Diabetes Mellitus Clinical Trial
— WARD-glucoseOfficial title:
The Effect of Continuous Glucose Monitoring With Real-time Alerts on Glycaemic Control in Surgical Patients With Diabetes: A Randomised, Clinical Multicentre Trial
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | January 1, 2026 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Medical history with diabetes mellitus (DM1 or DM2 (insulin-dependent and non-insulin-dependent) requiring antidiabetic drug(s) - 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: - Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area - 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital | Copenhagen | The Capital Region Of Denmark |
Denmark | Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet | Copenhagen | The Capital Region Of Denmark |
Denmark | Zealand University Hospital | Køge |
Lead Sponsor | Collaborator |
---|---|
Christian S. Meyhoff | Rigshospitalet, Denmark, Steno Diabetes Center Copenhagen, Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Serious adverse events | Frequency of any serious adverse event within 30 days, defined as any complication fulfilling the Clavien-Dindo classification of > 2 | 30 days postoperatively | |
Other | Serious adverse Device-related events | Severe Adverse Device-related Events (SADE) within 30 days | 30 days postoperatively | |
Other | Adverse events | Frequency of any adverse events within 30 days | 30 days postoperatively | |
Other | Length of stay | Postoperative Length of stay (LOS) in days | Perioperatively | |
Other | Readmission | Readmission within 6 months | 6 months postoperatively | |
Other | ICU admission | ICU admission within 6 months postoperatively | 6 months postoperatively | |
Other | Days alive and out of hospital | Days alive and out of hospital within 30 days | 30 days postoperatively | |
Other | Patient experience | Patient experience (semi-structured questionnaire will be carried out in a subset of randomised patients from both groups with the focus on sense of security and patient comfort) | Perioperatively | |
Other | Staff experience | Staff experience (semi-structured questionnaire will be carried out during the beginning and towards the end of the trial. It will focus from both groups with the focus on sense of security and patient comfort)) | Perioperatively | |
Primary | Time in range (TIR) of CGM glucose levels | Time in range (TIR) of CGM glucose levels (6.0-10.0 mmol/l) in minutes per 24 hours after discharge from the post-anaesthesia care unit (PACU) until 10 days postoperative (or until discharge) | Perioperatively | |
Secondary | Duration of hypoglycaemia | Duration of hypoglycaemia (<3.9 mmol/L (<70 mg/dL), assessed by CGM, in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge) | Perioperatively | |
Secondary | Duration of hyperglycaemia | Duration of hyperglycaemia (>10.0 mmol/L (>180 mg/dL), assessed by CGM, in minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge) | Perioperatively | |
Secondary | Number of hypoglycaemia events | Number of hypoglycaemia (<3.9 mmol/L (<70 mg/dL) events lasting > 15 minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Events will be reported as number of events per 24 hours and duration of events (defined from period of first detected deviation until the first reading in a normal glucose level | Perioperatively | |
Secondary | Number of hyperglycaemia events | Number of hyperglycaemia (>10.0 mmol/L (>180 mg/dL) events lasting > 15 minutes per 24 hours after discharge from PACU until 10 days postoperative (or until discharge). Events will be reported as number of events per 24 hours and duration of events (defined from period of first detected deviation until the first reading in a normal glucose level | Perioperatively | |
Secondary | Complications | Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days | 30 days postoperatively |
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