[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Steno Diabetes Center Copenhagen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":507},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,41,69,97,130,157,191,215,234,262,282,314,340,371,396,425,450,477],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100637770","changing-outpatient-diabetes-care-with-remote-patient-monitoring-a-real-world-evidence-study-with-pre-post-comparison-100637770",false,"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.","ALL",{"count":17,"type":18},12000,"ESTIMATED","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.",[22,23,24,25,26,27],"Diabetes","Diabetes Care","Diabetes Type 1","Diabetes Type 2","Remote Patient Monitoring","Digital Health","NOT_YET_RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":18},"2026-06",{"date":36,"type":18},"2028-07",{"name":38,"class":39},"Steno Diabetes Center Copenhagen","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":40},"100643158","measurements-before-and-after-participation-in-a-health-intervention-programme-in-halsnaes-municipality-100643158","NCT07641309","Measurements Before and After Participation in a Health Intervention Programme in Halsnaes Municipality","Effects for Individuals Following a Health Intervention Programme in Halsnaes Municipality; A Sub-project Under the Initiative: Quality Development in Community Healthcare: Steno Tvaers","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes, chronic obstructive pulmonary disease, or cardiovascular disease\n* At or above 18 years of age\n* Offered a health programme provided by Halsnæs Municipality\n\nExclusion Criteria:\n\n* None","18 Years",{"count":50,"type":18},194,"Based on the Danish Health Authority's quality standards for municipal prevention services for citizens with chronic diseases, Steno Diabetes Center Copenhagen (SDCC), Halsnaes Municipality, North Zealand Hospital, and others have entered into a cross-sectoral collaboration entitled \"Quality Development in Community Healthcare: Steno Tvaers - A Model for Differentiated Health Interventions for Citizens with Diabetes, Chronic Obstructive Pulmonary Disease (COPD), or Cardiovascular Disease sased in Halsnaes Municipality\" (hereafter referred to as Steno Tvaers). Based in Halsnaes Municipality, the aim of Steno Tvaers is to adapt and, where relevant, supplement existing healthcare services in the municipality to better meet the needs of and reach all citizens with chronic diseases.\n\nThe present sub-project \"Measurements before and after participation in a health intervention programme in Halsnaes Municipality\" (hereafter referred to as the sub-project) is conducted within the framework of Steno Tvaers. The objective of the current sub-project is to assess whether citizens with diabetes, COPD, or cardiovascular disease, who participate in a health intervention programme in Halsnaes Municipality, improve their functional capacity.\n\nFor citizens with diabetes, the sub-project also aims to assess whether participation in the programme results in improved blood glucose concentration, blood pressure, and medical adherence.\n\nThe hypothesis of the sub-project is that the organizational changes planned within Steno Tvaers for successful implementation of the quality standards will lead to a resulting health effect at the individual level.\n\nIt is important to note that the healthcare interventions are existing services, the quality and uptake of which are being enhanced through the Steno Tvaers project, and that this does not involve testing a new intervention. Participation in the project therefore only involves contributing data that are already being collected by the municipality, supplemented by responses to two questionnaires. For citizens with diabetes, this is further supplemented with data on blood glucose (HbA1c), blood pressure, attendance at follow-up visits with general practitioners and in hospital settings, as well as adherence to prescribed medication. Data are collected at the beginning and at the end of a health intervention programme, and at the end of the project, the data will be linked to selected national registers.",[53,54,55],"Type 2 Diabetes","Chronic Obstructive Pulmonary Disease (COPD)","Cardiovascular Disease",[57,58,59],"primary and community care sector","decentralized healthcare system","local healthcare system","RECRUITING","2026-06-10",{"date":63,"type":32},"2026-06-12",{"date":65,"type":32},"2026-05-28",{"date":67,"type":18},"2027-09",{"name":38,"class":39},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":15,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":40},"100507667","increased-risk-of-non-alcoholic-fatty-liver-disease-in-low-birth-weight-individuals-100507667","NCT05890365","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.","Inclusion Criteria:\n\n* 250 healthy, men and women born with a low birth weight (birth weight (BW) \\\u003C10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population)\n* born at term (weeks 39-41)\n\nExclusion Criteria:\n\n* BMI\\>35 kg\u002Fm2\n* Disease\u002Fmedication known to affect primary outcome\n* Self-reported high physical activity level\n* Alcohol intake above general recommendations.