NCT04822740

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

Detailed 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)

Conditions

• Acute Coronary Syndrome
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Control Glucose Monitoring System	With a sensor, transmitter and display device (receiver and/or compatible smart device). The CGMS sends glucose readings to a compatible smart device every 5 minutes. In this study the CGMS for all patients with use of the results of the device in real time by the health care team for the Experimental arm and without the use of the results by the health care team for Active Comparator (Conventional strategy .

Timeline

• Start date: 2022-12-07
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2021-03-30
• Last updated: 2023-11-18

Locations

1 site across 1 country: France