[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-type-2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-type-2":655},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,48,70,98,123,150,172,212,237,260,278,307,332,355,377,409,433,460,484,506,533,553,582,612,634],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100641925",false,"NCT07661381","An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.","\"An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes.\"","PREVAIL","Inclusion Criteria:\n\n* Age: ≥18 years\n* HbA1c: ≥53 mmol\u002Fmol (7 - 12%)\n* Signed informed consent form and willing to comply with the study procedures\n* Persons who are naïve for participation in a lifestyle program for the past two years\n* Being digitally competent\n* Mastering the Dutch language\n* Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)\n\nExclusion Criteria:\n\n* Medication use: any other glucose-lowering medication than metformin\n* Comorbidities or medical conditions requiring a special diet that conflicts with the study\n* Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)\n* Circumstances that lead to unreliable HbA1c values, such as blood donation\n* Pregnant or lactating women","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.",[27],"Diabetes Type 2",[29,30,31,32,33,34],"Lifestyle intervention","Artificial intelligence","Remote study","Dietary intake","Continuous glucose monitoring","Lifestyle coach","NOT_YET_RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-25","ACTUAL",{"date":41,"type":21},"2026-09",{"date":43,"type":21},"2028-12",{"name":45,"class":46},"University of Twente","OTHER",1,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100637770","NCT07617519","Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison","Inclusion Criteria:\n\n* All people with active clinical care at SDCC during each period and thereby included in the RPM.\n\nExclusion Criteria:\n\n* All people without active clinical care at SDCC during each period.",{"count":54,"type":21},12000,"OBSERVATIONAL","The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is:\n\nWhether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024.\n\nParticipants are included in the RPM-system as part of their regular medical care for diabetes.",[58,59,60,27,61,62],"Diabetes","Diabetes Care","Diabetes Type 1","Remote Patient Monitoring","Digital Health",{"date":38,"type":39},{"date":65,"type":21},"2026-06",{"date":67,"type":21},"2028-07",{"name":69,"class":46},"Steno Diabetes Center Copenhagen",{"id":71,"slug":4,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":47},"100621902","NCT07376655","Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life","Inclusion Criteria:\n\n* Be at high risk for chronic disease defined as:\n\nBody mass index (BMI)\\>25\n\nBMI\\\u003C=25 who are prediabetic or have type 2 diabetes\n\n* Aged 40 years or older\n\nExclusion Criteria:\n\n* Unable to walk",true,"40 Years",{"count":78,"type":21},20,[24],"The goals of this randomized trial is to learn:\n\n1. If the Thrive AI Health app will help adults improve their everyday habits (diet, exercise, and sleep).\n2. How often participants will use the Thrive AI Health app to which they will have free access\n\nThe Thrive AI Health app uses artificial intelligence (AI) to give personalized advice. It is designed to help people eat better, exercise more, manage stress, and sleep well.\n\nResearchers will compare changes in diet, exercise and sleep in participants using the app to those participants not using the app.\n\nParticipants will complete study questionnaires and an in-person visit at the beginning and end of the study.",[27,82],"Overweight or Obesity",[84,85,86,87],"Health app","Diet","Exercise","Sleep","RECRUITING","2026-06-15",{"date":91,"type":39},"2026-06-17",{"date":93,"type":39},"2026-06-04",{"date":95,"type":21},"2027-04",{"name":97,"class":46},"Yale University",{"id":99,"slug":4,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100471222","NCT05416060","Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age","Dulce Digital","Inclusion Criteria:\n\n* Hispanic\u002FLatino adults who are registered patients of Scripps Health\n* Diagnosis of Type 2 Diabetes\n* HbA1c greater than or equal to 8% within the last 60 days\n\nExclusion Criteria:\n\n* Severe illness precluding visits to clinic\n* Liver function tests (ALT and AST) \\> 3 times the upper limit of normal\n* Body mass index ≤ 23 kg\u002Fcm\n* History of malignancy, except subjects who have been disease-free for \\>2 years, or whose only malignancy has been basal or squamous cell skin carcinoma\n* Creatinine \\>3.5\n* History of drug or alcohol abuse within 12 months prior to randomization\n* Current enrollee in DSME\u002FS\n* Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening\n* Anemia\n* Lack of minimal literacy needed to participate in the text intervention\n* Severe auditory or visual problems\n* Primary language other than Spanish or English\n* Not willing to carry a mobile phone\n* Pregnant\n* Plans to relocate",{"count":105,"type":21},150,[24],"The proposed research, \"Dulce Digital 2.0,\" will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.",[27],[58,110,111,112,113,114],"Health Education","mHealth Technology","Group Education","Telehealth","Text-Based",{"date":91,"type":39},{"date":117,"type":39},"2023-03-23",{"date":119,"type":21},"2027-06-30",{"name":121,"class":46},"Scripps Whittier Diabetes Institute",2,{"id":124,"slug":4,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":131,"conditions":132,"keywords":138,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":47},"100639891","NCT07605572","Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity","GALENOS","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).\n3. Patients able to provide informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patients.\n2. History of multiple severe hypoglycemic episodes within the past two years.\n3. Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.\n4. Patients who have undergone cataract surgery or vitrectomy within the past 6 months.\n5. History of ketoacidosis or metabolic acidosis.\n6. History of corneal transplantation.",{"count":130,"type":21},100,"Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.",[133,134,135,136,27,137],"Dry Eye Disease (DED)","Diabete Mellitus","GLP-1","Ocular Surface","Cornea",[139,27,140,137],"Dry eye disease","GLP-1 Receptor Agonists","2026-05-29",{"date":143,"type":39},"2026-06-02",{"date":145,"type":39},"2026-03-01",{"date":147,"type":21},"2027-02-28",{"name":149,"class":46},"Attikon Hospital",{"id":151,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":47},"100509378","NCT05912647","Enhancing Diabetes Management Approaches for Patients With Uncontrolled Diabetes","A Multiphase Optimization Strategy to Enhance Diabetes Management Interventions for Patients With Uncontrolled Diabetes","ENRxICH","Inclusion Criteria:\n\n* Men and women ages 18-90 with diagnosed type 2 diabetes who speak and understand English or Spanish.\n* Taking at least one oral or injectable diabetes medication\n* HbA1c ≥ 7.5% based on point of care test.\n* Will reside in the geographical area throughout the study period.\n* Have access to a phone during the study period.