\n* Metabolic\u002Fliver disease\n* Weight gain\u002Floss of \\>3 kg within the past 6 months","34 Years","49 Years",{"count":79,"type":18},300,"The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.",[82,83],"Non-Alcoholic Fatty Liver Disease","Low Birth Weight",[85,86,87,88],"Metabolic disease","Adipose tissue biology","Liver fat","Non-alcoholic fatty liver disease","2026-06-09",{"date":91,"type":32},"2026-06-11",{"date":93,"type":32},"2023-12-14",{"date":95,"type":18},"2026-12",{"name":38,"class":39},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"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":105,"type":18},92,"INTERVENTIONAL",[108],"NA","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.",[111,112,113],"Diabetes Mellitus Type 2","Infection","CGM",[115,116,113,117,118,119,120,121],"automated insulin delivery systems","AID","continouse glucose monitoring","infectiouse disease","type 2 diabetes mellitus","diabetes mellitus type 2","GlucoTab","2026-06-08",{"date":63,"type":32},{"date":125,"type":18},"2026-07-01",{"date":127,"type":18},"2027-07-30",{"name":38,"class":39},2,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":15,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":106,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":156,"locationsCount":129},"100504020","non-alcoholic-fatty-liver-disease-in-low-birth-weight-individuals-100504020","NCT05842850","Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals","Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Reversibility and Mechanistic Studies.","Inclusion Criteria:\n\n* subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)\n\nExclusion Criteria:\n\n* BMI\\\u003C18.5 and BMI\\>30 kg\u002Fm2\n* Family history of diabetes (siblings, parent, and grandparents)\n* Disease\u002Fmedication known to affect primary outcome\n* Self-reported high physical activity level\n* Alcohol intake above general recommendations.\n* Metabolic\u002Fliver disease\n* Weight gain\u002Floss of \\>3 kg within the past 6 months","35 Years","40 Years",{"count":140,"type":18},8,[108],"The investigators will conduct a proof-of-principle 4-weeks low-calorie diet (LCD) intervention study in low birth weight (LBW) subjects and normal birth weight (NBW) controls with documented (MR scan) liver fat content equal to or above 5%. The investigators will provide extended in-depth mechanistic insight into the role of impaired subcutaneous adipose tissue (SAT) expandability in ectopic fat deposition before and after LCD.",[144],"NAFLD",[86,146,147,148,149],"Caloric restriction","Insulin resistance","Energy expenditure","Insulin secretion","2026-04-28",{"date":152,"type":32},"2026-05-04",{"date":154,"type":32},"2026-01-01",{"date":95,"type":18},{"name":38,"class":39},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":165,"sex":15,"minAge":48,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":106,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":40},"100573952","hormonal-control-of-energy-and-macronutrient-intake-in-obesity-memory-100573952","NCT06752967","Hormonal Control of Energy and Macronutrient Intake in Obesity (MEMORY)","Hormonal Control of Energy and Macronutrient Intake in Obesity","MEMORY","Inclusion Criteria:\n\n* Age 18-45 years\n* For women: Regular menstruation\n* BMI-range 18.5-39.9 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Not able or willing to eat or drink the test meals because of e.g., allergy or intolerance\n* Daily smoking\n* For women: Pregnancy \u002F planned pregnancy (within the study period) \u002F lactating\n* Self-reported history of an eating disorder\n* Self-reported weight change (kg) within two months prior to inclusion\n* HbA1c ≥48 mmol\u002Fmol\n* Treatment with antidepressants\n* Alcohol\u002Fdrug abuse or in treatment with disulfiram (antabus) at time of inclusion\n* Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal, or psychiatric disease; diabetes or other endocrine disease; immunosuppression\n* Current treatment with medication which significantly affect appetite or energy balance (e.g., GLP-1 receptor agonists)\n* Bariatric surgery\n* Unable to understand the informed consent and the study procedures\n* Concomitant participation in intervention studies\n* Participant's withdrawal of the informed consent\n* Other safety concerns - judged by the investigator",true,"45 Years",{"count":168,"type":18},45,[108],"The overall aim of the MEMORY study is to examine the concept of 'food memory' - how specific macronutrient compositions influence subsequent food preference and intake, and whether this differs across the BMI range from normal weight to obesity.",[172,173,174],"Obesity","Normal Weight","Overweight",[176,177,178,179,180,181,182],"ad libitum buffet","Food preferences","Macronutrient","Appetite","Appetite hormones","FGF21","Glucagon","2026-04-23",{"date":185,"type":32},"2026-04-24",{"date":187,"type":32},"2024-12-12",{"date":189,"type":18},"2026-06-29",{"name":38,"class":39},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":106,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":129},"100630238","digital-support-for-reducing-salt-intake-among-patients-with-diabetic-kidney-disease-protocol-for-a-controlled-clinical-trial-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":201,"type":18},104,[108],"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).",[25,205],"Kidney Disease",[207],"Type 2 Diabetes, Chronic Kidney Disease, Digital Health, Dietary Intervention, KDIGO Guidelines","2026-03-16",{"date":210,"type":32},"2026-03-20",{"date":210,"type":18},{"date":213,"type":18},"2027-12-31",{"name":38,"class":39},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":40},"100629398","steno780g-follow-up-study-100629398","NCT07474155","Steno780G Follow-up Study","Advanced Hybrid Closed-Loop Treatment in Adults With Type 1 Diabetes Not Meeting Glycaemic Targets - The Steno780G Follow-up Study","Inclusion Criteria:\n\n* Previous participation in the Steno780G study\n\nExclusion Criteria:\n\n* Lack of compliance with key study procedures at the discretion of the investigator.",{"count":223,"type":18},40,"Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin. Only few studies have described long-term use of AID systems over several years. Real-world studies suggest that the beneficial effects of AID systems on glycemic outcomes are sustained over time; however, a modest increase in body weight has been observed in some users, raising concerns about the metabolic trade-offs of improved glycemia. We aim to explore wether the improvements in glycemic outcomes and treatment satisfaction achieved with AID systems remain stable over multiple years, and secondly, if long-term treatment with AID systems may be associated with an increase in body weight.",[226],"Type 1 Diabetes","2026-03-10",{"date":208,"type":32},{"date":230,"type":18},"2026-03",{"date":232,"type":18},"2026-10",{"name":38,"class":39},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":106,"phases":245,"briefSummary":246,"conditions":247,"keywords":248,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":40},"100613146","a-feasibility-study-of-optimal-non-pharmacological-lifestyle-modifications-in-people-with-type-2-diabetes-100613146","NCT07262788","A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes","A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes (ON LiMiT)","ON LiMiT","Building on previous findings from T2D remission studies involving VLCD interventions, the study include individuals with recently diagnosed T2D who are overweight or obese and not receiving insulin therapy. This subgroup has demonstrated the greatest benefit from significant weight loss. Participants using GLP-1 receptor agonists (GLP-1 RAs) are eligible, provided their weight has been stable for at least three months prior to inclusion. Individuals on insulin therapy will be excluded. Allowing GLP-1 RA use enhances the study's generalizability, as approximately 29% of people with T2D in Denmark are currently treated with these medications.\n\nInclusion Criteria:\n\n* Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and\u002For sulfonylureas and\u002For DPP-4 inhibitors and\u002For SGLT2 inhibitors and\u002For incretin-based medication\n* HbA1c between 36-86 mmol\u002Fmol\n* T2D duration of ≤6 years\n* BMI ≥27 kg\u002Fm2\n* Body weight changes over 3 months ≤3 kg\n\nExclusion Criteria:\n\n* Insulin treatment within 6 months prior to screening (any type)\n* Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)\n* Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and\u002For an SGLT-2i has been prescribed.