 35 kilograms per square meter (kg\u002Fm2)\n\nExclusion Criteria:\n\n* Have type 1 diabetes","70 Years",{"count":343,"type":23},100,[85],"The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.",[30],[248,348,141],"Hypoglycemia",{"date":167,"type":42},{"date":351,"type":42},"2025-10-13",{"date":353,"type":23},"2026-12",{"name":259,"class":73},26,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":58,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},"100609513","phase-2-a-study-of-macupatide-ly3532226-and-eloralintide-ly3841136-alone-or-in-combination-in-adults-with-obesity-or-overweight-and-with-type-2-diabetes-100609513","NCT07215559","A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes","A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have an HbA1c ≥7.5% to ≤10.5% at screening\n* Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening\n\n  * Diet and exercise\n  * Stable dose of metformin\n  * Sodium-glucose cotransporter-2 (SGLT2) inhibitor\n* Have had a stable body weight (\\\u003C5% body weight gain and\u002For loss) for the 3 months prior to screening\n* Have a BMI of 27 or greater at screening\n\nExclusion Criteria:\n\n* Have any form of diabetes other than type 2 diabetes\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening\n* Have any of the following cardiovascular conditions within 3 months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include\n\n  * basal or squamous cell skin cancer\n  * in situ carcinomas of the cervix, or\n  * in situ prostate cancer\n* Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:\n\n  * amylin RA\n  * dual amylin and calcitonin RA\n  * glucagon-like peptide-1 receptor (GLP-1) RA\n  * glucose-dependent insulinotropic peptide (GIP)\u002FGLP-1 RA\n  * GLP-1\u002Fglucagon (GCG) RAs, or\n  * GIP\u002FGLP-1\u002FGCG RAs\n* Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides\n* Have used insulin for diabetic control within the prior year (short term use in certain situations allowed",{"count":364,"type":23},200,[85],"The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.",[29,368,30],"Overweight",[370,371],"GIP","Amylin",{"date":167,"type":42},{"date":374,"type":42},"2025-10-16",{"date":376,"type":23},"2027-05",{"name":259,"class":73},42,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":407,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":414,"locationsCount":415},"100637347","phase-3-a-study-of-orforglipron-ly3502970-in-participants-with-type-2-diabetes-who-observe-ramadan-fasting-100637347","NCT07613307","A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting","A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)","ACHIEVE-RAM","Inclusion Criteria:\n\n* Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.\n* Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol\u002Fmol)) to less than 9.5% (91 mmol\u002Fmol) at screening.\n* Intend to be compliant with the fast during the Ramadan period.\n* Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.\n* Have body mass index (BMI) of 25 kilograms per meter square (kg\u002Fm2) or higher at screening.\n\nExclusion Criteria:\n\n* Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes\n* Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* Have a history of chronic or acute pancreatitis any time prior to screening\n* Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.\n* Have a history of cholecystectomy (surgically removed gallbladder)\n* Have New York Heart Association Functional Classification IV congestive heart-failure.",{"count":388,"type":23},130,[162],"The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.",[30,392,393,394,395,396,397,398,399,400,401,402,403,404,405,406],"Diabetes Melletus","Glucose Metabolism Disorders","Metabolic Disorders","Nutritional and Metabolic Diseases","Endocrine System Diseases","Feeding Behavior","Behavior","Fasting","Glucagon-Like Peptide-1 Receptor","Glucagon-Like Peptide Receptors","Receptors, G-Protein-Coupled","Receptors, Cell Surface","Membrane Proteins","Proteins","Receptors, Peptide",[408,399],"Ramadan","2026-06-18",{"date":167,"type":42},{"date":412,"type":23},"2026-07",{"date":376,"type":23},{"name":259,"class":73},37,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":341,"enrollmentInfo":422,"targetDuration":4,"studyType":24,"phases":424,"briefSummary":425,"conditions":426,"keywords":427,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":4},"100642395","effectiveness-of-low-calorie-mind-hk-diet-and-very-low-calorie-diet-on-glycemic-control-and-cardiovascular-outcomes-in-adults-with-type-2-diabetes-a-12-week-randomized-controlled-trial-100642395","NCT07635121","Effectiveness of Low-Calorie MIND-HK Diet and Very Low-Calorie Diet on Glycemic Control and Cardiovascular Outcomes in Adults With Type 2 Diabetes: A 12-Week Randomized Controlled Trial","Inclusion Criteria:\n\n1. aged 40 to 70 years old;\n2. diagnosed with Type II DM; and\n3. Chinese ethnicity and able to speak and understand Cantonese.