Accuracy of Continuous Glucose Monitoring in Patients with Diabetes. a Prospective Observational Study

Launched by UNIVERSITY HOSPITAL BISPEBJERG AND FREDERIKSBERG · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how accurate continuous glucose monitoring (CGM) devices are for patients with diabetes, especially during times when their blood circulation might not be as good, like after surgery or in the ICU. The main goal is to see if the readings from the CGM are less reliable compared to standard blood glucose tests when patients are experiencing circulatory issues.

To be eligible for this study, participants must be at least 18 years old, have diabetes that requires medication, and either be having surgery that lasts longer than 45 minutes or be admitted to the ICU with circulation problems. During the trial, participants will wear a CGM device for up to 10 days while receiving standard diabetes care. This device will help researchers compare the CGM readings with regular blood tests to understand how well the CGM works in these situations. It's important to note that individuals with certain skin conditions or allergies may not be able to participate.

Gender

ALL

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