[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetes-type-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetes-type-1":324},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,40,70,98,133,155,181,199,220,247,266,297],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":4,"eligibilityCriteria":13,"healthyVolunteers":10,"sex":14,"minAge":4,"maxAge":4,"enrollmentInfo":15,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":16,"type":17},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.",[21,22,23,24,25,26],"Diabetes","Diabetes Care","Diabetes Type 1","Diabetes Type 2","Remote Patient Monitoring","Digital Health","NOT_YET_RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-25","ACTUAL",{"date":33,"type":17},"2026-06",{"date":35,"type":17},"2028-07",{"name":37,"class":38},"Steno Diabetes Center Copenhagen","OTHER",1,{"id":41,"slug":4,"hasResults":10,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":14,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100630857","NCT07493122","Study of IMC-S118AI in Type 1 Diabetes","A Dose-Escalation Study Evaluating the Safety and Pharmacokinetics of IMC-S118AI in HLA-A*02:01-Positive Participants With Type 1 Diabetes","Inclusion Criteria:\n\n* Body mass index (BMI): 18 to 25 kg\u002Fm2\n* History of a diagnosis of T1D\n* HLA type: HLA-A\\*02:01\n* Shows signs of remaining beta-cell function\n\nExclusion Criteria:\n\n* Non-T1D (type 2 diabetes, monogenic diabetes, and secondary diabetes)\n* History of recurrent hypoglycaemia due to non-compliance with insulin regimens\n* Prior treatment with immunomodulating therapy for T1D\n* Have a history of cardiovascular disease or impaired cardiac function\n* Current diagnosis of a malignancy or any history of malignancy","18 Years","45 Years",{"count":49,"type":17},154,"INTERVENTIONAL",[52],"PHASE1","This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens. This study will potentially also explore the effects of multiple-dosing regimens on preservation of beta-cell function in Stage 3 Type 1 diabetes.",[55,56,23],"Type 1 Diabetes","Type 1 Diabetes (T1D)",[58,59],"diabetes","type 1","2026-03-19",{"date":62,"type":31},"2026-03-25",{"date":64,"type":17},"2026-04",{"date":66,"type":17},"2030-11",{"name":68,"class":69},"Immunocore Ltd","INDUSTRY",{"id":71,"slug":4,"hasResults":10,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":10,"sex":14,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100596693","NCT07048795","Impact of the Mylife CamAPS FX System With the DEXCOM G6 Sensor on T1D Patients in France","Impact de l'Utilisation du système Mylife CamAPS FX associé au Capteur DEXCOM G6 Sur le contrôle glycémique et la qualité de Vie de Patients DT1, en Vie réelle, en France","EPICAM-G6","Inclusion Criteria:\n\n* Patients with type 1 diabetes who have been using a Dexcom or Abbott Libre glucose sensor (any model) for at least 14 days prior to the date of installation of the mylife YpsoPump, with at least 70% coverage, under the same sensor.\n* Patient for whom the diabetes specialist decides to initiate the mylife CamAPS FX hybrid closed loop.\n* Patient who received the information sheets and gave their consent to participate in the study and to the processing of their personal data.\n* Adult patient who signed an informed consent form to participate in the study or minor patient whose parents signed an informed consent form for their child's participation in the study.\n* Adult patient, minor patient old enough to complete the questionnaires or parent of a minor patient able to read and understand French.\n* Adult patient \u002F minor patient capable to complete the questionnaires or parent of a minor patient who agrees to complete the online self-questionnaires.\n\nExclusion Criteria:\n\n* Patient who used a hybrid closed-loop system, a fully closed-loop system, or a do-it-yourself loop system, regardless of the brand or model, within the past 6 months.\n* Patients participating or having participated in a clinical trial in the previous month that prevents them from participating in other studies.\n* Patient or parent unable to give consent.\n* Protected Patient (subject to a legal protection measure: guardianship, curatorship or legal safeguard).\n* Patient with a contraindication to the prescription of the mylife CamAPS FX hybrid closed-loop ( according to the Instructions For Use, IFU).\n* Patient with an unresolved skin condition in the area of sensor placement and\u002For in the tubing placement area (e.g. psoriasis, dermatitis herpetiformis, rash, staphylococcal infection).\n* Patient with unstable diabetic retinopathy requiring laser treatment.