\n* Willing to attend all orientation\u002Ftraining sessions.\n\nExclusion Criteria:\n\n* Having a caregiver who is the main decision maker in self-management.\n* Participating in another lifestyle, or medication adherence program.\n* Participated in standard MTM\u002FMTM-related intervention in the last 6 months.\n* Women who are pregnant or plan to get pregnant in the next 6 months.","90 Years",{"count":159,"type":21},376,[24],"The purpose of the study is to learn about the best way to enhance pharmacy-related care for diabetes self-management.\n\nThis research is being done because we want to improve use of medicines and diabetes management among adults with type 2 diabetes and find out which of type of support may improve diabetes self-management for adults.\n\nParticipants will be assigned to one of 4 groups, and will either:\n\n* receive care as usual; or,\n* receive added medicine management support from a pharmacist; or,\n* receive support from a Community Health Worker (CHW) to address life challenges; or,\n* receive both the pharmacist medicine management and the CHW support",[58,27],"2026-05-27",{"date":165,"type":39},"2026-06-01",{"date":167,"type":39},"2024-02-03",{"date":169,"type":21},"2027-12-01",{"name":171,"class":46},"University of Wisconsin, Madison",{"id":173,"slug":4,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":182,"conditions":183,"keywords":189,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":211},"100623747","NCT07400653","A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)","EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form (ICF)\n* Male or female adults, aged ≥18 years\n* Have a BMI at Screening of ≥27.0 kg\u002Fm2\n* Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria\n* Have HbA1c value between ≥6.5% (48 mmol\u002Fmol) and ≤10.0% (86.0 mmol\u002Fmol) at Screening with stable therapy for at least 90 days prior to Screening\u002FVisit 1. T2DM may be treated with:\n\n  --Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin\n* Participants must be motivated and willing to:\n\n  * Self-inject study medication (or be aided by caregiver if needed),\n  * Perform finger-stick glucose monitoring as required.\n* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria:\n\n* Female who is breastfeeding, or who is pregnant\n* Unwilling or unable to follow contraceptive requirements\n* Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.\n* Severe hypoglycemia and\u002For hypoglycemia unawareness within the 6 months prior to Screening\n* Poorly controlled hypertension\n* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)\n* Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss\n* Are receiving or have received within 3 months prior to screening chronic (\\>2 weeks or 14 days) systemic glucocorticoid therapy",{"count":179,"type":21},999,[181],"PHASE3","The purpose of this clinical study is to learn about the safety and effects of the study medicine to help adults with obesity or overweight and type 2 diabetes lose weight. Being overweight or obese means carrying too much body weight. Type 2 diabetes is a condition where there is too much sugar in the blood.\n\nThe study medicine is given by a shot under the skin in the belly area. The participants will be trained to do this at home once every week.\n\nAbout 660 out of 1000 adults will also receive the study medicine and about 330 out of 1000 adults will receive placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help us assess if the study medicine is safe and effective.\n\nPeople will take part in this study for about 21 months. During this time, they will have about 14 study visits at the site and 5 over the phone.",[184,185,186,187,188],"Obesity","Overweight and\u002For Obesity","Overweight","Diabetes, Type 2","Type 2 Diabetes",[190,191,192,193,194,195,196,197,198,199,186,184,200],"Overnutrition","Nutrition Disorders","Nutritional and Metabolic Diseases","Body Weight","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Diabetes Mellitus","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Diseases","Diabetes Mellitus, Type 2","2026-05-14",{"date":203,"type":39},"2026-05-18",{"date":205,"type":39},"2026-02-24",{"date":207,"type":21},"2028-05-16",{"name":209,"class":210},"Pfizer","INDUSTRY",183,{"id":213,"slug":4,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":47},"100603362","NCT07135531","Continuous Glucose Monitoring (CGM) in an Underserved Population","Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications","Inclusion Criteria:\n\n* Age 18-75 years\n* Type 2 diabetes mellitus\n* HbA1C ≥ 7.5%\n* At least on 1 insulin injection therapy daily\n* Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas\n* Patients with Medicaid or free care or uninsured\n* Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Currently on CGM or using insulin pump\n* Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) \\\u003C40\n* Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate\n* The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement\n* Pregnant","75 Years",{"count":220,"type":21},50,[24],"The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.",[58,196,27],[225,226,33,227],"Medicaid","Underinsured","Uninsured","2026-05-03",{"date":230,"type":39},"2026-05-05",{"date":232,"type":39},"2026-03-19",{"date":234,"type":21},"2027-07",{"name":236,"class":46},"Tulane University",{"id":238,"slug":4,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":47},"100472069","NCT05427084","Canagliflozin Targeting Vascular Inflammation","Canagliflozin Targeting Vascular Inflammation: An Ottawa Imaging Study - A Pilot Study","CANTORSING","Inclusion Criteria:\n\n* 1\\) Stable CAD (over 60 days post-myocardial infarction).\n* 2\\) Diabetes\n* 3\\) given informed consent.\n\nExclusion Criteria:\n\n1. severe LV dysfunction (EF\\\u003C50%);\n2. decompensated heart failure;\n3. active infection (e.g. pneumonia, active skin infections, and on antibiotics);\n4. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));\n5. pregnancy (all women of child bearing potential will have a negative BHCG test;\n6. breastfeeding;\n7. Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.\n8. glomerular filtration rate (GFR) \\\u003C50 ml\u002Fmin\u002F1.72m2;\n9. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);\n10. Hemoglobin \\\u003C 105(women) \\\u003C110 (men) g\u002FL; WBC \\\u003C 3.0x 10(9)\u002FL, platelet count\\\u003C 110x 10(9)\u002FL;\n11. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.\n12. unable to give informed consent;",{"count":245,"type":21},24,[247,181],"PHASE2","CANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of treatment. The investigators plan to enroll 8 patients in each arm (total sample size: 16 patients). Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm.",[27,250],"Coronary Artery Disease","2026-04-30",{"date":253,"type":39},"2026-05-06",{"date":255,"type":39},"2024-11-15",{"date":257,"type":21},"2026-12",{"name":259,"class":46},"Ottawa Heart Institute Research Corporation",{"id":261,"slug":4,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":277,"locationsCount":47},"100597739","NCT07062406","Enhancing Diabetes Care by Treating Insomnia","Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes","Inclusion Criteria:\n\n* aged 40 or older\n* receive primary care from participating clinic\n* diagnosis of type 2 diabetes\n* most recent hemoglobin A1c (HbA1c) \\>7% within the past year\n* Insomnia Severity Index (ISI) score ≥15\n* able to speak English\n\nExclusion Criteria:\n\n* diagnosed or self-reported sleep apnea\n* pregnant or planning to become pregnant during the study period\n* having a psychiatric or medical condition that would interfere with the ability to complete study procedures\n* participating in another diabetes clinical trial\n* living in same household as another participant\n* required to work night shifts",{"count":267,"type":21},30,[24],"Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role in diabetes management, sleep disturbances remain largely unaddressed in diabetes care. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, yet it is underutilized in primary care clinics such as federally qualified health centers (FQHCs) that serve high-risk populations.\n\nThe long-term goal of this research is to improve cardiometabolic health and reduce diabetes disparities by integrating sleep interventions into diabetes care. This pilot study aims to: (1) evaluate the impact of CBT-I on sleep and diabetes-related outcomes, and (2) assess the acceptability, feasibility, and fidelity of implementing a 6-week CBT-I program in an FQHC setting.\n\nThe investigators will conduct a randomized controlled trial (RCT) with 30 FQHC patients (aged 40+) with uncontrolled T2D (HbA1c \\>7%) and comorbid insomnia (Insomnia Severity Index (ISI) score ≥15). Participants will be randomly assigned to either the CBT-I intervention or usual care. Sleep (ISI scores, actigraphy) and cardiometabolic (HbA1c, fasting glucose, insulin) outcomes will be assessed at baseline and three months post-randomization. Implementation success will be evaluated using fidelity, feasibility, and acceptability measures. Findings will provide preliminary evidence for integrating CBT-I into primary care, informing larger trials to improve diabetes outcomes and reduce disparities in Louisiana.",[27,271],"Insomnia","2026-04-20",{"date":274,"type":39},"2026-04-22",{"date":165,"type":21},{"date":147,"type":21},{"name":236,"class":46},{"id":279,"slug":4,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":286,"conditions":287,"keywords":291,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":47},"100606533","NCT07176793","Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes","Preventing Type 2 Diabetes Following Gestational Diabetes: Implementation Mapping for a Multilevel Breastfeeding Support Strategy","Inclusion Criteria:\n\n* ≥18 years old and able to communicate in English\n* Fits into one of the following:\n\n  1. patients with GDM who are recently pregnant and\u002For postpartum;\n  2. health care providers (nurses, physicians, lactation consultants, etc.) who would implement the strategy\n  3. executive leadership\n\nExclusion Criteria:\n\n* Subjects not meeting the inclusion criteria will be considered ineligible for participation",{"count":285,"type":21},10,"The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.",[288,27,289,290],"Gestational Diabetes Mellitus (GDM)","Breastfeeding Continuation","Breastfeeding Support",[292,293,294,295,296,297],"Gestational Diabetes","Preventing Diabetes Type 2 after GDM","Breastfeeding","Focus Groups","Implementation mapping","Breastfeeding support strategy","2026-04-01",{"date":300,"type":39},"2026-04-07",{"date":302,"type":39},"2026-03-23",{"date":304,"type":21},"2026-06-30",{"name":306,"class":46},"University of California, Davis",{"id":308,"slug":4,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100632225","NCT07510919","CGM in Acute Ischemic Stroke","Continuous Glucose Monitoring for Enhanced Management of Hyperglycemia in Persons With Type 2 Diabetes Undergoing Endovascular Therapy for Acute Ischemic Stroke: a Randomized Controlled Trial.","SENSTROKE","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute ischemic stroke treated with endovascular therapy (EVT)\n* Type 2 diabetes mellitus, defined as one of the following:\n* documented diagnosis of type 2 diabetes mellitus\n* use of glucose-lowering medication\n* admission plasma glucose ≥11.1 mmol\u002FL\n* HbA1c ≥48 mmol\u002Fmol (≥6.5%)\n\nExclusion Criteria:\n\n* Current pregnancy\n* Extensive skin infections or dermatological conditions at the intended sensor site\n* Medical situations known to interfere with CGM accuracy, including:\n* Hypotension defined as a systolic blood pressure \\\u003C100 mmHg at 30 and 60 minutes after admission\n* Dialysis treatment\n* Estimated glomerular filtration rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73 m²\n* Use of medications known to interfere with CGM accuracy, including:\n* Acetaminophen \\>4 g\u002Fday\n* Dopamine\n* High-dose vitamin C (ascorbic acid)\n* Hydroxyurea \u002F hydroxycarbamide\n* Clinically relevant pancreatic disease\n* Systemic glucocorticoid therapy with a prednisone-equivalent dose \\>5 mg\u002Fday\n* Expected admission to an intensive care unit (ICU)",{"count":315,"type":21},82,[24],"The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management.\n\nThis study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose \\>10 mmol\u002FL) during the first 72 hours of hospitalization.\n\nResearchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients.\n\nParticipants will:\n\n* Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management\n* Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization\n* Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol",[319,320,27,321,322],"Acute Ischemic Stroke","Diabetes (DM)","Hyperglycemia","Stroke","2026-03-31",{"date":325,"type":39},"2026-04-06",{"date":327,"type":21},"2026-04",{"date":329,"type":21},"2028-08",{"name":331,"class":46},"Isala",{"id":333,"slug":4,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":352,"leadSponsor":354,"locationsCount":122},"100630238","NCT07485075","Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical Trial","SBI 2024-2026 STENO FOOD CONCEPT","StenoFOODApp","Inclusion Criteria:\n\n* Type 2 diabetes (ICD-10 DE11.x)\n* Age 18-74 years\n* BMI \\\u003C 35 kg\u002Fm²\n* eGFR 30-59 ml\u002Fmin and UACR \\> 30 mg\u002Fg\n* Stable medication for ≥3 months\n* Ability to read and understand Danish\n\nExclusion Criteria:\n\n* Type 1 diabetes or other diabetes types\n* Current vegan diet\n* Active cancer\n* Short bowel syndrome or celiac disease\n* Use of sodium chloride tablets\n* No access to digital platform (intervention group only)","74 Years",{"count":341,"type":21},104,[24],"This study evaluates whether a digital patient education program can improve adherence to KDIGO 2022 dietary recommendations (low sodium and optimal protein intake) among patients with type 2 diabetes and chronic kidney disease (eGFR 30-59 ml\u002Fmin).",[27,345],"Kidney Disease",[347],"Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines","2026-03-16",{"date":350,"type":39},"2026-03-20",{"date":350,"type":21},{"date":353,"type":21},"2027-12-31",{"name":69,"class":46},{"id":356,"slug":4,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":47},"100538877","NCT06296550","Enhancing Digitally Delivered Diabetes Education With Real-Time CGM","Enhancing