\n\nExclusion Criteria:\n\n1. patients on dialysis;\n2. Type I and Type II DM patients with insulin use;\n3. allergic to more than one type of food in the Low-calorie MIND-HK diet and very Low-calorie MIND- HK diet (e.g. nuts, berries, olive oil, or fish);\n4. Pregnant or Breastfeeding Women;\n5. Individuals with severe mental health conditions including severe depression, anxiety or other mental issues may struggle with the psychological demands of a very low calorie diet;\n6. People with low BMI less than 18.5;\n7. participation ni any dietary program within the past 3 months.",{"count":423,"type":23},180,[109],"The objective of this project is to assess the effectiveness of a low-calorie and very low-calorie Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND-HK) diet in improving glycemic control and cardiovascular outcomes in adults with T2DM. A total of 180 participants aged 40 to 70, diagnosed with T2DM, will be recruited and randomized into three groups: intervention 1 following the low-calorie MIND-HK diet, intervention 2 following the very low-calorie diet, and an attention control group. The two intervention groups will attend four in-person nutrition counseling sessions (one per week, 60 minutes per session, followed by a 30-minute Q\\&A) at a community centre and will use KetoMetrics Breath Ketone System and dietary mobile app, to track diet and monitor daily ketone levels for early signs of ketosis that may lead to diabetic ketoacidosis (DKA). The attention control group will receive an equal amount of attention through four in-person infectious disease counseling sessions. The primary outcome will be HbA1c levels. Secondary outcomes include fasting blood glucose, lipid profile, blood pressure, body mass index, waist circumference, breath ketone, scores from the Summary Diabetes Self-Care Activities (SDSCA) Questionnaire, and MIND diet scores. This study will contribute to the growing body of evidence on dietary interventions for managing T2DM in adults.",[112],[428,429,430],"Very low-calorie MIND-HK diet","Low-calorie MIND-HK diet","KetoMetrics Breath Ketone System","2026-06-17",{"date":252,"type":42},{"date":434,"type":23},"2026-07-01",{"date":436,"type":23},"2029-01-31",{"name":438,"class":49},"Hong Kong Metropolitan University",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":299,"sex":18,"minAge":19,"maxAge":446,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":126},"100636846","phase-1-a-research-study-to-evaluate-the-safety-of-nnc1679-0001-when-given-to-healthy-participants-and-participants-with-t2dm-100636846","NCT07570992","A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM","A Phase 1,Double-blinded,Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of NNC1679-0001 When Administered to Healthy Participants and Participants With T2DM","Inclusion Criteria:\n\nAll participants\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.\n* Male or female (sex at birth) of nonchildbearing potential.\n* Age 18-64 years (both inclusive) at the time of signing the informed consent.\n\nHealthy participants\n\n* Body mass index (BMI) 18.5-29.9 kilograms per square meter (kg\u002Fm\\^2) (both inclusive) at screening.\n* Glycated haemoglobin (HbA1c) lesser than or equal to (\\\u003C=) 6.4 percent (%) (47 \\[millimoles per mole\\] mmol\u002Fmol) at screening.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nParticipants with Type 2 Diabetes Mellitus (T2DM)\n\n* BMI 20.0-34.9 kg\u002Fm\\^2 (both inclusive) at screening.\n* HbA1c 6.5-9.0% (47.5-74.9 mmol\u002Fmol) at screening.\n* Diagnosed with T2DM greater than or equal to (\\>=)180 days before screening.\n* Stable (as judged by the investigator) daily dose(s) of metformin or combination of metformin and dipeptidyl peptidase IV (DPP-4) inhibitors and\u002For sodium-glucose co-transport 2 SGLT 2) inhibitors \\>= 90 days before screening.\n\nExclusion Criteria:\n\nAll participants\n\n* Screening alanine aminotransferase (ALT) values greater than (\\>) upper limit of normal (ULN) +10%, aspartate aminotransferase (AST) values \\>ULN +20%, or total bilirubin \\>ULN.\n* Renal impairment, defined as estimated glomerular filtration rate (eGFR) \\\u003C60.0 milliliter per minute per 1.73 square meter (mL\u002Fmin\u002F1.73m\\^2), at screening.\n* Clinical evidence of chronic kidney disease (CKD) and\u002For urinary albumin: creatinine ratio (UACR) \\>30 milligrams per gram (mg\u002Fg).\n* Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disorders.\n\nHealthy participants\n\n* Any disorder that, in the investigator's opinion, might jeopardise participants' safety or compliance with the protocol.\n* Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.\n\nParticipants with T2DM\n\n* Any disorder except for mild conditions under stable treatment associated with T2DM, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.\n* Supine blood pressure at screening outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic. This exclusion criterion also pertains to those participants who are receiving antihypertensive treatment.","64 Years",{"count":448,"type":23},58,[62],"This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC1679-0001) or placebo (a treatment that has no active medicine in it). NNC1679-0001 is a new experimental medicine that doctors cannot prescribe yet. Which treatment the participant gets is decided by chance. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff.",[452,30],"Healthy Volunteers",{"date":252,"type":42},{"date":455,"type":42},"2026-05-04",{"date":457,"type":23},"2028-06-25",{"name":96,"class":73},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":134,"maxAge":341,"enrollmentInfo":467,"targetDuration":4,"studyType":469,"phases":4,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":477},"100633913","a-real-world-study-to-investigate-cardiovascular-risk-profile-among-newly-diagnosed-type-2-diabetes-mellitus-t2dm-participants-100633913","NCT07532863","A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants","A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia","CRISTALSEA","Inclusion Criteria:\n\n* Aged greater than equal to (≥) 40 and less than (\\\u003C) 70 years\n* Male or female\n* Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023\n\nExclusion Criteria:\n\n* If any exclusion criterion is met, the participant will be excluded from the study.