\n* Patient with a concomitant condition or treatment that alters glucose metabolism and that, in the investigator's judgment, is likely to have a significant impact on glycemic control;\n* Patient whose follow-up cannot be carried out by the centre (relocation planned within 12 months of inclusion).",{"count":78,"type":17},125,"This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France. The study is conducted among participants with type 1 diabetes (T1D) using the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring (CGM) sensor (the System).\n\nThe main objective of the study is to evaluate, under real-life conditions, the impact of the System on glycemic control in participants with T1D after one year of use.\n\nSecondary objectives include assessing participant-reported outcomes, such as quality-of-life, treatment satisfaction, fear of hypoglycemia, and sleep quality, describing complications related to the system, the rate of hybrid closed-loop usage over one year, and analyzing system usage parameters (e.g., Boost\u002FEase-Off mode use, insulin-to-carbohydrate ratios, alarms).\n\nThe study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France.\n\nEndocrinologists \u002F diabetes specialists will monitor participants over the 12-month period after they start using the system and collect data at the three data collection time points.",[23],[82,83,84,85,86],"Diabetes Mellitus, Type 1","Real-life use","mylife CamAPS FX","YpsoPump","Hybrid closed loop","RECRUITING","2026-02-27",{"date":90,"type":31},"2026-03-03",{"date":92,"type":31},"2025-12-11",{"date":94,"type":17},"2027-12",{"name":96,"class":69},"mylife Diabetes Care AG",20,{"id":99,"slug":4,"hasResults":10,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":14,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"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",true,"50 Years","80 Years",{"count":109,"type":17},150,"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.",[24,23],[21,113,114,115,116,117,118,119,120,121,122],"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","2026-02-24",{"date":125,"type":31},"2026-02-25",{"date":127,"type":31},"2026-01-01",{"date":129,"type":17},"2032-01",{"name":131,"class":38},"Henrik Bo Wiberg Larsson",3,{"id":134,"slug":4,"hasResults":10,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":10,"sex":14,"minAge":139,"maxAge":46,"enrollmentInfo":140,"targetDuration":4,"studyType":50,"phases":142,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":132},"100621917","NCT07376850","Time in rANge vs. Time in nOrmal Glycemia for Better Glycemic Control","TANGO","Inclusion Criteria:\n\n* Diagnosis of T1D per ADA criteria\n* Age 5.0-17.99 at the start of study\n* CGM use \\>70% of the time during the month prior to enrollment\n* Maximum HbA1c of 86mmol\u002Fmol (10% in DCCT)\n\nExclusion Criteria:\n\n* No concurrent illnesses impacting glycemia\n* No treatments impacting glycemia\n* Severe hypoglycemia documented in the 60 day period leading up to patient recruitment\n* Current participation in any other interventional study\n* Any significant diseases \u002F conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise participant's safety\n* Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration","5 Years",{"count":141,"type":17},120,[143],"NA","The TANGO study is a 12-month study involving 120 children and adolescents with Type 1 Diabetes (T1D) across the Czech Republic, Israel, and Poland who use automated insulin delivery (AID) systems.\n\nCurrently, the global standard for diabetes management is \"Time in Range\" (TIR), which aims to keep blood sugar levels between 70-180 mg\u002FdL. However, newer technologies like AID systems may now allow for a tighter, more physiological goal called \"Time in Normal Glycemia\" (TING), which targets a range of 70-140 mg\u002FdL.\n\nThis study will randomly assign participants to follow either the standard TIR target or the tighter TING target to see if the narrower range improves overall blood sugar control and HbA1c without increasing the risk of hypoglycemia, family stress, or daily treatment burden.\n\nBy comparing these two approaches, researchers hope to determine if clinical guidelines should be updated to reflect a more precise glucose target for children and adolescents worldwide",[21,146,23],"Diabetes (DM)","2026-01-21",{"date":149,"type":31},"2026-01-29",{"date":151,"type":17},"2026-01",{"date":33,"type":17},{"name":154,"class":38},"University Hospital, Motol",{"id":156,"slug":4,"hasResults":10,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":10,"sex":14,"minAge":46,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":50,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":39},"100612836","NCT07258758","Diabetes Intervention Involving Person-centred Nutritional Education","Diabetes Intervention Involving Person-centred Nutritional Education (DINE) - Exploring the Benefits and Challenges of a Person-centred Education on the Nordic Diet for Adults With Type 1 Diabetes.","DINE","Inclusion Criteria:\n\n* Type 1 Diabetes.\n* Diabetes duration for more than 12 months at screening.