Digitally Delivered Diabetes Education With Real-Time CGM: A Comparative Study in People With Type 2 Diabetes","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes\n* Are not currently using a CGM\n* Are not using insulin therapies\n* Speak English, Spanish or Arabic\n* Have A1c between 7.5% and 12.0% in last 90 days\n* Have a cellphone that can receive\u002Fsend text messages and counts steps\n\nExclusion Criteria:\n\n* Are using insulin therapies\n* Are pregnant\n* Are currently using a CGM\n* Are currently participating in another diabetes-related study",{"count":362,"type":21},140,[24],"The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.",[27],[58,367,368],"CGM","Diabetes Education","2026-03-04",{"date":371,"type":39},"2026-03-06",{"date":373,"type":39},"2025-04-03",{"date":375,"type":21},"2027-04-30",{"name":121,"class":46},{"id":378,"slug":4,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":75,"sex":17,"minAge":384,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":408},"100621752","NCT07374705","Disentangling the Effect of Brain Insulin Resistance on Brain Health","Disentangling the Effect of Brain Insulin Resistance on Brain Health (BIR-BrainHealth)","BIR 1","Inclusion Criteria (all):\n\n* age 50-80 years\n\nInclusion Criteria (diabetes only):\n\n* Diagnosis of either type 1 diabetes or type 2 diabetes\n* Diabetes duration of ≥10 years for individuals with type 1 diabetes and ≥5 years for individuals with type 2 diabetes\n\nExclusion Criteria:\n\n* HbA1c \\>100 mmol\u002Fmol\n* Other type of diabetes\n* Weight \\>140 Kg\n* Treatment with drugs that cannot be paused for 12 hours\n* Diagnosis of dementia\n* Active and recent (1year) malignant disease\n* History of major stroke\n* Major depression and\u002For treatment with antipsychotics\n* History of traumatic brain injury\n* Other medical condition or disorder (e.g., epilepsy, recent concussion) that in the opinion of the investigator precludes compliance with the protocol, evaluation of the results or represent an unacceptable risk for the participant's safety.\n* Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that cannot be improved with aids such as glasses and hearing aids, or language barrier.)\n* Severe claustrophobia\n* Foreign bodies of metal in the body which prohibits brain MRI scans (e.g. pacemaker or screws\u002Fplates from surgery in the head or neck region)\n* Participants who do not wish to be informed about accidental findings by MRI\n* eGFR measurement \\\u003C45 within 3 months of study visit","50 Years","80 Years",{"count":105,"type":21},"People with diabetes are at increased risk of developing dementia, including Alzheimer's disease and vascular dementia. In addition, persons with diabetes have more pronounced age-related brain atrophy and cognitive difficulties compared to people without diabetes. The mechanisms behind the effects on the brain of diabetes are still unclear. New research suggests that the brains of some people with diabetes do not respond normally to insulin signals, a condition known as brain insulin resistance (BIR). To date, there have been no large clinical studies investigating BIR and its impact on brain health, but several smaller studies suggest that BIR may be a cause of cognitive decline and impaired brain health in people with diabetes. Another mechanism that may contribute to impaired brain health in people with diabetes is damage to the blood vessels in the brain. Damage to blood vessels is a well-known complication of diabetes, but how it affects the brain is not fully described. In this project, we will investigate the relationship between BIR and brain blood vessel dysfunction and its relationship to cognition and brain function. This is done by examining patients with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy controls. The participants will undergo MRI brain scans to assess the impact of BIR on the brain physiology and to evaluate brain blood vessel health. Participants will undergo comprehensive assessments of their cognitive abilities and thorough health examination.",[27,60],[58,390,391,392,393,394,395,396,397,398,399],"Brain Insulin Resistance","cognitive performance","cognitive dysfunction","structural changes in the brain","cerebrovascular function","brain health","blood-brain-barrier","diabetes type 1","diabetes type 2","biomarkers",{"date":401,"type":39},"2026-02-25",{"date":403,"type":39},"2026-01-01",{"date":405,"type":21},"2032-01",{"name":407,"class":46},"Henrik Bo Wiberg Larsson",3,{"id":410,"slug":4,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":414,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":429,"leadSponsor":431,"locationsCount":47},"100609871","NCT07220213","FELLAShip to Better Health","Inclusion Criteria:\n\n* Self-identified Black men\n* Age 18 or older\n* LE8 (Life's Essential 8) score (threshold not specified, but implies \"less than ideal\" CVH)\n* English speaking\n* Resides in the Metropolitan Birmingham, Alabama area\n* No physical activity restrictions imposed by a healthcare provider\n\nExclusion Criteria:\n\n* Not identifying as Black and male\n* Under age 18\n* Non-English speakers\n* Not living in the Birmingham, Alabama metro area\n* Having a healthcare provider-imposed restriction on physical activity\n* Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)","MALE",{"count":416,"type":21},90,[24],"The goal of this clinical trial is to evaluate the implementation and effectiveness of the FELLAship program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are:\n\n* Does participation in the FELLAship program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)?\n* What factors influence the adoption, delivery, and sustainability of the FELLAship program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors.\n\nParticipants will:\n\n* Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches.\n* Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care.\n* Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes.\n* Use a smartwatch, blood pressure cuff, and other tools to track progress in real time.\n* Participate in exit focus groups or interviews to share feedback about the intervention.\n* A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability.\n\nThis study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.",[420,421,422,423,424,27],"High Blood Glucose","High Cholesterol","High Cholesterol\u002FHyperlipidemia","Blood Sugar; High","Obesity & Overweight","2026-01-21",{"date":427,"type":39},"2026-01-22",{"date":403,"type":39},{"date":430,"type":21},"2027-01-01",{"name":432,"class":46},"University of Alabama at Birmingham",{"id":434,"slug":4,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":75,"sex":17,"minAge":440,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":447,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":47},"100619905","NCT07350694","Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors","Engagement of coMmunity Through Participatory Learning and Action for cOntrol and preVEntion of Type II Diabetes and Its Risk Factors [EMPOWER-D-Afg]: Feasibility Trial in Rural Kabul-Afghanistan","EMPOWER-D-Afg","Inclusion Criteria:\n\n* For intervention phase: Individuals aged 20 years and above. For baseline and endline assessments (before and after the intervention): Individuals aged 30 years and above.