\n* T1DM or gestational diabetes\n* Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM\n* Pregnant women\n* With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease\n* Died within 12 months after first diagnosis of T2DM\n* Lost to follow-up i.e., no visit 12 months (± 3 months) after first diagnosis of T2DM",{"count":468,"type":23},400,"OBSERVATIONAL","The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.",[30],{"date":409,"type":42},{"date":474,"type":42},"2026-03-13",{"date":434,"type":23},{"name":96,"class":73},6,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":486,"maxAge":341,"enrollmentInfo":487,"targetDuration":4,"studyType":24,"phases":489,"briefSummary":490,"conditions":491,"keywords":494,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100536635","safety-and-effectiveness-of-endoscopic-intestinal-re-cellularization-therapy-in-individuals-with-type-ii-diabetes-100536635","NCT06267391","Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes","A Multicenter, Randomized, Double-blind, Sham-controlled Study for Assessing the Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes (ReCET Study)","ReCET","Inclusion Criteria:\n\n* 22- 70 years of age, inclusive.\n* T2D diagnosis for at least 6 months.\n* HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.\n* BMI 27-40 kg\u002Fm2, inclusive.\n* On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1 or GLP-1\u002FGIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.\n* Individualized metabolic surgery (IMS) score ≤ 95.\n* Weight stability (≤5% weight change) for at least 12 weeks prior to the screening visit.\n* Agree not to donate blood during participation in the study.\n* Able to comply with study requirements and understand and sign the Informed Consent Form.\n* Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.\n* Willing and able to comply with study visits and study tasks as required per protocol.\n\nExclusion Criteria:\n\n* Diagnosed with type 1 diabetes.\n* History of diabetic ketoacidosis or hyperosmolar nonketotic coma.\n* Fasting serum C-peptide \\\u003C1 ng\u002FmL (333pmol\u002Fl).\n* Current use of insulin, or previous use of any types of insulin for \\>1 month at any time (except for treatment of gestational diabetes) in last 2 years.\n* Hypoglycemic unawareness.\n* History of ≥1 severe hypoglycemia episode in past 6 months\n* Discontinuation of a GLP-1RA or a GLP-1\u002FGIP dual-agonist within 6 months of the screening visit following at least one month of treatment.\n* Known autoimmune disease, including but not limited to, celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder, or as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test.\n* Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.\n* Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including eosinophilic esophagitis, stricture\u002Fstenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.\n* History of gastroparesis.\n* Acute gastrointestinal illness in the last 7 days.\n* Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease.\n* History of chronic or acute pancreatitis.\n* Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level \\>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory at screening visit. Patients with NAFLD are eligible if their ALT level is ≤3.0 times the ULN.\n* Current use of vitamin K antagonists, such as warfarin, or current use of direct-action oral anticoagulants (DOCAs) that cannot be safely discontinued periprocedurally.\n* Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 7 days before the procedure.\n* Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment through 4 weeks following the procedure. Alternative use of acetaminophen and low dose aspirin is allowed.\n* Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the screening visit.\n* Use of medications known to affect GI motility (e.g. metoclopramide\u002F Reglan)\n* Current use of weight loss medications such as Saxenda \\[liraglutide \\], Xenical® \\[orlistat\\], Acutrim® \\[phenylpropanolamine\\], Sanorex® \\[mazindol\\], Adipex® \\[phentermine\\], BELVIQ® \\[lorcaserin\\], Qsymia® \\[phentermine\u002Ftopiramate combination\\], Contrave® \\[naltrexone\u002Fbupropion\\], or other weight loss medications including over-the-counter \\[OTC\\] medications \\[for example, Allī®\\]) or have discontinued weight loss medications within 6 months.\n* Participation in any structured weight loss program or endoscopic weight loss intervention within 6 months of the screen visit.\n* Persistent anemia, defined as hemoglobin \\\u003C10 g\u002FdL.\n* Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.\n* History of blood donation or transfusion within 3 months prior to the Screening Visit.\n* Unstable or paroxysmal cardiac arrhythmia.\n* Any of the following cardiovascular conditions within 6-months prior to screening visit: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization due to congestive heart failure.\n* History of valvular heart disease or chronic heart failure (NYHA III or IV).\n* Estimated glomerular filtration rate (eGFR) ≤ 45 ml\u002Fmin\u002F1.73m2 calculated by CKD-EPI Creatinine Equation as determined by the central laboratory.\n* Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.\n* History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening).\n* Presence of any implanted electronic devices that cannot be turned off during the procedure\n* Presence of duodenal or biliary stents.