\n* Adults 18 years or older.\n* HbA1c more than 57mmol\u002Fmol.\n* Use of continuous glucose monitoring (CGM) sensor for more than three months at screening and during the study period.\n* Use of basal and bolus insulin regimen for more than three months at screening and during the study period.\n* Written Informed Consent.\n\nExclusion Criteria:\n\n* Women of childbearing potential: ongoing pregnancy or planned pregnancy during the study period.\n* Cognitive impairment or other disease that study physician find non-compatible with participation.\n* Planned change in glucose lowering treatment during study period (change of mealtime insulin analogue with same pharmacodynamic profile allowed).\n* Planned change of CGM sensor during the study.\n* Food allergies or intolerances that are incompatible with adhering to Nordic nutrition recommendations.\n* Current or planned treatment with corticosteroids during the study (other than for replacement therapy).",{"count":163,"type":17},54,[143],"The overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. The study will measure the intervention's impact on blood glucose levels, blood lipids, blood pressure, and adherence to a sustainable and healthy Nordic diet.\n\nThe main question the trial aims to answer is:\n\nDoes a person-centred nutritional education have an impact on glucose time in range for adults with Type 1 diabetes, compared with short dietary information?\n\nThe participants will:\n\n* Attend either a person-centred nutrition education (intervention) or receive short dietary information (control group).\n* Wear their sensor for continuous glucose monitoring (CGM) throughout the trial.\n* Visit the clinic for data collection (blood samples and clinical checks) at the start and end of the trial.\n* Keep a four-day food diary, fill out a food frequency questionnaire (FFQ) and estimate their food enjoyment at the start and end of the trial.",[23],[168,169,170,171,55],"Nutritional education","Person-centred care","Nordic diet","Diabetes intervention","2025-12-04",{"date":174,"type":31},"2025-12-12",{"date":176,"type":31},"2025-09-01",{"date":178,"type":17},"2027-06",{"name":180,"class":38},"Umeå University",{"id":182,"slug":4,"hasResults":10,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":10,"sex":14,"minAge":46,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":50,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":132},"100607814","NCT07193446","Optimising the Delivery of Diabetes Distress Informed Care for Its Prevention, Detection, and Management in Adults With Type 1 Diabetes: a Feasibility Study (D-stress Study)","Inclusion Criteria:\n\nAdults with type 1 diabetes\n\n* People aged 18 years old and older\n* With a T1DM diagnosis of more than one year\n* Who used a Continuous Glucose Monitoring device 3 months prior to trial entry\n\nHealth care professionals\n\n* Members of the multidisciplinary diabetes team\n* Who would like and be able to undertake training in Enhanced Usual Care (EUC)\n\nFamily or friend\n\n* People aged 18 years or older\n* Is involved with the care of the participant\n* The participant has consented to the family member or friend to be involved in the study\n\nREDUCE Facilitators\n\n• Eligibility as per the role specification in Section 6.2.2 of study Protocol\n\nExclusion Criteria:\n\nAdults with type 1 diabetes\n\n* Exclusion criteria will include those adults diagnosed less than one year ago. This is because the first 12 months following a diagnosis of T1DM is a period of unique stress due to the diagnosis, the acute onset, and requirement to learn complex new skills. Additionally, due to the honeymoon period, which can typically last up to a year, there is variety in the physiological trajectory which might have an impact that would be difficult to measure and account for in this study(Sokołowska, Chobot et al. 2016).\n* Women who are pregnant. This is because the additional burdens and anxieties this population is confronted with may risk confounding the trial findings\n* Exclusion of adults with current mental health diagnoses with current symptoms (e.g. psychosis or substance abuse or severe depression), will be evaluated and determined on a case-by-case basis by clinical care teams.\n\nHealth care professionals • People who are unwilling or unable to take on additional workload associated with D-stress e-learning and delivery of Enhanced Usual Care.\n\nFamily or friend\n\n• Participant with type 1 diabetes has not given consent for a family member or friend to participate in the study\n\nREDUCE Facilitators\n\n* • Professional accreditation with one of the following professional bodies: Nursing \\& Midwifery Council, Health \\& Care Professionals Council, British Association for Counselling \\& Psychotherapy, and UK Council for Psychotherapy.