\n* Kidney disease (eGFR \\\u003C60 ml\u002Fmin\u002F1,73m² and\u002For albuminuria (≥30 mg\u002Fg) for at least three months) and treated with SGLT-2i (current or planned)\n* Physical comorbidity, which precludes the physical activity during intervention\n* Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions\n* Unable to comply with trial procedures and\u002For interventions\n* Alcohol\u002Fdrug abuse\n* Planned or present pregnancy\u002Ffertility treatment, or lack of contraception during reproductive age\n* Unstable psychiatric disease that is deemed to impede participation in the project\n* Diagnosed with binge eating disorder\n* Participation (present or planned) in other clinical trials including lifestyle or pharmacy trials for any condition\n* If HbA1c ≥60 mmol\u002Fmol and the participant is on 2 or more anti-diabetic drugs and has a positive GAD65 and\u002For stimulated C-peptide \\\u003C800 pM","75 Years",{"count":244,"type":18},24,[108],"The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.",[53],[53,172,249,250,251,174,252,253],"Remission","Feasibility","Diet","Lifestyle Intervention","Exercise","2026-02-27",{"date":256,"type":32},"2026-03-03",{"date":258,"type":32},"2025-09-30",{"date":260,"type":18},"2027-03",{"name":38,"class":39},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":106,"phases":270,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100625793","phase-4-the-postprandial-hypo-avoid-study-100625793","NCT07427251","The Postprandial Hypo-Avoid Study","Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People With Type 1 Diabetes","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Type 1 diabetes ≥ 2 years\n* Using an automated insulin delivery system for ≥ 3 months\n* NovoRapid or Fiasp use ≥1 week\n* Proficiency in carbohydrate counting\n\nExclusion Criteria:\n\n* Allergies to lactose or glucagon\n* Known or suspected allergies to glucagon or related products\n* History of hypersensitivity or allergic reaction to glucagon or lactose\n* Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis\n* Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation\n* Lack of compliance with key study procedures at the discretion of the investigator\n* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrolment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (\\>12 months since last period) are not required to use contraception)\n* Inability to understand the individual information and to give informed consent",{"count":5,"type":18},[271],"PHASE4","The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system.\n\nThe primary endpoint is the difference in the change in plasma glucose (PG) from exercise initiation to the nadir during exercise and through the 2-hour post-exercise period between the glucagon (GCN) and carbohydrate (CHO) visits.",[274],"Type 1 Diabetes Mellitus","2026-02-24",{"date":254,"type":32},{"date":278,"type":18},"2026-03-15",{"date":280,"type":18},"2028-05-01",{"name":38,"class":39},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":15,"minAge":289,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":106,"phases":292,"briefSummary":293,"conditions":294,"keywords":298,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},"100612223","cognitive-screening-and-multidomain-intervention-targeting-cognitive-decline-in-type-2-diabetes-the-brain-care-study-100612223","NCT07250789","Cognitive Screening and Multidomain Intervention Targeting Cognitive Decline in Type 2 Diabetes (The Brain Care Study)","Cognitive Screening of Individuals Diagnosed With Type 2 Diabetes and the Impact of a Multidomain Intervention Targeting Cognitive Decline (The Brain Care Study)","Inclusion Criteria for the Prevalence Study (Cognitive Screening):\n\n* Age ≥ 65 years\n* Diagnosis of Type 2 Diabetes (T2D)\n* Patient at the outpatient clinic at either Bispebjerg Hospital, Rigshospitalet, or Steno Diabetes Center Copenhagen\n* Speaks and understands Danish (required for the cognitive tests)\n* Informed written consent\n\nInclusion Criteria for the Randomized Controlled Trial (Multidomain Intervention):\n\n* Meets all the above inclusion criteria, and at least one of the following:\n\n  1. A diabetes-specific dementia score ≥ 7 (equivalent to a 40% increased risk of developing dementia within the next 10 years), and a SCIP or MoCA score ≥ 0.5 SD below the age- and education-adjusted norm\n  2. A SCIP or MoCA score ≥ 1 SD below the age- and education-adjusted norm\n  3. At least 2 out of 5 SCIP subtests with a score ≥ 1 SD below the age- and education-adjusted norm\n\n     Exclusion Criteria for the Prevalence Study (Cognitive Screening):\n* Diagnosis of dementia or prior referral to a dementia clinic\n* Diagnosis of psychiatric, neurological, or other disorders that, in the investigator's opinion, hinder participation in cognitive screening, preclude compliance with the study protocol, or affect the evaluation of results\n\nExclusion Criteria for the Randomized Controlled Trial (Multidomain Intervention):\n\n* Meets all the above exclusion criteria\n* Participants whose cognitive MoCA screening indicates dementia will be excluded and advised to contact their physician\n* Participants unwilling to engage in parts of the multidomain intervention