Diabetes MellitusNCT06297850
Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study
An observational study of Diabetes Mellitus and Dysglycemia, run by University Hospital Bispebjerg and Frederiksberg at 4 sites in Denmark.
Trial summary
The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment. 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
- How many people
- 60 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Apr 2024to 1 Jan 2026
- Phase
- Observational
- 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
Study population: To the answer of our two research questions, we include both patients with diabetes undergoing surgery, and patients with diabetes admitted to the intensive care unit with circulatory impariment, as described in the criteria above. We aim to exclude only patients with direct contraindications to the wear of the CGM.
Who may be able to join
- Medical history with diabetes mellitus requiring antidiabetic drugs
- Age ≥18 years
- Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR
- Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index <1.5
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
- Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)
- Known allergy to plaster used in the CGM device
Trial locations and contacts
4 sites in 1 country.
Denmark4 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
Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital
Copenhagen, The Capital Region of Denmark, 2400
Surgical department, Bispebjerg and Frederiksberg Hospital,
Copenhagen, The Capital Region of Denmark, 2400
About this study
Official title: Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients With Diabetes in Situations With Circulatory Impairment. A Prospective Observational Study
The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.
The main questions it aims to answer are:
- Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?
Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.
Read the detailed description
This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment.
The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment. The glucose readings will be compared to standard practice with POC blood glucose measurements.
Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days.
The study will include 60 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.
- Being tested
- Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
- Keywords
- Diabetes Mellitus, Continuous glucose monitoring, 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 CGM device placed on the posterior aspect of the upper arm in which a sensor placed in the skin registers glucose values. Via Bluetooth, these readings are sent to a receiver near the patient every 5 minutes. The CGM system can alert when deviating glucose levels, but will for this observational study be blinding to patients and clinical staff. Thus, the patients' diabetic care will rely on standard practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between glucose
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements (matched pairs within 5 minutes) in the perioperative setting
Measured: Perioperatively
Secondary outcomes (3)
Agreement between glucose readings when at low glucose levels
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at low glucose levels (<3.9 mmol/l in the POC blood glucose measurement)
Measured: Perioperatively
Agreement between glucose readings when at normal glucose levels
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at normal glucose levels (>3.9-10.0 mmol/l in the POC blood glucose measurement)
Measured: Perioperatively
Agreement between glucose readings when at high glucose levels
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements at high glucose levels (>10.0 mmol/l in the POC blood glucose measurement)
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Jun 2025
- Study completion1 Jan 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Steno Diabetes Center Copenhagen, Zealand University Hospital
- Responsible party
- Principal investigator, Casper Pedersen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Eske K Aasvang, MD, DmSci, Study director, Dept. of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297850
- Sponsor's protocol ID
- WARD-Glucose Validation v.2.2
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2024
- Last updated
- 4 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, Johansen AB, Philipsen A, Norgaard K, Itenov TS, Eiberg JP, Jorgensen LN, Palm H, Meyhoff CS, Aasvang EK. Continuous glucose monitoring for diabetes mellitus in the perioperative and intensive care setting: a prospective observational validation study✰. Br J Anaesth. 2026 Oct 12:S0007-0912(26)00628-8. doi: 10.1016/j.bja.2026.08.014. Online ahead of print.
PubMed 42864191
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients With Diabetes in Situations With Circulatory Impairment. A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06297850
- Acronym / sponsor ID
- WARD-Glucose Validation v.2.2
- Keywords
- Diabetes Mellitus, Continuous glucose monitoring, Medical devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Steno Diabetes Center Copenhagen, Zealand University Hospital
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 7 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 observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.
The main questions it aims to answer are:
- Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?
Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.
Detailed description
This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment.
The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment. The glucose readings will be compared to standard practice with POC blood glucose measurements.
Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days.
The study will include 60 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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To the answer of our two research questions, we include both patients with diabetes undergoing surgery, and patients with diabetes admitted to the intensive care unit with circulatory impariment, as described in the criteria above. We aim to exclude only patients with direct contraindications to the wear of the CGM.
Key inclusion criteria (4 listed)
- Medical history with diabetes mellitus requiring antidiabetic drugs
- Age ≥18 years
- Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR
- Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index <1.5
Key exclusion criteria (3 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
- Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)
- Known allergy to plaster used in the CGM device
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 CGM device placed on the posterior aspect of the upper arm in which a sensor placed in the skin registers glucose values. Via Bluetooth, these readings are sent to a receiver near the patient every 5 minutes. The CGM system can alert when deviating glucose levels, but will for this observational study be blinding to patients and clinical staff. Thus, the patients' diabetic care will rely on standard practice. | Device | – |
Primary outcome
Agreement between glucose
Time frame: Perioperatively
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements (matched pairs within 5 minutes) in the perioperative setting
3 secondary outcomes
Agreement between glucose readings when at low glucose levels
Time frame: Perioperatively
Agreement between glucose readings when at normal glucose levels
Time frame: Perioperatively
Agreement between glucose readings when at high glucose levels
Time frame: Perioperatively
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 4 May 2026.
- Derived from this study: PubMed 42864191Pedersen C, Johansen AB, Philipsen A, Norgaard K, Itenov TS, Eiberg JP, Jorgensen LN, Palm H, Meyhoff CS, Aasvang EK. Continuous glucose monitoring for diabetes mellitus in the perioperative and intensive care setting: a prospective observational validation study✰. Br J Anaesth. 2026 Oct 12:S0007-0912(26)00628-8. doi: 10.1016/j.bja.2026.08.014. Online ahead of print.
- Individual participant dataSharing planned: No. We do not plan making individual patient data available to researchers outside the study group.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Eske K Aasvang, MD, DmSci study director
Dept. of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Dysglycemia, run by University Hospital Bispebjerg and Frederiksberg at 4 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 4 inclusion and 3 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 4 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 4 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.
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?
Agreement between glucose (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 NCT06297850, 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 4 May 2026.