[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602284":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Second Xiangya Hospital of Central South University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hybrid closed-loop insulin delivery system","EXPERIMENTAL","T2DM patients in the experimental group will receive the hybrid closed-loop insulin delivery system.",[13],"Device: Hybrid closed-loop insulin delivery system",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional insulin pump with CGM","ACTIVE_COMPARATOR","T2DM patients in the control group will receive conventional insulin pump therapy with CGM.",[19],"Device: conventional insulin pumps combined with CGM",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Perioperative patients with T2D receiving parenteral nutrition will receive hybrid closed-loop insulin delivery system for glycemic management.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"conventional insulin pumps combined with CGM","Perioperative patients with T2D receiving parenteral nutrition will receive conventional insulin pumps combined with CGM for glycemic management.",[15],[31],{"name":32,"affiliation":33,"role":34},"Xia Li, MD, PhD","Second Xiangya Hospial of Central South University","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+86 13974885753","lixia2014@vip.163.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan 410011","RECRUITING","Changsha","Hunan","410011","China","CN",{"type":50,"coordinates":51},"Point",[52,53],112.97087,28.19874,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":38,"phoneExt":25,"email":39},"Xia Li",{"type":34,"investigatorFullName":57,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Professor","100602284","hybrid-closed-loop-for-perioperative-glycemic-control-in-t2dm-with-parenteral-nutrition-100602284",false,"NCT07121504","Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition","Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization \\>72 hours).\n3. Glycemic control criteria (meeting any of the following):\n\n   ①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol\u002FL\n   * Established T2DM with poor glycemic control (HbA1c ≥7.5%) despite combination therapy (≥2 oral antidiabetic drugs) ③Insulin-treated patients with suboptimal control (HbA1c ≥7.0%) after adequate dose adjustment.\n4. Willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.\n2. Patients with type 1 diabetes or other specific types of diabetes.\n3. Patients with severe organ dysfunction, defined as:\n\n   * Cardiac function ≥Class III (NYHA classification)\n\n     * ALT\u002FAST \\>3× upper limit of normal (ULN) ③ eGFR ≤30 mL\u002Fmin\u002F1.73 m²\n\n       * Hemoglobin \\\u003C90 g\u002FL ⑤ WBC count \\\u003C4.0×10⁹\u002FL or platelets \\\u003C90×10⁹\u002FL ⑥ Hemodynamic instability\n4. Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.\n5. Patients with known hypersensitivity to any drugs or materials used in the study protocol.\n6. Patients who have contraindications to conventional insulin pump therapy.\n7. Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.\n8. Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.\n9. Patients who have other conditions deemed unsuitable for trial participation by investigators.\n10. Patients who suffer severe surgical complications.","ALL","18 Years",{"count":70,"type":71},40,"ESTIMATED","INTERVENTIONAL",[74],"NA","Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.",[77],"Type 2 Diabetes",[79,80,81],"hybrid closed-loop","perioperative","parenteral nutrition","2025-08-06",{"date":84,"type":85},"2025-08-13","ACTUAL",{"date":87,"type":85},"2025-06-26",{"date":89,"type":71},"2026-06-01",{"name":5,"class":6},1]