Evaluation of Continuous Glucose Monitoring in Patients With ACS and Type 2 Diabetes in ICU — EVASION  

Type 2 Diabetes Clinical Trial

Official title: Evaluation of the Use of a Continuous Glucose Monitoring System on Glycemic Equilibrium and Hypoglycemia in Diabetic Patients With Acute Coronary Syndrome Admitted in Intensive Care

Status Terminated

Clinical Trial Summary

The investigators hypothesize that the use of a continuous glucose monitoring system (CGMS) can reduce glycemic variability assessed by coefficient of variation (CV) during the acute phase of acute coronary syndrome (ACS) in patients with diabetes treated by insulin infusion.

The purpose of this project is to assess the impact of the use of CGMS on glycemic variability in diabetic patients with ACS .

This is a randomized, multicenter (2 centers), open study. The patients included, as soon as possible, after admission will be randomized before the beginning of insulin therapy with intravenous insulin .

Clinical Trial Description

The aim of this study is to assess the impact of the use of a continuous glucose monitoring system (CGMS) on glycemic variability in diabetic patients admitted in Intensive care unit (ICU) for an acute coronary syndrome ( ST Segment Elevation Myocardial Infarction (STEMI) or Non-ST segment elevation myocardial infarction (NSTEMI)) and treated with insulin infusion with a standardized protocol.

60 patients in 2 centers will be included, and all patient will have the CGMS.

Randomization will be done in the 12 hours after admission. Participants will be randomized in two groups :

• Conventional strategy: management of hyperglycemia with standard of care, glycemia monitoring with capillary blood glucose measurement. The goal is to maintain glycemia between 140-180mg/dL. CGMS will be blinded in this group.

• Novel strategy: management of hyperglycemia using CGMS. Measurements of CGMS will be transmitted in real time to medical staff and use to maintain glycemia between 140-180mg/dL. Alarms will be set to warn medical staff in case of glycemia outside the range.

The duration of follow-up for each patient will be 72 hours or until discharge from Intensive care unit (if <72 hours) ;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus, Type 2
• Syndrome
• Type 2 Diabetes

• NCT number: NCT04822740
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2022
• Completion date: January 30, 2023