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

Diabetes Mellitus Clinical Trial

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

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06297850
Study type Observational
Source University Hospital Bispebjerg and Frederiksberg
Contact Casper Pedersen, MD
Phone 004526712696
Email casper.pedersen@regionh.dk
Status Recruiting
Phase
Start date April 1, 2024
Completion date May 1, 2025
View Details
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