\n* Not a candidate for upper GI endoscopy or general anesthesia.\n* Active illicit substance abuse or alcoholism (\\>2 drinks\u002Fday regularly).\n* Active malignancy within the last 5 years (excluding non-melanoma skin cancers).\n* Women who are breastfeeding.\n* Participating in another ongoing clinical trial of an investigational drug or device.\n* Binge eating disorder, or any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.\n* Critically ill or has a life expectancy \\\u003C5 years.\n* Are investigator site personnel directly affiliated with this study and\u002For their immediate family member. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.","22 Years",{"count":488,"type":23},264,[109],"This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.",[492,493,30,201,144],"Type 2 Diabetes Mellitus","Type2diabetes",[201,144,495],"Duodenal Mucosal Resurfacing",{"date":252,"type":42},{"date":498,"type":42},"2024-05-01",{"date":500,"type":23},"2026-10-01",{"name":502,"class":73},"Endogenex, Inc.",45,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":512,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":24,"phases":515,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":50},"100541919","oasis-peer-support-for-t2dm-in-appalachia-peer-participant-100541919","NCT06336122","OASIS: Peer Support for T2DM in Appalachia (Peer Participant)","Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.","OASIS","Inclusion Criteria:\n\n* Age greater than or equal to 55 years\n* Resident in Rural Kentucky\n* Positive Diagnosis of Type 2 Diabetes Mellitus\n* HbA1c greater than or equal to 7.5%\n* Passing score on cognitive assessment administered by study personnel\n* English Speaking\n\nExclusion Criteria:\n\n* Age less than 55 years\n* Not a resident of a Rural Kentucky County\n* No Type 2 Diabetes Mellitus Diagnosis\n* HbA1c under 7.5%\n* Cognitive Impairment\n* Non-english speaking","55 Years",{"count":514,"type":23},76,[109],"The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:\n\n* Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?\n* If effective, which facets of the peer model are most effective? Peer coaches will undergo peer coach training.\n* Reach out to peer participants on a weekly\u002Fbiweekly time frame to discuss self-management and goal setting.\n\nRetain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.",[30],[519,520,30],"Appalachian Region","Peer Influence","2026-06-15",{"date":431,"type":42},{"date":524,"type":42},"2023-11-20",{"date":526,"type":23},"2027-03-31",{"name":528,"class":49},"The University of Texas Medical Branch, Galveston",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":299,"sex":18,"minAge":512,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":540,"conditions":541,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":552},"100524721","a-randomized-comparison-of-stage-based-care-versus-risk-factor-based-care-for-prevention-of-cardiovascular-events-100524721","NCT06112418","A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events","A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events","TRANSFORM","Inclusion Criteria:\n\n1. Provided electronic or written informed consent\n2. Men \\> 55, women \\> 65 years of age\n3. Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and\u002For fasting glucose 100-125 mg\u002FdL \\[5.6-6.9 mmol\u002FL\\]) and\u002For metabolic syndrome. Metabolic syndrome is defined as \\> 3 of the following criteria (International Diabetes Federation 2006):\n\n   * Body mass index ≥ 27 kg\u002Fm2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)\n   * Fasting triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or treated hypertriglyceridemia\n   * HDL-cholesterol (HDL-C) \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in men, \\\u003C50 mg\u002FdL (1.29 mmol\u002FL) in women or treatment for this lipid abnormality\n   * Systolic blood pressure (BP) ≥ 130 and\u002For diastolic BP≥ 85 mm Hg and\u002For treated hypertension\n   * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or HbA1c ≥ 5.7%\n4. Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group\n\nExclusion Criteria:\n\n1. History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure\n2. Planned arterial revascularization\n3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:\n\n   1. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator)\n   2. Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.\n   3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment\n   4. Weight \\> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site\n   5. Inability to hold breath for \\> 10 seconds\n   6. Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute at screening or prior to CCTA)\n   7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA\n   8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA\n4. Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \\\u003C 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)",{"count":538,"type":23},7500,[109],"TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.",[30,542,543],"PreDiabetes","Metabolic Syndrome",{"date":545,"type":42},"2026-06-16",{"date":547,"type":42},"2024-03-06",{"date":549,"type":23},"2029-03-05",{"name":551,"class":73},"Cleerly, Inc.",124,{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":509,"acronym":510,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":512,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":24,"phases":560,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":566,"leadSponsor":567,"locationsCount":50},"100516370","oasis-peer-support-for-t2dm-in-appalachia-peer-coaches-100516370","NCT06003634","OASIS: Peer Support for T2DM in Appalachia (Peer Coaches)","Inclusion Criteria:\n\n* Age greater than or equal to 55 years\n* Resident in Rural Kentucky\n* Positive diagnosis of Type 2 Diabetes Mellitus\n* HbA1c less than 7.5 for peer coaches\n* Passing score on cognitive assessment administered by study personnel\n* English Speaking\n\nExclusion Criteria:\n\n* Age less than 55 years\n* Not a resident of a Rural Kentucky County\n* No Type 2 Diabetes Mellitus Diagnosis\n* Cognitive Impairment\n* Non-English Speaking",{"count":7,"type":23},[109],"The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:\n\n* Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?