will be excluded","65 Years",{"count":291,"type":18},420,[108],"The purpose of The Brain Care Study is to investigate the prevalence of cognitive impairment in older adults with type 2 diabetes (T2D) and to evaluate the effectiveness of a multidomain intervention designed to prevent cognitive decline.",[22,111,53,295,296,297],"Type 2 Diabetes Mellitus (T2DM)","Cognitive Impairment","Cognitive Decline",[299,300,119,301,302,303,304],"diabetes","type 2 diabetes","t2d","t2dm","cognitive impairment","cognitive decline","2025-11-18",{"date":307,"type":32},"2025-11-26",{"date":309,"type":32},"2024-06-01",{"date":311,"type":18},"2029-06",{"name":38,"class":39},3,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":106,"phases":324,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":40},"100594610","the-steno-opti-bolus-timing-studies-100594610","NCT07021690","The Steno Opti-Bolus-Timing Studies","Timing Insulin for Meals Using AID Systems","OBT Studies","Inclusion criteria:\n\nType 1 diabetes ≥ 3 years Age 18-70 years User of the MiniMed 780G for at least 3 months Use of Novorapid insulin in the pump (for a minimum of two weeks) TIR \\> 70% for minimum of 14 days Use carbohydrate counting and bolus calculation Uploads insulin pump and CGM data to the Carelink Personal database Pump settings: carbohydrate ratio (300-500 rule), active insulin time of ≤ 3 hours and smartguard target glucose of 5.5 or 6.1 mmol\u002FL\n\nExclusion criteria:\n\nUse of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 4 weeks prior to study start Diagnosed with gastroparesis Females who are pregnant, breast-feeding Food allergies related to standardized meals Alcohol or drug abuse Inability to understand the individual information and to give informed consent.\n\nCurrent participation in another clinical trial that, in the judgment of the principal investigator, will compromise the study results","70 Years",{"count":223,"type":18},[108],"The project investigates the significance of the timing of insulin dosing for breakfast and lunch with an automated insulin pump and whether it matters if the meal primarily contains high or low glycemic index carbohydrates.\n\nWe hypothesise that a bolus given 15 minutes before the meal will result in the best blood glucose levels after the meal, regardless of the type of carbohydrates.\n\nParticipants will attend 6 experimental days over a maximum of 3 months, where they will be served either breakfast or lunch at the research site, depending on sub-study (breakfast or Lunch sub-study). Three different bolus timings will be tested, with either rapidly absorbed carbohydrates or slowly absorbed carbohydrates, in a randomized order for each participant. Participants will take insulin for the meal using the bolus calculator in the pump, either 15 minutes before, at the start of the meal, or 30 minutes after the meal. The development in sensor glucose will then be monitored for up to 4 hours after the meal.",[327],"Type 1 Diabetes (T1D)",[329,330,331],"AID system","bolus timing","Glycemic index","2025-06-13",{"date":334,"type":32},"2025-06-15",{"date":336,"type":18},"2025-06-30",{"date":338,"type":18},"2027-06",{"name":38,"class":39},{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":15,"minAge":346,"maxAge":48,"enrollmentInfo":347,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":349,"conditions":350,"keywords":356,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":40},"100451542","early-detection-of-long-term-diabetic-complications-in-children-and-adolescents-with-type-1-diabetes-100451542","NCT05159856","Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes","Inclusion Criteria:\n\n* T1D\\>12 months\n* 6-18 years old prior to inclusion\n* Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen\n* Speaks and reads Danish well enough to understanding the given oral and written information.\n* There is a written consent from the guardianship holder\u002Fholders for the child.\n\nExclusion Criteria:\n\n* T1D \\\u003C 12 months\n* Known cardiovascular disease\n* Antihypertensive treatment","6 Years",{"count":348,"type":18},400,"Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D).\n\nBackground: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed.\n\nMethods: A prospectivel study of 400 children, aged 6-18 years old, with T1D\\>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected.\n\nBlood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades.\n\nPerspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.",[351,352,353,354,355],"Diabetes Complications","type1diabetes","Children, Only","Diabetic Neuropathies","Arterial Stiffness",[357,358,359,360,361,362],"pediatric","arteriel stiffness","pulse wave velosity","neuropathy","type 1 diabetes","early diabetic complications","2025-05-28",{"date":365,"type":32},"2025-06-03",{"date":367,"type":32},"2022-05-03",{"date":369,"type":18},"2025-12",{"name":38,"class":39},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":106,"phases":381,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":40},"100527809","restricted-eating-time-in-the-treatment-of-type-2-diabetes-100527809","NCT06152588","Restricted Eating Time in the Treatment of Type 2 Diabetes","Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial.","RESET2","Inclusion Criteria:\n\n* Age: ≥18 years\n* Overweight or obesity (BMI ≥25 kg\u002Fm2)\n* T2D with HbA1c\\>53 mmol\u002Fmol\n* Habitual eating window ≥12 h\u002Fday (incl. foods\u002Fsnacks and energy-containing beverages)\n\nExclusion Criteria:\n\n* Bariatric surgery or planned bariatric surgery within study duration\n* Use of fast acting insulin and combination insulin products\n* Habitual CGM use\n* A wish to adhere to Ramadan\n* For women: current\u002Fplanned pregnancy or lactation\n* Alcohol or drug abuse (judged by investigator) or treatment with disulfiram\n* Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery)\n* Inability to understand written and oral information in Danish\n* Unable or unwilling to adhere to TRE; for instance, due to competing medical conditions.\n* Medical condition which, based on investigators assessment, challenges participation including but not limited to severe heart, vascular or lung disease, cancer, chemotherapy, psychiatric, gastrointestinal, rheumatic, or endocrine diseases etc.\n* Concomitant participation in other intervention study\n* Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that can-not be improved with aids such as glasses and hearing aids, or language barrier.)\n\nExclusion criteria for the sub-study:\n\n* Magnetic resonance imaging (MRI) contraindications based on the MR department's exclusion criteria including pacemaker or other implanted electronic devices, implanted metal objects not compatible to MRI scanning and severe claustrophobia\n* Participants who do not wish to be informed about accidental findings by MR.",{"count":380,"type":18},160,[108],"The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight\u002Fobesity and type 2 diabetes (T2D).",[53],[385,53,172,174,386,387],"Time-restricted eating","Fasting","Circadian rhythm","2025-05-13",{"date":390,"type":32},"2025-05-16",{"date":392,"type":32},"2024-03-21",{"date":394,"type":18},"2026-05-01",{"name":38,"class":39},{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":402,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":15,"minAge":48,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":106,"phases":406,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":129},"100527397","phase-2-prevention-of-chronic-kidney-diseasecdk-progression-in-type-1-diabetes-with-long-term-use-of-sodium-glucose-cotransporter-inhibitors-avoiding-kidney-hypoxia-100527397","NCT06147232","Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia","Prevention of CKD Progression in Type 1 Diabetes With Long Term Use of SGLTi Avoiding Kidney hypOxia(PLUTO)","PLUTO","Inclusion Criteria:\n\n1. Persons ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \\\u003C40 years; permanent insulin treatment initiated within 1 year of diagnosis)\n2. Albuminuria: UACR \\> 100 mg\u002Fg (in ≥2 out 3 morning spot urine collections prior to randomization)\n3. estimated Glomerular Filtration Rate(eGFR) ≥25 and \\\u003C 75 ml\u002Fmin\u002F1.73m2\n4. Participants must be on stable renin-angiotensin system blocking treatment 4 weeks before start of study drug and throughout study duration.\n5. Able to understand the written participant information and give informed consent\n\nExclusion Criteria:\n\n1. Non-diabetic kidney disease indicated by medical history and\u002For laboratory findings.\n2. eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2, dialysis or kidney transplantation.\n3. Previous diabetic ketoacidosis, except at debut.\n4. Dysregulated diabetes (HbA1c \\> 85 mmol\u002Fmol)\n5. Decreased awareness or unawareness\n6. Pregnancy, lactating or with a wish of pregnancy within the next year\n7. Low carbohydrate diet\n8. Receiving therapy with an SGLT inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT inhibitor.\n9. New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment\n10. Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment\n11. The receipt of any investigational product 90 days prior to this trial\n12. Unable to participate in study procedures\n13. Any clinically significant disorder, except for conditions associated with type 1 diabetes, which in the Investigators opinion could interfere with the results of the trial\n14. Participation in another intervention study\n15. Exclusion criteria for MRI: known claustrophobia, known chronic lung disease, surgery within past 6 weeks or having foreign bodies of metal in the body (e.g. pacemaker, metal plates, metal screws)\n16. Recurrent urogenital infections.",{"count":405,"type":18},69,[407],"PHASE2","Background: Sodium-glucose-cotransporter (SGLT) inhibition has been observed to reduce risk of cardiovascular events and kidney failure in persons with type 2 diabetes. People with type 1 diabetes also have increased risk of cardiovascular and kidney disease, and may benefit from SGLT-inhibition. The exact mechanism of how SGLT-inhibition benefits the kidneys are yet unknown. Change in renal hypoxia may be a factor.\n\nObjective: The primary aim of this study is to assess the effects of 12 weeks SGLT-1 and 2 inhibition on renal oxygenation in persons with type 1 diabetes and chronic kidney disease.\n\nFurther aims are to study if renal oxygen consumption and response to SGLT-inhibition differs between people of African-Caribbean or Northern European decent.\n\nAdditionally effects on left ventricular ejection fraction, kidney function and biomarkers in blood and urine will be explored.\n\nMethod: 12 weeks treatment with oral sotagliflozin or matching placebo as intervention. Kidney oxygenation and perfusion parameters and left ventricular ejection fraction will be assessed by functional magnetic resonance imaging. Kidney function and biomarkers will be assessed according to local hospital laboratory guidelines.\n\nDesign: Randomized, double-blinded, placebo-controlled, cross over intervention study.\n\nStudy population: 69 persons with type 1 diabetes and diabetic kidney disease with albuminuria will be included, 39 at Steno Diabetes Center Copenhagen, 30 at King's College London.\n\nEndpoints: Primary end-point: Change from 0 to 12 weeks in dynamic R2\\*-weighted signal after treatment with sotagliflozin compared to placebo. Secondary endpoints: Change from 0 to 12 weeks with sotagliflozin compared with placebo on renal perfusion, renal artery flow, renal oxygen consumption, renal parenchymal triglyceride fraction, renal fibrosis, left ventricular ejection fraction, urinary albumin-creatinin ratio, ketone bodies, erythropoietin, pro brain natriuretic peptide, and plasma- and urine inflammation- and fibrosis biomarkers as well as difference after 12 weeks treatment in glomerular filtration rate.\n\nTimeframe: Inclusion of patients from february 2024. Last visit september 2025. Presentation spring 2026, publication fall 2026.",[410,411,412,413,414,415,416],"Nephropathy","Diabetic Nephropathies","Diabetes Mellitus, Type 1","Albuminuria","Diabetic Complications Renal","Diabetic Complications Cardiovascular","Hypoxia","2025-01-22",{"date":419,"type":32},"2025-01-27",{"date":421,"type":18},"2025-02",{"date":423,"type":18},"2027-05",{"name":38,"class":39},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":15,"minAge":138,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":106,"phases":435,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":129},"100522395","phase-3-multifactorial-intervention-to-reduce-cardiovascular-disease-in-type-1-diabetes-100522395","NCT06082063","Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes","Steno1","Inclusion Criteria:\n\n1. Given written informed consent\n2. Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)) during \\>10 years.\n3. Presence of chronic kidney disease (UACR \\>30 mg\u002Fg or eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\\>35 kg\u002Fm2) OR 10-year CVD risk \\>10% according to Steno Type 1 Risk Engine.\n4. Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG.\n5. Ability to communicate with the investigator and understand informed consent.\n\nExclusion Criteria:\n\n1. Type 2 diabetes, MODY, secondary diabetes.\n2. History of pancreatitis.\n3. Body mass index \\\u003C 18.5 kg\u002Fm2\n4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.\n5. Known or suspected abuse of alcohol or recreational drugs.\n6. Participant in another intervention study.\n7. CKD stage 5.","90 Years",{"count":434,"type":18},2000,[436],"PHASE3","A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.",[439,440,226,441],"Cardiovascular Diseases","Heart Failure","Kidney Failure","2025-01-08",{"date":444,"type":32},"2025-01-10",{"date":446,"type":32},"2024-07-01",{"date":448,"type":18},"2029-07-01",{"name":38,"class":39},{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":15,"minAge":457,"maxAge":48,"enrollmentInfo":458,"targetDuration":4,"studyType":106,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":40},"100557003","a-trial-of-three--and-seven-days-insulin-infusions-set-100557003","NCT06532461","A Trial of Three- and Seven-days Insulin Infusions Set","A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes","Inclusion Criteria:\n\n* Diagnosed with T1D\n* Diabetes duration of more than 6 months prior to inclusion.