The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes.
NCT ID: NCT06314061
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2024-06-24
2026-06-01
Brief Summary
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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.
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Detailed Description
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The study aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control. The Dexcom G7 provides glucose readings every 5 minutes and can send alerts on dysglycaemia (hypo- and hyperglycaemia) to mobile devices held by the nursing staff.
Patients will wear the CGM before, during and up to 10 days postoperatively.
The study will include 200 patients.
This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Participants in the intervention group will wear the CGM-device Dexcom G7, and real-time alerts on dysglycaemia and rapidly increasing or falling glucose levels will alert the nursing staff.
Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
A continuous glucose monitor which through a sensor in the skin registers glucose levels every 5 minutes. Glucose levels are shown by connecting the sensor to a mobile device or the Dexcom G7 Receiver where realtime alerts on deviating glucose levels will be sent.
Control group
Participants in the control group will wear a blinded CGM device. The nursing staff will monitor glucose levels with standard care using POC blood glucose measurements.
No interventions assigned to this group
Interventions
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Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
A continuous glucose monitor which through a sensor in the skin registers glucose levels every 5 minutes. Glucose levels are shown by connecting the sensor to a mobile device or the Dexcom G7 Receiver where realtime alerts on deviating glucose levels will be sent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute or elective abdominal, orthopaedic, urological, or vascular surgery with estimated duration of surgery \>45 minutes
* Expected stay for at least one night in the hospital postoperatively
Exclusion Criteria
* Known allergy to the equipment plaster
* Known pregnancy
* Patients with pacemaker or implantable cardioverter defibrillator (ICD) device
* Previous or currently scheduled for pancreatectomy (complete or partial)
* Patients receiving hydroxyurea (these drugs may interfere with CGM readings)
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Steno Diabetes Center Copenhagen
OTHER
Zealand University Hospital
OTHER
Christian S. Meyhoff
OTHER
Responsible Party
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Christian S. Meyhoff
Professor, head of research, MD, PhD
Principal Investigators
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Christian S Meyhoff, MD, PhD
Role: STUDY_DIRECTOR
University Hospital Bispebjerg and Frederiksberg
Locations
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Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet
Copenhagen, The Capital Region of Denmark, Denmark
Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital
Copenhagen, The Capital Region of Denmark, Denmark
Zealand University Hospital
Køge, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WARD-glucose RCT v.2.2
Identifier Type: -
Identifier Source: org_study_id
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