Diabetes MellitusPhase 4WARD-glucoseNCT06314061
The Effect of Continuous Glucose Monitoring in Surgical Patients With Diabetes.
A Phase 4 study testing Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) in people with Diabetes Mellitus and Dysglycemia, run by Christian S. Meyhoff at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Dysglycemia, Perioperative Complication
- What is being tested?
- Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesDenmark
- Study dates
- 24 Jun 2024to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet
Copenhagen, The Capital Region of Denmark, 2100
Department of Anaesthesiology and Intensive Care, Bispebjerg Hospital
Copenhagen, The Capital Region of Denmark, 2400
Zealand University Hospital
Køge, 4600
About this study
Official 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:
Read more
- 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Dysglycemia, Perioperative Complication
- Being tested
- Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
- Keywords
- Diabetes Mellitus, Continuous glucose monitoring, Perioperative medicine, Medical devices
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)Device
Also called Dexcom 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Perioperatively
Secondary outcomes (5)
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)
Measured: Perioperatively
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)
Measured: Perioperatively
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
Measured: Perioperatively
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
Measured: Perioperatively
Complications
Severity of complications assessed by the Comprehensive Complication Index (CCI) within 30 days
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start24 Jun 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel, 2-group randomised trial blinded for participants
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian S. Meyhoff
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Steno Diabetes Center Copenhagen, Zealand University Hospital
- Responsible party
- Sponsor-investigator, Christian S. Meyhoff, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian S Meyhoff, MD, PhD, Study director, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314061
- Sponsor's protocol ID
- WARD-glucose RCT v.2.2
- Acronym
- WARD-glucose
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan making individual patient data available to researchers outside the study group.
Publications
Pedersen C, Philipsen A, Norgaard K, Aasvang EK, Meyhoff CS. Continuous Glucose Monitoring With Real-Time Alerts to Achieve Glycaemic Control in Surgical Patients With Diabetes: Protocol for a Multicentre, Randomised, Clinical Trial. Acta Anaesthesiol Scand. 2026 Apr;70(4):e70219. doi: 10.1111/aas.70219.
PubMed 41821293
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Glucose Monitoring With Real-time Alerts on Glycaemic Control in Surgical Patients With Diabetes: A Randomised, Clinical Multicentre Trial
- ClinicalTrials.gov ID
- NCT06314061
- Acronym / sponsor ID
- WARD-glucose / WARD-glucose RCT v.2.2
- Conditions
- Diabetes Mellitus, Dysglycemia, Perioperative Complication
- Keywords
- Diabetes Mellitus, Continuous glucose monitoring, Perioperative medicine, Medical devices
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Christian S. MeyhoffUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Steno Diabetes Center Copenhagen, Zealand University Hospital
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel, 2-group randomised trial blinded for participants
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)Also: Dexcom G7A 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. | Device | Intervention group |
Primary outcome
Time in range (TIR) of CGM glucose levels
Time frame: 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)
5 secondary outcomes
Duration of hypoglycaemia
Time frame: Perioperatively
Duration of hyperglycaemia
Time frame: Perioperatively
Number of hypoglycaemia events
Time frame: Perioperatively
Number of hyperglycaemia events
Time frame: Perioperatively
Complications
Time frame: 30 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 41821293Pedersen C, Philipsen A, Norgaard K, Aasvang EK, Meyhoff CS. Continuous Glucose Monitoring With Real-Time Alerts to Achieve Glycaemic Control in Surgical Patients With Diabetes: Protocol for a Multicentre, Randomised, Clinical Trial. Acta Anaesthesiol Scand. 2026 Apr;70(4):e70219. doi: 10.1111/aas.70219.
- Individual participant dataSharing planned: No. We do not plan making individual patient data available to researchers outside the study group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Meyhoff, MD, PhD study director
University Hospital Bispebjerg and Frederiksberg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7) in people with Diabetes Mellitus and Dysglycemia, run by Christian S. Meyhoff at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (TIR) of CGM glucose levels (time frame: Perioperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.