[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562254":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":31,"locations":38,"responsibleParty":53,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":30,"enrollmentInfo":64,"targetDuration":30,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":87,"whyStopped":30,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Mealtime and Postmeal Dosing of Ultra Rapid Lispro Insulin (URLi)","EXPERIMENTAL","This arm consists of participants with Type 1 Diabetes Mellitus (T1DM) who are using the Medtronic 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi). Participants will undergo two intervention phases: in one phase, URLi will be administered at mealtime (premeal dosing), and in the other phase, URLi will be administered immediately after meals (postmeal dosing). The dosage form is subcutaneous insulin infusion, and the insulin dose is based on individual carbohydrate counting. Each intervention phase will last for up to 4 weeks, with glycemic control and patient preferences assessed at the end of each phase.",[13,14],"Drug: Ultra Rapid Lispro (URLi)","Device: Insulin pump with continuous glucose monitoring (CGM)",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Ultra Rapid Lispro (URLi)","Dosage Form:\n\nSubcutaneous insulin infusion\n\nDosage:\n\nBased on individual carbohydrate counting, adjusted using the MiniMed 780G hybrid closed-loop system.\n\nFrequency:\n\nAdministered at mealtime (premeal) during one phase and immediately after meals (postmeal) during the other phase.\n\nDuration:\n\nEach intervention phase lasts up to 4 weeks.\n\nArm or Group\u002FIntervention Cross-Reference:\n\nBoth interventions (mealtime and postmeal dosing) are applied to the single arm of the study.",[9],[22],"Lyumjev",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Insulin pump with continuous glucose monitoring (CGM)","The insulin pump with continuous glucose monitoring (CGM) system is used by patients with Type 1 Diabetes Mellitus (T1DM) as part of their regular treatment regimen. This system combines an insulin pump with real-time glucose monitoring, adjusting basal insulin delivery every 5 minutes based on continuous glucose data. In this study, participants are already using the system before the trial begins. The research does not examine the effect of the CGM itself but rather focuses on the timing of insulin bolus delivery (mealtime vs. postmeal) using their existing treatment system.\n\nFrequency:\n\nThe system delivers basal insulin continuously and requires the patient to manually deliver bolus doses at mealtime (premeal) or postmeal, depending on the study phase.\n\nDuration:\n\nThe device is used continuously throughout the entire study period, with each intervention phase (premeal vs. postmeal dosing) lasting up to 4 weeks.\n\nArm or Group\u002FIntervention Cross-Reference:\n\nThis device will be us",[9],[29],"MiniMed 780G Hybrid Closed-Loop System",null,[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Roy Eldor, MD; PhD","CONTACT","0527360680","+972","roye@tlvmc.gov.il",[39],{"facility":40,"status":30,"city":41,"state":30,"zip":30,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Tel-Aviv Medical Center","Tel Aviv","Israel","IL",{"type":45,"coordinates":46},"Point",[47,48],34.78057,32.08088,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":35,"phoneExt":36,"email":37},"Roy Eldor, MD; Phd",{"type":54,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100562254","phase-4-mealtime-or-post-meal-dosing-of-urli-in-medtronic-780g-hybrid-closed-loop-system-100562254",false,"NCT06600776","Mealtime or Post-meal Dosing of URLi in Medtronic 780G Hybrid Closed Loop System","A Pilot Study Comparing the Efficacy of Dosing Ultra Rapid Insulin Lispro in a Medtronic 780G Hybrid Closed Loop System at Mealtime or Postmeal","Inclusion Criteria:\n\nParticipants must be 18 years of age or older (inclusive).\n\nDiagnosed with Type 1 Diabetes Mellitus (T1DM).\n\nAlready using the MiniMed 780G hybrid closed-loop system with Ultra Rapid Lispro Insulin (URLi) for at least 2 months prior to study enrollment.\n\nAble and willing to provide informed consent electronically.\n\nWilling and able to comply with the scheduled visits and other study procedures, including remote monitoring and completing questionnaires.\n\nExclusion Criteria:\n\nParticipants with a medical history of untreated active proliferative retinopathy.\n\nNote: Subjects with non-proliferative retinopathy may be included. Subjects with treated proliferative retinopathy may be included based on the investigator's clinical judgment.\n\nSevere acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or interfere with the interpretation of study results, as judged by the investigator.","ALL","18 Years",{"count":65,"type":66},50,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","This is a pilot study to compare premeal to postmeal dosing of ultra rapid lispro insulin (URLi) used in a MiniMed 780G system hybrid closed loop system. Subjects with type 1 diabetes mellitus (T1DM) already using a 780G hybrid closed loop system with URLi will be included. After signing a remote digital informed consent, a baseline record of the MiniMed 780G system will be downloaded from the Medtronic digital platform (Carelink system \\[1\\]) and subjects will be asked to fill an online questionnaire regarding their time of insulin dosing preferences and a 3-day online food diary \\[2\\]. During the intervention period subjects will be asked to provide a bolus dose of insulin only at the end of meals for up to 4 weeks. During the last week of the intervention period, subjects will be asked to fill out a 3-day online food diary \\[2\\]. At the end of the intervention period- a Carelink report \\[1\\] will be collected remotely and subjects will be asked to fill again the online questionnaire regarding their time of dosing preferences.\n\n1. Primary Objective: To assess the efficacy of premeal dosing to post-meal dosing on parameters of glycemic control as obtained from continuous glucose monitoring.\n2. Secondary Objective: To assess patient dosing preferences and the effect of premeal dosing vs. post-meal dosing on patient reported outcomes\n\nRef:\n\n1. carelink.medtronic.eu\n2. NutRatio.com.",[72],"Type 1 Diabetes (T1D)",[74,75,76,77,78,22,79,80,81,82,83,84,85,86],"Automated Insulin Delivery","Continuous Glucose Monitoring (CGM)","Glycemic Control","Hybrid Closed Loop System","Insulin Bolus","Mealtime Dosing","Medtronic 780G","Patient Preferences","Postmeal Dosing","Postprandial Glycemia","Time in Range (TIR)","Type 1 Diabetes Mellitus (T1DM)","Ultra Rapid Lispro Insulin (URLi)","NOT_YET_RECRUITING","2024-09-22",{"date":90,"type":91},"2024-09-24","ACTUAL",{"date":93,"type":66},"2024-10-06",{"date":95,"type":66},"2025-10-21",{"name":5,"class":6},1]