\n* Participants residing in the randomized clusters of Kabul, Afghanistan Individuals willing to participate in the study and provide consent.\n* All individuals with normoglycemia, intermediate hyperglycaemia, and diabetes are encouraged to participate.\n* Participants who can attend the scheduled meetings and interventions as per the study protocol.\n\nExclusion Criteria:\n\n* For Intervention phase: Individuals below the age of 20 years. For baseline and endline assessments (before and after the intervention): individuals below the age of 30 years.\n* Individuals unwilling to provide consent for participation.\n* Participants with reported health conditions that may hinder their active involvement in the study.\n* Individuals with non-compliance with research protocols","20 Years",{"count":442,"type":21},250,[24],"This project aims to adapt, implement, and evaluate PLA based intervention in Rural Kabul, Afghanistan for TIIDM prevention and control.",[27,446],"Type II Diabetes Mellitus",[448,449,446,450],"Community-Based Participatory Research","Participatory Learning and Action Research","Intermediate hyperglycemia","2026-01-11",{"date":453,"type":39},"2026-01-20",{"date":455,"type":39},"2024-12-24",{"date":457,"type":21},"2027-09-30",{"name":459,"class":46},"HealthNet Transcultural Psychosocial Organization",{"id":461,"slug":4,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":17,"minAge":466,"maxAge":467,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":47},"100619926","NCT07350967","Magnetic Compression Anastomosis Procedure for Partial Jejuno-ileal Diversion: Evaluating the Feasibility of a Novel Endoscopic Magnetic Metabolic Interventional Therapy","2025\u002F08\u002FEMMIT","Inclusion Criteria:\n\n1. Participants are willing and able to give informed consent for participation in the study.\n2. Male or Female, aged ≥ 25 years to ≤ 65 years inclusive at the time of informed consent\n3. BMI 30-50\n\n   * Prior sleeve gastrectomy (\\> 12 months) or other metabolic surgical procedures with T2DM (characterized by HbA1c \\> 6.5%) or weight regain\n   * T2DM without a history of gastrectomy or other metabolic surgical procedures (diagnosis for \\> 6M and \\\u003C10 yrs) taking at least oral antidiabetic medication with fasting glucose \\\u003C 200mg\u002Fdl and HbA1c \\>6.5 %\n4. Agrees to abstain from any form of additional bariatric or reconstructive surgery that could influence body weight for a duration of 1 year\n\nExclusion Criteria:\n\n1. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months\n2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)\n3. Current enrolment in another research study or previous participation within 30 days of enrolment\n4. Use of injectable insulin\n5. Uncontrolled T2DM\n6. Uncontrolled hypertension, dyslipidemia, or sleep apnea\n7. Current history of injected Glucagon Like Peptide 1 (GLP1)\n8. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies\n9. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging\n10. Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures\n11. Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures\n12. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum\n13. Refractory gastroesophageal reflux disease (GERD)\n14. Barrett's esophagus\n15. Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques\n16. Presence of an implantable pacemaker or defibrillator\n17. Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site\n\nSubjects will be deemed ineligible to participate if they fulfill any of the following criteria:\n\n1\\. Pregnancy or breastfeeding mothers, or individuals planning to become pregnant in next 9-12 months 2. Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.) 3. Current enrolment in another research study or previous participation within 30 days of enrolment 4. Use of injectable insulin 5. Uncontrolled T2DM 6. Uncontrolled hypertension, dyslipidemia, or sleep apnea 7. Current history of injected Glucagon Like Peptide 1 (GLP1) 8. Evidence of type 1 diabetes or of pancreatic exhaustion, as indicated by a C peptide fasting level less than 1 or, for type 1 diabetes, based on measurable levels of serum anti-GAD-65 autoantibodies or, at investigator's discretion, based on measurable levels of other T1D-associated autoantibodies 9. History of highly unusual or challenging gastrointestinal tract anatomy ascertained through earlier endoscopic examination or other diagnostic imaging 10. Previous intestinal, colonic, or duodenal surgery, excluding bariatric procedures 11. Prior surgical interventions, trauma, prosthetic implants, diseases, or genetic factors that hinder or contraindicate the procedure, including scarring and abnormal anatomical structures 12. History of (or known to be at prohibitive risk for) any of the following diseases of the small bowel or closely related conditions: Crohn's disease or other inflammatory bowel disease, celiac disease, resection for cancer, or intra-abdominal adhesive disease including intussusception, perforated appendix and Meckel's diverticulum 13. Refractory gastroesophageal reflux disease (GERD) 14. Barrett's esophagus 15. Any anatomical anomaly that obstructs orogastric access via gastroscope and catheters, as well as manipulation techniques 16. Presence of an implantable pacemaker or defibrillator 17. Any comorbidity or current physiological condition of the subject that, in the opinion of the surgeon or anesthesiologist, poses safety concerns rendering the subject medically unfit for the procedure. This encompasses any conditions for which endoscopic or laparoscopic surgery would be contraindicated, as well as any significant congenital or acquired anomalies of the gastrointestinal tract at or distal to the magnet placement site 18. History of small bowel surgery such as small bowel resection 19. Active H. pylori infection (prospective participants with active H. pylori may continue with the screening process if they are treated via medication and re-testing verifies the condition has resolved.) 20. History of chronic or acute pancreatitis 21. Known active hepatitis or active liver disease 22. Symptomatic gallstones or kidney stones or acute cholecystitis 23. History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia 24. Use of anticoagulation therapy (excluding aspirin) which cannot be discontinued for 7 days before and 14 days after the procedure 25. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure (use of low-dose aspirin allowable) 26. History of serious complications of T2DM including coronary artery disease, hypertension, peripheral vascular disease, diabetic retinopathy, and\u002For diabetes-related soft tissue infection 27. Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide) 28. Receiving weight loss medications such as Meridia, Xenical, or over-the-counter weight loss medications 29. Persistent anemia, defined as Hgb\\\u003C10 g dL-1 30. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Disease (MDRD) \\\u003C30 ml\u002Fmin\u002F1.73m2 31. Active systemic infection 32. Chemotherapeutic cancer treatment within past 9 months, history of abdominal radiation, or active malignancy within the past 5 years 33. Active illicit substance abuse or alcoholism 34. Unhealed ulcers, bleeding lesions, tumors, or any other lesions at the target site for magnet deployment 35. Anticipated requirement for MR imaging within the first two months following the procedure 36. Any anatomical anomaly that prevents or contraindicates laparoscopic access and general laparoscopic procedures 37. Underwent a surgical or interventional procedure within 30 days prior to the current procedure 38. Any scheduled surgical or interventional procedure planned within 30 days following the current procedure 39. Any stroke or transient ischemic attack (TIA) within six months prior to obtaining consent 40. Any other serological markers likely to be associated with poor outcomes 41. Inability to adhere to the follow-up schedule and assessments 42. Any circumstance that, according to the investigator's judgment, could hinder the completion of follow-up evaluations up to Day 360 (for instance, a health issue that might elevate the risks linked to study involvement or could obstruct the analysis of study findings, failure to comply with the visit timetable, or inadequate adherence to the treatment protocol)\n\n\\-","25 Years","65 Years",{"count":469,"type":21},5,[24],"English, Hindi and Gujarati",[27,473],"Bariatric Surgery",[475],"Magnetic Compression Anastomosis","2026-01-09",{"date":453,"type":39},{"date":479,"type":39},"2025-11-11",{"date":481,"type":21},"2026-11-30",{"name":483,"class":210},"iIDEAS Group Holdings Limited",{"id":485,"slug":4,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":17,"minAge":491,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":4},"100617804","NCT07323381","Effects of Henagliflozin Proline and Metformin XR on Body Composition in Geriatric Patients With Newly Diagnosed T2DM","A Multicenter, Randomized, Parallel-group Clinical Study on the Effects of Henagliflozin Proline Tablets and Metformin Sustained-release Tablets on Body Composition in Geriatric Patients With Newly Diagnosed Type 2 Diabetes Mellitus","HABIT-GEMs","Inclusion Criteria:\n\nVoluntarily sign the informed consent form, be able to understand the procedures and methods of this study, and be willing to strictly comply with the clinical trial protocol to complete the study.\n\nAged between 60 and 85 years (inclusive) at the time of screening, regardless of gender.\n\nDiagnosed with Type 2 Diabetes Mellitus according to WHO criteria, and not having used any glucose-lowering medications in the recent 3 months.\n\n7.0% ≤ HbA1c ≤ 11.0% and Fasting Plasma Glucose ≤ 15 mmol\u002FL. Body fat percentage: ≥25% for males, ≥30% for females.\n\nExclusion Criteria:\n\nKnown or suspected allergy to metformin, SGLT2 inhibitors, or excipients of the investigational product.\n\nHistory of Type 1 Diabetes or other forms of insulin-dependent diabetes. Acute metabolic complications within the past 6 months, such as ketoacidosis, lactic acidosis, or hyperosmolar coma.\n\nHistory of severe or recurrent hypoglycemic episodes. Presence of diabetes insipidus. Unstable thyroid function with treatment doses not stabilized within the past 3 months.\n\nHistory of cardiovascular events within the past 6 months. Patients with uncontrolled hypertension or hypotension. Presence of clinical symptoms or recurrent urinary tract infections or genital infections.\n\nHistory of osteoporosis, hematological diseases, malignancy, significant gastrointestinal disorders, fluid retention states, hypovolemia, or uncontrolled psychiatric disorders.\n\nSystemic corticosteroid therapy for more than 7 days within the past 3 months. History of bariatric surgery within the past 12 months, use of weight-control medications within the past 3 months, or current participation in a weight-loss program not in the maintenance phase.\n\nGastrointestinal surgery that affects absorption within the past 3 months; long-term use of medications directly affecting gastrointestinal motility; or acute stress conditions such as surgery, infection, or hospitalization within the past 3 months.\n\nParticipation in any other drug clinical trial within the past 3 months. ALT or AST levels \\> 3 times the upper limit of normal; Hemoglobin ≤ 100 g\u002FL; Renal impairment, defined as eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m²; Fasting triglycerides ≥ 5.64 mmol\u002FL.\n\nHistory of diabetic retinopathy. Significantly abnormal 12-lead ECG. Any other condition deemed by the investigator as unsuitable for the subject's participation in this study.","60 Years","85 Years",{"count":494,"type":21},116,[496],"PHASE4","The goal of this clinical trial is to compare the effects of Henagliflozin Proline Tablets versus Metformin Extended-Release on body composition in elderly, drug-naïve patients with Type 2 Diabetes. The main questions it aims to answer are:\n\nThe effect of each treatment on the change in body composition, as measured by Appendicular Skeletal Muscle Index (ASMI), from baseline to 24 weeks.\n\nThe effect of each treatment on the change in HbA1c from baseline to 24 weeks. The comparative safety profile and other efficacy measures (e.g. fasting plasma glucose and additional body composition parameters) between the two treatments.\n\nResearchers will compare the Henagliflozin Proline treatment group to the Metformin Extended-Release treatment group to evaluate potential differences in changes in muscle mass and metabolic parameters.\n\nParticipants will:\n\nBe randomly assigned to one of the two treatment groups. Attend multiple clinic visits and telephone follow-ups over a 28-week period.\n\nAt clinic visits, undergo procedures including:\n\nPhysical examinations (height, weight, blood pressure, circumferences). Body composition analysis using bioelectrical impedance analysis (BIA). Physical function tests (handgrip strength, 5-times sit-to-stand test, 6-meter walk speed).\n\nBlood and urine tests for efficacy and safety biomarkers. Dietary recording and exercise guidance. Start with a once-daily dose of either Henagliflozin Proline (5 mg) or Metformin XR (1000 mg), with a potential dose adjustment at Week 12.",[27],{"date":500,"type":39},"2026-01-07",{"date":502,"type":21},"2025-12-30",{"date":457,"type":21},{"name":505,"class":46},"Bin Lu",{"id":507,"slug":4,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":532},"100604445","NCT07149610","Connected Care for Type 2 Diabetes Self-Management","Connected Care for Type 2 Diabetes: a Study Protocol for a Structured Self-Management Intervention Through Technology and Healthcare Collaboration","RCT_SM","Inclusion Criteria:\n\n* patients with T2DM (as confirmed by the physician's diagnosis);\n* belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno);\n* age \\> = 18;\n* resident in the Marche region;\n* HbA1c \\> 7 on most recent laboratory report within the last 3 months;\n* no changes in diabetes medication in the previous 6 months;\n* no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks;\n* owning smartphone\u002Fmobile phone with an internet connection;\n* capable to consent;\n* fulfilling and signing the informed consent;\n* with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\\>A2 of the CEFR levels).