\n* Currently using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery.\n* Planning to using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery.\n* Being between 7 and 18 years of age prior to inclusion\n* Insulin needs per day above 8 units\n\nExclusion Criteria:\n\n* Those who are unable to read and understand Danish\n* Those with impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and\u002For be reached by phone or videocall","7 Years",{"count":459,"type":18},80,[108],"More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog",[226],[464,465,466,467,468],"Ultrasound","Electric Bioimpedance Spectroscopy","tissue viability imaging","Hyperechogenicity","Lipohypertrophy","2024-08-02",{"date":471,"type":32},"2024-08-06",{"date":473,"type":32},"2024-07-20",{"date":475,"type":18},"2026-12-31",{"name":38,"class":39},{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":15,"minAge":457,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":106,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":506,"locationsCount":313},"100552169","automated-insulin-delivery-for-type-1-diabetes---beyond-glucose-metrics-100552169","NCT06469593","Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics","AID-BEYOND: Automated Insulin Delivery for Type 1 Diabetes - Beyond Glucose Metrics","AID-BEYOND","Inclusion Criteria (Adults):\n\n* Age ≥18 years\n* Type 1 diabetes ≥3 years\n* CGM or intermittently scanned CGM (isCGM) use ≥6 months\n* Approval from the responsible health care provider (HCP) to start AID\n* Specific AID system chosen ahead of screening after participant has been thoroughly informed\n\nInclusion Criteria (Children):\n\n* Age 7-17 years\n* Type 1 diabetes ≥6 months\n* CGM or isCGM use ≥6 months\n* Approval from the responsible HCP to start AID\n* Specific AID system chosen ahead of screening after participant has been thoroughly informed\n\nExclusion Criteria:\n\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start\n* Use of commercial or open-source AID systems prior to study participation\n* Daily use of paracetamol (acetaminophen)\n* Breast-feeding, pregnancy or planning to become pregnant within 4 months\n* Alcohol or drug abuse\n* Severe cardiac disease\n* Retinopathy contraindicating HbA1c \\\u003C53 mmol\u002Fmol\n* Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the person unsuitable for study participation\n* Lack of compliance with key study procedures at the discretion of the investigator",{"count":486,"type":18},200,[108],"The goal of this clinical trial is to determine if transitioning to automated insulin delivery (AID) systems, can improve objectively measured sleep quality and quantity and alleviate cardiovascular risk factors in both children and adults diagnosed with type 1 diabetes. The main questions it aims to answer are:\n\n* Does the intervention improve sleep efficiency as measured by the HomeSleepTest, EEG based device, 4 months after initiation?\n* Can the use of AID treatment alleviate cardiovascular risk measured by heart rate variability (HRV), blood pressure and inflammatory markers?\n* Researchers will compare AID systems to usual treatment, including both multiple daily injections and sensor augmented pumps to see if the above benefits can be achieved with AID in comparison. Participants will be randomized 1:1 to either start AID treatment or to continue their usual care. The study will be open label.\n\nParticipants will, at baseline and after 4 months:\n\n* Have taken blood and urine samples to measure metabolic and inflammatory parameters\n* Perform digital cognitive testing using the CANTAB software\n* Fill out questionnaires related to quality of life, fear of hypoglycemia, hypoglycemia awareness, eating habits and sleep quality\n* Wear a blinded CGM for 10 days\n* Monitor sleep at home using the HomeSleepTest for 3 consecutive nights\n* Wear a Holter monitor for 24 hours to determine HRV parameters\n* Measure blood pressure for 24 hours at 30 min intervals\n* Wear an ActiGraph for 7 days to assess sleep and activity, supported by daily electronic sleep diaries\n\nParticipants randomized to AID treatment will receive education in the use of the systems.\n\nVirtual follow-up visits are scheduled at week 1, 5 and 9 for both control and intervention groups during the study, following baseline examinations.",[412],[491,492,493,494,226,495,496,497,498,499],"Closed-loop insulin pump","Automated insulin delivery","AID systems","Artificial pancreas","T1D","Sleep","Cognition","Cardiovascular risk","Inflammation","2024-06-17",{"date":502,"type":32},"2024-06-21",{"date":504,"type":32},"2024-06-15",{"date":213,"type":18},{"name":38,"class":39},""]