protocolSection identificationModule nctId: NCT06314061, orgStudyIdInfo id: WARD-glucose RCT v.2.2, briefTitle: The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes., acronym: WARD-glucose, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Christian S. Meyhoff, class: OTHER, collaborators name: Rigshospitalet, Denmark, collaborators name: Steno Diabetes Center Copenhagen, collaborators name: Zealand University Hospital, descriptionModule briefSummary: The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.The main question it aims to answer is:• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes?Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge., conditionsModule conditions: Diabetes Mellitus, conditions: Dysglycemia, conditions: Perioperative Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel, 2-group randomised trial blinded for participants, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will not be alerted of dysglycaemia by the Dexcom G7 application, which will be muted. Thus, the alerts on deviating glucose levels will only be given to the care provider (the nursing staff at the ward), whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7), outcomesModule primaryOutcomes measure: Time in range (TIR) of CGM glucose levels, secondaryOutcomes measure: Duration of hypoglycaemia, secondaryOutcomes measure: Duration of hyperglycaemia, secondaryOutcomes measure: Number of hypoglycaemia events, secondaryOutcomes measure: Number of hyperglycaemia events, secondaryOutcomes measure: Complications, otherOutcomes measure: Serious adverse events, otherOutcomes measure: Serious adverse Device-related events, otherOutcomes measure: Adverse events, otherOutcomes measure: Length of stay, otherOutcomes measure: Readmission, otherOutcomes measure: ICU admission, otherOutcomes measure: Days alive and out of hospital, otherOutcomes measure: Patient experience, otherOutcomes measure: Staff experience, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, city: Copenhagen, state: The Capital Region Of Denmark, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital, city: Copenhagen, state: The Capital Region Of Denmark, zip: 2400, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Zealand University Hospital, city: Køge, zip: 4600, country: Denmark, contacts name: Annelotte Philipsen, MD, PhD, role: CONTACT, email: annph@regionsjaelland.dk, geoPoint lat: 55.45802, lon: 12.18214, hasResults: False