\n* If effective, which facets of the peer model are most effective? Peer coaches will undergo peer coach training.\n* Reach out to peer participants on a weekly\u002Fbiweekly time frame to discuss self-management and goal setting.\n* Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.",[30],[519,520,30],{"date":431,"type":42},{"date":524,"type":42},{"date":526,"type":23},{"name":528,"class":49},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":469,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":583,"leadSponsor":585,"locationsCount":586},"100641221","research-study-to-examine-blood-sugar-control-treatment-satisfaction-and-adherence-in-people-with-type-2-diabetes-after-switching-from-daily-basal-insulin-to-once-weekly-insulin-icodec-100641221","NCT07658417","Research Study to Examine Blood Sugar Control, Treatment Satisfaction and Adherence in People With Type 2 Diabetes After Switching From Daily Basal Insulin to Once-weekly Insulin Icodec","A Real-world, Multi-centre, Prospective, Non-interventional, Single-arm Study Investigating Glycaemic Control, Treatment Satisfaction and Adherence Associated With the Switch From Daily Basal Insulin to Insulin Icodec in People Living With Type 2 Diabetes in China","ICOSWITCH REAL","Inclusion Criteria:\n\n1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to protocol).\n2. The decision to initiate treatment with commercially available insulin icodec has been made by the participant\u002FLegally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include participant in this study.\n3. Male or female, age above or equal to 18 years at the time of signing informed consent.\n4. Diagnosed with T2D greater than or equal to (≥) 1 year before signing informed consent.\n5. Treated with once- or twice-daily basal insulin injections ≥ 6 months before signing informed consent. Any other antidiabetic medications are allowed, except for bolus insulin during the 90 days prior to switching to icodec for a period of 14 days or more.\n6. Available glycated haemoglobin (HbA1c) within 90 days prior to the 'Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Initiation visit' (V1) if in line with local clinical practice.\n7. Treatment-naïve to once-weekly insulin prior to the 'Initiation Visit' (V1)\n\nExclusion Criteria:\n\n1. Previous participation in this study. Participation is defined as having given informed consent in this study.\n2. Treatment with any investigational drug within 30 days prior to enrolment into study.\n3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.",{"count":577,"type":23},216,"The purpose of this study is to investigate the use of insulin icodec in the real-world setting in a population that broadly reflects people living with T2D and for whom switching to a once-weekly insulin icodec has been deemed relevant and beneficial by the treating physician. The study will last for approximately 30 weeks.",[30],"2026-06-13",{"date":252,"type":42},{"date":521,"type":23},{"date":584,"type":23},"2027-12-01",{"name":96,"class":73},15,{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":594,"enrollmentInfo":595,"targetDuration":4,"studyType":24,"phases":597,"briefSummary":598,"conditions":599,"keywords":608,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":50},"100593800","primary-care-pragmatic-real-world-experience-for-automated-insulin-delivery-100593800","NCT07011147","Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery","PREPARE 4 AID","Inclusion Criteria:\n\n1. Age at time of consent \\>18 and \\\u003C89 years\n2. Either 2.a. or 2.b.:\n\n   1. Clinical diagnosis of type 1 diabetes for at least one year and using insulin for at least 1 year\n   2. Clinical diagnosis of type 2 diabetes, on current injected or infused insulin regimen for at least 3 months prior to screening (e.g., basal-bolus, basal only, or pre-mix)\n3. Stable doses of glucose lowering medications over the preceding 4 weeks as determined by Investigator, including GLP-1 receptor agonists (GLP-1 RA) and GLP-1\u002FGIP RA agents\n4. Stable doses of weight loss medications (including GLP-1 RA and GLP-1\u002FGIP RA agents) over the preceding 4 weeks as determined by the investigator.\n5. For those using the iLet Bionic Pancreas (during the RCT arm or observational extension phase), willingness to stay on current doses of medications throughout the study that may affect glycemia directly and\u002For indirectly, except for a dose reduction or discontinuation.