\n* Professional or personal understanding of Type 1 diabetes\n* Professional or personal understanding of NHS diabetes care and guidelines\n* Professional or personal understanding of diabetes distress\n* Professional understanding of mental and emotional health\n* Professional experience of in-person and\u002For online group facilitation especially in managing diverse needs within a group and the expression of strong emotions\n* Willingness to be a research participant",{"count":187,"type":17},110,[143],"Up to one in two adults with type 1 diabetes find living with and managing diabetes to be emotionally challenging. This 'emotional side' of diabetes - feeling worried, frustrated, overwhelmed, sad, burnt-out - is called diabetes distress. It affects people's quality of life and can hinder them from managing their diabetes as well as they can.\n\nIn the UK, the NHS needs to better understand how to best support people feeling emotionally burdened by diabetes. So, we have worked with diabetes distress specialists around the world to develop an NHS pathway to care for diabetes distress. This pathway to care involves training diabetes teams to recognise, assess and talk about diabetes distress at routine appointments. If people have a high diabetes distress level, they may be able to take part in an online group program to help them manage their type 1 diabetes and emotions. The feasibility study will test this pathway to care with people with type 1 diabetes in the NHS setting.",[23],"2025-11-26",{"date":172,"type":31},{"date":194,"type":31},"2025-10-31",{"date":196,"type":17},"2026-09-01",{"name":198,"class":38},"Guy's and St Thomas' NHS Foundation Trust",{"id":200,"slug":4,"hasResults":10,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":10,"sex":14,"minAge":46,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":50,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100601475","NCT07110974","Diabetes Distress and Quality of Life in University Students With Type 1 DM","Assessment of Diabetes Distress and Quality of Life in Sohag University Students With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Already diagnosed Type 1 diabetes mellitus\n2. receiving insulin\n\nExclusion Criteria:\n\n1. refuses to participate in the study.\n2. deaf or mute.",{"count":206,"type":17},200,[143],"This study aims to encourage and support Sohag University Students with type 1 Diabetes Mellitus (T1DM). It will discover students with poor glycemic control, diabetic retinopathy, and renal complications. In addition to focus on those students suffering from Diabetes Distress (DD) and poor Quality of Life (QOL) due to type 1 Diabetes Mellitus (T1DM).",[23,210],"Diabetes Distress","2025-08-01",{"date":213,"type":31},"2025-08-08",{"date":215,"type":17},"2025-10",{"date":217,"type":17},"2026-10",{"name":219,"class":38},"Sohag University",{"id":221,"slug":4,"hasResults":10,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":10,"sex":14,"minAge":46,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":50,"phases":227,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100572867","NCT06738849","EkiYou-Study-2 : A National Multicentric Trial of the EkiYou Application for Insulin Bolus Calculation","EkiYou-Study-2 : Multicenter Randomised Controlled Trial of the EkiYou Application for Insulin Bolus Calculation","Inclusion Criteria:\n\n* be aged 18 or over,\n* have type 1 or type 2 diabetes or diabetes secondary to pancreatic disease,\n* have been treated with multi-injection basal\u002Fbolus insulin therapy for at least 6 months,\n* using a compatible rapid insulin with the device Ekiyou such as : Novorapid, Humalog, Apidra, Asparte Sanofi, Fiasp or Lyumjev,\n* using a compatible long-acting insulin with the device EkiYou such as : Lantus, Abasaglar, Toujeo, Levemir or Tresiba,\n* have been using a continuous glucose monitoring device such as Dexcom G6, Dexcom One, Dexcom One+ or FreeStyle Libre for at least 3 months,\n* have given their physician access to their glucose data via a glucose data management platform,\n* for type 2 diabetic patients using an hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors), have no change in dosage regimen for at least 3 months\n* have recorded at least 70% of CGM data over a 14-day window close to the inclusion date,\n* have at least one smartphone running Android 5.0 or higher or iOS 12.0 or higher connected to the internet and able to receive CGM data available to them on the day of the inclusion,\n* able to read or use a smartphone with no visual impairment needing specific typography,\n* for patients of childbearing potential, a pregnancy test must have been carried out prior to inclusion, or an effective and adequate method of contraception must be used,\n* be affiliated to a French social security scheme.