\n\nExclusion Criteria:\n\n* acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and\u002For neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe\u002Fmajor depression and other relevant psychiatric disorders;\n* estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n* plan to receive surgery that could limit physical activity during the study period;\n* pregnant or breastfeeding;\n* participation in another studies;\n* lack of written informed consent.",{"count":514,"type":21},388,[24],"The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome).\n\nResearchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home\n\nParticipants of the treated group will:\n\n* receive dedicated training on the use of the m-health solution\n* receive the personalization of the m-health solution\n* use the m-health solution to: 1) track and view the data related to their health status (e.g., glycaemic status, lifestyle habits, diet) and treatment plane; 2) receive alerts and motivational messages; communicate with the Health Care Professionals (HCPs) of the Diabetic Centre (CAD) in case of need; 3) access to the educational material and to the technical assistance, when needed.\n\nHCPs will be able to monitor the patients' data and clinical parameters and to communicate with the patients. After a baseline evaluation (T0), three follow-up evaluations will be conducted at 6, 12 and 18 months (T1-T2-T3 respectively) , during the usual physician' visits, as part of clinical routine.\n\nThe evaluation phases (T0, T1, T2, T3) will be conducted through data derived from: 1) self-administered and paper-based questionnaires, validated in the Italian language; 2) the clinical assessment of patients; 3) the m-health solution, as data automatically derived from the m-health solution; 4) a focus group carried out in a subsample of participants.\n\nData regarding different health-related areas (T2DM severity; medication adherence; lifestyle habits; self-efficacy related to management of the disease; quality of life), usability of the m-health solution, participants' experience with the intervention, utilization of the m-health solution by the patients, and the cost-effectiveness of the intervention, will be evaluated.\n\nPatients participating in the study will not be required to make any additional visits or undergo any laboratory analysis beyond those specified in their therapeutic plan.",[27],[519,520,521,522,523],"self-management","digital solution","Diabete type 2","Chronic diseases","glycated hemoglobin",{"date":525,"type":39},"2025-12-31",{"date":527,"type":39},"2025-10-13",{"date":529,"type":21},"2026-12-31",{"name":531,"class":46},"Marche Region Regional Health Agency",13,{"id":534,"slug":4,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":467,"enrollmentInfo":540,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":47},"100500666","NCT05799222","Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population","Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population","MINT","Inclusion Criteria:\n\n* Age 18-65\n* Body mass index (BMI) greater than or equal to 27 kg\u002Fm\\^2\n* HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg\u002FdL within the previous 6 months\n* Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022\n\nExclusion Criteria:\n\n* Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment\n* HbA1c greater than or equal to 10 percent\n* Plans to pursue bariatric surgery over the 6 months post-study enrollment\n* Weight loss of greater than 5 kg within the previous 3 months\n* Current active eating disorder, with the exception of binge eating disorder\n* Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention\n* Active illicit substance abuse\n* Pregnant, breastfeeding, or considering pregnancy within the next 6 months\n* Current participation in another clinical research trial deemed by investigator to conflict with current study",{"count":78,"type":21},"This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity\u002Foverweight and diabetes\u002Fpre-diabetes who have a low income.",[186,543,27,184],"PreDiabetes","2025-12-18",{"date":546,"type":39},"2025-12-24",{"date":548,"type":39},"2023-03-28",{"date":550,"type":21},"2026-11-10",{"name":552,"class":46},"Massachusetts General Hospital",{"id":554,"slug":4,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":569,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":47},"100604376","NCT07148713","Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine","Pilot of a CGM-Augmented Food Is Medicine Intervention","ALIGN","Inclusion Criteria:\n\n* Able to complete study activities in English\n* Aged ≥18 years\n* Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes\n\n  * Chart review will be conducted by the study team and a diagnosis of type 2 diabetes (E.11.xx) from either the problem list or a diagnosis linked to an encounter will be used as confirmation. Discrepancies in diagnosis codes will be resolved by review of provider notes within the past 3 years.\n* HbA1c \\> 8.0% in the last 12 months via point of care or venous measurement. If there are multiple values, the most recent one will be considered.\n* Receiving primary or specialty care within UNC Health as defined by at least one visit with a primary care provider or endocrine provider within the past year\n* Indication of a barrier to healthy eating consisting of report of food insecurity (defined as a score greater or equal to 1.0 on the 6-item USDA Food Security Survey Module (FSSM)) and\u002FOR nutrition insecurity (defined as more often than 'Rarely' on the One-Item Gretchen Swanson Nutrition Screener, OR more often than 'Not Very Hard' on the Two-item Nutrition Security Screener (NSS))\n\n  * Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS\n* No plans to move from the area for at least 4 months\n* Willing and able to provide written informed consent and participate in all study activities\n\nExclusion Criteria:\n\n* Type 1 or other diabetes\n* Use of insulin or secretagogues in the preceding 6 months\n* Use of CGM in the preceding 6 months\n* Inability to use CGM and related technology (e.g., the companion app), including lack of a smartphone that is compatible with Stelo (information on compatible phones available in Appendix 1) or known allergy to adhesive\n* Known psychosis or major psychiatric illness that prevents participation with study activities\n* Pregnancy or planned pregnancy in the next 4 months-glycemic targets are different for pregnant women compared to non-pregnant women with diabetes and our intervention is designed for non-pregnant glycemic targets\n* Participant in diabetes, nutrition, or weight research intervention in last 12 months",{"count":561,"type":21},60,[24],"This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity. This study will learn if a FIM intervention (\"intervention\") that includes access to real-time CGM and nutrition counseling can increase engagement, improve glycemic management, and support healthy eating in this population, compared to the FIM intervention alone (\"comparator\").