\n6. Have a primary care clinician willing to refer them to the study, confirm their diabetes diagnosis (for example: type 1 diabetes or type 2 diabetes), and recommend and manage the iLet for the duration of the study\n7. Willing to comply with all study procedures for the duration of the study\n8. Willing to wear a Dexcom CGM device and iLet system for duration of time randomized to iLet use or OEP\n9. Willing to use the following insulin: lispro (including non-branded lispro and Humalog) or aspart (including non-branded aspart, Fiasp, and Novolog)\n10. Investigator has confidence that the participant has the cognitive ability and can successfully operate all study devices and can adhere to the protocol\n11. Willing and able to sign and date the Informed Consent Form (ICF)\n12. If capable of becoming pregnant, willing and able to have pregnancy testing and use an acceptable method of contraception during the study period\n\n    a. Capable of becoming pregnant means that menstruation has started and the participant is not surgically sterile or post-menopausal (12 months without menses) b. Acceptable methods of contraception include: i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).\n\n    ii. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).\n\n    iii. Placement of an intrauterine device or intrauterine hormone-releasing system.\n\n    iv. Barrier methods of contraception (condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository).\n\n    v. Has a vasectomized or sterile partner (where partner is sole partner of participant) and where vasectomy has been confirmed by medical assessment.\n\n    vi. Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study.\n13. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration\n14. Have hardware and internet access capable of 2-way video and audio communication\n\nExclusion Criteria:\n\n1. Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)\n2. Unable to speak and read English, as iLet BP support materials and device menus are currently available in English only\n3. Diagnosis of maturity-onset diabetes of the young (MODY)\n4. Plan to change usual diabetes regimen between screening and study randomization\n\n   1. This would include changing from MDI to pump or from pump to MDI, starting a new class of type 2 diabetes medication, or starting or increasing GLP-1 RA or GLP-1\u002FGIP RA medication\n   2. This would NOT include changes to any insulin doses, including pump settings, short- and\u002For long-acting insulin doses and type of insulin; changing type 2 diabetes medication dosing (except GLP-1 RA or GLP-1\u002FGIP RA); or changing type of type 2 diabetes medication within the same class\n5. Weigh more than 255 kg (561 pounds) as this is the maximum weight that can be entered into the iLet user interface\n6. History of bariatric surgery within 12 months prior to enrollment or plans for bariatric surgery within the period of study participation\n7. Current use of a closed-loop or hybrid closed-loop insulin delivery system that is not FDA-cleared (e.g. \"DIY Loop\", \"AAPS\", \"iAPS\" or \"Open APS\")\n8. Diagnosed blood disorder or dyscrasia associated with hemolysis, including for example: sickle cell disease and thalassemia, which in the Investigator's opinion could interfere with HbA1c accuracy\n9. Planned use of hydroxyurea at any dose and\u002For of acetaminophen at doses exceeding 1 gram (1000 mg) every 6 hours.\n10. Plans to receive a blood transfusion over the course of the study or has received a transfusion within 3 months prior to enrollment\n11. Current participation in another diabetes-related clinical trial\n12. History of diabetes due to cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy\n13. Have a history of intermittent oral or injectable glucocorticoid treatment within 8 weeks prior to screening or plans to take intermittent oral or injectable glucocorticoid during the study (chronic, stable treatment is acceptable, unplanned use is acceptable)\n14. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the 6 months prior to screening, unrelated to an intercurrent illness or to a kinked, dislodged, or occluded cannula\n15. Established history of allergy or severe reaction to adhesive or tape that must be used in the study\n16. Treated currently or within the past 30 days prior to enrollment, or plan to begin treatment, with sulfonylurea, pramlintide, or SGLT-2 inhibitor medication\n17. Any planned surgery during the study that would be considered major in the opinion of the investigator\n18. Pregnant or lactating, or planning to become pregnant in the next 6 months\n19. Renal failure on dialysis or chronic renal disease with a GFR or eGFR \\\u003C30mL\u002Fmin (values within the last two years will be accepted; if none available or \\>2 years prior, participant will be instructed to obtain GFR or eGFR through their usual care provider and to make copy of result available to study team)\n20. Any condition or circumstance that, in the opinion of the site principal investigator, could interfere with the safe or effective completion of the study or which could compromise the results of the study c. Conditions to be considered by the investigator may include, but are not limited to, the following: i. Active clinical diagnosis of substance use disorder ii. Chronic use of opiates and\u002For benzodiazepines which, in the opinion of the investigator, might make it difficult for the participant to follow study procedures iii. Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening, a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting iv. Known history of prolonged QTc interval, malignant arrhythmia, or severe congenital heart disease v. Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV vi. History of TIA or stroke in the last 12 months vii. Untreated or inadequately treated mental illness viii. History of untreated or inadequately treated eating disorder within the last 2 years, such as anorexia, bulimia, or diabulimia, or omission of insulin to manipulate weight ix. History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment\n21. Plans to travel outside of the US and its territories for more than four weeks consecutively\n22. Plans not to have internet\u002Fvideo\u002Fphone access for more than one week consecutively\n23. Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also 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 clinical trial\n24. Previous use of the iLet for more than four weeks (including use of the commercially available iLet or prior participation in a study involving wearing the iLet for more than four weeks)","89 Years",{"count":596,"type":23},240,[109],"The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:\n\nCan the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?\n\nResearchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.\n\nParticipants will:\n\nUse the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks",[600,144,601,602,112,603,604,201,605,606,607],"Type 1 Diabetes (T1D)","Diabetes, Autoimmune","Diabetes Mellitus","Diabetes Mellitus, Type I","Diabetes, Type II","Diabetes Mellitus, Insulin-Dependent","Diabetes Mellitus Type II","Diabetes Type 2 on Insulin",[609,610,611,612,613,614,615,616,116,617,618],"automated insulin delivery","type 1 diabetes","type 2 diabetes","bionic pancreas","closed loop","pancreas, artificial","t1d","t2d","insulin","primary care","2026-06-10",{"date":312,"type":42},{"date":622,"type":42},"2026-01-16",{"date":624,"type":23},"2029-04-01",{"name":626,"class":49},"University of Colorado, Denver",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":635,"minAge":19,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":24,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":126},"100560199","michigan-mens-diabetes-project-iiimendiii-mind-and-motion-100560199","NCT06574035","Michigan Men's Diabetes Project III(MenDIII): Mind and Motion","Michigan Men's Diabetes Project 3 (MenD 3): Mind and Motion","MenDIII","Inclusion Criteria:\n\n* African American\u002FBlack males\n* age 18 years or older\n* ambulatory status\n* diagnosis of Type 2 Diabetes (T2D) for one year duration or longer\n* be under the care of a physician for their diabetes, self report an A1C of 7.0% or more in the last year\n* be willing to participate in study events (weekly physical activity, exercise and CBT sessions, group discussion sessions, and in-person health assessments)\n* have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks\n* live in the Wayne or Washtenaw County\\\\\n* have reliable transportation to in-person events\n\nExclusion Criteria:\n\n* stage 2 hypertension as defined by Joint National Committee (JNC) VIII\n* recent cardiac events\n* recent laser surgery for proliferative retinopathy\n* history of stroke\n* lower limb amputation\n* peripheral neuropathy\n* severe Chronic Obstructive Pulmonary Disease (COPD) (e.g., basal oxygen)\n* class III or IV heart failure\n* medical instability.\n\nPer American College of Sports Medicine (ACSM) guidelines, medical exclusion criteria will also include currently experiencing:\n\n* ongoing unstable angina\n* uncontrolled cardiac arrhythmia with hemodynamic compromise\n* active endocarditis\n* symptomatic severe aortic stenosis\n* acute myocarditis or pericarditis\n* acute aortic dissection\n* acute pulmonary embolism\n* pulmonary infarction\n* deep venous thrombosis\n* physical disability that precludes safe and adequate testing\n* chest discomfort with exertion\n* unreasonable breathlessness, or dizziness, fainting, or blackouts.\n\nAs part of the screening process, the investigators will ask the participant to self-report on these conditions. Participants who are currently receiving psychotherapy services for the treatment of depression from a mental health provider will be excluded. Participants who are currently receiving only medication management from a psychiatrist will be included.\n\nIf you are interested in the study, please complete our screening survey: https:\u002F\u002Fredcapproduction.umms.med.umich.edu\u002Fsurveys\u002F?s=JNPPEDANX7KLPPF9. Thank you so much!","MALE",{"count":637,"type":23},80,[109],"The Michigan Men's Diabetes Project III: Mind \\& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet\u002Fphone\u002Fcomputer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours\u002Fsessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.",[30,641,642],"Depressive Symptoms","Depression",{"date":644,"type":42},"2026-06-12",{"date":646,"type":42},"2025-01-13",{"date":255,"type":23},{"name":649,"class":49},"University of Michigan",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":24,"phases":659,"briefSummary":660,"conditions":661,"keywords":664,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":671,"startDateStruct":672,"completionDateStruct":673,"leadSponsor":675,"locationsCount":50},"100641892","automated-insulin-delivery-versus-daily-injections-for-hospital-diabetes-care-100641892","NCT07645079","Automated Insulin Delivery Versus Daily Injections for Hospital Diabetes Care","Inpatient Diabetes Management With Automated Insulin Delivery Systems Compared to Multiple Daily Injections With a Basal-bolus Regimen - a Randomized Controlled Trial","Inclusion Criteria:\n\n* A documented history of Type 2 diabetes mellitus (T2DM) which requires subcutaneous insulin therapy\n* acute infectious disease of any kind\n* age ≥ 18 years old\n* willingness and ability to comply with theclinical investigation plan\n* ability to communicate with the trial personal\n* an expected length of hospital stay for at least 