\n\nExclusion Criteria:\n\n* pregnant or breast-feeding women,\n* type 1 diabetic patients treated with any hypoglycemia-inducing agent other than insulin (including hypoglycemic sulfonamides and SGLT-2 inhibitors),\n* insulin-resistant patient: prescribed daily insulin dose \\> 1 U\u002Fkg\u002Fday or \\> 200 U\u002Fday,\n* patient with very low insulin requirements: daily insulin dose \\\u003C 15 U\u002Fday,\n* patient with gastroparesis,\n* diabetic ketoacidosis or severe level 3 hypoglycemia requiring third-party intervention within the 6 months prior to inclusion,\n* pancreatic disease secondary to chronic ethanolism,\n* known medical condition that, in the investigator's opinion, may interfere with the protocol,\n* patient who cannot be monitored for 3 months,\n* intellectual ability compromising use of the application, comprehension or completion of questionnaires,\n* participation in another clinical trial or administration of a non-authorised drug in the 4 weeks preceding the screening,\n* person taking part in another research study with an exclusion period still in progress,\n* under guardianship or curatorship,\n* imprisoned or otherwise deprived of liberty.",{"count":49,"type":17},[143],"EkiYou-Study-2 is an interventional multicenter randomised controlled clinical investigation according to EU 2017\u002F745. It is conducted in 154 adults with diabetes and treated by multiple daily insulin injections that will be followed for 6 months.\n\nAfter a randomization, participants will receive for 6 months EkiYou V2 Digital Therapy that will help them to estimate their daily bolus and basal insulin doses. This device weekly adjusts insulin parameters including : basal insulin dose, insulin to carb ratios and correction factor.\n\nThe control group will stay with their standard care, and after the first three months of control period, they will receive EkiYou V2 for the last three months.\n\nThe aim of this study is to examine the performance of the EkiYou V2 Digital Therapy compared with conventional methods for people with diabetes treated with multi-injections as part of a basal-bolus regimen. We also aim to assess the level of satisfaction and user experience with the EkiYou application, as well as the quality of life of study participants.",[23,230,231],"Diabetes Type 2 on Insulin","Pancreatogenous Diabetes",[233,234,235,236],"decision support system","digital therapy","bolus advisor","flexible insulin therapy","2025-06-17",{"date":239,"type":31},"2025-06-18",{"date":241,"type":31},"2024-11-05",{"date":243,"type":17},"2026-11-30",{"name":245,"class":69},"DiappyMed",16,{"id":248,"slug":4,"hasResults":10,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":105,"sex":14,"minAge":46,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":39},"100592112","NCT06989190","The MIND Study - Microangiopathy IN Diabetes","Phase 1: Severe Diabetic Complications (50 patients)\n\nInclusion Criteria:\n\n* Severe type 1 diabetes (microangiopathy \u002F diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.\n* Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered\n\nPhase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included.\n\nInclusion criteria:\n\n* Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease)\n* Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients.\n* Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and\u002For microalbuminuria and\u002For early signs of neuropathy (group b), 100 patients.\n* Patient with moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c), 50 patients.\n\nHealthy controls:\n\n\\- Healthy control matched to the type 1 diabetes patients in age and gender, with no known risk of increased cardiovascular disease.\n\nExclusion Criteria:\n\n* Patients unable to understand patient information due to cognitive impairment\n* Patients unable to understand patient information due to language barriers\n* Ongoing acute infection or inflammatory condition\n* Pregnant or breastfeeding women\n* Patients with damaged and\u002For scarred tissue in the areas of interest for the investigational or comparator devices","60 Years",{"count":254,"type":17},400,"This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.",[23],"2025-05-16",{"date":259,"type":31},"2025-05-25",{"date":261,"type":31},"2023-12-19",{"date":263,"type":17},"2026-12",{"name":265,"class":69},"HJN Sverige AB\u002FNeko Health",{"id":267,"slug":4,"hasResults":10,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":10,"sex":14,"minAge":46,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":50,"phases":275,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":39},"100584855","NCT06894784","A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes","Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)","SEMPA","The inclusion criteria at the time of enrollment are:\n\n* Males and females aged 18 or older.\n* Clinical diagnosis of T1D for at least one year.\n* Use of AID system for at least three months.\n* Body Mass Index (BMI) ≥ 23 kg\u002Fm2.