\n\nAt the study baseline, participants will be randomized to either the intervention or the comparator arm for 16 weeks. The intervention will occur during the first 12 weeks (phase 1: intervention phase) and will be compared to a standard FIM approach without CGM or counseling. Phase 2 (extension phase) will last 4 weeks and will consist of all participants in the intervention and comparator arm receiving both FIM and CGM for self-directed use. The study will also explore participant experiences through a series of semi-structured interviews with a subset of randomly selected participants to identify opportunities for scaling the intervention to a broader population.",[565,188,566,567,368,27,568],"Nutrition","T2DM","T2DM (Type 2 Diabetes Mellitus)","Diabetes Mellitis",[58,566,565,570,571,188,572,573],"Food is Medicine","Continuous glucose monitor","Food insecurity","Nutrition insecurity","2025-11-10",{"date":576,"type":39},"2025-11-12",{"date":578,"type":39},"2025-09-19",{"date":65,"type":21},{"name":581,"class":46},"University of North Carolina, Chapel Hill",{"id":583,"slug":4,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":75,"sex":17,"minAge":18,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":599,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":47},"100602674","NCT07126587","Healthy Living Anson Study","Healthy Living Anson","HLA","Inclusion Criteria:\n\n* Potential participants must be a resident of Anson County.\n* At least 18 years of age.\n* Have or be at risk for a chronic disease.\n* Ability to make own dietary decisions.\n* Ability to travel to a central Anson County location for data collection and group class sessions.\n* Ability and willingness to try the prepared meals.\n* Ability to store 10 frozen meals in a freezer.\n* Ability to communicate in English\n* No dietary restrictions or food allergies such that a Mediterranean diet is not appropriate.","99 Years",{"count":591,"type":21},120,[24],"The goal of this randomized delayed control intervention research study is to see if participants who receive education and healthy prepared meals improve the quality of their diet compared to participants who receive only physical activity education and coaching.",[595,27,596,597,598,421],"Obesity (Disorder)","Heart Disease","Hypertension","Cancer",[586,600,601,602,603],"HLA study","nutrition","healthy eating","overweight (BMI ≥ 25)","2025-10-29",{"date":606,"type":39},"2025-10-30",{"date":608,"type":39},"2025-09-24",{"date":610,"type":21},"2028-03-30",{"name":581,"class":46},{"id":613,"slug":4,"hasResults":11,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":633},"100572602","NCT06735404","RAPIDE: The Feasibility of a Hybrid Care Model","Regular and Unplanned Care Adaptive Dashboard for Cross-border Emergencies (RAPIDE): The Feasibility of a Hybrid Care Model","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\nPatients with type 2 diabetes mellitus, WITH:\n\n* At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND\n* A high number of medical consultations at the GP practice and\u002For referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.\n\nPatients with chronic heart failure, WITH:\n\n* At least 2 different types of chronic comorbidities (as defined in the list of chronic comorbidities); AND\n* A high number of medical consultations at the GP practice and\u002For referrals to the hospital in the last 24 months, as identified by the clinical expertise of the treating GP.\n\nExclusion Criteria:\n\n* Terminally ill patients\n* Comorbidity of a severe psychiatric disorder (i.e. psychosis-related disorders, dementia, and bipolar disorder)\n* Patients who are cognitively impaired",{"count":619,"type":21},180,[24],"Rationale: During cross-border health emergencies, such as seen with the COVID-19 pandemic, health and care services are rapidly being overwhelmed by high numbers of patients requiring care, leading to stretches in the whole healthcare system. Delays and backlogs in regular care, as the result of the stretched health care services, leave millions of patients with regular care needs unattended, resulting in disastrous healthcare outcomes. If disastrous healthcare outcomes across the population are to be avoided, healthcare systems must become more robust, resilient, and flexible in the face of future health emergencies and allow for rapid changes in the care delivery services.\n\nObjective: To evaluate the feasibility of delivering a hybrid care model alongside care as usual through observations, and questionnaires and interviews on patient reported views, opinions, and experiences. This hybrid care model aims to reduce the burden on health and care systems during a health emergency, decrease the need to scale down regular care, and ensure patient safety and quality of care.\n\nStudy design: One year cohort study, using observations, questionnaires, and interviews.\n\nStudy population: Patients with type 2 diabetes and\u002For chronic heart failure with comorbidities and\u002For having a high care consumption according to the treating general practitioner.\n\nIntervention: The hybrid care model will consist of a combination of digital tools and\u002For task shifting of certain healthcare providers. Examples are:\n\n* Telemonitoring: patients perform self-measurements through e.g. sensors, wearables, or (mobile) applications to get insight in their health status (supporting self-management) and report this to their healthcare provider(s), when relevant\n* Teleconsultation: patients communicate with their healthcare provider(s) remotely\n* Personal health portals and self-management applications\n* Online prescription requests: patients request prescription online Main study parameters\u002Fendpoints: The impact of the hybrid care model on patient reported experiences (PREMs) and patient reported outcomes (PROMs).\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Evaluating the feasibility of this hybrid care model will only be done through observations, questionnaires, and interviews at home (during three home visits at baseline, after six months, and after one year). No invasive (physical) procedures will be performed.",[27,623],"Heart Failure","2025-09-11",{"date":626,"type":39},"2025-09-12",{"date":628,"type":21},"2026-01",{"date":630,"type":21},"2027-03",{"name":632,"class":46},"Radboud University Medical Center",4,{"id":635,"slug":4,"hasResults":11,"nctId":636,"briefTitle":637,"officialTitle":638,"acronym":639,"eligibilityCriteria":640,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":653,"locationsCount":122},"100549726","NCT06437782","Exploration of Health Literacy in Diabetes in Reunion Island and France","Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France","HLQ-Diabete","Inclusion Criteria:\n\nPatient with type 1, 2 or gestational diabetes taken care in hospital\n\nExclusion Criteria:\n\n* Patient unable to understand and respect study procedures\n* Patient with cognitive disorder\n* Patient with serious acute complication due to diabetes within 15 days before inclusion\n* Stroke history with neurologic consequences\n* Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance",{"count":642,"type":21},1350,"The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nParticipants will complete the Health Literacy Questionnaire (HLQ) once.",[645,27,646],"Diabetes type1","Diabetes, Gestational","2025-07-28",{"date":649,"type":39},"2025-07-30",{"date":651,"type":39},"2025-04-17",{"date":65,"type":21},{"name":654,"class":46},"Centre Hospitalier Universitaire de la Réunion",""]