2 days after enrolment\n\nExclusion Criteria:\n\n* Patients already using AID for their glycemic management\n* Patients in use of an insulin pump\n* Skin pathologies that hinder application of a FreeStyle Libre-3 CGM and mylife YpsoPump\n* Participation in another trial, which could influence the outcome of the trial\n* Any mental condition rendering the patient incapable of giving informed consent\n* Known or suspected allergy to adhesive material\u002Ftape of the Libre-3-sensor and\u002For YpsoPump\n* Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient\n* Diagnoses\u002Ftreatments\u002Fclinical parameters prohibiting use of Insulin\u002FAID such as\n\n  * Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m2 OR\n  * Treated with hydroxyurea\u002Fhydroxycarbamide OR\n  * Nutritional therapy (continuous enteral or parenteral feeding) OR\n  * Clinically relevant pancreatic disease OR\n  * Aystemic glucocorticoid treatment with prednisone equivalent dose \\>5 mg\u002Fday OR\n  * Expected to require admission to the intensive-care unit OR \\> Patients in dialysis",{"count":658,"type":23},92,[109],"Aim\n\nThe investigators aim to investigate if automated insulin delivery systems (AID) improve in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard-of-care with a pen-basal-bolus insulin regimen manually titrated by general staff at Herlev-Gentofte Hospital and a clinical decision support system (GlucoTab) titrating the basal-bolus regimen automatically daily at Graz University Hospital.\n\nPopulation\n\nHospitalized patients with type 2 diabetes in non-intensive care units (non-ICU) at medical wards at Copenhagen University Hospitals of Herley-Gentofte (affiliated with Steno Diabetes Center Copenhagen) and Medical University Hospital of Graz (N = 92).\n\nDesign\n\nThis is an investigator-initiated, two-armed, two-site, prospective, randomized, open-label, blinded endpoint (PROBE) trial.\n\nObjectives\n\nThe objective is to determine the glycemic and clinical effects of inpatient AID systems in non-ICU patients with type 2 diabetes. Participants will be randomized in a usual-of-care and an AID arm. Diabetes management will be performed by usual care in the control arm based on a basal-bolus insulin regimen and point-of-care (POC) glucose testing. A continuous glucose monitoring (CGM) system (Abbott FreeStyle Libre 3) will be used in all groups for outcome analysis and comparison between the groups. The CGM will be blinded for the control arm, to not interfere with the usual of care because of the higher amount of glucose data. The AID-arm will be managed by an AID system with real-time CGM data transmitted to nursing stations.\n\nOutcomes\n\nPrimary outcome: The primary outcome is the difference in CGM-recorded time in range (TIR) (70-180 mg\u002Fdl (3.9-10.0 mmol\u002Fl)) between the POC- and the CGM-arm according to the 2023 in-hospital CGM consensus during the entire hospital stay.\n\nSecondary outcomes: Outcomes are reported according to the 2023 in-hospital CGM consensus and specified in the protocol during the entire hospital stay, including three levels of time above range (TAR) 180-250mg\u002Fdl (10.0-13.9 mmol\u002Fl), \\>250mg\u002Fdl (\\>13.9 mmol\u002Fl), and \\>180mg\u002Fdl (\\>10.0 mmol\u002Fl); three levels of time below range (TBR) 54-70mg\u002Fdl (3.0-3.9 mmol\u002Fl), \\\u003C54mg\u002Fdl (\\\u003C3.0 mmol\u002Fl), and \\\u003C70mg\u002Fdl (\\\u003C3.9 mmol\u002Fl); events of hypoglycemia in three levels, 54-68mg\u002Fdl (3.0-3.8 mmol\u002Fl), \\\u003C54mg\u002Fdl (\\\u003C 3.0 mmol\u002Fl), and \\\u003C70mg\u002Fdl (\\\u003C3.9 mmol\u002Fl), where the glucose values between the two hypoglycemic events must all be \\>70mg\u002Fdl (\\>3.9 mmol\u002Fl) for at least 15 consecutive minutes(1), including prolonged hypoglycemic events (\\> 120 minutes), recurrent hypoglycemic events (events preceded by another hypoglycemic event), and recurrent hypoglycemic days (percentage of days with at least one hypoglycemic event on separate days that is preceded by another in-hospital day with hypoglycemia(1)); mean glucose level; standard deviation (SD) of the CGM glucose distribution; coefficient of variation (CV); and insulin doses during hospitalization.\n\nClinical outcomes: The investigator assess the length of hospital stay as calculated from time of admission until discharge; in-hospital mortality; admissions to intensive care unit; any in-hospital-related complications occurring at least one day after randomization and until discharge, as documented and defined by the treating physician in the electronic health record (e.g., acute kidney injurie, sepsis, etc.)\n\nMethod\n\nFor the usual-of-care-arm, glucose assessment is done by standard POC glucose testing and insulin is manually titrated by general staff at Herlev-Gentofte Hospital and the glucose assessment is done by standard POC glucose testing and insulin is manually titrated by the GlucoTab system titrating the basal-bolus regimen automatically daily at Graz University Hospital. For the AID-arm, CGM data informs in real time the mylife Ypsopump for automated insulin delivery.\n\nDevice\n\nThe investigational device is the AID system, containing of the mylife YpsoPump and the FreeStyle Libre 3 sensor.",[112,662,663],"Infection","CGM",[665,666,663,667,668,308,669,670],"automated insulin delivery systems","AID","continouse glucose monitoring","infectiouse disease","diabetes mellitus type 2","GlucoTab",{"date":644,"type":42},{"date":434,"type":23},{"date":674,"type":23},"2027-07-30",{"name":676,"class":49},"Steno Diabetes Center Copenhagen"]