[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574169":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":24,"responsibleParty":41,"collaborators":24,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":24,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":24,"enrollmentInfo":52,"targetDuration":24,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":24},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RT-CGM","EXPERIMENTAL","Intraoperative blood glucose monitoring and management based on a real-time RT-CGM system.",[13],"Device: RT-CGM",{"label":15,"type":6,"description":16,"interventionNames":17},"Control","Patients enrolled in the control group will have the CGM sensor attached the day before surgery but the CGM , interstitial glucose readings, and alerts will be masked during the operation.",[18],"Device: Control",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","In the RT-CGM group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol\u002FL, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. RT-CGM monitoring will also be employed during surgery. A tablet in the operating room will be configured with low and high glucose alerts set at 3.9 mmol\u002FL and 10.0 mmol\u002FL, respectively. When an alarm is triggered, arterial blood gases will be rechecked, and glucose levels will be adjusted based on the arterial blood glucose results. If interstitial glucose values do not reach the intervention threshold, arterial blood gas measurements are recommended every 30 minutes.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"In the control group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol\u002FL, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. CGM monitoring will also be employed during surgery, but the CGM interstitial glucose readings and alerts will be masked during the operation. The final intraoperative glucose management approach will be determined by the anesthesiologist, considering the patient's condition and surgical circumstances. The anesthesiologist can choose the intravenous insulin adjustment protocol we recommend.",[15],[29],{"name":30,"affiliation":5,"role":31},"Le Shen, PhD","PRINCIPAL_INVESTIGATOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","13810248138","pumchshenle@163.com",{"name":38,"role":34,"phone":39,"phoneExt":24,"email":40},"Le Zhang, Master","18801372430","3240348551@qq.com",{"type":42,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100574169","effects-of-intraoperative-glycemic-management-strategies-assisted-with-rt-cgm-on-tir-and-postoperative-recovery-100574169",false,"NCT06755788","Effects of Intraoperative Glycemic Management Strategies Assisted with RT-CGM on TIR and Postoperative Recovery","Effects of Intraoperative Glycemic Management Strategies Assisted with RT-CGM on TIR and Postoperative Recovery During Pancreaticoduodenectomy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18\n* Scheduled for pancreaticoduodenectomy\n* ASA classification I-III\n\nExclusion Criteria:\n\n* Emergency surgery\n* scheduled for MRI the day before surgery\n* Allergy to CGM sensor\n* Communication barriers or refusal to participate\n* BMI \\\u003C 18.5 kg\u002Fm²","ALL","18 Years",{"count":53,"type":54},246,"ESTIMATED","INTERVENTIONAL",[57],"NA","The purpose of this study is to investigate the effect of intraoperative blood glucose management based on real-time continuous glucose monitoring ( RT-CGM) on time in range (TIR) and postoperative recovery during pancreaticoduodenectomy. The primary outcome is intraoperative TIR. Additionally, it aims to compare the differences in other glucose metrics, quality of postoperative recovery, and 30-day postoperative complications and mortality between the two glycemic management methods .",[60],"Continuous Glucose Monitoring",[62,63,64],"glycemic management","pancreaticoduodenectomy","time in range","NOT_YET_RECRUITING","2024-12-31",{"date":68,"type":69},"2025-01-01","ACTUAL",{"date":71,"type":54},"2024-12-25",{"date":73,"type":54},"2025-12-31",{"name":5,"class":6}]