[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552113":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":57,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Sykehuset i Vestfold HF","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous glucose monitor","EXPERIMENTAL","The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week.\n\nAfter the screening week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will also use a continuous glucose monitor and receiver which displays real-time glucose levels, for 6 weeks, to learn how to avoid hypoglycaemia.",[13],"Device: Continuous glucose monitor (Dexcom® G7)",{"label":15,"type":16,"description":17,"interventionNames":18},"No continuous glucose monitor","NO_INTERVENTION","The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week.\n\nAfter the screening week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will not use a continuous glucose monitor during the following 5 weeks, but during week 6 the patient will wear a blinded continuous glucose monitor.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Continuous glucose monitor (Dexcom® G7)","Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Heidi Borgeraas, PhD","CONTACT","004746707000","heibor@siv.no",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust","RECRUITING","Tønsberg","Vestfold","3103","Norway","NO",{"type":41,"coordinates":42},"Point",[43,44],10.40762,59.26754,{"lat":44,"lon":43},[47,49,53,55],{"name":27,"role":28,"phone":48,"phoneExt":18,"email":30},"+47 46707000",{"name":50,"role":28,"phone":51,"phoneExt":18,"email":52},"Dag Hofsø, MD, PhD","+47 90591666","dag.hofso@siv.no",{"name":27,"role":54,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"name":50,"role":56,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":54,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Heidi Borgeraas","Principal investigator","100552113","glucose-monitoring-in-treatment-of-postprandial-hypoglycemia-after-gastric-bypass-surgery-100552113",false,"NCT06468865","Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery","Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial","HypoSurge","Inclusion Criteria:\n\n* Gastric bypass surgery at least 1 year ago\n* Age ≥18 years\n* Symptomatic postprandial hypoglycaemia; capillary glucose level \\\u003C3.0 mmol\u002FL 1-4 hours after meals\n\nExclusion Criteria:\n\n* Not able to give informed consent\n* Reduced compliance due to severe mental and psychiatric conditions\n* Use of insulin or sulfonylureas\n* Use of systemic corticosteroids\n* Primary or secondary adrenal insufficiency\n* Insulinoma\n* Severe heart-, lung, liver- or kidney disease, cancer, malnutrition and other medical conditions causing fragility\n* Performed bariatric revisional surgery\n* Drug- or alcohol abuse\n* Pregnancy\n* Use of acarbose or octreotide in the treatment of postprandial hypoglycemia\n* Use of continuous glucose monitor",true,"ALL","18 Years",{"count":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery. The main question it aims to answer is:\n\n• Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after gastric bypass surgery?\n\nResearchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.\n\nParticipants will:\n\n* Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week.\n* Visit the clinic 2-3 times and have 2-3 phone consultations.\n* Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.",[79,80],"Hypoglycemia Non-Diabetic","Gastric Bypass Surgery","2024-11-01",{"date":83,"type":84},"2024-11-05","ACTUAL",{"date":86,"type":73},"2024-11-12",{"date":88,"type":73},"2026-12-31",{"name":5,"class":6},1]