NCT06297850

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Hospital Bispebjerg and Frederiksberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-03-07
• Last updated: 2025-12-03

Locations

4 sites across 1 country: Denmark

Regulatory

• FDA-regulated device study