Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study

NCT ID: NCT06297850

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-01

Brief 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.

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.

Conditions

Diabetes Mellitus; Dysglycemia; Perioperative Complication; Circulatory; Complications

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Dexcom G7 Continuous Glucose Monitoring (CGM) System (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.

Intervention Type: DEVICE

Other Intervention Names

Dexcom G7

Eligibility Criteria

Inclusion Criteria

• 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

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
• Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)
• Known allergy to plaster used in the CGM device

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: collaborator

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: lead

Responsible Party

Casper Pedersen

MD, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eske K Aasvang, MD, DmSci

Role: STUDY_DIRECTOR

Dept. of Anaesthesiology, Centre for Cancer and Organ Diseases, Rigshospitalet, Denmark

Locations

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

Department of Orthopaedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital

Copenhagen, The Capital Region of Denmark, Denmark

Surgical department, Bispebjerg and Frederiksberg Hospital,

Copenhagen, The Capital Region of Denmark, Denmark

Countries

Denmark

Other Identifiers

WARD-Glucose Validation v.2.2

Identifier Type: -

Identifier Source: org_study_id