\n\nThe exclusion criteria are:\n\n* Use of GLP1-RA within one month of admission.\n* Use of SGLT2i within two weeks of admission.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were \\\u003C 4.0 mmol\u002FL, resulting in seizure, loss of consciousness, or the need to present to the emergency department).\n* Diabetic ketoacidosis episode within six months of admission.\n* History of acute pancreatitis, chronic pancreatitis, or gallbladder disease.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe impairment of renal function with an eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method.\n* Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement.\n* Bariatric surgery within six months of admission.\n* A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement.\n* Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment.",{"count":274,"type":17},36,[276],"PHASE3","The goal of this clinical trial is to learn if Empagliflozin and Semaglutide, individually and combined, added to Automated Insulin Delivery (AID) works to improve time-in-range in adults living with Type 1 Diabetes. It will also evaluate the safety of Empagliflozin and Semaglutide in this context.\n\nThe primary hypothesis of this study is :\n\n\\- The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to placebo when added to AID therapy.\n\nThe secondary hypotheses are :\n\n* The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to semaglutide alone when added to AID therapy.\n* The combination of semaglutide and empagliflozin will increase time-in-range compared to empagliflozin alone when added to AID therapy.\n\nIn this study, the research team will compare Empagliflozin and Semaglutide to a placebo (a look-alike substance that contains no drug) to see if they improve time-in-range.\n\nThis study has four groups:\n\nGroup 1: semaglutide injection + empagliflozin tablet. Group 2: semaglutide injection + placebo tablet. Group 3: placebo injection + empagliflozin tablet. Group 4: placebo injection + placebo tablet.\n\nThis is a 2x2 factorial crossover study. This means that all participants will undergo both injection intervention (placebo and semaglutide) arms. Within each injection arm, participants will take both tablets (placebo and empagliflozin). By the end of the study, every participant will have taken part in each study group.",[23],[280,281,282,283,284,285,286,287,82],"T1D","Combination Therapy","Automated Insulin Delivery","SGLT2-i","GLP1-RA","Insulin","Artificial Pancreas","GLP-1 receptor agonist","2025-03-25",{"date":290,"type":31},"2025-03-30",{"date":292,"type":17},"2025-04",{"date":294,"type":17},"2027-01",{"name":296,"class":38},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":298,"slug":4,"hasResults":10,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":105,"sex":14,"minAge":139,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":39},"100382303","NCT04257877","Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)","Targeted Proteomic Analysis in the Plasma of Children With Diabetes Type 1 and Its Association With Peripheral Diabetic Neuropathy","PAPD","Inclusion Criteria:\n\n1. Children with confirmed DT1 under insulin substitution therapy\n2. Age 5-10 years\n3. Good glycemic control with HbA1c ≤ 7.0%\n4. Prepubertal patients\n5. Absence of other diseases\n6. Signed informed consent of the parents or guardians of patients\n\nExclusion Criteria:\n\n1. Presence of organic cause for neuropathy\n2. Presence of other chronic disease\n3. Poor glycemic control\n\n3\\. Medication","10 Years",{"count":306,"type":17},50,"The aim of the present study is to investigate a targeted proteomic analysis in plasma of children - of Greek origin- with type 1 diabetes (DT1) and its correlation with the electrophysiological findings that accompany diabetic peripheral neuropathy.\n\nDiabetic neuropathy is the most frequent chronic complication in adults with DT1 and rarely appears in childhood. Nevertheless, cases of acute mononeuritis have been described at the time of diagnosis of DT1. According to recent reports several biomarkers, including proteomic analysis, have been proposed for the early detection of peripheral neuropathy in children and young adults with T1DM.\n\nIn the present study the researchers will attempt to investigate the role of biomarkers with targeted proteomic analysis in the plasma of children with DT1 in combination with an electrophysiological study, which includes a nerve conduction study, to detect early diabetic peripheral neuropathy, before the appearance of clinical manifestations.",[23,309,310],"Proteomics","Diabetic Peripheral Neuropathy",[312,313,120,314],"plasma proteomics","children","nerve conduction","2024-07-29",{"date":317,"type":31},"2024-07-31",{"date":319,"type":31},"2018-11-20",{"date":321,"type":17},"2025-01-20",{"name":323,"class":38},"Aristotle University Of Thessaloniki",""]