Diabetes Mellitus, Dysglycemia, Perioperative Complication
Conditions
Keywords
Diabetes Mellitus, Continuous glucose monitoring, Perioperative medicine, Medical devices
Brief summary
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.
Detailed description
This is a prospective randomised controlled multicentre trial on patients living with diabetes who undergo surgery at Rigshospitalet, Copenhagen University, Bispebjerg and Frederiksberg Hospital, Copenhagen University, and Zealand University Hospital, Køge, Denmark 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.
Interventions
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.
Sponsors
Christian S. Meyhoff
Rigshospitalet, Denmark
Steno Diabetes Center Copenhagen
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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)
Intervention model description
Parallel, 2-group randomised trial blinded for participants
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range (TIR) of CGM glucose levels | Perioperatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hypoglycaemia | Perioperatively | 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) |
| Duration of hyperglycaemia | Perioperatively | 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) |
| Number of hypoglycaemia events | Perioperatively | 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 |
| Number of hyperglycaemia events | Perioperatively | 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 |
| Complications | 30 days postoperatively | Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days |
Countries
Denmark
Contacts
STUDY_DIRECTORChristian S Meyhoff, MD, PhD
University Hospital Bispebjerg and Frederiksberg
Outcome results
None listed